{"meta":{"title":"GLP-1 and peptide regulatory status by country","description":"One record per molecule and country: the regulatory status, a plain summary, the date it was verified, and every primary source behind it.","publisher":"GLP1 Base","url":"https://glp1base.com/data","license":"https://creativecommons.org/licenses/by/4.0/","licenseName":"Creative Commons Attribution 4.0 International (CC BY 4.0)","attribution":"GLP1 Base (https://glp1base.com), powered by KeenShift. Licensed CC-BY-4.0.","howToCite":"GLP1 Base (2026). GLP-1 and peptide regulatory status by country [dataset]. KeenShift. https://glp1base.com/data (accessed YYYY-MM-DD). CC-BY-4.0.","dateModified":"2026-09-29","disclaimer":"Educational information only. Not medical advice, not a recommendation to use any substance, and not an offer to supply. Talk to a licensed clinician about your own care.","contact":"mitsi@keenshift.ai","count":432,"statusValues":{"approved":{"label":"Approved","meaning":"The regulator has approved it as a medicine."},"approved-restricted":{"label":"Approved, restricted","meaning":"Approved, but with limits on who can get it or how."},"generic-available":{"label":"Generics available","meaning":"Approved generic versions are sold."},"compounding-allowed":{"label":"Compounding allowed","meaning":"Pharmacies may make custom versions under rules."},"compounding-restricted":{"label":"Compounding restricted","meaning":"Pharmacy-made copies are tightly limited."},"under-review":{"label":"Under review","meaning":"A regulator is actively reviewing it."},"not-approved":{"label":"Not approved","meaning":"Not approved as a medicine here."},"prohibited":{"label":"Prohibited","meaning":"Supply is banned or actively enforced against."},"no-specific-rule":{"label":"No specific rule","meaning":"No rule written for it specifically; general law applies."},"unknown":{"label":"Unverified","meaning":"We have not verified this yet."}}},"records":[{"molecule":"amycretin","moleculeName":"Amycretin","country":"australia","countryName":"Australia","countryIso2":"AU","status":"not-approved","statusLabel":"Not approved","headline":"Investigational only. No amycretin product is on the ARTG and no application appears on the TGA's evaluation list.","detail":"A keyword search of the ARTG on 29 September 2026 returned no amycretin product, and the TGA list of prescription medicines under evaluation (updated 21 September 2026) shows no amycretin application. Products not on the ARTG are unapproved therapeutic goods that have not been assessed by the TGA. Any access outside a clinical trial would need a special pathway.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/amycretin-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/artg?keywords=amycretin","title":"ARTG keyword search for 'amycretin' (no matching results)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/prescription-medicines-under-evaluation","title":"Prescription medicines under evaluation (last updated 21 September 2026)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-21","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/products/unapproved-therapeutic-goods/access-pathways","title":"Access pathways for unapproved therapeutic goods","publisher":"Therapeutic Goods Administration (TGA)","date":"2025-10","accessed":"2026-09-29"}]},{"molecule":"aod-9604","moleculeName":"AOD-9604","country":"australia","countryName":"Australia","countryIso2":"AU","status":"prohibited","statusLabel":"Prohibited","headline":"Unapproved and controlled: AOD9604 is prescription-only and possession without authority is illegal under the Poisons Standard.","detail":"AOD9604 is listed in Schedule 4 and Appendix D clause 5 of the Poisons Standard, so it is prescription-only and possessing it without authority is illegal. A keyword search of the ARTG on 29 September 2026 found no AOD9604 product. Like other unapproved peptides, it cannot lawfully be imported, advertised or supplied outside the narrow exemptions the TGA describes.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/aod-9604-in-australia","sources":[{"url":"https://www.legislation.gov.au/F2026L00633/latest/text","title":"Therapeutic Goods (Poisons Standard - June 2026) Instrument 2026","publisher":"Federal Register of Legislation (Australian Government)","date":"2026-05","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/artg?keywords=AOD-9604","title":"ARTG keyword search for 'AOD-9604' (1177 loose-match results, all pages checked; none is a AOD-9604 product)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/understanding-your-responsibilities-when-importing-compounding-and-supplying-unapproved-peptide-products","title":"Understanding your responsibilities when importing, compounding and supplying unapproved peptide products","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-04-13","accessed":"2026-09-29"}]},{"molecule":"bpc-157","moleculeName":"BPC-157","country":"australia","countryName":"Australia","countryIso2":"AU","status":"prohibited","statusLabel":"Prohibited","headline":"Unapproved and tightly controlled: prescription-only, possession without authority is illegal since 1 June 2024, and the TGA has taken an alleged advertiser to court.","detail":"BPC-157 has been in Schedule 4 and Appendix D clause 5 of the Poisons Standard since 1 June 2024, after 48 import referrals to the TGA, so possessing it without authority such as a prescription is illegal. It is not on the ARTG; the TGA names it as an unapproved peptide product and warns that importing, advertising, manufacturing or supplying such products is unlawful. In September 2026 the TGA started civil Federal Court proceedings, seeking declarations and penalties, over alleged advertising of BPC-157 and other peptides. It is also a non-approved substance under the sports anti-doping list.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/bpc-157-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/publication/scheduling-decisions-final/notice-final-decision-amend-or-not-amend-current-poisons-standard-acms-43-accs-37-joint-acms-accs-35","title":"Notice of final decision to amend (or not amend) the current Poisons Standard - ACMS #43, ACCS #37, Joint ACMS-ACCS #35 (BPC-157)","publisher":"Therapeutic Goods Administration (TGA)","date":"2024-05-22","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.au/F2026L00633/latest/text","title":"Therapeutic Goods (Poisons Standard - June 2026) Instrument 2026","publisher":"Federal Register of Legislation (Australian Government)","date":"2026-05","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/understanding-your-responsibilities-when-importing-compounding-and-supplying-unapproved-peptide-products","title":"Understanding your responsibilities when importing, compounding and supplying unapproved peptide products","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-04-13","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/news/media-releases/tga-flexes-its-muscle-against-illegal-peptides-and-steroids","title":"TGA flexes its muscle against illegal peptides and steroids","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-08-17","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/news/media-releases/former-company-and-directors-behind-biov8-face-court-alleged-unlawful-advertising-peptides","title":"Former company and directors behind BioV8 to face court for alleged unlawful advertising of peptides","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-28","accessed":"2026-09-29"},{"url":"https://www.sportintegrity.gov.au/what-we-do/anti-doping/prohibited-list","title":"Prohibited List Explained","publisher":"Sport Integrity Australia","date":"2026","accessed":"2026-09-29"}]},{"molecule":"bremelanotide","moleculeName":"Bremelanotide (PT-141)","country":"australia","countryName":"Australia","countryIso2":"AU","status":"not-approved","statusLabel":"Not approved","headline":"Not on the ARTG and not shown as under TGA evaluation. It is an unapproved therapeutic good in Australia.","detail":"A keyword search of the ARTG on 29 September 2026 found no bremelanotide product, and the TGA list of prescription medicines under evaluation (updated 21 September 2026) shows no application. Products that are not on the ARTG have not been assessed by the TGA. Advertising them to the public is generally unlawful, and a prescriber would need a lawful pathway such as the Special Access Scheme.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/bremelanotide-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/artg?keywords=bremelanotide","title":"ARTG keyword search for 'bremelanotide' (no matching results)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/prescription-medicines-under-evaluation","title":"Prescription medicines under evaluation (last updated 21 September 2026)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-21","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/products/unapproved-therapeutic-goods/access-pathways","title":"Access pathways for unapproved therapeutic goods","publisher":"Therapeutic Goods Administration (TGA)","date":"2025-10","accessed":"2026-09-29"}]},{"molecule":"cagrilintide","moleculeName":"Cagrilintide (and CagriSema)","country":"australia","countryName":"Australia","countryIso2":"AU","status":"not-approved","statusLabel":"Not approved","headline":"Not approved and not shown as under TGA evaluation. No cagrilintide product is on the ARTG.","detail":"A keyword search of the ARTG on 29 September 2026 returned no cagrilintide product, and the TGA list of prescription medicines under evaluation (updated 21 September 2026) shows no cagrilintide or cagrilintide-combination application. It remains an investigational medicine in Australia; an unapproved product cannot be advertised to the public and can be imported or supplied only under specific pathways.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/cagrilintide-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/artg?keywords=cagrilintide","title":"ARTG keyword search for 'cagrilintide' (no matching results)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/prescription-medicines-under-evaluation","title":"Prescription medicines under evaluation (last updated 21 September 2026)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-21","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/products/unapproved-therapeutic-goods/access-pathways","title":"Access pathways for unapproved therapeutic goods","publisher":"Therapeutic Goods Administration (TGA)","date":"2025-10","accessed":"2026-09-29"}]},{"molecule":"cjc-1295","moleculeName":"CJC-1295","country":"australia","countryName":"Australia","countryIso2":"AU","status":"prohibited","statusLabel":"Prohibited","headline":"Unapproved and controlled: CJC-1295 is prescription-only, possession without authority is illegal, and the TGA has named and seized it.","detail":"CJC-1295 is listed in Schedule 4 and Appendix D clause 5 of the Poisons Standard, so possession without authority is illegal. The TGA named it in its April and June 2026 peptide warnings and seized it from premises in New South Wales in August 2026. It is also among the peptides named in the TGA's September 2026 Federal Court case over alleged unlawful advertising by the former BioV8 company. A keyword search of the ARTG on 29 September 2026 found no CJC-1295 product.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/cjc-1295-in-australia","sources":[{"url":"https://www.legislation.gov.au/F2026L00633/latest/text","title":"Therapeutic Goods (Poisons Standard - June 2026) Instrument 2026","publisher":"Federal Register of Legislation (Australian Government)","date":"2026-05","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/understanding-your-responsibilities-when-importing-compounding-and-supplying-unapproved-peptide-products","title":"Understanding your responsibilities when importing, compounding and supplying unapproved peptide products","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-04-13","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/news/media-releases/concerns-regarding-public-health-risks-associated-unapproved-peptide-products","title":"Concerns regarding the public health risks associated with unapproved peptide products","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-06-19","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/news/media-releases/tga-flexes-its-muscle-against-illegal-peptides-and-steroids","title":"TGA flexes its muscle against illegal peptides and steroids","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-08-17","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/artg?keywords=CJC-1295","title":"ARTG keyword search for 'CJC-1295' (no matching results)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/news/media-releases/former-company-and-directors-behind-biov8-face-court-alleged-unlawful-advertising-peptides","title":"Former company and directors behind BioV8 to face court for alleged unlawful advertising of peptides","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-28","accessed":"2026-09-29"}]},{"molecule":"dsip","moleculeName":"DSIP (delta sleep-inducing peptide)","country":"australia","countryName":"Australia","countryIso2":"AU","status":"not-approved","statusLabel":"Not approved","headline":"No DSIP product is on the ARTG. It counts as an unapproved peptide, and advertising or supplying it is likely unlawful.","detail":"A keyword search of the ARTG on 29 September 2026 found no delta sleep-inducing peptide product, and the Poisons Standard has no entry naming it. As an unapproved peptide it has not been assessed by the TGA, and the TGA says advertising unapproved peptides to the public is generally unlawful. DSIP was not named in the TGA peptide statements that we reviewed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/dsip-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/artg?keywords=DSIP","title":"ARTG keyword search for 'DSIP' (138 loose-match results, all pages checked; none is a DSIP product)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/understanding-your-responsibilities-when-importing-compounding-and-supplying-unapproved-peptide-products","title":"Understanding your responsibilities when importing, compounding and supplying unapproved peptide products","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-04-13","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/news/media-releases/unapproved-peptide-product-promoters-and-suppliers-are-put-notice","title":"Unapproved peptide product promoters and suppliers are put on notice","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-07-20","accessed":"2026-09-29"}]},{"molecule":"dulaglutide","moleculeName":"Dulaglutide","country":"australia","countryName":"Australia","countryIso2":"AU","status":"approved","statusLabel":"Approved","headline":"Approved as Trulicity for type 2 diabetes since January 2015 and listed on the PBS. Compounded GLP-1 copies are barred.","detail":"Trulicity was registered on the ARTG on 19 January 2015 for type 2 diabetes. The PBS A-Z medicine listing includes dulaglutide. Since 1 October 2024 pharmacists must not compound medicines containing GLP-1 receptor agonist analogues, and the usual exemption for individually prescribed compounded medicines does not cover them.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/dulaglutide-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/artg/217965","title":"TRULICITY dulaglutide solution for injection prefilled pen (ARTG 217965)","publisher":"Therapeutic Goods Administration (TGA)","date":"2015-01","accessed":"2026-09-29"},{"url":"https://www.pbs.gov.au/browse/medicine-listing?initial=d","title":"PBS A-Z medicine listing: D (includes dulaglutide)","publisher":"Australian Government Department of Health, Disability and Ageing (PBS)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/guidance/manufacturing-supplying-and-advertising-compounded-medicines-lawfully","title":"Manufacturing, supplying and advertising compounded medicines lawfully","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-05-14","accessed":"2026-09-29"}]},{"molecule":"ecnoglutide","moleculeName":"Ecnoglutide","country":"australia","countryName":"Australia","countryIso2":"AU","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in Australia. No ecnoglutide product is on the ARTG and no application appears on the TGA's evaluation list.","detail":"A keyword search of the ARTG on 29 September 2026 returned no ecnoglutide product, and the TGA list of prescription medicines under evaluation (updated 21 September 2026) shows no ecnoglutide application. It is an unapproved therapeutic good in Australia and has not been assessed by the TGA for safety, quality or effectiveness.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ecnoglutide-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/artg?keywords=ecnoglutide","title":"ARTG keyword search for 'ecnoglutide' (no matching results)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/prescription-medicines-under-evaluation","title":"Prescription medicines under evaluation (last updated 21 September 2026)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-21","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/products/unapproved-therapeutic-goods/access-pathways","title":"Access pathways for unapproved therapeutic goods","publisher":"Therapeutic Goods Administration (TGA)","date":"2025-10","accessed":"2026-09-29"}]},{"molecule":"elamipretide","moleculeName":"Elamipretide (SS-31)","country":"australia","countryName":"Australia","countryIso2":"AU","status":"not-approved","statusLabel":"Not approved","headline":"No elamipretide product is on the ARTG and none appears on the TGA's evaluation list.","detail":"A keyword search of the ARTG on 29 September 2026 returned no elamipretide product, and the TGA list of prescription medicines under evaluation (updated 21 September 2026) shows no elamipretide application. It is an unapproved therapeutic good in Australia; access for an individual patient would need a route such as the Special Access Scheme.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/elamipretide-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/artg?keywords=elamipretide","title":"ARTG keyword search for 'elamipretide' (no matching results)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/prescription-medicines-under-evaluation","title":"Prescription medicines under evaluation (last updated 21 September 2026)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-21","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/business-services/special-access-scheme-and-authorised-prescriber-online-system/access-unapproved-therapeutic-goods-individual-patients-special-access-scheme","title":"Access to unapproved therapeutic goods for individual patients (Special Access Scheme)","publisher":"Therapeutic Goods Administration (TGA)","date":"2025-12-03","accessed":"2026-09-29"}]},{"molecule":"eloralintide","moleculeName":"Eloralintide","country":"australia","countryName":"Australia","countryIso2":"AU","status":"not-approved","statusLabel":"Not approved","headline":"Investigational only. No eloralintide product is on the ARTG and no application appears on the TGA's evaluation list.","detail":"A keyword search of the ARTG on 29 September 2026 returned no eloralintide product, and the TGA list of prescription medicines under evaluation (updated 21 September 2026) shows no eloralintide application. It is therefore an unapproved therapeutic good in Australia and has not been assessed by the TGA for safety, quality or effectiveness.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/eloralintide-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/artg?keywords=eloralintide","title":"ARTG keyword search for 'eloralintide' (no matching results)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/prescription-medicines-under-evaluation","title":"Prescription medicines under evaluation (last updated 21 September 2026)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-21","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/products/unapproved-therapeutic-goods/access-pathways","title":"Access pathways for unapproved therapeutic goods","publisher":"Therapeutic Goods Administration (TGA)","date":"2025-10","accessed":"2026-09-29"}]},{"molecule":"epitalon","moleculeName":"Epitalon","country":"australia","countryName":"Australia","countryIso2":"AU","status":"not-approved","statusLabel":"Not approved","headline":"No epitalon product is on the ARTG. It counts as an unapproved peptide, and advertising or supplying it is likely unlawful.","detail":"A keyword search of the ARTG on 29 September 2026 found no epitalon product, and the Poisons Standard has no entry naming it. As an unapproved peptide it has not been assessed by the TGA for safety, quality or effectiveness, and the TGA says unlawful importation, supply and advertising of unapproved peptides is a priority compliance area. Epitalon was not named in the TGA peptide statements that we reviewed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/epitalon-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/artg?keywords=epitalon","title":"ARTG keyword search for 'epitalon' (no matching results)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/understanding-your-responsibilities-when-importing-compounding-and-supplying-unapproved-peptide-products","title":"Understanding your responsibilities when importing, compounding and supplying unapproved peptide products","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-04-13","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/news/media-releases/tga-strengthens-compliance-focus-unapproved-peptide-products-part-evolving-risk-response","title":"TGA strengthens compliance focus on unapproved peptide products as part of evolving risk response","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-06-10","accessed":"2026-09-29"}]},{"molecule":"exenatide","moleculeName":"Exenatide","country":"australia","countryName":"Australia","countryIso2":"AU","status":"not-approved","statusLabel":"Not approved","headline":"TGA assessed Byetta and Bydureon (2013), but a search of the ARTG on 29 Sep 2026 finds no current exenatide entry.","detail":"The TGA published an assessment report for Byetta and Bydureon (exenatide) in 2013, so it was approved in the past. A keyword search of the ARTG on 29 September 2026 returned no matching results, and no exenatide application appears on the TGA under-evaluation list (updated 21 September 2026). Exenatide is a GLP-1 receptor agonist, so the general ban on compounding GLP-1 receptor agonist analogues applies to any pharmacy activity. Anyone needing it would need an unapproved-medicine access route.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/exenatide-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/auspar/auspar-exenatide","title":"AusPAR: Byetta / Bydureon (exenatide)","publisher":"Therapeutic Goods Administration (TGA)","date":"2013-03-27","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/artg?keywords=exenatide","title":"ARTG keyword search for 'exenatide' (no matching results)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/prescription-medicines-under-evaluation","title":"Prescription medicines under evaluation (last updated 21 September 2026)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-21","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/guidance/manufacturing-supplying-and-advertising-compounded-medicines-lawfully","title":"Manufacturing, supplying and advertising compounded medicines lawfully","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-05-14","accessed":"2026-09-29"}]},{"molecule":"ghk-cu","moleculeName":"GHK-Cu (copper peptide)","country":"australia","countryName":"Australia","countryIso2":"AU","status":"not-approved","statusLabel":"Not approved","headline":"Not on the ARTG. The TGA names GHK-Cu as an unapproved peptide product and warns against importing or advertising it.","detail":"The TGA's April and June 2026 statements list GHK-Cu among unapproved peptide products that have not been evaluated for safety, quality or effectiveness. A keyword search of the ARTG on 29 September 2026 found no GHK-Cu or copper tripeptide product, GHK-Cu is not named in the Poisons Standard, although its Schedule 4 entry for copper compounds for human use (with exceptions for low-copper preparations) may apply to some products. That advice concerns therapeutic uses; it does not address any cosmetic ingredient rules. Unlawful advertising, import, manufacture or supply of unapproved peptides is a compliance priority.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ghk-cu-in-australia","sources":[{"url":"https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/understanding-your-responsibilities-when-importing-compounding-and-supplying-unapproved-peptide-products","title":"Understanding your responsibilities when importing, compounding and supplying unapproved peptide products","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-04-13","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/news/media-releases/concerns-regarding-public-health-risks-associated-unapproved-peptide-products","title":"Concerns regarding the public health risks associated with unapproved peptide products","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-06-19","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/artg?keywords=GHK","title":"ARTG keyword search for 'GHK' (2081 loose-match results, all pages checked; none is a GHK product)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.au/F2026L00633/latest/text","title":"Therapeutic Goods (Poisons Standard - June 2026) Instrument 2026","publisher":"Federal Register of Legislation (Australian Government)","date":"2026-05","accessed":"2026-09-29"}]},{"molecule":"ipamorelin","moleculeName":"Ipamorelin","country":"australia","countryName":"Australia","countryIso2":"AU","status":"prohibited","statusLabel":"Prohibited","headline":"Unapproved and controlled: ipamorelin is prescription-only and possession without authority is illegal under the Poisons Standard.","detail":"Ipamorelin is named in Schedule 4 and in Appendix D clause 5 of the Poisons Standard, so it is prescription-only and possessing it without authority is illegal. A keyword search of the ARTG on 29 September 2026 found no ipamorelin product. Sport Integrity Australia gives it, with sermorelin, as an example of synthetic peptides sold for anti-ageing and muscle building that fall under the banned peptide hormone class.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ipamorelin-in-australia","sources":[{"url":"https://www.legislation.gov.au/F2026L00633/latest/text","title":"Therapeutic Goods (Poisons Standard - June 2026) Instrument 2026","publisher":"Federal Register of Legislation (Australian Government)","date":"2026-05","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/artg?keywords=ipamorelin","title":"ARTG keyword search for 'ipamorelin' (no matching results)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/understanding-your-responsibilities-when-importing-compounding-and-supplying-unapproved-peptide-products","title":"Understanding your responsibilities when importing, compounding and supplying unapproved peptide products","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-04-13","accessed":"2026-09-29"},{"url":"https://www.sportintegrity.gov.au/what-we-do/anti-doping/prohibited-list","title":"Prohibited List Explained","publisher":"Sport Integrity Australia","date":"2026","accessed":"2026-09-29"}]},{"molecule":"kisspeptin","moleculeName":"Kisspeptin","country":"australia","countryName":"Australia","countryIso2":"AU","status":"not-approved","statusLabel":"Not approved","headline":"No kisspeptin product is on the ARTG. It counts as an unapproved peptide, and advertising or supplying it is likely unlawful.","detail":"A keyword search of the ARTG on 29 September 2026 returned no kisspeptin product, and the Poisons Standard has no entry naming it. As an unapproved peptide it has not been assessed by the TGA for safety, quality or effectiveness. Kisspeptin was not named in the TGA peptide statements that we reviewed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/kisspeptin-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/artg?keywords=kisspeptin","title":"ARTG keyword search for 'kisspeptin' (no matching results)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/understanding-your-responsibilities-when-importing-compounding-and-supplying-unapproved-peptide-products","title":"Understanding your responsibilities when importing, compounding and supplying unapproved peptide products","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-04-13","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/news/media-releases/tga-strengthens-compliance-focus-unapproved-peptide-products-part-evolving-risk-response","title":"TGA strengthens compliance focus on unapproved peptide products as part of evolving risk response","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-06-10","accessed":"2026-09-29"}]},{"molecule":"kpv","moleculeName":"KPV","country":"australia","countryName":"Australia","countryIso2":"AU","status":"not-approved","statusLabel":"Not approved","headline":"No KPV product is on the ARTG. It counts as an unapproved peptide, and advertising or supplying it is likely unlawful.","detail":"A keyword search of the ARTG on 29 September 2026 found no KPV product, and the Poisons Standard has no entry naming it. The TGA states that peptide products not on the ARTG are unapproved, have not been evaluated for safety or quality, and that advertising them to the public, particularly on social media, is likely to breach the law. KPV was not named in the TGA's peptide statements that we reviewed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/kpv-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/artg?keywords=KPV","title":"ARTG keyword search for 'KPV' (283 loose-match results, all pages checked; none is a KPV product)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/understanding-your-responsibilities-when-importing-compounding-and-supplying-unapproved-peptide-products","title":"Understanding your responsibilities when importing, compounding and supplying unapproved peptide products","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-04-13","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/news/media-releases/unapproved-peptide-product-promoters-and-suppliers-are-put-notice","title":"Unapproved peptide product promoters and suppliers are put on notice","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-07-20","accessed":"2026-09-29"}]},{"molecule":"liraglutide","moleculeName":"Liraglutide","country":"australia","countryName":"Australia","countryIso2":"AU","status":"generic-available","statusLabel":"Generics available","headline":"Approved as Victoza and Saxenda; generic liraglutide pens were added to the ARTG from March 2025. Compounded versions barred since 1 October 2024.","detail":"Victoza was registered on 26 August 2010 and Saxenda (the weight-management brand) on 24 December 2015. Generic liraglutide pens were entered on the ARTG on 12 March 2025, which is the basis for the generic-available label; registration alone does not show what is stocked. Since 1 October 2024 pharmacists must not compound medicines containing GLP-1 receptor agonist analogues, and the usual exemption for individually prescribed compounded medicines does not cover them.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/liraglutide-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/artg/153980","title":"VICTOZA liraglutide solution for injection pre-filled pen (ARTG 153980)","publisher":"Therapeutic Goods Administration (TGA)","date":"2010-08","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/artg/225804","title":"SAXENDA liraglutide solution for injection pre-filled pen (ARTG 225804)","publisher":"Therapeutic Goods Administration (TGA)","date":"2015-12","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/artg/449145","title":"LIRAGLUTIDE SANDOZ liraglutide solution for injection pre-filled pen (ARTG 449145)","publisher":"Therapeutic Goods Administration (TGA)","date":"2025-03","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/guidance/manufacturing-supplying-and-advertising-compounded-medicines-lawfully","title":"Manufacturing, supplying and advertising compounded medicines lawfully","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-05-14","accessed":"2026-09-29"}]},{"molecule":"ll-37","moleculeName":"LL-37","country":"australia","countryName":"Australia","countryIso2":"AU","status":"not-approved","statusLabel":"Not approved","headline":"No LL-37 product is on the ARTG. It counts as an unapproved peptide, and advertising or supplying it is likely unlawful.","detail":"A keyword search of the ARTG on 29 September 2026 found no LL-37 product, and the Poisons Standard has no entry naming it. As an unapproved peptide it has not been assessed by the TGA for safety, quality or effectiveness. LL-37 was not named in the TGA peptide statements that we reviewed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ll-37-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/artg?keywords=LL-37","title":"ARTG keyword search for 'LL-37' (55 loose-match results, all pages checked; none is a LL-37 product)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/understanding-your-responsibilities-when-importing-compounding-and-supplying-unapproved-peptide-products","title":"Understanding your responsibilities when importing, compounding and supplying unapproved peptide products","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-04-13","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/news/media-releases/tga-strengthens-compliance-focus-unapproved-peptide-products-part-evolving-risk-response","title":"TGA strengthens compliance focus on unapproved peptide products as part of evolving risk response","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-06-10","accessed":"2026-09-29"}]},{"molecule":"maridebart-cafraglutide","moleculeName":"Maridebart cafraglutide (MariTide)","country":"australia","countryName":"Australia","countryIso2":"AU","status":"not-approved","statusLabel":"Not approved","headline":"Investigational only. No maridebart cafraglutide product is on the ARTG and no application appears on the TGA's evaluation list.","detail":"A keyword search of the ARTG on 29 September 2026 returned no maridebart product, and the TGA list of prescription medicines under evaluation (updated 21 September 2026) shows no application for it. It is an unapproved therapeutic good in Australia and has not been assessed by the TGA.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/maridebart-cafraglutide-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/artg?keywords=maridebart","title":"ARTG keyword search for 'maridebart' (no matching results)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/prescription-medicines-under-evaluation","title":"Prescription medicines under evaluation (last updated 21 September 2026)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-21","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/products/unapproved-therapeutic-goods/access-pathways","title":"Access pathways for unapproved therapeutic goods","publisher":"Therapeutic Goods Administration (TGA)","date":"2025-10","accessed":"2026-09-29"}]},{"molecule":"mazdutide","moleculeName":"Mazdutide","country":"australia","countryName":"Australia","countryIso2":"AU","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in Australia. No mazdutide product is on the ARTG and no application appears on the TGA's evaluation list.","detail":"A keyword search of the ARTG on 29 September 2026 returned no mazdutide product, and the TGA list of prescription medicines under evaluation (updated 21 September 2026) shows no mazdutide application. Any mazdutide sold to Australians would be an unapproved therapeutic good that the TGA has not assessed for safety, quality or effectiveness.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/mazdutide-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/artg?keywords=mazdutide","title":"ARTG keyword search for 'mazdutide' (no matching results)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/prescription-medicines-under-evaluation","title":"Prescription medicines under evaluation (last updated 21 September 2026)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-21","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/products/unapproved-therapeutic-goods/access-pathways","title":"Access pathways for unapproved therapeutic goods","publisher":"Therapeutic Goods Administration (TGA)","date":"2025-10","accessed":"2026-09-29"}]},{"molecule":"melanotan-ii","moleculeName":"Melanotan II","country":"australia","countryName":"Australia","countryIso2":"AU","status":"prohibited","statusLabel":"Prohibited","headline":"Not approved for any use. Melanotan II is prescription-only, has no ARTG product, and a seller was issued 27 TGA infringement notices (paid May 2026).","detail":"Melanotan II is a Schedule 4 prescription-only medicine in Australia, is not approved as a tanning agent, and no product containing it is on the ARTG. The TGA issued 27 infringement notices totalling $101,412 to a New South Wales individual for alleged unlawful supply; they were paid in May 2026. In August 2026 the TGA warned that seized nasal sprays contained widely varying amounts of Melanotan II and told people to stop using such products.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/melanotan-ii-in-australia","sources":[{"url":"https://www.tga.gov.au/news/media-releases/individual-issued-27-infringement-notices-allegedly-supplying-melanotan-ii","title":"Individual issued 27 infringement notices for allegedly supplying Melanotan II","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/melanotan-ii-tanning-peptide-products-found-be-inconsistently-dosed","title":"Melanotan II tanning peptide products found to be inconsistently dosed","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-08-17","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.au/F2026L00633/latest/text","title":"Therapeutic Goods (Poisons Standard - June 2026) Instrument 2026","publisher":"Federal Register of Legislation (Australian Government)","date":"2026-05","accessed":"2026-09-29"}]},{"molecule":"mots-c","moleculeName":"MOTS-c","country":"australia","countryName":"Australia","countryIso2":"AU","status":"not-approved","statusLabel":"Not approved","headline":"No MOTS-c product is on the ARTG. It counts as an unapproved peptide, and advertising or supplying it is likely unlawful.","detail":"A keyword search of the ARTG on 29 September 2026 found no MOTS-c product, and the Poisons Standard has no entry naming it. The TGA states that unapproved peptide products have not been evaluated for safety, quality or effectiveness, and that importing, advertising, manufacturing and supplying them is unlawful. MOTS-c was not named in the TGA peptide statements that we reviewed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/mots-c-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/artg?keywords=MOTS-c","title":"ARTG keyword search for 'MOTS-c' (14 loose-match results, all pages checked; none is a MOTS-c product)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/understanding-your-responsibilities-when-importing-compounding-and-supplying-unapproved-peptide-products","title":"Understanding your responsibilities when importing, compounding and supplying unapproved peptide products","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-04-13","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/news/media-releases/unapproved-peptide-product-promoters-and-suppliers-are-put-notice","title":"Unapproved peptide product promoters and suppliers are put on notice","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-07-20","accessed":"2026-09-29"}]},{"molecule":"nad-plus","moleculeName":"NAD+","country":"australia","countryName":"Australia","countryIso2":"AU","status":"not-approved","statusLabel":"Not approved","headline":"No injectable NAD+ product is approved. ARTG entries that name NAD (nadide) are export-only listings that must not be supplied in Australia.","detail":"A keyword search of the ARTG on 29 September 2026 for 'nadide' (NAD) returned 13 entries, all under the export-only listed category; for example, the public summary for ARTG 371660 states the product must not be supplied for sale in Australia. The Poisons Standard does not name NAD (nadide), so any injectable or IV use would be an unapproved product or compounded medicine under the TGA's compounding rules.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/nad-plus-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/artg?keywords=nadide","title":"ARTG keyword search for 'nadide' (13 entries, export-only category)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/artg/371660","title":"SL-NAD+ (ARTG 371660), Medicine Listed (Export Only)","publisher":"Therapeutic Goods Administration (TGA)","date":"2021-07","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/guidance/manufacturing-supplying-and-advertising-compounded-medicines-lawfully","title":"Manufacturing, supplying and advertising compounded medicines lawfully","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-05-14","accessed":"2026-09-29"},{"url":"https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=371660&agid=(PrintDetailsPublic)&actionid=1","title":"Public Summary: ARTG entry 371660 SL-NAD+, Medicine Listed (Export Only)","publisher":"Therapeutic Goods Administration (TGA)","date":"2021-07-26","accessed":"2026-09-29"}]},{"molecule":"orforglipron","moleculeName":"Orforglipron","country":"australia","countryName":"Australia","countryIso2":"AU","status":"under-review","statusLabel":"Under review","headline":"Not yet approved. Eli Lilly's application for weight management and type 2 diabetes was accepted by the TGA in January 2026 and is under evaluation.","detail":"The TGA's list of prescription medicines under evaluation shows an application for orforglipron calcium from Eli Lilly Australia (type A, a new medicine), accepted in January 2026. The proposed uses are weight loss and long-term weight management in adults with obesity, or overweight with a weight-related condition, and treatment of adults with type 2 diabetes. The TGA notes that listing does not guarantee registration or PBS entry. A keyword search of the ARTG on 29 September 2026 found no orforglipron entry, so it cannot be supplied as an approved product yet.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/orforglipron-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/prescription-medicines-under-evaluation/tba-eli-lilly-australia-pty-ltd","title":"Prescription medicines under evaluation: orforglipron calcium (Eli Lilly Australia Pty Ltd, accepted January 2026)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-01","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/prescription-medicines-under-evaluation","title":"Prescription medicines under evaluation (last updated 21 September 2026)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-21","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/artg?keywords=orforglipron","title":"ARTG keyword search for 'orforglipron' (no matching results)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"pramlintide","moleculeName":"Pramlintide","country":"australia","countryName":"Australia","countryIso2":"AU","status":"not-approved","statusLabel":"Not approved","headline":"Not on the ARTG and no application on the TGA's evaluation list. It could only be reached through unapproved-medicine pathways.","detail":"A keyword search of the ARTG on 29 September 2026 returned no pramlintide product, and none appears on the TGA list of prescription medicines under evaluation (updated 21 September 2026). Medicines that are not on the ARTG are unapproved therapeutic goods; a doctor may seek access for an individual patient through the Special Access Scheme, and the TGA has not assessed such products for safety, quality or effectiveness.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/pramlintide-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/artg?keywords=pramlintide","title":"ARTG keyword search for 'pramlintide' (no matching results)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/prescription-medicines-under-evaluation","title":"Prescription medicines under evaluation (last updated 21 September 2026)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-21","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/products/unapproved-therapeutic-goods/access-pathways","title":"Access pathways for unapproved therapeutic goods","publisher":"Therapeutic Goods Administration (TGA)","date":"2025-10","accessed":"2026-09-29"}]},{"molecule":"retatrutide","moleculeName":"Retatrutide","country":"australia","countryName":"Australia","countryIso2":"AU","status":"prohibited","statusLabel":"Prohibited","headline":"Not approved by the TGA or any comparable regulator. The TGA names retatrutide in peptide warnings and seizures, and a product sold as retatrutide contained semaglutide instead.","detail":"Retatrutide is still in human clinical trials and has not been approved by the TGA or a comparable regulator. The TGA named it, with BPC-157, GHK-Cu, TB-500 and CJC-1295, as an unapproved peptide product in April and June 2026, and seized retatrutide from premises in New South Wales in August 2026. In a September 2026 safety alert, laboratory testing of a vial sold as retatrutide found undeclared semaglutide and no retatrutide, after a hospital admission. Importing, advertising, manufacturing or supplying unapproved peptide products is unlawful.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/retatrutide-in-australia","sources":[{"url":"https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/tga-tests-counterfeit-retatrutide-product-following-serious-adverse-event-report","title":"TGA tests counterfeit retatrutide product following serious adverse event report","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-14","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/understanding-your-responsibilities-when-importing-compounding-and-supplying-unapproved-peptide-products","title":"Understanding your responsibilities when importing, compounding and supplying unapproved peptide products","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-04-13","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/news/media-releases/concerns-regarding-public-health-risks-associated-unapproved-peptide-products","title":"Concerns regarding the public health risks associated with unapproved peptide products","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-06-19","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/news/media-releases/tga-flexes-its-muscle-against-illegal-peptides-and-steroids","title":"TGA flexes its muscle against illegal peptides and steroids","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-08-17","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/artg?keywords=retatrutide","title":"ARTG keyword search for 'retatrutide' (no matching results)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"selank","moleculeName":"Selank","country":"australia","countryName":"Australia","countryIso2":"AU","status":"not-approved","statusLabel":"Not approved","headline":"No selank product is on the ARTG. It counts as an unapproved peptide, and advertising or supplying it is likely unlawful.","detail":"A keyword search of the ARTG on 29 September 2026 found no selank product, and the Poisons Standard has no entry naming it. As an unapproved peptide it has not been assessed by the TGA for safety, quality or effectiveness, and the TGA warns that advertising such products, particularly through social media or influencers, is likely to breach the law. Selank was not named in the TGA peptide statements that we reviewed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/selank-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/artg?keywords=selank","title":"ARTG keyword search for 'selank' (49 loose-match results, all pages checked; none is a selank product)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/understanding-your-responsibilities-when-importing-compounding-and-supplying-unapproved-peptide-products","title":"Understanding your responsibilities when importing, compounding and supplying unapproved peptide products","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-04-13","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/news/media-releases/tga-strengthens-compliance-focus-unapproved-peptide-products-part-evolving-risk-response","title":"TGA strengthens compliance focus on unapproved peptide products as part of evolving risk response","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-06-10","accessed":"2026-09-29"}]},{"molecule":"semaglutide","moleculeName":"Semaglutide","country":"australia","countryName":"Australia","countryIso2":"AU","status":"approved","statusLabel":"Approved","headline":"Approved on the ARTG as Ozempic, Rybelsus and Wegovy. PBS covers Ozempic for type 2 diabetes; Wegovy is not yet PBS-listed. Compounded copies barred since 1 Oct 2024.","detail":"Semaglutide was first registered in Australia on 28 August 2019 (Ozempic, type 2 diabetes). Rybelsus (tablets) followed on 7 February 2022, and Wegovy for chronic weight management in adults on 1 September 2022, with a use in adolescents aged 12 and over added on 29 February 2024. The PBS lists semaglutide injection for type 2 diabetes. PBAC recommended Wegovy for people with established cardiovascular disease and obesity in November 2025, but as at 1 September 2026 the PBS record shows the listing had not yet occurred. A revised Novo Nordisk proposal for Wegovy in established atherosclerotic cardiovascular disease with obesity is listed for the November 2026 PBAC meeting. Since 1 October 2024 pharmacists must not compound medicines containing GLP-1 receptor agonist analogues, and the usual exemption for individually prescribed compounded medicines does not cover them. A further Ozempic use (leg-artery claudication in type 2 diabetes) is under TGA evaluation.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/semaglutide-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/artg/308324","title":"OZEMPIC semaglutide solution for injection pre-filled pen (ARTG 308324)","publisher":"Therapeutic Goods Administration (TGA)","date":"2019-08","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/artg/356286","title":"WEGOVY semaglutide solution for injection pre-filled pen (ARTG 356286)","publisher":"Therapeutic Goods Administration (TGA)","date":"2022-09","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/artg/346198","title":"RYBELSUS semaglutide tablet blister pack (ARTG 346198)","publisher":"Therapeutic Goods Administration (TGA)","date":"2022-02","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/auspar/auspar-wegovy-0","title":"AusPAR: Wegovy (semaglutide), extension of indication (weight management in adolescents aged 12 and over; ARTG entry 29 February 2024)","publisher":"Therapeutic Goods Administration (TGA)","date":"2024-09-05","accessed":"2026-09-29"},{"url":"https://www.pbs.gov.au/medicinestatus/document/1260","title":"PBS Medicines Status: semaglutide (Ozempic), type 2 diabetes mellitus","publisher":"Australian Government Department of Health, Disability and Ageing (PBS)","date":"2026-03-31","accessed":"2026-09-29"},{"url":"https://www.pbs.gov.au/medicinestatus/document/1460","title":"PBS Medicines Status: semaglutide (Wegovy), established cardiovascular disease with obesity","publisher":"Australian Government Department of Health, Disability and Ageing (PBS)","date":"2026-07-23","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/guidance/manufacturing-supplying-and-advertising-compounded-medicines-lawfully","title":"Manufacturing, supplying and advertising compounded medicines lawfully","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-05-14","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/prescription-medicines-under-evaluation/ozempic-novo-nordisk-pharmaceuticals-pty-ltd","title":"Prescription medicines under evaluation: Ozempic (semaglutide), claudication in peripheral arterial disease (accepted September 2025)","publisher":"Therapeutic Goods Administration (TGA)","date":"2025-09","accessed":"2026-09-29"},{"url":"https://www.pbs.gov.au/medicinestatus/document/1650","title":"PBS Medicines Status: semaglutide (Wegovy), established atherosclerotic cardiovascular disease with obesity (November 2026 PBAC meeting)","publisher":"Australian Government Department of Health, Disability and Ageing (PBS)","date":"2026-07-23","accessed":"2026-09-29"}]},{"molecule":"semax","moleculeName":"Semax","country":"australia","countryName":"Australia","countryIso2":"AU","status":"not-approved","statusLabel":"Not approved","headline":"No semax product is on the ARTG. It counts as an unapproved peptide, and advertising or supplying it is likely unlawful.","detail":"A keyword search of the ARTG on 29 September 2026 found no semax product, and the Poisons Standard has no entry naming it. As an unapproved peptide it has not been assessed by the TGA, and the TGA says unlawful import, advertising, manufacture and supply of such products is a compliance priority. Semax was not named in the TGA peptide statements that we reviewed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/semax-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/artg?keywords=semax","title":"ARTG keyword search for 'semax' (33 loose-match results, all pages checked; none is a semax product)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/understanding-your-responsibilities-when-importing-compounding-and-supplying-unapproved-peptide-products","title":"Understanding your responsibilities when importing, compounding and supplying unapproved peptide products","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-04-13","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/news/media-releases/tga-strengthens-compliance-focus-unapproved-peptide-products-part-evolving-risk-response","title":"TGA strengthens compliance focus on unapproved peptide products as part of evolving risk response","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-06-10","accessed":"2026-09-29"}]},{"molecule":"sermorelin","moleculeName":"Sermorelin","country":"australia","countryName":"Australia","countryIso2":"AU","status":"not-approved","statusLabel":"Not approved","headline":"Not on the ARTG. Sermorelin is prescription-only (Schedule 4), and as a GHRH analogue it may also fall under the Appendix D possession control.","detail":"Sermorelin is listed by name in Schedule 4 of the Poisons Standard, so it is prescription-only. It is a 29-amino-acid analogue of growth hormone releasing hormone (GHRH), and Appendix D clause 5 (possession without authority is illegal) lists GHRHs \"including those separately specified in Schedule 4\", so that control may also apply; check with a state or territory health department. A keyword search of the ARTG on 29 September 2026 found no sermorelin product. As an unapproved good it cannot be advertised to the public, and a prescriber or pharmacist would need to meet the TGA rules for unapproved and compounded medicines. Sport Integrity Australia names it as an example of a banned peptide hormone.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/sermorelin-in-australia","sources":[{"url":"https://www.legislation.gov.au/F2026L00633/latest/text","title":"Therapeutic Goods (Poisons Standard - June 2026) Instrument 2026","publisher":"Federal Register of Legislation (Australian Government)","date":"2026-05","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/artg?keywords=sermorelin","title":"ARTG keyword search for 'sermorelin' (no matching results)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/guidance/manufacturing-supplying-and-advertising-compounded-medicines-lawfully","title":"Manufacturing, supplying and advertising compounded medicines lawfully","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-05-14","accessed":"2026-09-29"},{"url":"https://www.sportintegrity.gov.au/what-we-do/anti-doping/prohibited-list","title":"Prohibited List Explained","publisher":"Sport Integrity Australia","date":"2026","accessed":"2026-09-29"},{"url":"https://pubmed.ncbi.nlm.nih.gov/18031173/","title":"Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency (BioDrugs 1999;12(2):139-57)","publisher":"BioDrugs (Adis)","date":"1999-08","accessed":"2026-09-29"}]},{"molecule":"setmelanotide","moleculeName":"Setmelanotide","country":"australia","countryName":"Australia","countryIso2":"AU","status":"not-approved","statusLabel":"Not approved","headline":"No setmelanotide product is on the ARTG and none appears on the TGA's evaluation list. Access would need an unapproved-medicine pathway.","detail":"A keyword search of the ARTG on 29 September 2026 found no setmelanotide product, including under the brand Imcivree, and the TGA list of prescription medicines under evaluation (updated 21 September 2026) shows no application. Registered doctors can apply to the TGA for access to an unapproved medicine for an individual patient through the Special Access Scheme.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/setmelanotide-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/artg?keywords=setmelanotide","title":"ARTG keyword search for 'setmelanotide' (no matching results)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/prescription-medicines-under-evaluation","title":"Prescription medicines under evaluation (last updated 21 September 2026)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-21","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/business-services/special-access-scheme-and-authorised-prescriber-online-system/access-unapproved-therapeutic-goods-individual-patients-special-access-scheme","title":"Access to unapproved therapeutic goods for individual patients (Special Access Scheme)","publisher":"Therapeutic Goods Administration (TGA)","date":"2025-12-03","accessed":"2026-09-29"}]},{"molecule":"survodutide","moleculeName":"Survodutide","country":"australia","countryName":"Australia","countryIso2":"AU","status":"not-approved","statusLabel":"Not approved","headline":"Investigational only. No survodutide product is on the ARTG and no application appears on the TGA's evaluation list.","detail":"A keyword search of the ARTG on 29 September 2026 returned no survodutide product, and the TGA list of prescription medicines under evaluation (updated 21 September 2026) shows no survodutide application. It is an unapproved therapeutic good in Australia, so it has not been assessed by the TGA and cannot be advertised to the public.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/survodutide-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/artg?keywords=survodutide","title":"ARTG keyword search for 'survodutide' (no matching results)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/prescription-medicines-under-evaluation","title":"Prescription medicines under evaluation (last updated 21 September 2026)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-21","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/products/unapproved-therapeutic-goods/access-pathways","title":"Access pathways for unapproved therapeutic goods","publisher":"Therapeutic Goods Administration (TGA)","date":"2025-10","accessed":"2026-09-29"}]},{"molecule":"tb-500","moleculeName":"TB-500 (thymosin beta-4 fragment)","country":"australia","countryName":"Australia","countryIso2":"AU","status":"prohibited","statusLabel":"Prohibited","headline":"Unapproved and controlled: TB-500 and thymosin beta 4 are prescription-only, possession without authority is illegal, and the TGA has seized it.","detail":"The Poisons Standard lists TB500 and thymosin beta 4 in Schedule 4 and in Appendix D clause 5, so possession without authority is illegal. The TGA names TB-500 as an unapproved peptide product and seized a product combining BPC-157 and TB-500 in New South Wales in August 2026. A keyword search of the ARTG on 29 September 2026 found no TB-500 or thymosin product for human use.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tb-500-in-australia","sources":[{"url":"https://www.legislation.gov.au/F2026L00633/latest/text","title":"Therapeutic Goods (Poisons Standard - June 2026) Instrument 2026","publisher":"Federal Register of Legislation (Australian Government)","date":"2026-05","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/understanding-your-responsibilities-when-importing-compounding-and-supplying-unapproved-peptide-products","title":"Understanding your responsibilities when importing, compounding and supplying unapproved peptide products","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-04-13","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/news/media-releases/tga-flexes-its-muscle-against-illegal-peptides-and-steroids","title":"TGA flexes its muscle against illegal peptides and steroids","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-08-17","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/artg?keywords=TB-500","title":"ARTG keyword search for 'TB-500' (11 loose-match results, all pages checked; none is a TB-500 product)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"tesamorelin","moleculeName":"Tesamorelin","country":"australia","countryName":"Australia","countryIso2":"AU","status":"not-approved","statusLabel":"Not approved","headline":"Not on the ARTG. The Poisons Standard lists growth hormone releasing hormones as a prescription-only class with a possession control.","detail":"A keyword search of the ARTG on 29 September 2026 found no tesamorelin product, including under the brand Egrifta. The Poisons Standard does not name tesamorelin, but it lists growth hormone releasing hormones (GHRHs) as a class in Schedule 4 and in Appendix D clause 5 (possession without authority is illegal); check that class entry with the TGA or a state health department before assuming it does not apply. Unapproved goods can be accessed only through routes such as the Special Access Scheme.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tesamorelin-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/artg?keywords=tesamorelin","title":"ARTG keyword search for 'tesamorelin' (no matching results)","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.au/F2026L00633/latest/text","title":"Therapeutic Goods (Poisons Standard - June 2026) Instrument 2026","publisher":"Federal Register of Legislation (Australian Government)","date":"2026-05","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/products/unapproved-therapeutic-goods/access-pathways","title":"Access pathways for unapproved therapeutic goods","publisher":"Therapeutic Goods Administration (TGA)","date":"2025-10","accessed":"2026-09-29"}]},{"molecule":"tirzepatide","moleculeName":"Tirzepatide","country":"australia","countryName":"Australia","countryIso2":"AU","status":"approved","statusLabel":"Approved","headline":"Approved as Mounjaro for type 2 diabetes (Dec 2022) and weight management (Sep 2024). Not PBS-listed: the sponsor is not proceeding for now. Compounding barred since Oct 2024.","detail":"Mounjaro entered the ARTG on 23 December 2022 for adults with type 2 diabetes, and on 10 September 2024 for chronic weight management in adults with obesity, or overweight plus a weight-related condition. PBAC recommended it for type 2 diabetes in March 2026, but the PBS record (as at 1 September 2026) says the company has advised it is not proceeding in the listing process at this time, so it is not subsidised. Two further uses are under TGA evaluation: type 2 diabetes from age 10, and cardiovascular risk reduction. Since 1 October 2024 pharmacists must not compound medicines containing GLP-1 receptor agonist analogues, and the usual exemption for individually prescribed compounded medicines does not cover them.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tirzepatide-in-australia","sources":[{"url":"https://www.tga.gov.au/resources/artg/379330","title":"MOUNJARO tirzepatide solution for injection pre-filled pen (ARTG 379330)","publisher":"Therapeutic Goods Administration (TGA)","date":"2022-12","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/auspar/auspar-mounjaro","title":"AusPAR: Mounjaro (tirzepatide), new chemical entity","publisher":"Therapeutic Goods Administration (TGA)","date":"2023-11-16","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/auspar/auspar-mounjaro-0","title":"AusPAR: Mounjaro (tirzepatide), extension of indications (chronic weight management)","publisher":"Therapeutic Goods Administration (TGA)","date":"2024-09-26","accessed":"2026-09-29"},{"url":"https://www.pbs.gov.au/medicinestatus/document/1609","title":"PBS Medicines Status: tirzepatide (Mounjaro), type 2 diabetes mellitus","publisher":"Australian Government Department of Health, Disability and Ageing (PBS)","date":"2026-06-30","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/prescription-medicines-under-evaluation/mounjaro-eli-lilly-australia-pty-ltd","title":"Prescription medicines under evaluation: Mounjaro (tirzepatide), proposed use from age 10 (accepted September 2025)","publisher":"Therapeutic Goods Administration (TGA)","date":"2025-09","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/prescription-medicines-under-evaluation/mounjaro-eli-lilly-australia-pty-ltd-0","title":"Prescription medicines under evaluation: Mounjaro (tirzepatide), cardiovascular risk reduction (accepted December 2025)","publisher":"Therapeutic Goods Administration (TGA)","date":"2025-12","accessed":"2026-09-29"},{"url":"https://www.tga.gov.au/resources/guidance/manufacturing-supplying-and-advertising-compounded-medicines-lawfully","title":"Manufacturing, supplying and advertising compounded medicines lawfully","publisher":"Therapeutic Goods Administration (TGA)","date":"2026-05-14","accessed":"2026-09-29"}]},{"molecule":"amycretin","moleculeName":"Amycretin","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"Amycretin is an investigational drug with no Brazilian registration","detail":"Amycretin has no entry in Anvisa's open-data medicines register (checked 2026-09-29), and no Brazilian application was found. It is still in clinical development and cannot legally be marketed in Brazil, because Anvisa requires registration before any medicine is sold.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/amycretin-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"aod-9604","moleculeName":"AOD-9604","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"No Brazilian registration for AOD-9604; the unregistered-peptide rules apply","detail":"AOD-9604 has no entry in Anvisa's medicines register (checked 2026-09-29) and is not among the five peptides named in Anvisa's July 2026 alert. Under Anvisa rules a medicine without a Brazilian registration cannot be marketed. Anvisa also says no supplement may be injected and no cosmetic can be injectable.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/aod-9604-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa","title":"Checamos: peptídeos que prometem milagres NÃO estão registrados na Anvisa","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-07-02","accessed":"2026-09-29"}]},{"molecule":"bpc-157","moleculeName":"BPC-157","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"Not registered in Brazil; Anvisa says injectable BPC-157 sold online is irregular and cannot be sold","detail":"BPC-157 is one of five peptides named in Anvisa's alert of 2026-07-02. On 2026-07-02 Anvisa said it is not registered as a medicine, supplement or cosmetic, that no supplement in Brazil may be injectable, and that injectable products of this kind cannot be sold for health or aesthetic use. Anvisa says only properly regularised compounding pharmacies may prepare medicines, individually and on prescription, but it also says BPC-157 is not regularised in any category. It is also prohibited in sport under the WADA S0 category, which the Brazilian anti-doping authority applies.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/bpc-157-in-brazil","sources":[{"url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa","title":"Checamos: peptídeos que prometem milagres NÃO estão registrados na Anvisa","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-07-02","accessed":"2026-09-29"},{"url":"https://www.metropoles.com/saude/anvisa-alerta-peptideos-ilegais","title":"Anvisa alerta que peptídeos injetáveis vendidos online são ilegais","publisher":"Metrópoles","date":"2026-07-03","accessed":"2026-09-29"},{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.usada.org/spirit-of-sport/bpc-157-peptide-prohibited/","title":"BPC-157: Experimental Peptide Creates Risk for Athletes","publisher":"U.S. Anti-Doping Agency (USADA)","date":"2020-03-03","accessed":"2026-09-29"},{"url":"https://www.gov.br/abcd/pt-br/noticias/noticias-de-2026/a-lista-de-substancias-e-metodos-proibidos-de-2026-ja-esta-em-vigor","title":"A Lista de Substâncias e Métodos Proibidos de 2026 já está em vigor","publisher":"Autoridade Brasileira de Controle de Dopagem (ABCD)","date":"2026-01-01","accessed":"2026-09-29"}]},{"molecule":"bremelanotide","moleculeName":"Bremelanotide (PT-141)","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"No Brazilian registration for bremelanotide (PT-141)","detail":"Bremelanotide has no entry in Anvisa's open-data medicines register (checked 2026-09-29), and no Brazilian application was found. It has not been named in Anvisa's peptide alerts. Without registration it cannot be marketed in Brazil.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/bremelanotide-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"cagrilintide","moleculeName":"Cagrilintide (and CagriSema)","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"Not registered in Brazil; no filing for cagrilintide or CagriSema was found","detail":"Neither cagrilintide nor the CagriSema combination has an entry in Anvisa's register (checked 2026-09-29). I could not find public evidence of a Brazilian application, so the status is not-approved rather than under review. Anvisa's rule is that a medicine without a Brazilian registration cannot be marketed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/cagrilintide-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"cjc-1295","moleculeName":"CJC-1295","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"Not registered in Brazil; Anvisa says injectable CJC-1295 sold online is irregular","detail":"CJC-1295 is one of five peptides named in Anvisa's alert of 2026-07-02. On 2026-07-02 Anvisa said it is not registered as a medicine, supplement or cosmetic, that no supplement in Brazil may be injectable, and that injectable products of this kind cannot be sold for health or aesthetic use. It has no entry in the medicines register (checked 2026-09-29). Anvisa says compounding is limited to individual prescriptions at regularised pharmacies, and that the substance is not regularised in any category.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/cjc-1295-in-brazil","sources":[{"url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa","title":"Checamos: peptídeos que prometem milagres NÃO estão registrados na Anvisa","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-07-02","accessed":"2026-09-29"},{"url":"https://www.metropoles.com/saude/anvisa-alerta-peptideos-ilegais","title":"Anvisa alerta que peptídeos injetáveis vendidos online são ilegais","publisher":"Metrópoles","date":"2026-07-03","accessed":"2026-09-29"},{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"dsip","moleculeName":"DSIP (delta sleep-inducing peptide)","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"No Brazilian registration for DSIP; the unregistered-peptide rules apply","detail":"DSIP has no entry in Anvisa's medicines register (checked 2026-09-29) and is not among the five peptides named in Anvisa's July 2026 alert. Under Anvisa rules a medicine without a Brazilian registration cannot be marketed. Anvisa also says no supplement may be injected and no cosmetic can be injectable.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/dsip-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa","title":"Checamos: peptídeos que prometem milagres NÃO estão registrados na Anvisa","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-07-02","accessed":"2026-09-29"}]},{"molecule":"dulaglutide","moleculeName":"Dulaglutide","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"approved","statusLabel":"Approved","headline":"Approved as Trulicity, registered by Anvisa in 2015 for type 2 diabetes","detail":"Trulicity (Eli Lilly) has an active Anvisa registration dating from 2015, classed as an antidiabetic. Dulaglutide is one of the five GLP-1 active ingredients covered by RDC 973/2025, so prescriptions are retained by the pharmacy and sales are recorded in SNGPC. No generic or similar dulaglutide product was found in the register. News reports describe Trulicity as approved in Brazil for type 2 diabetes.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/dulaglutide-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://portal6.com.br/2026/09/14/anvisa-aprova-14-novas-canetas-para-diabetes-e-obesidade-em-2026/","title":"Anvisa aprova 14 novas canetas para diabetes e obesidade em 2026","publisher":"Portal 6","date":"2026-09-14","accessed":"2026-09-29"},{"url":"https://site.cff.org.br/noticia/Noticias-gerais/16/01/2026/anvisa-estabelece-novas-regras-para-prescricao-e-dispensacao-de-medicamentos-agonistas-de-glp-1","title":"Anvisa estabelece novas regras para prescrição e dispensação de medicamentos agonistas de GLP-1","publisher":"Conselho Federal de Farmácia (CFF)","date":"2026-01-16","accessed":"2026-09-29"}]},{"molecule":"ecnoglutide","moleculeName":"Ecnoglutide","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"Ecnoglutide has no Brazilian registration and is not on the market","detail":"Ecnoglutide has no entry in Anvisa's open-data medicines register (checked 2026-09-29), and no Brazilian application was found. It is an investigational drug or is approved only elsewhere. Anvisa's rule is that a medicine without a Brazilian registration cannot be marketed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ecnoglutide-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"elamipretide","moleculeName":"Elamipretide (SS-31)","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"No Brazilian registration for elamipretide","detail":"Elamipretide has no entry in Anvisa's open-data medicines register (checked 2026-09-29), and no Brazilian application was found. Under Anvisa rules a medicine without a Brazilian registration cannot be marketed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/elamipretide-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"eloralintide","moleculeName":"Eloralintide","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"Eloralintide is an investigational drug with no Brazilian registration","detail":"Eloralintide has no entry in Anvisa's open-data medicines register (checked 2026-09-29), and no Brazilian application was found. It is still in clinical development and cannot legally be marketed in Brazil, because Anvisa requires registration before any medicine is sold.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/eloralintide-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"epitalon","moleculeName":"Epitalon","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"No Brazilian registration for epitalon; the unregistered-peptide rules apply","detail":"Epitalon has no entry in Anvisa's medicines register (checked 2026-09-29) and is not among the five peptides named in Anvisa's July 2026 alert. Under Anvisa rules a medicine without a Brazilian registration cannot be marketed. Anvisa also says no supplement may be injected and no cosmetic can be injectable.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/epitalon-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa","title":"Checamos: peptídeos que prometem milagres NÃO estão registrados na Anvisa","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-07-02","accessed":"2026-09-29"}]},{"molecule":"exenatide","moleculeName":"Exenatide","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"No active registration: the Byetta and Bydureon registrations show as inactive in Anvisa's register","detail":"Anvisa's register lists Byetta (registered from 2007) and Bydureon (2017) entries under Eli Lilly, Bristol-Myers Squibb and AstraZeneca, but all show status 'Inativo'. That means no current marketing authorisation. Because it has no active registration, exenatide cannot be marketed in Brazil today. Lixisenatide, a related drug, is covered by RDC 973/2025 through the Soliqua registration.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/exenatide-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://site.cff.org.br/noticia/Noticias-gerais/16/01/2026/anvisa-estabelece-novas-regras-para-prescricao-e-dispensacao-de-medicamentos-agonistas-de-glp-1","title":"Anvisa estabelece novas regras para prescrição e dispensação de medicamentos agonistas de GLP-1","publisher":"Conselho Federal de Farmácia (CFF)","date":"2026-01-16","accessed":"2026-09-29"}]},{"molecule":"ghk-cu","moleculeName":"GHK-Cu (copper peptide)","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"Injectable GHK-Cu is unregistered in Brazil and has been among goods seized by Anvisa","detail":"GHK-Cu is named in Anvisa's alert of 2026-07-02. On 2026-07-02 Anvisa said it is not registered as a medicine, supplement or cosmetic, that no supplement in Brazil may be injectable, and that injectable products of this kind cannot be sold for health or aesthetic use. Anvisa adds that if a cosmetic is offered as an injection it is an irregular cosmetic. In September 2026, 198 units of GHK-Cu were among the goods seized at Rio's Galeão airport. The alert concerns injectable products and does not address topical cosmetics.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ghk-cu-in-brazil","sources":[{"url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa","title":"Checamos: peptídeos que prometem milagres NÃO estão registrados na Anvisa","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-07-02","accessed":"2026-09-29"},{"url":"https://www.metropoles.com/saude/anvisa-apreende-tirzepatida-e-anabolizantes-irregulares-no-galeao","title":"Anvisa apreende tirzepatida e anabolizantes irregulares no Galeão","publisher":"Metrópoles","date":"2026-09-23","accessed":"2026-09-29"},{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"ipamorelin","moleculeName":"Ipamorelin","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"Not registered in Brazil; Anvisa says injectable ipamorelin sold online is irregular","detail":"Ipamorelin is one of five peptides named in Anvisa's alert of 2026-07-02. On 2026-07-02 Anvisa said it is not registered as a medicine, supplement or cosmetic, that no supplement in Brazil may be injectable, and that injectable products of this kind cannot be sold for health or aesthetic use. It has no entry in the medicines register (checked 2026-09-29). Anvisa says compounding is limited to individual prescriptions at regularised pharmacies, and that the substance is not regularised in any category.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ipamorelin-in-brazil","sources":[{"url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa","title":"Checamos: peptídeos que prometem milagres NÃO estão registrados na Anvisa","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-07-02","accessed":"2026-09-29"},{"url":"https://www.metropoles.com/saude/anvisa-alerta-peptideos-ilegais","title":"Anvisa alerta que peptídeos injetáveis vendidos online são ilegais","publisher":"Metrópoles","date":"2026-07-03","accessed":"2026-09-29"},{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"kisspeptin","moleculeName":"Kisspeptin","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"No Brazilian registration for kisspeptin; the unregistered-peptide rules apply","detail":"Kisspeptin has no entry in Anvisa's medicines register (checked 2026-09-29) and is not among the five peptides named in Anvisa's July 2026 alert. Under Anvisa rules a medicine without a Brazilian registration cannot be marketed. Anvisa also says no supplement may be injected and no cosmetic can be injectable.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/kisspeptin-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa","title":"Checamos: peptídeos que prometem milagres NÃO estão registrados na Anvisa","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-07-02","accessed":"2026-09-29"}]},{"molecule":"kpv","moleculeName":"KPV","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"No Brazilian registration for KPV; the same unregistered-peptide rules apply","detail":"KPV has no entry in Anvisa's medicines register (checked 2026-09-29) and is not one of the five peptides named in the July 2026 Anvisa alert. Under Anvisa rules a medicine without a Brazilian registration cannot be marketed. Anvisa also says no food supplement may be injected and no cosmetic can be injectable, so injectable KPV has no legal category.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/kpv-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa","title":"Checamos: peptídeos que prometem milagres NÃO estão registrados na Anvisa","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-07-02","accessed":"2026-09-29"}]},{"molecule":"liraglutide","moleculeName":"Liraglutide","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"approved","statusLabel":"Approved","headline":"Approved as Victoza (diabetes) and Saxenda (weight), with Brazilian versions and new generics","detail":"Victoza was registered in 2010 and Saxenda in 2016, and Saxenda's use was extended to adolescents from 12 years in August 2020. EMS's Olire (obesity) and Lirux (type 2 diabetes) were registered in December 2024 and reached pharmacies in August 2025. Germed's Liraclick was registered as a similar medicine on 2026-06-01, and two EMS generics were registered on 2026-09-08, with no launch or price reported yet for the generics. Prescription retention applies under RDC 973/2025. Conitec declined to add it to the public health system in August 2025.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/liraglutide-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.gov.br/anvisa/pt-br/assuntos/medicamentos/novos-medicamentos-e-indicacoes/saxenda-liraglutida-nova-indicacao","title":"Saxenda (liraglutida): nova indicação","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2020-08-03","accessed":"2026-09-29"},{"url":"https://site.cff.org.br/noticia/Noticias-gerais/04/08/2025/farmaceutica-lanca-primeira-caneta-emagrecedora-nacional-com-liraglutida-para-obesidade-e-diabetes","title":"Farmacêutica lança primeira caneta emagrecedora nacional com liraglutida para obesidade e diabetes","publisher":"Conselho Federal de Farmácia (CFF)","date":"2025-08-04","accessed":"2026-09-29"},{"url":"https://panoramafarmaceutico.com.br/anvisa-aprova-genericos-de-liraglutida/","title":"Anvisa aprova genéricos de liraglutida","publisher":"Panorama Farmacêutico","date":"2026-09-09","accessed":"2026-09-29"},{"url":"https://site.cff.org.br/noticia/Noticias-gerais/21/08/2025/conitec-rejeita-inclusao-de-medicamentos-contra-diabetes-e-obesidade-no-sus","title":"Conitec rejeita inclusão de medicamentos contra diabetes e obesidade no SUS","publisher":"Conselho Federal de Farmácia (CFF)","date":"2025-08-21","accessed":"2026-09-29"}]},{"molecule":"ll-37","moleculeName":"LL-37","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"No Brazilian registration for LL-37; the unregistered-peptide rules apply","detail":"LL-37 has no entry in Anvisa's medicines register (checked 2026-09-29) and is not among the five peptides named in Anvisa's July 2026 alert. Under Anvisa rules a medicine without a Brazilian registration cannot be marketed. Anvisa also says no supplement may be injected and no cosmetic can be injectable.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ll-37-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa","title":"Checamos: peptídeos que prometem milagres NÃO estão registrados na Anvisa","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-07-02","accessed":"2026-09-29"}]},{"molecule":"maridebart-cafraglutide","moleculeName":"Maridebart cafraglutide (MariTide)","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"Maridebart cafraglutide has no Brazilian registration and is not on the market","detail":"Maridebart cafraglutide has no entry in Anvisa's open-data medicines register (checked 2026-09-29), and no Brazilian application was found. It is an investigational drug or is approved only elsewhere. Anvisa's rule is that a medicine without a Brazilian registration cannot be marketed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/maridebart-cafraglutide-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"mazdutide","moleculeName":"Mazdutide","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"Mazdutide has no Brazilian registration and is not on the market","detail":"Mazdutide has no entry in Anvisa's open-data medicines register (checked 2026-09-29), and no Brazilian application was found. It is an investigational drug or is approved only elsewhere. Anvisa's rule is that a medicine without a Brazilian registration cannot be marketed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/mazdutide-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"melanotan-ii","moleculeName":"Melanotan II","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"No Brazilian registration for melanotan II; a pharmacy-education institute says it is sold illegally online","detail":"Melanotan II has no entry in Anvisa's medicines register (checked 2026-09-29). A July 2026 article by ICTQ, a pharmacy-education institute, says it is sold illegally online, is not approved for aesthetic use, and has no controls on its quality or safety. It is not named in Anvisa's July 2026 alert, but the rule that unregistered products cannot be marketed applies.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/melanotan-ii-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://ictq.com.br/farmacia-clinica/5326-bronzeado-sem-sol-viraliza-nas-redes-com-peptideo-ilegal-e-sem-controle","title":"Bronzeado sem sol viraliza nas redes com peptídeo ilegal e sem controle","publisher":"ICTQ","date":"2026-07-10","accessed":"2026-09-29"},{"url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa","title":"Checamos: peptídeos que prometem milagres NÃO estão registrados na Anvisa","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-07-02","accessed":"2026-09-29"}]},{"molecule":"mots-c","moleculeName":"MOTS-c","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"No Brazilian registration for MOTS-c; the unregistered-peptide rules apply","detail":"MOTS-c has no entry in Anvisa's medicines register (checked 2026-09-29) and is not among the five peptides named in Anvisa's July 2026 alert. Under Anvisa rules a medicine without a Brazilian registration cannot be marketed. Anvisa says injectable peptides of this kind cannot be sold as supplements or cosmetics.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/mots-c-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa","title":"Checamos: peptídeos que prometem milagres NÃO estão registrados na Anvisa","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-07-02","accessed":"2026-09-29"}]},{"molecule":"nad-plus","moleculeName":"NAD+","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"No registered NAD+ medicine in Brazil; Anvisa says no supplement may be injectable","detail":"NAD+ has no registered medicine in Anvisa's medicines register (checked 2026-09-29) and is not among the five peptides named in Anvisa's July 2026 alert. Anvisa states that no food supplement in Brazil may be given by injection. Oral supplement products fall under separate supplement rules that were not checked for this record.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/nad-plus-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa","title":"Checamos: peptídeos que prometem milagres NÃO estão registrados na Anvisa","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-07-02","accessed":"2026-09-29"}]},{"molecule":"orforglipron","moleculeName":"Orforglipron","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"under-review","statusLabel":"Under review","headline":"Reported as filed with Anvisa by Lilly; no public Anvisa decision yet","detail":"In April 2026 trade press, citing Valor Econômico, reported that the application had already been submitted to Anvisa. The same report quoted a Lilly executive who expected a Brazilian launch by the second half of 2027, depending on the pace of review. A report from August 2026 said that as of 2026-08-11 it found no public Anvisa decision and no official document confirming a filing. So the filing rests on company statements, and orforglipron is not in Anvisa's register. It is not available legally in Brazil.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/orforglipron-in-brazil","sources":[{"url":"https://panoramafarmaceutico.com.br/pilula-emagrecedora-da-lilly-ja-tem-data-para-chegar-no-brasil/","title":"Pílula emagrecedora da Lilly já tem data para chegar no Brasil","publisher":"Panorama Farmacêutico","date":"2026-04-09","accessed":"2026-09-29"},{"url":"https://jornalgrandebahia.com.br/2026/08/reino-unido-aprova-foundayo-pilula-diaria-da-eli-lilly-para-obesidade-e-diabetes-lancamento-privado-e-previsto-para-agosto-e-brasil-segue-sem-data/","title":"Reino Unido aprova Foundayo, pílula diária da Eli Lilly para obesidade e diabetes; Brasil segue sem data","publisher":"Jornal Grande Bahia","date":"2026-08-13","accessed":"2026-09-29"},{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"pramlintide","moleculeName":"Pramlintide","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"No Brazilian registration for pramlintide","detail":"Pramlintide has no entry in Anvisa's open-data medicines register (checked 2026-09-29), and Anvisa's rule is that a medicine without a Brazilian registration cannot be marketed. No Anvisa application for it was found.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/pramlintide-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"retatrutide","moleculeName":"Retatrutide","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"prohibited","statusLabel":"Prohibited","headline":"Not approved anywhere; Anvisa says products sold as retatrutide are illegal and has seized them","detail":"On 2026-07-24 Anvisa said retatrutide is not approved in any country, that its maker has not asked Anvisa for registration, and that it is being offered on irregular websites and seized at Brazil's borders. Anvisa also says selling irregular medicines is a crime under the Penal Code. On 2026-09-08 Resolution 3.480/2026 banned sale, import, advertising and use of the products offered by a website that advertised unregistered tirzepatide and products claimed to contain retatrutide, and ordered them seized. Metrópoles reported that 572 units of retatrutide were among the goods seized at Rio's Galeão airport in the first half of September 2026. Anvisa warns that the contents of such products cannot be verified.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/retatrutide-in-brazil","sources":[{"url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/retatrutida-ainda-nao-esta-aprovada-para-uso-em-nenhum-lugar-do-mundo","title":"Retatrutida ainda NÃO está aprovada para uso em nenhum lugar do mundo","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-07-24","accessed":"2026-09-29"},{"url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-proibe-caneta-emagrecedora-t36","title":"Anvisa proíbe caneta emagrecedora T36","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-16","accessed":"2026-09-29"},{"url":"https://www.metropoles.com/saude/anvisa-apreende-tirzepatida-e-anabolizantes-irregulares-no-galeao","title":"Anvisa apreende tirzepatida e anabolizantes irregulares no Galeão","publisher":"Metrópoles","date":"2026-09-23","accessed":"2026-09-29"},{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"selank","moleculeName":"Selank","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"No Anvisa registration for Selank; a medical council warns against injectable use","detail":"Selank has no entry in Anvisa's medicines register (checked 2026-09-29). The Paraná medical council's dermatology technical note of April 2026 lists it among peptides without an Anvisa registration for injectable use, and warns of risks not yet recognised. It is not named in Anvisa's July 2026 alert, but the same rule applies that an unregistered product cannot be marketed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/selank-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.crmpr.org.br/Camara-Tecnica-de-Dermatologia-elabora-nota-tecnica-de-alerta-sobre-uso-invasivo-de-peptid-11-61244.shtml","title":"Câmara Técnica de Dermatologia elabora nota técnica de alerta sobre uso invasivo de peptídeos","publisher":"Conselho Regional de Medicina do Paraná (CRM-PR)","date":"2026-04-07","accessed":"2026-09-29"},{"url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa","title":"Checamos: peptídeos que prometem milagres NÃO estão registrados na Anvisa","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-07-02","accessed":"2026-09-29"}]},{"molecule":"semaglutide","moleculeName":"Semaglutide","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"approved","statusLabel":"Approved","headline":"Approved as Ozempic, Rybelsus and Wegovy, with Brazilian-made versions approved from May 2026","detail":"Anvisa registered Ozempic (2018), Rybelsus (2020, tablets) and Wegovy (2023, weight management; liver indication added December 2025). Anvisa says the patent expired on 2026-03-20 but registration is still required. Ozivy (EMS, 2026-05-26) is a synthetic version classed as a new drug for type 2 diabetes, and the first generics (EMS, Germed) were registered in August 2026. Anvisa registered five more synthetic semaglutide products for type 2 diabetes on 2026-07-29. It is prescription-only with retention under RDC 973/2025. Since Despacho 97/2025, biotechnology-derived semaglutide may be imported for compounding only if it comes from the registered manufacturer. Anvisa said synthetic semaglutide could not be compounded until a synthetic medicine was registered, which first happened with Ozivy. Anvisa is revising the compounding rules.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/semaglutide-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-aprova-primeira-caneta-de-semaglutida-sintetica-analoga-ao-ozempic-para-diabetes","title":"Anvisa aprova primeira caneta de semaglutida sintética análoga ao Ozempic para diabetes","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-05-26","accessed":"2026-09-29"},{"url":"https://www.gov.br/anvisa/pt-br/assuntos/medicamentos/novos-medicamentos-e-indicacoes/wegovy-semaglutida","title":"Wegovy (semaglutida): novo registro","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2023-01-02","accessed":"2026-09-29"},{"url":"https://www.gov.br/anvisa/pt-br/assuntos/medicamentos/novos-medicamentos-e-indicacoes/wegovy-semaglutida-nova-indicacao","title":"Wegovy (semaglutida): nova indicação","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2025-12-15","accessed":"2026-09-29"},{"url":"https://www.gov.br/anvisa/pt-br/assuntos/medicamentos/novos-medicamentos-e-indicacoes/rybelsus-semaglutida-novo-registro","title":"Rybelsus (semaglutida): novo registro","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2020-10-26","accessed":"2026-09-29"},{"url":"https://www.gov.br/anvisa/pt-br/assuntos/medicamentos/novos-medicamentos-e-indicacoes/ozempic-semaglutida-nova-indicacao","title":"Ozempic (semaglutida): nova indicação","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-02-02","accessed":"2026-09-29"},{"url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-registra-cinco-novas-canetas-de-semaglutida","title":"Anvisa registra cinco novas canetas de semaglutida","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-07-29","accessed":"2026-09-29"},{"url":"https://agenciabrasil.ebc.com.br/saude/noticia/2026-08/anvisa-aprova-nova-caneta-emagrecedora-base-de-semaglutida","title":"Anvisa aprova nova caneta emagrecedora à base de semaglutida","publisher":"Agência Brasil (EBC)","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://portal6.com.br/2026/09/14/anvisa-aprova-14-novas-canetas-para-diabetes-e-obesidade-em-2026/","title":"Anvisa aprova 14 novas canetas para diabetes e obesidade em 2026","publisher":"Portal 6","date":"2026-09-14","accessed":"2026-09-29"},{"url":"https://agenciabrasil.ebc.com.br/saude/noticia/2025-08/anvisa-proibe-versoes-manipuladas-da-semaglutida-usada-no-ozempic","title":"Anvisa proíbe versões manipuladas da semaglutida, usada no Ozempic","publisher":"Agência Brasil (EBC)","date":"2025-08-26","accessed":"2026-09-29"}]},{"molecule":"semax","moleculeName":"Semax","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"No Anvisa registration for Semax; a medical council warns against injectable use","detail":"Semax has no entry in Anvisa's medicines register (checked 2026-09-29). The Paraná medical council's dermatology technical note of April 2026 lists it among peptides without an Anvisa registration for injectable use, and warns of risks not yet recognised. It is not named in Anvisa's July 2026 alert, but the same rule applies that an unregistered product cannot be marketed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/semax-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.crmpr.org.br/Camara-Tecnica-de-Dermatologia-elabora-nota-tecnica-de-alerta-sobre-uso-invasivo-de-peptid-11-61244.shtml","title":"Câmara Técnica de Dermatologia elabora nota técnica de alerta sobre uso invasivo de peptídeos","publisher":"Conselho Regional de Medicina do Paraná (CRM-PR)","date":"2026-04-07","accessed":"2026-09-29"},{"url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa","title":"Checamos: peptídeos que prometem milagres NÃO estão registrados na Anvisa","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-07-02","accessed":"2026-09-29"}]},{"molecule":"sermorelin","moleculeName":"Sermorelin","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"No Brazilian registration for sermorelin; the unregistered-peptide rules apply","detail":"Sermorelin has no entry in Anvisa's medicines register (checked 2026-09-29) and is not among the five peptides named in Anvisa's July 2026 alert. Under Anvisa rules a medicine without a Brazilian registration cannot be marketed. Anvisa's alert also states that unregistered injectable peptides have no guarantees of safety, quality or origin.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/sermorelin-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa","title":"Checamos: peptídeos que prometem milagres NÃO estão registrados na Anvisa","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-07-02","accessed":"2026-09-29"}]},{"molecule":"setmelanotide","moleculeName":"Setmelanotide","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"No Anvisa registration found for setmelanotide","detail":"Setmelanotide has no entry in Anvisa's open-data medicines register (checked 2026-09-29). I found no public information about a Brazilian application or special access route, so this is based on the register alone. Without registration it cannot be marketed in Brazil.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/setmelanotide-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"survodutide","moleculeName":"Survodutide","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"Survodutide has no Brazilian registration and is not on the market","detail":"Survodutide has no entry in Anvisa's open-data medicines register (checked 2026-09-29), and no Brazilian application was found. It is an investigational drug or is approved only elsewhere. Anvisa's rule is that a medicine without a Brazilian registration cannot be marketed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/survodutide-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"tb-500","moleculeName":"TB-500 (thymosin beta-4 fragment)","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"Not registered in Brazil; Anvisa says it has no authorisation as a supplement and injectables are irregular","detail":"TB-500 is one of five peptides named in Anvisa's alert of 2026-07-02. Anvisa states that BPC-157 and TB-500 have no authorisation for use as food supplements, and that no supplement may be injected. It is not in the medicines register (checked 2026-09-29). Compounding is allowed only for individual prescriptions at regularised pharmacies, but Anvisa says the substance is not regularised in any category.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tb-500-in-brazil","sources":[{"url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa","title":"Checamos: peptídeos que prometem milagres NÃO estão registrados na Anvisa","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-07-02","accessed":"2026-09-29"},{"url":"https://www.metropoles.com/saude/anvisa-alerta-peptideos-ilegais","title":"Anvisa alerta que peptídeos injetáveis vendidos online são ilegais","publisher":"Metrópoles","date":"2026-07-03","accessed":"2026-09-29"},{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"tesamorelin","moleculeName":"Tesamorelin","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"not-approved","statusLabel":"Not approved","headline":"No Anvisa registration for tesamorelin; a medical council lists it among unregistered injectable peptides","detail":"Tesamorelin has no entry in Anvisa's medicines register (checked 2026-09-29). The Paraná medical council's dermatology technical note of April 2026 lists tesamorelin among peptides that do not have an Anvisa registration for injectable use. It cannot legally be marketed in Brazil without registration.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tesamorelin-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.crmpr.org.br/Camara-Tecnica-de-Dermatologia-elabora-nota-tecnica-de-alerta-sobre-uso-invasivo-de-peptid-11-61244.shtml","title":"Câmara Técnica de Dermatologia elabora nota técnica de alerta sobre uso invasivo de peptídeos","publisher":"Conselho Regional de Medicina do Paraná (CRM-PR)","date":"2026-04-07","accessed":"2026-09-29"}]},{"molecule":"tirzepatide","moleculeName":"Tirzepatide","country":"brazil","countryName":"Brazil","countryIso2":"BR","status":"approved","statusLabel":"Approved","headline":"Approved as Mounjaro for type 2 diabetes and, since June 2025, chronic weight management","detail":"Mounjaro (Eli Lilly) was registered in September 2023, and in June 2025 Anvisa added chronic weight management for adults with obesity or overweight plus related conditions. A multidose presentation was registered on 2026-03-18. Mounjaro is the only tirzepatide medicine in the register, and it is prescription-only with retention under RDC 973/2025. Anvisa did not ban tirzepatide compounding in August 2025, so it is still allowed on an individual prescription, but Anvisa is revising the rules. In June 2026 Resolution 2.238/2026 suspended one compounder's tirzepatide production for selling standardised, non-individualised product. The same resolution banned several unregistered tirzepatide products, including one from the United States.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tirzepatide-in-brazil","sources":[{"url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","title":"Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.gov.br/anvisa/pt-br/assuntos/medicamentos/novos-medicamentos-e-indicacoes/mounjaro-r-tirzepatida-nova-indicacao","title":"Mounjaro (tirzepatida): nova indicação","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2025-06-09","accessed":"2026-09-29"},{"url":"https://site.cff.org.br/noticia/Noticias-gerais/16/01/2026/anvisa-estabelece-novas-regras-para-prescricao-e-dispensacao-de-medicamentos-agonistas-de-glp-1","title":"Anvisa estabelece novas regras para prescrição e dispensação de medicamentos agonistas de GLP-1","publisher":"Conselho Federal de Farmácia (CFF)","date":"2026-01-16","accessed":"2026-09-29"},{"url":"https://agenciabrasil.ebc.com.br/saude/noticia/2025-08/anvisa-proibe-versoes-manipuladas-da-semaglutida-usada-no-ozempic","title":"Anvisa proíbe versões manipuladas da semaglutida, usada no Ozempic","publisher":"Agência Brasil (EBC)","date":"2025-08-26","accessed":"2026-09-29"},{"url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-proibe-venda-de-tirzepatida-irregular","title":"Anvisa proíbe venda de tirzepatida irregular","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-06-02","accessed":"2026-09-29"},{"url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-anuncia-novas-medidas-de-combate-a-irregularidades-na-importacao-e-manipulacao-de-canetas-emagrecedoras","title":"Anvisa anuncia novas medidas de combate a irregularidades na importação e manipulação de canetas emagrecedoras","publisher":"Agência Nacional de Vigilância Sanitária (Anvisa)","date":"2026-04-06","accessed":"2026-09-29"}]},{"molecule":"amycretin","moleculeName":"Amycretin","country":"canada","countryName":"Canada","countryIso2":"CA","status":"not-approved","statusLabel":"Not approved","headline":"Amycretin is an investigational drug with no Health Canada authorisation","detail":"Amycretin does not appear in Health Canada's Drug Product Database or in the new drug submissions under review list current as of 2026-08-31, so there is no authorised product and no pending file we could find. Unauthorised drug products are illegal to sell in Canada. Any legal access today would be through an authorised clinical trial.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/amycretin-in-canada","sources":[{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=amycretin","title":"Drug Product Database API: active-ingredient search for amycretin","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review/new-drug-submissions-under-review.html","title":"Drug and Health Product Submissions Under Review: New drug submissions under review (list current as of 2026-08-31)","publisher":"Health Canada","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","title":"Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)","publisher":"Health Canada","date":"2026-04-09","accessed":"2026-09-29"}]},{"molecule":"aod-9604","moleculeName":"AOD-9604","country":"canada","countryName":"Canada","countryIso2":"CA","status":"prohibited","statusLabel":"Prohibited","headline":"Not authorised; named in Health Canada seizure notices (2025) and banned in sport","detail":"AOD-9604 does not appear in Health Canada's Drug Product Database. Health Canada's notices on unauthorised injectable peptides seized from Canada Peptide (2025-08-01) and at Rize Fitness in Vancouver (2025-12-24) name AOD-9604, and say selling unauthorised drugs is illegal. The WADA Prohibited List 2026 names AOD-9604 as a growth hormone fragment banned at all times (S2.2.3).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/aod-9604-in-canada","sources":[{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=aod","title":"Drug Product Database API: active-ingredient search for aod","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","title":"Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)","publisher":"Health Canada","date":"2026-04-09","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"World Anti-Doping Code International Standard: Prohibited List 2026","publisher":"World Anti-Doping Agency","date":"2025-09","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious","title":"Unauthorized injectable peptide drugs seized and sold by Canada Peptide may pose serious health risks (RA-77807)","publisher":"Health Canada","date":"2025-08-01","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious","title":"Unauthorized health products sold online and seized at Rize Fitness may pose serious health risks","publisher":"Health Canada","date":"2025-12-24","accessed":"2026-09-29"}]},{"molecule":"bpc-157","moleculeName":"BPC-157","country":"canada","countryName":"Canada","countryIso2":"CA","status":"prohibited","statusLabel":"Prohibited","headline":"Not authorised; seized by Health Canada and subject to a Type I recall of unauthorised powder in May 2026","detail":"There is no authorised BPC-157 product in Canada. Health Canada names BPC-157 in its 2026-04-09 advisory, in seizure notices from 2025 (Optimum Wellness Centre, Canada Peptide, Rize Fitness) and in a Type I recall on 2026-05-07 of BPC-157 and GHK-Cu powder that reached compounding and community pharmacies as unauthorised active ingredients. Selling it is illegal, and research-use-only labels give no exemption. In sport, the WADA Prohibited List 2026 bans BPC-157 under S0 (non-approved substances).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/bpc-157-in-canada","sources":[{"url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","title":"Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)","publisher":"Health Canada","date":"2026-04-09","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/ghk-cu-bpc-157-powder-unauthorized-active-pharmaceutical-ingredients","title":"GHK-Cu & BPC-157 powder: Unauthorized active pharmaceutical ingredients (Type I recall)","publisher":"Health Canada","date":"2026-05-07","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta","title":"Unauthorized injectable peptide drugs seized from Optimum Wellness Centre in Calgary, Alberta may pose serious health risks","publisher":"Health Canada","date":"2025-04-02","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"World Anti-Doping Code International Standard: Prohibited List 2026","publisher":"World Anti-Doping Agency","date":"2025-09","accessed":"2026-09-29"},{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=bpc","title":"Drug Product Database API: active-ingredient search for bpc","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious","title":"Unauthorized injectable peptide drugs seized and sold by Canada Peptide may pose serious health risks (RA-77807)","publisher":"Health Canada","date":"2025-08-01","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious","title":"Unauthorized health products sold online and seized at Rize Fitness may pose serious health risks","publisher":"Health Canada","date":"2025-12-24","accessed":"2026-09-29"}]},{"molecule":"bremelanotide","moleculeName":"Bremelanotide (PT-141)","country":"canada","countryName":"Canada","countryIso2":"CA","status":"prohibited","statusLabel":"Prohibited","headline":"Not authorised; Health Canada seizure notices in 2025 name bremelanotide (PT-141) as an unauthorised injectable","detail":"No bremelanotide product is in Health Canada's Drug Product Database. Health Canada's notices about Optimum Wellness Centre in Calgary (2025-04-02, naming PT-141) and Canada Peptide (2025-08-01, naming bremelanotide) list it among unauthorised injectable peptides, and say it is illegal to sell products Health Canada has not authorised. Health Canada says peptides are generally regulated as prescription drugs and that unauthorised drug products are illegal in Canada.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/bremelanotide-in-canada","sources":[{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta","title":"Unauthorized injectable peptide drugs seized from Optimum Wellness Centre in Calgary, Alberta may pose serious health risks","publisher":"Health Canada","date":"2025-04-02","accessed":"2026-09-29"},{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=bremelanotide","title":"Drug Product Database API: active-ingredient search for bremelanotide","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","title":"Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)","publisher":"Health Canada","date":"2026-04-09","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious","title":"Unauthorized injectable peptide drugs seized and sold by Canada Peptide may pose serious health risks (RA-77807)","publisher":"Health Canada","date":"2025-08-01","accessed":"2026-09-29"}]},{"molecule":"cagrilintide","moleculeName":"Cagrilintide (and CagriSema)","country":"canada","countryName":"Canada","countryIso2":"CA","status":"under-review","statusLabel":"Under review","headline":"Cagrilintide with semaglutide (CagriSema) under review since March 2026; no cagrilintide product is authorised","detail":"Health Canada's list of new drug submissions under review, current as of 2026-08-31, includes cagrilintide with semaglutide from Novo Nordisk Canada, accepted into review in 2026-03 as a new active substance. Cagrilintide is not in the Drug Product Database, so no cagrilintide product can be sold in Canada yet.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/cagrilintide-in-canada","sources":[{"url":"https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review/new-drug-submissions-under-review.html","title":"Drug and Health Product Submissions Under Review: New drug submissions under review (list current as of 2026-08-31)","publisher":"Health Canada","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=cagrilintide","title":"Drug Product Database API: active-ingredient search for cagrilintide","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"cjc-1295","moleculeName":"CJC-1295","country":"canada","countryName":"Canada","countryIso2":"CA","status":"prohibited","statusLabel":"Prohibited","headline":"Not authorised; named in seizure notices from 2025 and 2026 and banned in sport","detail":"No CJC-1295 product is authorised in Canada. Health Canada names it in the 2026-04-09 advisory, the December 2025 Rize Fitness seizure and the April 2025 Optimum Wellness Centre seizure, and says selling unauthorised drugs is illegal. The WADA Prohibited List 2026 bans CJC-1295 as a growth hormone releasing factor (S2.2.4).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/cjc-1295-in-canada","sources":[{"url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","title":"Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)","publisher":"Health Canada","date":"2026-04-09","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious","title":"Unauthorized health products sold online and seized at Rize Fitness may pose serious health risks","publisher":"Health Canada","date":"2025-12-24","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta","title":"Unauthorized injectable peptide drugs seized from Optimum Wellness Centre in Calgary, Alberta may pose serious health risks","publisher":"Health Canada","date":"2025-04-02","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"World Anti-Doping Code International Standard: Prohibited List 2026","publisher":"World Anti-Doping Agency","date":"2025-09","accessed":"2026-09-29"},{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=cjc","title":"Drug Product Database API: active-ingredient search for cjc","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"dsip","moleculeName":"DSIP (delta sleep-inducing peptide)","country":"canada","countryName":"Canada","countryIso2":"CA","status":"prohibited","statusLabel":"Prohibited","headline":"Not authorised; named in Health Canada's April 2026 advisory of seized unauthorised injectables","detail":"There is no authorised DSIP product in Canada. Health Canada lists DSIP among examples of unauthorised injectable peptide drugs it has seized (2026-04-09), says unauthorised drugs are illegal and that research-use-only labels give no exemption.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/dsip-in-canada","sources":[{"url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","title":"Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)","publisher":"Health Canada","date":"2026-04-09","accessed":"2026-09-29"},{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=dsip","title":"Drug Product Database API: active-ingredient search for dsip","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"dulaglutide","moleculeName":"Dulaglutide","country":"canada","countryName":"Canada","countryIso2":"CA","status":"approved","statusLabel":"Approved","headline":"Approved as Trulicity for type 2 diabetes; no generic submissions on Health Canada's list","detail":"Eli Lilly's Trulicity has been marketed in Canada since 2015-11 for adults with type 2 diabetes, and its monograph also covers reducing the risk of non-fatal stroke in adults with type 2 diabetes who have multiple cardiovascular risk factors or established cardiovascular disease. It is not authorised for weight management. The generic submissions list current as of 2026-08-31 shows no dulaglutide submissions.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/dulaglutide-in-canada","sources":[{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=dulaglutide","title":"Drug Product Database API: active-ingredient search for dulaglutide","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://pdf.hres.ca/dpd_pm/00076182.PDF","title":"Product Monograph: TRULICITY (dulaglutide injection)","publisher":"Eli Lilly Canada Inc.","date":"2024-07-05","accessed":"2026-09-29"},{"url":"https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/generic-submissions-under-review.html","title":"Generic submissions under review (list current as of 2026-08-31)","publisher":"Health Canada","date":"2026-08-31","accessed":"2026-09-29"}]},{"molecule":"ecnoglutide","moleculeName":"Ecnoglutide","country":"canada","countryName":"Canada","countryIso2":"CA","status":"not-approved","statusLabel":"Not approved","headline":"Ecnoglutide is an investigational drug with no Health Canada authorisation","detail":"Ecnoglutide does not appear in Health Canada's Drug Product Database or in the new drug submissions under review list current as of 2026-08-31, so there is no authorised product and no pending file we could find. Unauthorised drug products are illegal to sell in Canada. Any legal access today would be through an authorised clinical trial.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ecnoglutide-in-canada","sources":[{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=ecnoglutide","title":"Drug Product Database API: active-ingredient search for ecnoglutide","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review/new-drug-submissions-under-review.html","title":"Drug and Health Product Submissions Under Review: New drug submissions under review (list current as of 2026-08-31)","publisher":"Health Canada","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","title":"Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)","publisher":"Health Canada","date":"2026-04-09","accessed":"2026-09-29"}]},{"molecule":"elamipretide","moleculeName":"Elamipretide (SS-31)","country":"canada","countryName":"Canada","countryIso2":"CA","status":"prohibited","statusLabel":"Prohibited","headline":"Not authorised; Health Canada named SS-31 (elamipretide) among unauthorised injectables it seized in April 2026","detail":"There is no elamipretide product in Health Canada's Drug Product Database. The public advisory of 2026-04-09 lists SS-31 among examples of unauthorised injectable peptide drugs seized by Health Canada, states that unauthorised drugs are illegal, and says 'For Research Use Only' labelling gives no exemption.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/elamipretide-in-canada","sources":[{"url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","title":"Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)","publisher":"Health Canada","date":"2026-04-09","accessed":"2026-09-29"},{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=elamipretide","title":"Drug Product Database API: active-ingredient search for elamipretide","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"eloralintide","moleculeName":"Eloralintide","country":"canada","countryName":"Canada","countryIso2":"CA","status":"not-approved","statusLabel":"Not approved","headline":"Eloralintide is an investigational drug with no Health Canada authorisation","detail":"Eloralintide does not appear in Health Canada's Drug Product Database or in the new drug submissions under review list current as of 2026-08-31, so there is no authorised product and no pending file we could find. Unauthorised drug products are illegal to sell in Canada. Any legal access today would be through an authorised clinical trial.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/eloralintide-in-canada","sources":[{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=eloralintide","title":"Drug Product Database API: active-ingredient search for eloralintide","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review/new-drug-submissions-under-review.html","title":"Drug and Health Product Submissions Under Review: New drug submissions under review (list current as of 2026-08-31)","publisher":"Health Canada","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","title":"Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)","publisher":"Health Canada","date":"2026-04-09","accessed":"2026-09-29"}]},{"molecule":"epitalon","moleculeName":"Epitalon","country":"canada","countryName":"Canada","countryIso2":"CA","status":"prohibited","statusLabel":"Prohibited","headline":"Not authorised; named in Health Canada's seizure notices from 2025 and 2026","detail":"No epitalon product is authorised in Canada. Health Canada lists epitalon among unauthorised injectable peptides it has seized (2026-04-09), and the Optimum Wellness Centre notice of April 2025 also names it. It calls the sale of such products illegal and says research-use-only labels give no exemption.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/epitalon-in-canada","sources":[{"url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","title":"Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)","publisher":"Health Canada","date":"2026-04-09","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta","title":"Unauthorized injectable peptide drugs seized from Optimum Wellness Centre in Calgary, Alberta may pose serious health risks","publisher":"Health Canada","date":"2025-04-02","accessed":"2026-09-29"},{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=epitalon","title":"Drug Product Database API: active-ingredient search for epitalon","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"exenatide","moleculeName":"Exenatide","country":"canada","countryName":"Canada","countryIso2":"CA","status":"not-approved","statusLabel":"Not approved","headline":"No exenatide product is authorised on the market; Byetta and Bydureon were cancelled in 2022","detail":"Health Canada's Drug Product Database lists AstraZeneca's Byetta (cancelled post-market in January and February 2022) and Bydureon (cancelled post-market on 2022-04-01), and Bydureon BCise was cancelled before it reached the market on 2022-05-30. No exenatide product is currently marketed, and none appears on the generic submissions list current as of 2026-08-31.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/exenatide-in-canada","sources":[{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=exenatide","title":"Drug Product Database API: active-ingredient search for exenatide","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/generic-submissions-under-review.html","title":"Generic submissions under review (list current as of 2026-08-31)","publisher":"Health Canada","date":"2026-08-31","accessed":"2026-09-29"}]},{"molecule":"ghk-cu","moleculeName":"GHK-Cu (copper peptide)","country":"canada","countryName":"Canada","countryIso2":"CA","status":"prohibited","statusLabel":"Prohibited","headline":"Not authorised as an injectable drug; named in Health Canada's 2026 seizure advisory and a May 2026 Type I recall","detail":"No GHK-Cu drug product is authorised in Canada. Health Canada lists GHK-Cu among unauthorised injectable peptides it has seized (2026-04-09), and on 2026-05-07 a Type I recall covered GHK-Cu and BPC-157 powder distributed to compounding and community pharmacies as unauthorised active ingredients. These notices concern drug and injectable uses; this record does not cover cosmetic products.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ghk-cu-in-canada","sources":[{"url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","title":"Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)","publisher":"Health Canada","date":"2026-04-09","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/ghk-cu-bpc-157-powder-unauthorized-active-pharmaceutical-ingredients","title":"GHK-Cu & BPC-157 powder: Unauthorized active pharmaceutical ingredients (Type I recall)","publisher":"Health Canada","date":"2026-05-07","accessed":"2026-09-29"},{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=ghk","title":"Drug Product Database API: active-ingredient search for ghk","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"ipamorelin","moleculeName":"Ipamorelin","country":"canada","countryName":"Canada","countryIso2":"CA","status":"prohibited","statusLabel":"Prohibited","headline":"Not authorised; named in seizure notices from 2025 and 2026 and banned in sport","detail":"No ipamorelin product is authorised in Canada. Health Canada names ipamorelin in its 2026-04-09 advisory, the December 2025 Rize Fitness seizure and the April 2025 Optimum Wellness Centre seizure, and says selling unauthorised drugs is illegal. The WADA Prohibited List 2026 bans ipamorelin as a growth hormone secretagogue (S2.2.4).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ipamorelin-in-canada","sources":[{"url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","title":"Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)","publisher":"Health Canada","date":"2026-04-09","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious","title":"Unauthorized health products sold online and seized at Rize Fitness may pose serious health risks","publisher":"Health Canada","date":"2025-12-24","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta","title":"Unauthorized injectable peptide drugs seized from Optimum Wellness Centre in Calgary, Alberta may pose serious health risks","publisher":"Health Canada","date":"2025-04-02","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"World Anti-Doping Code International Standard: Prohibited List 2026","publisher":"World Anti-Doping Agency","date":"2025-09","accessed":"2026-09-29"},{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=ipamorelin","title":"Drug Product Database API: active-ingredient search for ipamorelin","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"kisspeptin","moleculeName":"Kisspeptin","country":"canada","countryName":"Canada","countryIso2":"CA","status":"prohibited","statusLabel":"Prohibited","headline":"Not authorised; named in three Health Canada seizure notices (2025) and banned in sport","detail":"Kisspeptin does not appear in Health Canada's Drug Product Database. Health Canada's notices on unauthorised injectable peptides seized from Optimum Wellness Centre (2025-04-02, kisspeptin-10), Canada Peptide (2025-08-01) and Rize Fitness (2025-12-24) name kisspeptin, and say selling unauthorised drugs is illegal. The WADA Prohibited List 2026 bans kisspeptin and its agonists in males under S2.2.1.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/kisspeptin-in-canada","sources":[{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=kisspeptin","title":"Drug Product Database API: active-ingredient search for kisspeptin","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","title":"Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)","publisher":"Health Canada","date":"2026-04-09","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"World Anti-Doping Code International Standard: Prohibited List 2026","publisher":"World Anti-Doping Agency","date":"2025-09","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta","title":"Unauthorized injectable peptide drugs seized from Optimum Wellness Centre in Calgary, Alberta may pose serious health risks (RA-77218)","publisher":"Health Canada","date":"2025-04-02","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious","title":"Unauthorized injectable peptide drugs seized and sold by Canada Peptide may pose serious health risks (RA-77807)","publisher":"Health Canada","date":"2025-08-01","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious","title":"Unauthorized health products sold online and seized at Rize Fitness may pose serious health risks","publisher":"Health Canada","date":"2025-12-24","accessed":"2026-09-29"}]},{"molecule":"kpv","moleculeName":"KPV","country":"canada","countryName":"Canada","countryIso2":"CA","status":"prohibited","statusLabel":"Prohibited","headline":"Not authorised; named in Health Canada's April 2026 advisory of seized unauthorised injectables","detail":"There is no authorised KPV product in Canada. Health Canada lists KPV among examples of unauthorised injectable peptide drugs it has seized (2026-04-09), says unauthorised drugs are illegal, and that research-use-only labels give no exemption. Health Canada says peptides are generally regulated as prescription drugs and that unauthorised drug products are illegal in Canada.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/kpv-in-canada","sources":[{"url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","title":"Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)","publisher":"Health Canada","date":"2026-04-09","accessed":"2026-09-29"},{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=kpv","title":"Drug Product Database API: active-ingredient search for kpv","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"liraglutide","moleculeName":"Liraglutide","country":"canada","countryName":"Canada","countryIso2":"CA","status":"approved","statusLabel":"Approved","headline":"Approved as Victoza (type 2 diabetes) and Saxenda (weight management); no generic listed yet, 11 submissions pending","detail":"Novo Nordisk's Victoza has been marketed since 2010-05 for type 2 diabetes (adults, and ages 10 and up with metformin) and Saxenda since 2015-05 for chronic weight management in adults with obesity, or overweight with a comorbidity, and in ages 12 to under 18 who meet the monograph's criteria. The combination product Xultophy was cancelled post-market on 2025-12-31. The Drug Product Database shows no generic liraglutide, while the list current as of 2026-08-31 shows 11 generic liraglutide submissions from Biocon, Dr. Reddy's, Zydus, Teva, JAMP and Sun Pharma.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/liraglutide-in-canada","sources":[{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=liraglutide","title":"Drug Product Database API: active-ingredient search for liraglutide","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://pdf.hres.ca/dpd_pm/00081455.PDF","title":"Product Monograph: VICTOZA (liraglutide injection)","publisher":"Novo Nordisk Canada Inc.","date":"2025-08-21","accessed":"2026-09-29"},{"url":"https://pdf.hres.ca/dpd_pm/00081736.PDF","title":"Product Monograph: SAXENDA (liraglutide injection)","publisher":"Novo Nordisk Canada Inc.","date":"2025-09-10","accessed":"2026-09-29"},{"url":"https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/generic-submissions-under-review.html","title":"Generic submissions under review (list current as of 2026-08-31)","publisher":"Health Canada","date":"2026-08-31","accessed":"2026-09-29"}]},{"molecule":"ll-37","moleculeName":"LL-37","country":"canada","countryName":"Canada","countryIso2":"CA","status":"prohibited","statusLabel":"Prohibited","headline":"Not authorised; named in Health Canada's 2025 Canada Peptide seizure notice","detail":"LL-37 does not appear in Health Canada's Drug Product Database. Health Canada's notice of 2025-08-01 lists LL-37 among unauthorised injectable peptide drugs seized from and sold by Canada Peptide, and says selling unauthorised drugs is illegal in Canada. Health Canada states that peptides are generally regulated as prescription drugs.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ll-37-in-canada","sources":[{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=ll-37","title":"Drug Product Database API: active-ingredient search for LL-37","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","title":"Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)","publisher":"Health Canada","date":"2026-04-09","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious","title":"Unauthorized injectable peptide drugs seized and sold by Canada Peptide may pose serious health risks (RA-77807)","publisher":"Health Canada","date":"2025-08-01","accessed":"2026-09-29"}]},{"molecule":"maridebart-cafraglutide","moleculeName":"Maridebart cafraglutide (MariTide)","country":"canada","countryName":"Canada","countryIso2":"CA","status":"not-approved","statusLabel":"Not approved","headline":"Maridebart cafraglutide (MariTide) is an investigational drug with no Health Canada authorisation","detail":"Maridebart cafraglutide (MariTide) does not appear in Health Canada's Drug Product Database or in the new drug submissions under review list current as of 2026-08-31, so there is no authorised product and no pending file we could find. Unauthorised drug products are illegal to sell in Canada. Any legal access today would be through an authorised clinical trial.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/maridebart-cafraglutide-in-canada","sources":[{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=maridebart-cafraglutide","title":"Drug Product Database API: active-ingredient search for maridebart-cafraglutide","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review/new-drug-submissions-under-review.html","title":"Drug and Health Product Submissions Under Review: New drug submissions under review (list current as of 2026-08-31)","publisher":"Health Canada","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","title":"Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)","publisher":"Health Canada","date":"2026-04-09","accessed":"2026-09-29"}]},{"molecule":"mazdutide","moleculeName":"Mazdutide","country":"canada","countryName":"Canada","countryIso2":"CA","status":"not-approved","statusLabel":"Not approved","headline":"Mazdutide is an investigational drug with no Health Canada authorisation","detail":"Mazdutide does not appear in Health Canada's Drug Product Database or in the new drug submissions under review list current as of 2026-08-31, so there is no authorised product and no pending file we could find. Unauthorised drug products are illegal to sell in Canada. Any legal access today would be through an authorised clinical trial.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/mazdutide-in-canada","sources":[{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=mazdutide","title":"Drug Product Database API: active-ingredient search for mazdutide","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review/new-drug-submissions-under-review.html","title":"Drug and Health Product Submissions Under Review: New drug submissions under review (list current as of 2026-08-31)","publisher":"Health Canada","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","title":"Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)","publisher":"Health Canada","date":"2026-04-09","accessed":"2026-09-29"}]},{"molecule":"melanotan-ii","moleculeName":"Melanotan II","country":"canada","countryName":"Canada","countryIso2":"CA","status":"prohibited","statusLabel":"Prohibited","headline":"Not authorised; Health Canada has seized melanotan I and II products (2025 and 2026 notices)","detail":"No melanotan product is authorised in Canada. Health Canada lists melanotan I and II among unauthorised injectables it has seized (2026-04-09), and the Canada Peptide (2025-08-01) and Optimum Wellness Centre (2025-04-02) notices name Melanotan II. Health Canada states selling unauthorised drugs is illegal and that research-use-only labels give no exemption.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/melanotan-ii-in-canada","sources":[{"url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","title":"Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)","publisher":"Health Canada","date":"2026-04-09","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious","title":"Unauthorized injectable peptide drugs seized and sold by Canada Peptide may pose serious health risks","publisher":"Health Canada","date":"2025-08-01","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta","title":"Unauthorized injectable peptide drugs seized from Optimum Wellness Centre in Calgary, Alberta may pose serious health risks","publisher":"Health Canada","date":"2025-04-02","accessed":"2026-09-29"},{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=melanotan","title":"Drug Product Database API: active-ingredient search for melanotan","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"mots-c","moleculeName":"MOTS-c","country":"canada","countryName":"Canada","countryIso2":"CA","status":"prohibited","statusLabel":"Prohibited","headline":"Not authorised; named in Health Canada's April 2026 seizure advisory and banned in sport","detail":"No MOTS-c product is authorised in Canada. Health Canada lists MOTS-c among unauthorised injectable peptide drugs it has seized (2026-04-09) and says unauthorised drugs are illegal. The WADA Prohibited List 2026 names MOTS-c among AMPK activators in S4.4.1.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/mots-c-in-canada","sources":[{"url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","title":"Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)","publisher":"Health Canada","date":"2026-04-09","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"World Anti-Doping Code International Standard: Prohibited List 2026","publisher":"World Anti-Doping Agency","date":"2025-09","accessed":"2026-09-29"},{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=mots","title":"Drug Product Database API: active-ingredient search for mots","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"nad-plus","moleculeName":"NAD+","country":"canada","countryName":"Canada","countryIso2":"CA","status":"prohibited","statusLabel":"Prohibited","headline":"Injectable NAD+ is not authorised; named in Health Canada's April 2026 advisory of seized unauthorised injectables","detail":"Health Canada lists NAD+ among examples of unauthorised injectable peptide drugs it has seized (advisory of 2026-04-09), and says unauthorised drugs are illegal and research-use-only labels give no exemption. No injectable NAD+ drug appears in the Drug Product Database. This record covers injectable drug products only, not oral supplements.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/nad-plus-in-canada","sources":[{"url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","title":"Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)","publisher":"Health Canada","date":"2026-04-09","accessed":"2026-09-29"},{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=nicotinamide%20adenine%20dinucleotide","title":"Drug Product Database API: active-ingredient search for nicotinamide adenine dinucleotide","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"orforglipron","moleculeName":"Orforglipron","country":"canada","countryName":"Canada","countryIso2":"CA","status":"under-review","statusLabel":"Under review","headline":"Under review at Health Canada since January 2026 (Eli Lilly, new active substance); not yet authorised","detail":"Health Canada's list of new drug submissions under review, current as of 2026-08-31, includes orforglipron calcium from Eli Lilly Canada, accepted into review in 2026-01 as a new active substance and part of an aligned review with a health technology assessment body. No orforglipron product appears in the Drug Product Database, so it cannot be sold in Canada until Health Canada authorises it.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/orforglipron-in-canada","sources":[{"url":"https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review/new-drug-submissions-under-review.html","title":"Drug and Health Product Submissions Under Review: New drug submissions under review (list current as of 2026-08-31)","publisher":"Health Canada","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=orforglipron","title":"Drug Product Database API: active-ingredient search for orforglipron","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"pramlintide","moleculeName":"Pramlintide","country":"canada","countryName":"Canada","countryIso2":"CA","status":"not-approved","statusLabel":"Not approved","headline":"No pramlintide product is authorised in Canada","detail":"A search of Health Canada's Drug Product Database finds no product containing pramlintide, and it does not appear in the new drug submissions under review list current as of 2026-08-31. Under Canadian law, a drug without Health Canada authorisation and a DIN cannot lawfully be sold, and Health Canada calls unauthorised drugs illegal.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/pramlintide-in-canada","sources":[{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=pramlintide","title":"Drug Product Database API: active-ingredient search for pramlintide","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review/new-drug-submissions-under-review.html","title":"Drug and Health Product Submissions Under Review: New drug submissions under review (list current as of 2026-08-31)","publisher":"Health Canada","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","title":"Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)","publisher":"Health Canada","date":"2026-04-09","accessed":"2026-09-29"}]},{"molecule":"retatrutide","moleculeName":"Retatrutide","country":"canada","countryName":"Canada","countryIso2":"CA","status":"prohibited","statusLabel":"Prohibited","headline":"Not authorised; Health Canada named retatrutide among unauthorised injectable drugs it has seized (April 2026)","detail":"Retatrutide has no Health Canada authorisation and does not appear in the Drug Product Database. Health Canada's public advisory of 2026-04-09 lists retatrutide among examples of unauthorised injectable peptide drugs it has seized, says unauthorised drugs are illegal in Canada, and says 'For Research Use Only' labels do not make products legal. Retatrutide was also named in the Canada Peptide (2025-08-01) and Rize Fitness (2025-12-24) seizure notices. Health Canada is working with the Canada Border Services Agency to stop such shipments.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/retatrutide-in-canada","sources":[{"url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","title":"Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)","publisher":"Health Canada","date":"2026-04-09","accessed":"2026-09-29"},{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=retatrutide","title":"Drug Product Database API: active-ingredient search for retatrutide","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review/new-drug-submissions-under-review.html","title":"Drug and Health Product Submissions Under Review: New drug submissions under review (list current as of 2026-08-31)","publisher":"Health Canada","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious","title":"Unauthorized injectable peptide drugs seized and sold by Canada Peptide may pose serious health risks (RA-77807)","publisher":"Health Canada","date":"2025-08-01","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious","title":"Unauthorized health products sold online and seized at Rize Fitness may pose serious health risks","publisher":"Health Canada","date":"2025-12-24","accessed":"2026-09-29"}]},{"molecule":"selank","moleculeName":"Selank","country":"canada","countryName":"Canada","countryIso2":"CA","status":"prohibited","statusLabel":"Prohibited","headline":"Not authorised; named in Health Canada's 2025 seizure notices (Optimum Wellness Centre, Canada Peptide)","detail":"Selank does not appear in Health Canada's Drug Product Database. Health Canada's notices on unauthorised injectable peptides seized from Optimum Wellness Centre in Calgary (2025-04-02) and from Canada Peptide (2025-08-01) both name Selank, and say these products are illegal to sell in Canada.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/selank-in-canada","sources":[{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=selank","title":"Drug Product Database API: active-ingredient search for selank","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","title":"Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)","publisher":"Health Canada","date":"2026-04-09","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta","title":"Unauthorized injectable peptide drugs seized from Optimum Wellness Centre in Calgary, Alberta may pose serious health risks (RA-77218)","publisher":"Health Canada","date":"2025-04-02","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious","title":"Unauthorized injectable peptide drugs seized and sold by Canada Peptide may pose serious health risks (RA-77807)","publisher":"Health Canada","date":"2025-08-01","accessed":"2026-09-29"}]},{"molecule":"semaglutide","moleculeName":"Semaglutide","country":"canada","countryName":"Canada","countryIso2":"CA","status":"generic-available","statusLabel":"Generics available","headline":"Approved as Ozempic, Rybelsus and Wegovy; generic semaglutide approved from April 2026 and on sale since May 2026","detail":"Health Canada's Drug Product Database lists Novo Nordisk's Ozempic (marketed since 2018-02) and Rybelsus (2020-04) for type 2 diabetes and Wegovy for chronic weight management, cardiovascular risk reduction and MASH (the MASH indication is conditional under the NOC/c policy). Dr. Reddy's generic was approved on 2026-04-28, making Canada the first G7 country to approve a generic, followed by Apotex (2026-05-01), Sevmia (Apotex, generic weight-management semaglutide, 2026-06-29), Aspen and Sandoz (2026-09-16). The Drug Product Database shows the Dr. Reddy's and Apotex products as marketed since May 2026. In August and September 2026 Health Canada posted Type II recalls of specific generic lots: Dr. Reddy's (a mislabelled pen, and an out-of-specification impurity) and Apotex (pens that may show and deliver the wrong dose). Compounding copies of a commercially available product are discouraged by Health Canada policy, and a compounded semaglutide preparation made with an unauthorised ingredient was recalled in January 2025. Health Canada also seized unauthorised semaglutide at Rize Fitness in Vancouver (December 2025).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/semaglutide-in-canada","sources":[{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=semaglutide","title":"Drug Product Database API: active-ingredient search for semaglutide","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://pdf.hres.ca/dpd_pm/00085314.PDF","title":"Product Monograph: OZEMPIC (semaglutide injection)","publisher":"Novo Nordisk Canada Inc.","date":"2026-07-13","accessed":"2026-09-29"},{"url":"https://pdf.hres.ca/dpd_pm/00082777.PDF","title":"Product Monograph: WEGOVY (semaglutide injection)","publisher":"Novo Nordisk Canada Inc.","date":"2025-12-10","accessed":"2026-09-29"},{"url":"https://www.canada.ca/en/health-canada/news/2026/05/canada-approves-second-generic-semaglutide-the-first-g7-country-to-do-so.html","title":"Canada approves second generic semaglutide, the first G7 country to do so","publisher":"Health Canada","date":"2026-05-01","accessed":"2026-09-29"},{"url":"https://www.canada.ca/en/health-canada/news/2026/06/canada-approves-first-generic-semaglutide-for-weight-loss.html","title":"Canada approves first generic semaglutide for weight loss","publisher":"Health Canada","date":"2026-06-29","accessed":"2026-09-29"},{"url":"https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/policy-manufacturing-compounding-drug-products.html","title":"Policy on Manufacturing and Compounding Drug Products in Canada (POL-0051)","publisher":"Health Canada","date":"2009-01-26","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/semaglutide-pyridoxine-produced-unauthorized-active-pharmaceutical-ingredient","title":"Semaglutide + Pyridoxine: produced with an unauthorized active pharmaceutical ingredient","publisher":"Health Canada","date":"2025-01-21","accessed":"2026-09-29"},{"url":"https://www.canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html","title":"Canada becomes the first G7 country to approve a generic version of semaglutide","publisher":"Health Canada","date":"2026-04-28","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/semaglutide-injection-incorrect-pen-package","title":"Semaglutide Injection: Incorrect Pen in Package (Type II recall, RA-82477)","publisher":"Health Canada","date":"2026-08-11","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/semaglutide-injection-out-specification-impurity","title":"Semaglutide Injection: Out-of-Specification (Impurity) (Type II recall, RA-82537)","publisher":"Health Canada","date":"2026-08-26","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/apo-semaglutide-injection-incorrect-dose-display","title":"Apo-Semaglutide Injection: Incorrect dose display (Type II recall, RA-82536)","publisher":"Health Canada","date":"2026-08-27","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/apo-semaglutide-injection-incorrect-dose-display-0","title":"Apo-Semaglutide Injection: Incorrect dose display (Type II recall, RA-82679)","publisher":"Health Canada","date":"2026-09-24","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious","title":"Unauthorized health products sold online and seized at Rize Fitness may pose serious health risks","publisher":"Health Canada","date":"2025-12-24","accessed":"2026-09-29"}]},{"molecule":"semax","moleculeName":"Semax","country":"canada","countryName":"Canada","countryIso2":"CA","status":"prohibited","statusLabel":"Prohibited","headline":"Not authorised; named in Health Canada's 2025 Canada Peptide seizure notice","detail":"Semax does not appear in Health Canada's Drug Product Database. Health Canada's notice of 2025-08-01 lists Semax among unauthorised injectable peptide drugs seized from and sold by Canada Peptide, and says selling unauthorised drugs is illegal in Canada. Health Canada states that peptides are generally regulated as prescription drugs.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/semax-in-canada","sources":[{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=semax","title":"Drug Product Database API: active-ingredient search for semax","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","title":"Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)","publisher":"Health Canada","date":"2026-04-09","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious","title":"Unauthorized injectable peptide drugs seized and sold by Canada Peptide may pose serious health risks (RA-77807)","publisher":"Health Canada","date":"2025-08-01","accessed":"2026-09-29"}]},{"molecule":"sermorelin","moleculeName":"Sermorelin","country":"canada","countryName":"Canada","countryIso2":"CA","status":"prohibited","statusLabel":"Prohibited","headline":"Not authorised; named in Health Canada's 2025 Canada Peptide seizure notice and banned in sport","detail":"Sermorelin does not appear in Health Canada's Drug Product Database, so no authorised product exists. Health Canada's notice of 2025-08-01 lists sermorelin among unauthorised injectable peptide drugs seized from and sold by Canada Peptide, and says selling unauthorised drugs is illegal. The WADA Prohibited List 2026 bans sermorelin as a growth hormone releasing factor (S2.2.4).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/sermorelin-in-canada","sources":[{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=sermorelin","title":"Drug Product Database API: active-ingredient search for sermorelin","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","title":"Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)","publisher":"Health Canada","date":"2026-04-09","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"World Anti-Doping Code International Standard: Prohibited List 2026","publisher":"World Anti-Doping Agency","date":"2025-09","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious","title":"Unauthorized injectable peptide drugs seized and sold by Canada Peptide may pose serious health risks (RA-77807)","publisher":"Health Canada","date":"2025-08-01","accessed":"2026-09-29"}]},{"molecule":"setmelanotide","moleculeName":"Setmelanotide","country":"canada","countryName":"Canada","countryIso2":"CA","status":"approved-restricted","statusLabel":"Approved, restricted","headline":"Approved as Imcivree for weight management in acquired hypothalamic obesity, BBS and specific genetic deficiencies","detail":"Health Canada authorised Rhythm Pharmaceuticals' Imcivree (marketed since 2023-07-12). The monograph revised 2026-09-18 covers weight management in ages 4 and up with acquired hypothalamic obesity, and in ages 6 and up with obesity from Bardet-Biedl syndrome or from genetically confirmed POMC, PCSK1 or LEPR deficiency. It says setmelanotide is not indicated for other types of obesity, including general obesity.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/setmelanotide-in-canada","sources":[{"url":"https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102647","title":"Drug Product Database: IMCIVREE product record","publisher":"Health Canada (Drug Product Database)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://pdf.hres.ca/dpd_pm/00086135.PDF","title":"Product Monograph: IMCIVREE (setmelanotide injection)","publisher":"Rhythm Pharmaceuticals / Q&C Services","date":"2026-09-18","accessed":"2026-09-29"},{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=setmelanotide","title":"Drug Product Database API: active-ingredient search for setmelanotide","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"survodutide","moleculeName":"Survodutide","country":"canada","countryName":"Canada","countryIso2":"CA","status":"not-approved","statusLabel":"Not approved","headline":"Survodutide is an investigational drug with no Health Canada authorisation","detail":"Survodutide does not appear in Health Canada's Drug Product Database or in the new drug submissions under review list current as of 2026-08-31, so there is no authorised product and no pending file we could find. Unauthorised drug products are illegal to sell in Canada. Any legal access today would be through an authorised clinical trial.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/survodutide-in-canada","sources":[{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=survodutide","title":"Drug Product Database API: active-ingredient search for survodutide","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review/new-drug-submissions-under-review.html","title":"Drug and Health Product Submissions Under Review: New drug submissions under review (list current as of 2026-08-31)","publisher":"Health Canada","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","title":"Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)","publisher":"Health Canada","date":"2026-04-09","accessed":"2026-09-29"}]},{"molecule":"tb-500","moleculeName":"TB-500 (thymosin beta-4 fragment)","country":"canada","countryName":"Canada","countryIso2":"CA","status":"prohibited","statusLabel":"Prohibited","headline":"Not authorised; named in Health Canada's 2026 seizure advisory and banned in sport","detail":"No TB-500 or thymosin beta-4 product is authorised in Canada. Health Canada lists TB-500 among unauthorised injectable peptides it has seized (advisory of 2026-04-09), and the Optimum Wellness Centre (2025-04-02), Canada Peptide (2025-08-01) and Rize Fitness (2025-12-24) notices also name thymosin beta-4 (TB-500). Selling unauthorised injectables is illegal. The WADA Prohibited List 2026 bans thymosin-beta-4 and its derivatives, such as TB-500, in S2.3.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tb-500-in-canada","sources":[{"url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","title":"Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)","publisher":"Health Canada","date":"2026-04-09","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta","title":"Unauthorized injectable peptide drugs seized from Optimum Wellness Centre in Calgary, Alberta may pose serious health risks","publisher":"Health Canada","date":"2025-04-02","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"World Anti-Doping Code International Standard: Prohibited List 2026","publisher":"World Anti-Doping Agency","date":"2025-09","accessed":"2026-09-29"},{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=thymosin","title":"Drug Product Database API: active-ingredient search for thymosin","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious","title":"Unauthorized injectable peptide drugs seized and sold by Canada Peptide may pose serious health risks (RA-77807)","publisher":"Health Canada","date":"2025-08-01","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious","title":"Unauthorized health products sold online and seized at Rize Fitness may pose serious health risks","publisher":"Health Canada","date":"2025-12-24","accessed":"2026-09-29"}]},{"molecule":"tesamorelin","moleculeName":"Tesamorelin","country":"canada","countryName":"Canada","countryIso2":"CA","status":"prohibited","statusLabel":"Prohibited","headline":"Not authorised since Egrifta was cancelled in 2022; Health Canada has seized unauthorised tesamorelin (2025 notices)","detail":"Theratechnologies' Egrifta was sold in Canada from 2015-06 until its post-market cancellation on 2022-09-30, and a second Egrifta listing was cancelled before market on 2023-07-13. Nothing is currently marketed. Health Canada's notices on unauthorised injectable peptides seized from Canada Peptide (2025-08-01) and at Rize Fitness (2025-12-24) both name tesamorelin, and say selling unauthorised drugs is illegal. The WADA Prohibited List 2026 bans it in sport (S2.2.4).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tesamorelin-in-canada","sources":[{"url":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=tesamorelin","title":"Drug Product Database API: active-ingredient search for tesamorelin","publisher":"Health Canada (Drug Product Database)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=92311","title":"Drug Product Database: EGRIFTA product record (cancelled post-market 2022-09-30)","publisher":"Health Canada (Drug Product Database)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious","title":"Unauthorized health products sold online and seized at Rize Fitness may pose serious health risks","publisher":"Health Canada","date":"2025-12-24","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"World Anti-Doping Code International Standard: Prohibited List 2026","publisher":"World Anti-Doping Agency","date":"2025-09","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious","title":"Unauthorized injectable peptide drugs seized and sold by Canada Peptide may pose serious health risks (RA-77807)","publisher":"Health Canada","date":"2025-08-01","accessed":"2026-09-29"}]},{"molecule":"tirzepatide","moleculeName":"Tirzepatide","country":"canada","countryName":"Canada","countryIso2":"CA","status":"approved","statusLabel":"Approved","headline":"Approved as Mounjaro (type 2 diabetes) and Zepbound (weight management, sleep apnea); no generic submissions","detail":"Eli Lilly's Mounjaro is authorised for type 2 diabetes in adults and in children aged 10 to under 18, and Zepbound (marketed since 2025-07-09 per the Drug Product Database) for chronic weight management and moderate to severe obstructive sleep apnea in adults with obesity. The generic submissions list current as of 2026-08-31 shows none for tirzepatide. Health Canada seized unauthorised tirzepatide sold by Canada Peptide in 2025 and warned in January 2026 about fake or unauthorised GLP-1 products; compounded copies of an available product are discouraged under Health Canada's compounding policy.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tirzepatide-in-canada","sources":[{"url":"https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106082","title":"Drug Product Database: ZEPBOUND product record","publisher":"Health Canada (Drug Product Database)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://pdf.hres.ca/dpd_pm/00084997.PDF","title":"Product Monograph: ZEPBOUND (tirzepatide injection)","publisher":"Eli Lilly Canada Inc.","date":"2026-06-11","accessed":"2026-09-29"},{"url":"https://pdf.hres.ca/dpd_pm/00085122.PDF","title":"Product Monograph: MOUNJARO (tirzepatide injection)","publisher":"Eli Lilly Canada Inc.","date":"2026-06-23","accessed":"2026-09-29"},{"url":"https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/generic-submissions-under-review.html","title":"Generic submissions under review (list current as of 2026-08-31)","publisher":"Health Canada","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious","title":"Unauthorized injectable peptide drugs seized and sold by Canada Peptide may pose serious health risks","publisher":"Health Canada","date":"2025-08-01","accessed":"2026-09-29"},{"url":"https://recalls-rappels.canada.ca/en/alert-recall/thinking-about-buying-glp-1-drugs-ozempic-or-mounjaro-beware-fake-or-unauthorized","title":"Thinking about buying GLP-1 drugs like Ozempic or Mounjaro? Beware of fake or unauthorized products","publisher":"Health Canada","date":"2026-01-21","accessed":"2026-09-29"}]},{"molecule":"amycretin","moleculeName":"Amycretin","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in China; Novo Nordisk has only clinical-trial applications on file.","detail":"CDE's public register lists four Novo Nordisk import applications for amycretin (three tablet records accepted in April 2024 and one injection record accepted in December 2024), all at the clinical-trial stage. No marketing application was found and no approval exists, so amycretin cannot lawfully be sold as a medicine in China.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/amycretin-in-china","sources":[{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html","title":"Drug Administration Law of the PRC (中华人民共和国药品管理法)","publisher":"National Medical Products Administration (NMPA)","date":"2019-08-26","accessed":"2026-09-29"}]},{"molecule":"aod-9604","moleculeName":"AOD-9604","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"Not an approved medicine in China; unlawful to sell as a drug, and it is banned in sport.","detail":"AOD-9604 has no NMPA approval that we could find and no application in CDE's public register. Producing or importing it as a drug without approval is prohibited by Article 98 of the Drug Administration Law. The WADA Prohibited List names AOD-9604 among banned growth hormone fragments for athletes.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/aod-9604-in-china","sources":[{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html","title":"Drug Administration Law of the PRC (中华人民共和国药品管理法)","publisher":"National Medical Products Administration (NMPA)","date":"2019-08-26","accessed":"2026-09-29"},{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/en/prohibited-list","title":"The Prohibited List (2026)","publisher":"World Anti-Doping Agency (WADA)","date":"2026","accessed":"2026-09-29"}]},{"molecule":"bpc-157","moleculeName":"BPC-157","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"Not an approved medicine in China; producing, importing or selling it as a drug is unlawful, and it is banned in sport.","detail":"No NMPA marketing approval for BPC-157 exists that we could find, and CDE's public register holds no application under that name. Under Articles 98 and 124 of the Drug Administration Law, producing or importing a drug without an approval document is prohibited and punishable by confiscation and fines, and hospital preparations cannot be sold on the market. The WADA Prohibited List names BPC-157 as a non-approved substance banned at all times for athletes.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/bpc-157-in-china","sources":[{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html","title":"Drug Administration Law of the PRC (中华人民共和国药品管理法)","publisher":"National Medical Products Administration (NMPA)","date":"2019-08-26","accessed":"2026-09-29"},{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/en/prohibited-list","title":"The Prohibited List (2026)","publisher":"World Anti-Doping Agency (WADA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.chinada.cn/","title":"China Anti-Doping Agency (CHINADA) official website","publisher":"China Anti-Doping Agency (CHINADA)","date":"2026","accessed":"2026-09-29"}]},{"molecule":"bremelanotide","moleculeName":"Bremelanotide (PT-141)","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in China; the only CDE record we found is a 2019 import clinical-trial application.","detail":"CDE's public register shows one import clinical-trial application for bremelanotide injection by Palatin Technologies, accepted on 2019-04-22. We found no marketing application and no entry on the NMPA innovative-drug approvals list. China requires a marketing approval document before a drug can be produced, imported or sold (Drug Administration Law, Articles 24 and 98). NMPA's own database could not be searched, so an approval under a different Chinese name cannot be fully excluded.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/bremelanotide-in-china","sources":[{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/index.html","title":"NMPA innovative drug approvals list (创新药品名录)","publisher":"National Medical Products Administration (NMPA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html","title":"Drug Administration Law of the PRC (中华人民共和国药品管理法)","publisher":"National Medical Products Administration (NMPA)","date":"2019-08-26","accessed":"2026-09-29"}]},{"molecule":"cagrilintide","moleculeName":"Cagrilintide (and CagriSema)","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in China; CagriSema has been tested in China but only trial-stage filings are visible.","detail":"Novo Nordisk ran a CagriSema weight-management trial in China (37 Chinese sites, completed), and CDE's public register shows CagriSema clinical-trial supplementary filings accepted on 2026-07-30 and a one-off import of CagriSema reference-standard material on 2026-09-28. We found no marketing application, and the drug is not approved. Selling it as a medicine would be unlawful without approval.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/cagrilintide-in-china","sources":[{"url":"https://clinicaltrials.gov/study/NCT05996848","title":"A research study to see how well CagriSema helps people in China with excess body weight lose weight (NCT05996848)","publisher":"U.S. National Library of Medicine (ClinicalTrials.gov)","date":"2023-08","accessed":"2026-09-29"},{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html","title":"Drug Administration Law of the PRC (中华人民共和国药品管理法)","publisher":"National Medical Products Administration (NMPA)","date":"2019-08-26","accessed":"2026-09-29"}]},{"molecule":"cjc-1295","moleculeName":"CJC-1295","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"Not an approved medicine in China; unlawful to sell as a drug, and it is banned in sport.","detail":"CJC-1295 has no NMPA approval that we could find and no application in CDE's public register. Producing or importing it as a drug without approval is prohibited by Article 98 of the Drug Administration Law. The WADA Prohibited List names CJC-1295 among banned growth-hormone-releasing factors for athletes.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/cjc-1295-in-china","sources":[{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html","title":"Drug Administration Law of the PRC (中华人民共和国药品管理法)","publisher":"National Medical Products Administration (NMPA)","date":"2019-08-26","accessed":"2026-09-29"},{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/en/prohibited-list","title":"The Prohibited List (2026)","publisher":"World Anti-Doping Agency (WADA)","date":"2026","accessed":"2026-09-29"}]},{"molecule":"dsip","moleculeName":"DSIP (delta sleep-inducing peptide)","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"No NMPA approval found for DSIP; it cannot lawfully be sold as a medicine in China.","detail":"We found no NMPA approval and no application for delta sleep-inducing peptide in CDE's public register. Producing or importing a drug without an approval document is prohibited by Article 98 of the Drug Administration Law, with confiscation and fines under Article 124.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/dsip-in-china","sources":[{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html","title":"Drug Administration Law of the PRC (中华人民共和国药品管理法)","publisher":"National Medical Products Administration (NMPA)","date":"2019-08-26","accessed":"2026-09-29"},{"url":"https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_3275cb2a929d4c34ac8c0421b2a9c257.html","title":"Provisions for Drug Registration (SAMR Order No. 27; 药品注册管理办法)","publisher":"State Administration for Market Regulation (SAMR)","date":"2020-01-22","accessed":"2026-09-29"},{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"dulaglutide","moleculeName":"Dulaglutide","country":"china","countryName":"China","countryIso2":"CN","status":"approved","statusLabel":"Approved","headline":"Approved in China and on the national insurance list for type 2 diabetes, with restrictions; a domestic biosimilar application is in review.","detail":"Lilly's dulaglutide injection is on the 2025 national insurance list for type 2 diabetes in patients whose blood sugar is poorly controlled on metformin or insulin and who have a BMI of 25 or more, with the first prescription written by a specialist at a second-level or higher hospital. CDE's register shows Lilly supplementary filings in 2025 and domestic biosimilar marketing applications from Boan (accepted 2024-05; no longer on CDE's in-review list on 2026-09-29, and we could not confirm the outcome) and Shuanglu (accepted 2026-02; still in review). No weight-management indication is listed in the insurance entry.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/dulaglutide-in-china","sources":[{"url":"https://www.nhsa.gov.cn/module/download/downfile.jsp?classid=0&filename=a32f9f2f3fc046afaf08471f87456ce3.pdf","title":"National Basic Medical Insurance, Maternity Insurance and Work-Related Injury Insurance Drug List (2025 edition), effective 2026-01-01","publisher":"National Healthcare Security Administration (NHSA)","date":"2025-12","accessed":"2026-09-29"},{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"ecnoglutide","moleculeName":"Ecnoglutide","country":"china","countryName":"China","countryIso2":"CN","status":"approved","statusLabel":"Approved","headline":"Approved in China for type 2 diabetes (January 2026) and weight management (March 2026); Chinese-developed.","detail":"NMPA approved Sciwind's ecnoglutide injection for blood-sugar control in adults with type 2 diabetes on 2026-01-30. Sciwind announced on 2026-03-06 that NMPA also approved it for chronic weight management in Chinese adults with overweight or obesity, based on the SLIMMER phase 3 trial. It is not on the 2025 national insurance list, which took effect before the approvals.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ecnoglutide-in-china","sources":[{"url":"https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20260130142923121.html","title":"NMPA approves ecnoglutide injection for marketing (国家药监局批准埃诺格鲁肽注射液上市)","publisher":"National Medical Products Administration (NMPA)","date":"2026-01-30","accessed":"2026-09-29"},{"url":"https://www.sciwindbio.com/portal/index/newsdetail/id/125.html","title":"Sciwind Biosciences announces ecnoglutide injection approved by China's NMPA for chronic weight management","publisher":"Hangzhou Sciwind Biosciences","date":"2026-03-06","accessed":"2026-09-29"},{"url":"https://www.nhsa.gov.cn/module/download/downfile.jsp?classid=0&filename=a32f9f2f3fc046afaf08471f87456ce3.pdf","title":"National Basic Medical Insurance, Maternity Insurance and Work-Related Injury Insurance Drug List (2025 edition), effective 2026-01-01","publisher":"National Healthcare Security Administration (NHSA)","date":"2025-12","accessed":"2026-09-29"}]},{"molecule":"elamipretide","moleculeName":"Elamipretide (SS-31)","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in China; Stealth BioTherapeutics filed an import clinical-trial application in 2026.","detail":"CDE's public register shows an import clinical-trial application for elamipretide injection by Stealth BioTherapeutics, accepted on 2026-06-05. We found no marketing application and no entry on the NMPA innovative-drug approvals list, so it cannot lawfully be sold as a medicine in China (Drug Administration Law, Articles 24 and 98). NMPA's own database could not be searched, so an approval under a different Chinese name cannot be fully excluded.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/elamipretide-in-china","sources":[{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/index.html","title":"NMPA innovative drug approvals list (创新药品名录)","publisher":"National Medical Products Administration (NMPA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html","title":"Drug Administration Law of the PRC (中华人民共和国药品管理法)","publisher":"National Medical Products Administration (NMPA)","date":"2019-08-26","accessed":"2026-09-29"}]},{"molecule":"eloralintide","moleculeName":"Eloralintide","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in China; Lilly has import clinical-trial filings and Chinese phase 3 sites, but no marketing application was found.","detail":"Eloralintide is in Lilly's phase 3 obesity programme, and the registered study NCT07321886 lists 14 Chinese sites. CDE's public register shows Lilly import clinical-trial applications for eloralintide injection accepted in December 2025 and August 2026. We found no marketing application and no NMPA approval, so it cannot lawfully be sold as a medicine in China.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/eloralintide-in-china","sources":[{"url":"https://clinicaltrials.gov/study/NCT07321886","title":"A study of eloralintide (LY3841136) in participants with obesity or overweight without type 2 diabetes (NCT07321886)","publisher":"U.S. National Library of Medicine (ClinicalTrials.gov)","date":"2026-02","accessed":"2026-09-29"},{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html","title":"Drug Administration Law of the PRC (中华人民共和国药品管理法)","publisher":"National Medical Products Administration (NMPA)","date":"2019-08-26","accessed":"2026-09-29"}]},{"molecule":"epitalon","moleculeName":"Epitalon","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"No NMPA approval found for epitalon; it cannot lawfully be sold as a medicine in China.","detail":"We found no NMPA approval and no application for epitalon in CDE's public register. Under Article 98 of the Drug Administration Law, a drug must have an approval document before it is produced or imported, and hospital preparations may not be sold on the market.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/epitalon-in-china","sources":[{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html","title":"Drug Administration Law of the PRC (中华人民共和国药品管理法)","publisher":"National Medical Products Administration (NMPA)","date":"2019-08-26","accessed":"2026-09-29"},{"url":"https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_3275cb2a929d4c34ac8c0421b2a9c257.html","title":"Provisions for Drug Registration (SAMR Order No. 27; 药品注册管理办法)","publisher":"State Administration for Market Regulation (SAMR)","date":"2020-01-22","accessed":"2026-09-29"},{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"exenatide","moleculeName":"Exenatide","country":"china","countryName":"China","countryIso2":"CN","status":"generic-available","statusLabel":"Generics available","headline":"Approved, with a domestic generic approved in 2025; insurance covers it for type 2 diabetes.","detail":"Exenatide injection, the original AstraZeneca product, remains registered in China (import re-registration filed in 2023). On 2025-07-01 Chengdu Shengnuo Biotechnology (圣诺生物) announced that NMPA had issued a registration certificate for its domestic generic exenatide injection, for improving blood-sugar control in type 2 diabetes. The 2025 national insurance list includes exenatide injection for type 2 diabetes only.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/exenatide-in-china","sources":[{"url":"http://static.cninfo.com.cn/finalpage/2025-07-01/1224037851.PDF","title":"Chengdu Shengnuo Biotechnology: exenatide injection obtains drug registration certificate (圣诺生物关于自愿披露艾塞那肽注射液获得药品注册证书的公告)","publisher":"Chengdu Shengnuo Biotechnology (圣诺生物; Shanghai Stock Exchange STAR Market filing)","date":"2025-07-01","accessed":"2026-09-29"},{"url":"https://www.nhsa.gov.cn/module/download/downfile.jsp?classid=0&filename=a32f9f2f3fc046afaf08471f87456ce3.pdf","title":"National Basic Medical Insurance, Maternity Insurance and Work-Related Injury Insurance Drug List (2025 edition), effective 2026-01-01","publisher":"National Healthcare Security Administration (NHSA)","date":"2025-12","accessed":"2026-09-29"},{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"ghk-cu","moleculeName":"GHK-Cu (copper peptide)","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"No NMPA drug approval found for GHK-Cu; it cannot lawfully be sold as a medicine in China.","detail":"We found no NMPA drug approval and no application for GHK-Cu (copper peptide) in CDE's public register. Selling it as an injectable or other medicine would need a marketing approval under Article 98 of the Drug Administration Law, and hospital preparations cannot be sold on the market. This record covers medicines only; cosmetic ingredients are regulated separately and were not reviewed here.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ghk-cu-in-china","sources":[{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html","title":"Drug Administration Law of the PRC (中华人民共和国药品管理法)","publisher":"National Medical Products Administration (NMPA)","date":"2019-08-26","accessed":"2026-09-29"},{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_3275cb2a929d4c34ac8c0421b2a9c257.html","title":"Provisions for Drug Registration (SAMR Order No. 27; 药品注册管理办法)","publisher":"State Administration for Market Regulation (SAMR)","date":"2020-01-22","accessed":"2026-09-29"}]},{"molecule":"ipamorelin","moleculeName":"Ipamorelin","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"Not an approved medicine in China; unlawful to sell as a drug, and it is banned in sport.","detail":"Ipamorelin has no NMPA approval that we could find and no application in CDE's public register. Producing or importing it as a drug without approval is prohibited by Article 98 of the Drug Administration Law. The WADA Prohibited List names ipamorelin among banned growth hormone secretagogues for athletes.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ipamorelin-in-china","sources":[{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html","title":"Drug Administration Law of the PRC (中华人民共和国药品管理法)","publisher":"National Medical Products Administration (NMPA)","date":"2019-08-26","accessed":"2026-09-29"},{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/en/prohibited-list","title":"The Prohibited List (2026)","publisher":"World Anti-Doping Agency (WADA)","date":"2026","accessed":"2026-09-29"}]},{"molecule":"kisspeptin","moleculeName":"Kisspeptin","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"No NMPA approval found for kisspeptin; it cannot lawfully be sold as a medicine in China.","detail":"We found no NMPA approval and no application for kisspeptin in CDE's public register. A drug may not be produced or imported in China without an approval document (Drug Administration Law, Article 98), and hospital preparations may not be sold on the market.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/kisspeptin-in-china","sources":[{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html","title":"Drug Administration Law of the PRC (中华人民共和国药品管理法)","publisher":"National Medical Products Administration (NMPA)","date":"2019-08-26","accessed":"2026-09-29"},{"url":"https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_3275cb2a929d4c34ac8c0421b2a9c257.html","title":"Provisions for Drug Registration (SAMR Order No. 27; 药品注册管理办法)","publisher":"State Administration for Market Regulation (SAMR)","date":"2020-01-22","accessed":"2026-09-29"},{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"kpv","moleculeName":"KPV","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"No NMPA approval found for KPV; it cannot lawfully be sold as a medicine in China.","detail":"We found no NMPA approval and no application for KPV in CDE's public register. Producing, importing or selling it as a drug without an approval document is prohibited by Article 98 of the Drug Administration Law, with confiscation and fines under Article 124.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/kpv-in-china","sources":[{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html","title":"Drug Administration Law of the PRC (中华人民共和国药品管理法)","publisher":"National Medical Products Administration (NMPA)","date":"2019-08-26","accessed":"2026-09-29"},{"url":"https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_3275cb2a929d4c34ac8c0421b2a9c257.html","title":"Provisions for Drug Registration (SAMR Order No. 27; 药品注册管理办法)","publisher":"State Administration for Market Regulation (SAMR)","date":"2020-01-22","accessed":"2026-09-29"},{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"liraglutide","moleculeName":"Liraglutide","country":"china","countryName":"China","countryIso2":"CN","status":"generic-available","statusLabel":"Generics available","headline":"Approved, with Chinese-made biosimilar versions on the market since 2023 and insurance cover for type 2 diabetes.","detail":"The originator liraglutide entered the Chinese market in 2011 for adults with type 2 diabetes. NMPA approved Tonghua Dongbao's biosimilar liraglutide injection in December 2023 and Zhifei's subsidiary's biosimilar in July 2026, the latter for blood-sugar control and for lowering major heart and circulation events in adults with type 2 diabetes and cardiovascular disease. Zhifei's filing states that, per NMPA's website, six liraglutide injections were approved in China at that time. CDE's register shows further supplementary filings by other domestic makers. The 2025 national insurance list includes liraglutide injection for type 2 diabetes only.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/liraglutide-in-china","sources":[{"url":"http://static.cninfo.com.cn/finalpage/2023-12-05/1218507445.PDF","title":"Tonghua Dongbao: liraglutide injection obtains drug registration certificate (通化东宝关于利拉鲁肽注射液获得药品注册证书的公告)","publisher":"Tonghua Dongbao Pharmaceutical (Shanghai Stock Exchange filing)","date":"2023-12-05","accessed":"2026-09-29"},{"url":"http://static.cninfo.com.cn/finalpage/2026-07-10/1225418612.PDF","title":"Zhifei Biological: liraglutide injection obtains drug registration certificate (智飞生物关于利拉鲁肽注射液获得药品注册证书的公告)","publisher":"Chongqing Zhifei Biological Products (Shenzhen Stock Exchange filing)","date":"2026-07-10","accessed":"2026-09-29"},{"url":"https://www.nhsa.gov.cn/module/download/downfile.jsp?classid=0&filename=a32f9f2f3fc046afaf08471f87456ce3.pdf","title":"National Basic Medical Insurance, Maternity Insurance and Work-Related Injury Insurance Drug List (2025 edition), effective 2026-01-01","publisher":"National Healthcare Security Administration (NHSA)","date":"2025-12","accessed":"2026-09-29"},{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"ll-37","moleculeName":"LL-37","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"No NMPA approval found for LL-37; it cannot lawfully be sold as a medicine in China.","detail":"We found no NMPA approval and no application for LL-37 in CDE's public register. Producing or importing it as a drug without an approval document is prohibited by Article 98 of the Drug Administration Law, with confiscation and fines under Article 124.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ll-37-in-china","sources":[{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html","title":"Drug Administration Law of the PRC (中华人民共和国药品管理法)","publisher":"National Medical Products Administration (NMPA)","date":"2019-08-26","accessed":"2026-09-29"},{"url":"https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_3275cb2a929d4c34ac8c0421b2a9c257.html","title":"Provisions for Drug Registration (SAMR Order No. 27; 药品注册管理办法)","publisher":"State Administration for Market Regulation (SAMR)","date":"2020-01-22","accessed":"2026-09-29"},{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"maridebart-cafraglutide","moleculeName":"Maridebart cafraglutide (MariTide)","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in China; Amgen has trial-stage filings and Chinese sites in its outcomes trial.","detail":"CDE's public register shows Amgen import clinical-trial applications for AMG 133 (maridebart cafraglutide) accepted on 2026-07-13. Amgen's cardiovascular outcomes trial lists 40 sites in China. No marketing application was found, so the drug cannot lawfully be sold as a medicine in China.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/maridebart-cafraglutide-in-china","sources":[{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://clinicaltrials.gov/study/NCT07037433","title":"Evaluating the impact of maridebart cafraglutide on cardiovascular outcomes in participants with atherosclerotic cardiovascular disease and obesity (NCT07037433)","publisher":"U.S. National Library of Medicine (ClinicalTrials.gov)","date":"2025-07","accessed":"2026-09-29"},{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html","title":"Drug Administration Law of the PRC (中华人民共和国药品管理法)","publisher":"National Medical Products Administration (NMPA)","date":"2019-08-26","accessed":"2026-09-29"}]},{"molecule":"mazdutide","moleculeName":"Mazdutide","country":"china","countryName":"China","countryIso2":"CN","status":"approved","statusLabel":"Approved","headline":"Approved in China (first in the world) for weight management and type 2 diabetes; a higher-strength application is under review.","detail":"NMPA approved Innovent's mazdutide injection as a Class 1 innovative drug on 2025-06-27, for long-term weight management in adults with a BMI of 28 or more, or 24 or more with a related condition. Innovent's release of 2025-11-25 confirms a type 2 diabetes indication and announces that CDE accepted a supplementary application for a higher strength in moderate-to-severe obesity. CDE's register shows supplementary applications accepted on 2025-11-25 that were still on its in-review list on 2026-09-29, plus further supplementary filings in 2026. Mazdutide is not on the 2025 national insurance list.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/mazdutide-in-china","sources":[{"url":"https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20250627145044169.html","title":"NMPA approves mazdutide injection for marketing (国家药监局批准玛仕度肽注射液上市)","publisher":"National Medical Products Administration (NMPA)","date":"2025-06-27","accessed":"2026-09-29"},{"url":"https://www.prnewswire.com/news-releases/innovent-announces-mazdutide-first-dual-gcgglp-1-receptor-agonist-received-approval-from-chinas-nmpa-for-chronic-weight-management-302493152.html","title":"Innovent announces mazdutide, first dual GCG/GLP-1 receptor agonist, received approval from China's NMPA for chronic weight management","publisher":"PR Newswire (Innovent Biologics)","date":"2025-06-27","accessed":"2026-09-29"},{"url":"https://www.prnewswire.com/news-releases/mazdutide-9mg-supplementary-application-accepted-for-review-by-chinas-nmpa-potentially-offering-a-novel-drug-option-for-moderate-to-severe-obese-population-302625421.html","title":"Mazdutide 9mg supplementary application accepted for review by China's NMPA","publisher":"PR Newswire (Innovent Biologics)","date":"2025-11-25","accessed":"2026-09-29"},{"url":"https://www.prnewswire.com/news-releases/innovent-announces-2026-interim-results-and-business-updates-302859305.html","title":"Innovent announces 2026 interim results and business updates","publisher":"PR Newswire (Innovent Biologics)","date":"2026-08-25","accessed":"2026-09-29"},{"url":"https://www.nhsa.gov.cn/module/download/downfile.jsp?classid=0&filename=a32f9f2f3fc046afaf08471f87456ce3.pdf","title":"National Basic Medical Insurance, Maternity Insurance and Work-Related Injury Insurance Drug List (2025 edition), effective 2026-01-01","publisher":"National Healthcare Security Administration (NHSA)","date":"2025-12","accessed":"2026-09-29"}]},{"molecule":"melanotan-ii","moleculeName":"Melanotan II","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"No NMPA approval found for melanotan II; it cannot lawfully be sold as a medicine in China.","detail":"We found no NMPA approval and no application for melanotan II in CDE's public register. Producing, importing or selling it as a drug without an approval document is prohibited by Article 98 of the Drug Administration Law, and Article 124 sets confiscation and fines.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/melanotan-ii-in-china","sources":[{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html","title":"Drug Administration Law of the PRC (中华人民共和国药品管理法)","publisher":"National Medical Products Administration (NMPA)","date":"2019-08-26","accessed":"2026-09-29"},{"url":"https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_3275cb2a929d4c34ac8c0421b2a9c257.html","title":"Provisions for Drug Registration (SAMR Order No. 27; 药品注册管理办法)","publisher":"State Administration for Market Regulation (SAMR)","date":"2020-01-22","accessed":"2026-09-29"},{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"mots-c","moleculeName":"MOTS-c","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"Not an approved medicine in China; unlawful to sell as a drug, and it is named on the WADA banned list.","detail":"MOTS-c has no NMPA approval that we could find and no application in CDE's public register. Producing or importing it as a drug without approval is prohibited by Article 98 of the Drug Administration Law. The WADA Prohibited List names MOTS-c among banned metabolic modulators for athletes.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/mots-c-in-china","sources":[{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html","title":"Drug Administration Law of the PRC (中华人民共和国药品管理法)","publisher":"National Medical Products Administration (NMPA)","date":"2019-08-26","accessed":"2026-09-29"},{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/en/prohibited-list","title":"The Prohibited List (2026)","publisher":"World Anti-Doping Agency (WADA)","date":"2026","accessed":"2026-09-29"}]},{"molecule":"nad-plus","moleculeName":"NAD+","country":"china","countryName":"China","countryIso2":"CN","status":"approved-restricted","statusLabel":"Approved, restricted","headline":"Coenzyme I (NAD) for injection has domestic prescription-drug filings; wellness or anti-ageing use is not an approved purpose.","detail":"CDE's public register lists domestic applications for coenzyme I for injection (NAD), including supplementary applications filed in 2012 (Hefei Pingguang) and in 2019 and 2025 (Kaifeng Kangnuo), which are only filed for products that already have an approval, a 2012 generic application, and new-drug clinical applications for improved coenzyme I for injection in 2023 and 2025. We did not retrieve the approval certificate or the approved indications, so the exact label is not confirmed here. Any approved product is subject to the Drug Administration Law's rules on sale and advertising, and \"NAD+\" wellness products or services are not covered by this record.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/nad-plus-in-china","sources":[{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_27f2fba302ab48239dfde1a5b5095156.html","title":"Measures for the Supervision of Online Drug Sales (SAMR Order No. 58; 药品网络销售监督管理办法)","publisher":"State Administration for Market Regulation (SAMR)","date":"2022-08","accessed":"2026-09-29"},{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20230328161808137.html","title":"Advertising Law of the PRC, 2021 amendment (中华人民共和国广告法)","publisher":"National Medical Products Administration (NMPA)","date":"2021-04-29","accessed":"2026-09-29"}]},{"molecule":"orforglipron","moleculeName":"Orforglipron","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in China; Lilly has clinical-trial filings and Chinese trial sites, but we found no marketing application.","detail":"CDE's public register shows Lilly's clinical-trial applications for LY3502970 capsules accepted in 2023 and 66 further import clinical-trial applications for orforglipron capsules and tablets (May 2024 to 2026-06-04), and the obesity master protocol on ClinicalTrials.gov includes 12 sites in China. We found no marketing application under the name or code, and the NMPA innovative-drug approval pages we reviewed (from mid-2025) show none, so the drug cannot lawfully be sold as a medicine in China. Lilly's second-quarter 2026 report mentions a US submission for type 2 diabetes and does not mention a China filing.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/orforglipron-in-china","sources":[{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://clinicaltrials.gov/study/NCT06993792","title":"A master protocol for orforglipron in participants with obesity or overweight with and without type 2 diabetes (NCT06993792)","publisher":"U.S. National Library of Medicine (ClinicalTrials.gov)","date":"2025-05","accessed":"2026-09-29"},{"url":"https://www.prnewswire.com/news-releases/lilly-reports-second-quarter-2026-financial-results-raises-full-year-guidance-and-highlights-continued-growth-and-pipeline-progress-302843165.html","title":"Lilly reports second-quarter 2026 financial results","publisher":"PR Newswire (Eli Lilly and Company)","date":"2026-08-05","accessed":"2026-09-29"},{"url":"https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/index.html","title":"NMPA innovative drug approvals list (创新药品名录)","publisher":"National Medical Products Administration (NMPA)","date":"2026-09","accessed":"2026-09-29"}]},{"molecule":"pramlintide","moleculeName":"Pramlintide","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in China; only old clinical-stage filings by domestic developers appear in the public register.","detail":"CDE's public register lists nine records for pramlintide acetate, filed between 2008 and 2014 by domestic developers (Hainan Zhonghe in 2008, Hanyu Pharmaceutical in 2010 and 2014, and two 2009 records without a named company), all new-drug or supplementary filings and none a marketing application for an approved product. Pramlintide is not on the 2025 national insurance list and we found no NMPA approval, so it cannot lawfully be sold as a medicine in China.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/pramlintide-in-china","sources":[{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.nhsa.gov.cn/module/download/downfile.jsp?classid=0&filename=a32f9f2f3fc046afaf08471f87456ce3.pdf","title":"National Basic Medical Insurance, Maternity Insurance and Work-Related Injury Insurance Drug List (2025 edition), effective 2026-01-01","publisher":"National Healthcare Security Administration (NHSA)","date":"2025-12","accessed":"2026-09-29"},{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html","title":"Drug Administration Law of the PRC (中华人民共和国药品管理法)","publisher":"National Medical Products Administration (NMPA)","date":"2019-08-26","accessed":"2026-09-29"}]},{"molecule":"retatrutide","moleculeName":"Retatrutide","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in China or anywhere else; only trial-stage filings exist.","detail":"CDE's public register shows seven Lilly clinical-trial-stage records for LY3437943 (2021 to April 2023) and five more import clinical-trial applications for retatrutide injection accepted on 2025-09-12, and a phase 1 study in Chinese participants was completed in 2023. We found no marketing application. Lilly stated on 2026-08-12 that no medicine containing retatrutide has been approved for human use by any regulator. Anything sold in China as retatrutide would be an unapproved drug under Article 98 of the Drug Administration Law.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/retatrutide-in-china","sources":[{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://clinicaltrials.gov/study/NCT05548231","title":"A study of LY3437943 (retatrutide) in Chinese participants with obesity or overweight (NCT05548231)","publisher":"U.S. National Library of Medicine (ClinicalTrials.gov)","date":"2022-10","accessed":"2026-09-29"},{"url":"https://www.prnewswire.com/news-releases/lilly-calls-on-online-platforms-payment-companies-and-regulators-to-shut-down-the-illegal-retatrutide-black-market-302849551.html","title":"Lilly calls on online platforms, payment companies and regulators to shut down the illegal retatrutide black market","publisher":"PR Newswire (Eli Lilly and Company)","date":"2026-08-12","accessed":"2026-09-29"},{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html","title":"Drug Administration Law of the PRC (中华人民共和国药品管理法)","publisher":"National Medical Products Administration (NMPA)","date":"2019-08-26","accessed":"2026-09-29"}]},{"molecule":"selank","moleculeName":"Selank","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"No NMPA approval found for Selank; it cannot lawfully be sold as a medicine in China.","detail":"We found no NMPA approval and no application for Selank in CDE's public register. Producing or importing a drug without an approval document is prohibited by Article 98 of the Drug Administration Law, and Article 124 sets confiscation and fines.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/selank-in-china","sources":[{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html","title":"Drug Administration Law of the PRC (中华人民共和国药品管理法)","publisher":"National Medical Products Administration (NMPA)","date":"2019-08-26","accessed":"2026-09-29"},{"url":"https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_3275cb2a929d4c34ac8c0421b2a9c257.html","title":"Provisions for Drug Registration (SAMR Order No. 27; 药品注册管理办法)","publisher":"State Administration for Market Regulation (SAMR)","date":"2020-01-22","accessed":"2026-09-29"},{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"semaglutide","moleculeName":"Semaglutide","country":"china","countryName":"China","countryIso2":"CN","status":"approved","statusLabel":"Approved","headline":"Approved in China as an imported brand; domestic generics are still waiting for approval.","detail":"Novo Nordisk's originator semaglutide injection is on the market in China, and the 2025 national insurance list (from 2026-01-01) covers it only for type 2 diabetes. Novo Nordisk's weight-management brand (Wegovy) is also sold: its price per pen roughly halved in late 2025, and a Chinese developer used it as the comparator in a phase 3 weight trial. On 2026-09-08 a listed developer stated that, per NMPA's website, no domestically made semaglutide is approved, and CDE's public register shows many domestic applications, including a weight-management application accepted on 2026-07-02 and a new import marketing application for semaglutide tablets accepted on 2026-08-27. Novo Nordisk's semaglutide tablets already have post-approval supplementary filings in the register (from 2024), which points to an approved tablet product. The compound patent was reported to expire on 2026-03-20. There is no pharmacy compounding route in China.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/semaglutide-in-china","sources":[{"url":"https://www.nhsa.gov.cn/module/download/downfile.jsp?classid=0&filename=a32f9f2f3fc046afaf08471f87456ce3.pdf","title":"National Basic Medical Insurance, Maternity Insurance and Work-Related Injury Insurance Drug List (2025 edition), effective 2026-01-01","publisher":"National Healthcare Security Administration (NHSA)","date":"2025-12","accessed":"2026-09-29"},{"url":"http://static.cninfo.com.cn/finalpage/2026-09-08/1225553187.PDF","title":"Zhifei Biological: semaglutide injection production-registration application accepted (智飞生物关于司美格鲁肽注射液申请生产注册获得受理的公告)","publisher":"Chongqing Zhifei Biological Products (Shenzhen Stock Exchange filing)","date":"2026-09-08","accessed":"2026-09-29"},{"url":"http://static.cninfo.com.cn/finalpage/2026-05-07/1225279740.PDF","title":"Hanyu Pharmaceutical: phase III data for semaglutide injection (翰宇药业关于司美格鲁肽注射液取得III期临床试验数据的公告)","publisher":"Shenzhen Hybio Pharmaceutical (Shenzhen Stock Exchange filing)","date":"2026-05-07","accessed":"2026-09-29"},{"url":"http://static.cninfo.com.cn/finalpage/2026-07-04/1225408176.PDF","title":"Hanyu Pharmaceutical: semaglutide injection (weight management) marketing application accepted (翰宇药业关于司美格鲁肽注射液（减重）上市申请获得受理的公告)","publisher":"Shenzhen Hybio Pharmaceutical (Shenzhen Stock Exchange filing)","date":"2026-07-04","accessed":"2026-09-29"},{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.yicaiglobal.com/news/prices-of-imported-glp-1-weight-loss-drugs-halve-as-patent-protection-in-china-to-expire","title":"Prices of imported GLP-1 weight-loss drugs halve as patent protection in China to expire","publisher":"Yicai Global","date":"2025-12-29","accessed":"2026-09-29"}]},{"molecule":"semax","moleculeName":"Semax","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"No NMPA approval found for Semax; it cannot lawfully be sold as a medicine in China.","detail":"We found no NMPA approval and no application for Semax in CDE's public register. Under Article 98 of the Drug Administration Law a drug may not be produced or imported without an approval document, and Article 124 sets confiscation and fines; only small quantities of a drug already lawfully marketed abroad can receive mitigation.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/semax-in-china","sources":[{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html","title":"Drug Administration Law of the PRC (中华人民共和国药品管理法)","publisher":"National Medical Products Administration (NMPA)","date":"2019-08-26","accessed":"2026-09-29"},{"url":"https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_3275cb2a929d4c34ac8c0421b2a9c257.html","title":"Provisions for Drug Registration (SAMR Order No. 27; 药品注册管理办法)","publisher":"State Administration for Market Regulation (SAMR)","date":"2020-01-22","accessed":"2026-09-29"},{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"sermorelin","moleculeName":"Sermorelin","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"No NMPA approval found for sermorelin; it cannot lawfully be sold as a medicine in China and is banned in sport.","detail":"We found no NMPA approval for sermorelin. CDE's public register has no record under its international name; under its Chinese name (舍莫瑞林) it shows only new-drug filings from 2002 and a supplementary filing from 2005 by a Hainan research institute, with no later activity. Producing or importing a drug without an approval document is prohibited by Article 98 of the Drug Administration Law. The WADA Prohibited List names sermorelin among banned growth-hormone-releasing factors for athletes.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/sermorelin-in-china","sources":[{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html","title":"Drug Administration Law of the PRC (中华人民共和国药品管理法)","publisher":"National Medical Products Administration (NMPA)","date":"2019-08-26","accessed":"2026-09-29"},{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/en/prohibited-list","title":"The Prohibited List (2026)","publisher":"World Anti-Doping Agency (WADA)","date":"2026","accessed":"2026-09-29"}]},{"molecule":"setmelanotide","moleculeName":"Setmelanotide","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in China; the only CDE record we found is a 2022 import clinical-trial application.","detail":"CDE's public register shows one import clinical-trial application for setmelanotide injection, accepted on 2022-06-22 (Rhythm Pharmaceuticals with Citrine Medicine). We found no marketing application and no entry on the NMPA innovative-drug approvals list. China requires a marketing approval document before a drug can be produced, imported or sold (Drug Administration Law, Articles 24 and 98). NMPA's own database could not be searched, so an approval under a different Chinese name cannot be fully excluded.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/setmelanotide-in-china","sources":[{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/index.html","title":"NMPA innovative drug approvals list (创新药品名录)","publisher":"National Medical Products Administration (NMPA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html","title":"Drug Administration Law of the PRC (中华人民共和国药品管理法)","publisher":"National Medical Products Administration (NMPA)","date":"2019-08-26","accessed":"2026-09-29"}]},{"molecule":"survodutide","moleculeName":"Survodutide","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in China; Boehringer Ingelheim has trial-stage filings and a Chinese study only.","detail":"CDE's public register holds 90 records for BI 456906 (survodutide), the most recent being trial-related import and supplementary filings (2025-10 and 2026), and we found no marketing application. A phase 1 study in Chinese adults with overweight or obesity ran from 2024 and was completed in April 2025. Survodutide has no approval anywhere that we could confirm, so it cannot lawfully be sold as a medicine in China.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/survodutide-in-china","sources":[{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://clinicaltrials.gov/study/NCT06492135","title":"A study in Chinese people with overweight or obesity to test how different doses of survodutide are taken up in the body (NCT06492135)","publisher":"U.S. National Library of Medicine (ClinicalTrials.gov)","date":"2024-08","accessed":"2026-09-29"},{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html","title":"Drug Administration Law of the PRC (中华人民共和国药品管理法)","publisher":"National Medical Products Administration (NMPA)","date":"2019-08-26","accessed":"2026-09-29"}]},{"molecule":"tb-500","moleculeName":"TB-500 (thymosin beta-4 fragment)","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"Not an approved medicine in China; it is unlawful to make, import or sell it as a drug, and it is banned in sport.","detail":"TB-500 (a thymosin beta-4 fragment) has no NMPA approval that we could find, and no application under that name appears in CDE's public register. China's Drug Administration Law prohibits producing or importing a drug without an approval document (Article 98). The WADA Prohibited List names thymosin-beta-4 and its derivatives, such as TB-500, among banned growth factors. CDE's register shows only 2014 new-drug filings for the parent protein, thymosin beta-4, by a domestic company, with no approval found. Approved thymosin products in China, such as thymalfasin, are different substances.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tb-500-in-china","sources":[{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html","title":"Drug Administration Law of the PRC (中华人民共和国药品管理法)","publisher":"National Medical Products Administration (NMPA)","date":"2019-08-26","accessed":"2026-09-29"},{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/en/prohibited-list","title":"The Prohibited List (2026)","publisher":"World Anti-Doping Agency (WADA)","date":"2026","accessed":"2026-09-29"}]},{"molecule":"tesamorelin","moleculeName":"Tesamorelin","country":"china","countryName":"China","countryIso2":"CN","status":"not-approved","statusLabel":"Not approved","headline":"No NMPA approval found for tesamorelin; it cannot lawfully be sold as a medicine in China.","detail":"We found no application or approval for tesamorelin in CDE's public register under its international name or the Chinese name 替莫瑞林, nor on the NMPA innovative-drug approvals list. China requires a marketing approval document before a drug can be produced, imported or sold (Drug Administration Law, Article 98). Our search of NMPA's own database was not possible, so an approval under a different Chinese name cannot be fully excluded. The WADA Prohibited List names tesamorelin among growth-hormone-releasing factors that are banned for athletes.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tesamorelin-in-china","sources":[{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/index.html","title":"NMPA innovative drug approvals list (创新药品名录)","publisher":"National Medical Products Administration (NMPA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html","title":"Drug Administration Law of the PRC (中华人民共和国药品管理法)","publisher":"National Medical Products Administration (NMPA)","date":"2019-08-26","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/en/prohibited-list","title":"The Prohibited List (2026)","publisher":"World Anti-Doping Agency (WADA)","date":"2026","accessed":"2026-09-29"}]},{"molecule":"tirzepatide","moleculeName":"Tirzepatide","country":"china","countryName":"China","countryIso2":"CN","status":"approved","statusLabel":"Approved","headline":"Approved in China; Lilly's imported and locally made products are sold, and insurance covers it for type 2 diabetes only.","detail":"Tirzepatide is marketed by Lilly in China, with both an imported and a localised product on sale according to a 2026-08-08 company filing. That filing, which reports the first domestic generic application, lists the reference product's indications as type 2 diabetes, long-term weight management in adults (BMI 28 or more, or 24 or more with a related condition) and moderate-to-severe sleep apnoea with obesity. The 2025 national insurance list, effective 2026-01-01, lists tirzepatide for adults with type 2 diabetes only, and Lilly's second-quarter 2026 report notes the addition of Mounjaro to China's NRDL in the first quarter of 2026. No compounding channel exists.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tirzepatide-in-china","sources":[{"url":"https://www.nhsa.gov.cn/module/download/downfile.jsp?classid=0&filename=a32f9f2f3fc046afaf08471f87456ce3.pdf","title":"National Basic Medical Insurance, Maternity Insurance and Work-Related Injury Insurance Drug List (2025 edition), effective 2026-01-01","publisher":"National Healthcare Security Administration (NHSA)","date":"2025-12","accessed":"2026-09-29"},{"url":"http://static.cninfo.com.cn/finalpage/2026-08-08/1225463132.PDF","title":"Hanyu Pharmaceutical: tirzepatide injection first-generic marketing application accepted (翰宇药业关于替尔泊肽注射液首仿上市申请获得受理的公告)","publisher":"Shenzhen Hybio Pharmaceutical (Shenzhen Stock Exchange filing)","date":"2026-08-08","accessed":"2026-09-29"},{"url":"https://www.prnewswire.com/news-releases/lilly-reports-second-quarter-2026-financial-results-raises-full-year-guidance-and-highlights-continued-growth-and-pipeline-progress-302843165.html","title":"Lilly reports second-quarter 2026 financial results","publisher":"PR Newswire (Eli Lilly and Company)","date":"2026-08-05","accessed":"2026-09-29"},{"url":"https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d","title":"CDE public register of accepted drug applications (受理品种目录浏览)","publisher":"Center for Drug Evaluation (CDE), NMPA","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"amycretin","moleculeName":"Amycretin","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"Investigational; no EU marketing authorisation and no application under evaluation","detail":"Amycretin does not appear in the Union Register or in EMA's September 2026 list of applications under evaluation. It is an investigational medicine with no EU authorisation. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/amycretin-in-european-union","sources":[{"url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","title":"Union Register of medicinal products for human use","publisher":"European Commission","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.ema.europa.eu/en/documents/report/applications-new-human-medicines-under-evaluation-september-2026_en.xlsx","title":"Applications for new human medicines under evaluation by the CHMP (September 2026)","publisher":"European Medicines Agency","date":"2026-09-04","accessed":"2026-09-29"},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101","title":"Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)","publisher":"European Union (EUR-Lex)","date":"2025-01-01","accessed":"2026-09-29"}]},{"molecule":"aod-9604","moleculeName":"AOD-9604","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"No EU marketing authorisation; banned in sport (WADA S2.2.3)","detail":"AOD-9604 has no EU marketing authorisation and does not appear in the EMA dataset or the Union Register. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation. WADA's 2026 Prohibited List names AOD-9604 and hGH 176-191 under S2.2.3 (growth hormone fragments).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/aod-9604-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","title":"EMA medicines data (JSON report): human and veterinary medicines, with authorisation status","publisher":"European Medicines Agency","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101","title":"Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)","publisher":"European Union (EUR-Lex)","date":"2025-01-01","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"The 2026 Prohibited List","publisher":"World Anti-Doping Agency","date":"2025-09","accessed":"2026-09-29"}]},{"molecule":"bpc-157","moleculeName":"BPC-157","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"Not authorised as a medicine in the EU; also on the WADA prohibited list (S0)","detail":"BPC-157 has no marketing authorisation in the EU, and it does not appear in the EMA dataset or the Union Register. A substance that may be given to people to change body functions counts as a medicinal product under Article 1(2) of Directive 2001/83/EC, and the definition is not limited to how a product is labelled (Art. 1(2)(b)); in borderline cases the medicines rules take priority (Art. 2(2)). Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation. WADA lists BPC-157 by name under S0 (non-approved substances), so it is banned in sport at all times.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/bpc-157-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","title":"EMA medicines data (JSON report): human and veterinary medicines, with authorisation status","publisher":"European Medicines Agency","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101","title":"Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)","publisher":"European Union (EUR-Lex)","date":"2025-01-01","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"The 2026 Prohibited List","publisher":"World Anti-Doping Agency","date":"2025-09","accessed":"2026-09-29"}]},{"molecule":"bremelanotide","moleculeName":"Bremelanotide (PT-141)","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"No EU marketing authorisation; not listed in EMA or Union Register data","detail":"Bremelanotide does not appear in the EMA medicines dataset or in the Union Register, so there is no EU-wide authorisation. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation. National registers were not searched one by one.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/bremelanotide-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","title":"EMA medicines data (JSON report): human and veterinary medicines, with authorisation status","publisher":"European Medicines Agency","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","title":"Union Register of medicinal products for human use","publisher":"European Commission","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101","title":"Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)","publisher":"European Union (EUR-Lex)","date":"2025-01-01","accessed":"2026-09-29"}]},{"molecule":"cagrilintide","moleculeName":"Cagrilintide (and CagriSema)","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"No EU marketing authorisation; no application on EMA's September 2026 evaluation list","detail":"Cagrilintide, alone or combined with semaglutide (CagriSema), has no EU authorisation. It does not appear in the Union Register or in EMA's September 2026 list of applications under evaluation, so it is still an investigational medicine in the EU. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/cagrilintide-in-european-union","sources":[{"url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","title":"Union Register of medicinal products for human use","publisher":"European Commission","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.ema.europa.eu/en/documents/report/applications-new-human-medicines-under-evaluation-september-2026_en.xlsx","title":"Applications for new human medicines under evaluation by the CHMP (September 2026)","publisher":"European Medicines Agency","date":"2026-09-04","accessed":"2026-09-29"},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101","title":"Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)","publisher":"European Union (EUR-Lex)","date":"2025-01-01","accessed":"2026-09-29"}]},{"molecule":"cjc-1295","moleculeName":"CJC-1295","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"No EU marketing authorisation; banned in sport (WADA S2.2.4)","detail":"CJC-1295 has no EU marketing authorisation and does not appear in the EMA dataset or the Union Register. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation. WADA's 2026 Prohibited List names CJC-1295 (and CJC-1293) under S2.2.4 as growth-hormone-releasing hormone analogues.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/cjc-1295-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","title":"EMA medicines data (JSON report): human and veterinary medicines, with authorisation status","publisher":"European Medicines Agency","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101","title":"Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)","publisher":"European Union (EUR-Lex)","date":"2025-01-01","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"The 2026 Prohibited List","publisher":"World Anti-Doping Agency","date":"2025-09","accessed":"2026-09-29"}]},{"molecule":"dsip","moleculeName":"DSIP (delta sleep-inducing peptide)","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"No EU marketing authorisation; not listed in EMA or Union Register data","detail":"DSIP (delta sleep-inducing peptide) does not appear in the EMA medicines dataset or the Union Register, so there is no EU-wide authorisation. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation. No EU regulator has issued a DSIP-specific decision that we found.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/dsip-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","title":"EMA medicines data (JSON report): human and veterinary medicines, with authorisation status","publisher":"European Medicines Agency","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","title":"Union Register of medicinal products for human use","publisher":"European Commission","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101","title":"Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)","publisher":"European Union (EUR-Lex)","date":"2025-01-01","accessed":"2026-09-29"}]},{"molecule":"dulaglutide","moleculeName":"Dulaglutide","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"approved","statusLabel":"Approved","headline":"Authorised EU-wide as Trulicity for type 2 diabetes (from age 10); no weight-management indication","detail":"Trulicity has been centrally authorised since 21 November 2014 for insufficiently controlled type 2 diabetes in patients aged 10 years and above. Its EU label does not include a weight-management indication. It is a prescription-only medicine.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/dulaglutide-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/trulicity","title":"Trulicity: EPAR (European public assessment report)","publisher":"European Medicines Agency","date":"2026-01-30","accessed":"2026-09-29"},{"url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","title":"Union Register of medicinal products for human use","publisher":"European Commission","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"ecnoglutide","moleculeName":"Ecnoglutide","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"No EU marketing authorisation and no application under evaluation","detail":"Ecnoglutide does not appear in the Union Register or in EMA's September 2026 list of applications under evaluation, so it has no EU authorisation. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ecnoglutide-in-european-union","sources":[{"url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","title":"Union Register of medicinal products for human use","publisher":"European Commission","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.ema.europa.eu/en/documents/report/applications-new-human-medicines-under-evaluation-september-2026_en.xlsx","title":"Applications for new human medicines under evaluation by the CHMP (September 2026)","publisher":"European Medicines Agency","date":"2026-09-04","accessed":"2026-09-29"},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101","title":"Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)","publisher":"European Union (EUR-Lex)","date":"2025-01-01","accessed":"2026-09-29"}]},{"molecule":"elamipretide","moleculeName":"Elamipretide (SS-31)","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"No EU marketing authorisation; only EU orphan designations exist","detail":"Elamipretide has no EU marketing authorisation. It holds two EU orphan designations (Barth syndrome, designated 20 May 2021, and myopathic mitochondrial DNA depletion syndrome, designated 16 May 2022). An orphan designation is a development incentive and not an approval. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/elamipretide-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-21-2430","title":"EU/3/21/2430: orphan designation for elamipretide (Barth syndrome)","publisher":"European Medicines Agency","date":"2021-05-20","accessed":"2026-09-29"},{"url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","title":"EMA medicines data (JSON report): human and veterinary medicines, with authorisation status","publisher":"European Medicines Agency","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","title":"Union Register of medicinal products for human use","publisher":"European Commission","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"eloralintide","moleculeName":"Eloralintide","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"Investigational; no EU marketing authorisation and no application under evaluation","detail":"Eloralintide does not appear in the Union Register or in EMA's September 2026 list of applications under evaluation. It has no EU authorisation and can only be used in authorised clinical trials. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/eloralintide-in-european-union","sources":[{"url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","title":"Union Register of medicinal products for human use","publisher":"European Commission","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.ema.europa.eu/en/documents/report/applications-new-human-medicines-under-evaluation-september-2026_en.xlsx","title":"Applications for new human medicines under evaluation by the CHMP (September 2026)","publisher":"European Medicines Agency","date":"2026-09-04","accessed":"2026-09-29"},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101","title":"Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)","publisher":"European Union (EUR-Lex)","date":"2025-01-01","accessed":"2026-09-29"}]},{"molecule":"epitalon","moleculeName":"Epitalon","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"No EU marketing authorisation; not listed in EMA or Union Register data","detail":"Epitalon (epithalon) does not appear in the EMA medicines dataset or the Union Register, so there is no EU-wide authorisation. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation. No EU regulator has issued an epitalon-specific decision that we found.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/epitalon-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","title":"EMA medicines data (JSON report): human and veterinary medicines, with authorisation status","publisher":"European Medicines Agency","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","title":"Union Register of medicinal products for human use","publisher":"European Commission","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101","title":"Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)","publisher":"European Union (EUR-Lex)","date":"2025-01-01","accessed":"2026-09-29"}]},{"molecule":"exenatide","moleculeName":"Exenatide","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"approved","statusLabel":"Approved","headline":"Authorised EU-wide for type 2 diabetes as Byetta (2006) and Bydureon (2011)","detail":"Exenatide is authorised centrally as Byetta (authorised 2006) and Bydureon (authorised 2011), both from AstraZeneca and both for type 2 diabetes in adults alongside other glucose-lowering medicines. Neither has a weight-management indication in the EU. They are prescription-only medicines.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/exenatide-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/byetta","title":"Byetta: EPAR (European public assessment report)","publisher":"European Medicines Agency","date":"2024-11-06","accessed":"2026-09-29"},{"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/bydureon","title":"Bydureon: EPAR (European public assessment report)","publisher":"European Medicines Agency","date":"2024-11-21","accessed":"2026-09-29"}]},{"molecule":"ghk-cu","moleculeName":"GHK-Cu (copper peptide)","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"No EU marketing authorisation as a medicine; no specific EU medicines rule beyond the general one","detail":"GHK-Cu (copper tripeptide) has no marketing authorisation as a medicine in the EU and does not appear in the EMA dataset or the Union Register. Presented as a treatment, or given to people to change body functions, it falls under the EU definition of a medicinal product and would need authorisation. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation. This record does not assess its separate status as a cosmetic ingredient.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ghk-cu-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","title":"EMA medicines data (JSON report): human and veterinary medicines, with authorisation status","publisher":"European Medicines Agency","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","title":"Union Register of medicinal products for human use","publisher":"European Commission","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101","title":"Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)","publisher":"European Union (EUR-Lex)","date":"2025-01-01","accessed":"2026-09-29"}]},{"molecule":"ipamorelin","moleculeName":"Ipamorelin","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"No EU marketing authorisation; banned in sport (WADA S2.2.4)","detail":"Ipamorelin has no EU marketing authorisation and does not appear in the EMA dataset or the Union Register. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation. WADA's 2026 Prohibited List names ipamorelin under S2.2.4 (growth hormone secretagogues), so athletes under the World Anti-Doping Code cannot use it.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ipamorelin-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","title":"EMA medicines data (JSON report): human and veterinary medicines, with authorisation status","publisher":"European Medicines Agency","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101","title":"Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)","publisher":"European Union (EUR-Lex)","date":"2025-01-01","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"The 2026 Prohibited List","publisher":"World Anti-Doping Agency","date":"2025-09","accessed":"2026-09-29"}]},{"molecule":"kisspeptin","moleculeName":"Kisspeptin","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"No EU marketing authorisation; in sport, banned for males (WADA S2.2.1)","detail":"Kisspeptin has no EU marketing authorisation and does not appear in the EMA dataset or the Union Register. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation. WADA's 2026 Prohibited List names kisspeptin and its agonist analogues under S2.2.1 (testosterone-stimulating peptides, in males).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/kisspeptin-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","title":"EMA medicines data (JSON report): human and veterinary medicines, with authorisation status","publisher":"European Medicines Agency","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101","title":"Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)","publisher":"European Union (EUR-Lex)","date":"2025-01-01","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"The 2026 Prohibited List","publisher":"World Anti-Doping Agency","date":"2025-09","accessed":"2026-09-29"}]},{"molecule":"kpv","moleculeName":"KPV","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"No EU marketing authorisation; not listed in EMA or Union Register data","detail":"KPV does not appear in the EMA medicines dataset or the Union Register, so there is no EU-wide authorisation for it as a medicine. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation. No EU regulator has issued a KPV-specific decision that we found.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/kpv-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","title":"EMA medicines data (JSON report): human and veterinary medicines, with authorisation status","publisher":"European Medicines Agency","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","title":"Union Register of medicinal products for human use","publisher":"European Commission","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101","title":"Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)","publisher":"European Union (EUR-Lex)","date":"2025-01-01","accessed":"2026-09-29"}]},{"molecule":"liraglutide","moleculeName":"Liraglutide","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"approved","statusLabel":"Approved","headline":"Authorised EU-wide (Victoza, Saxenda) plus two STADA liraglutide products authorised in July 2026","detail":"Victoza (2009, type 2 diabetes) and Saxenda (2015, weight management) are centrally authorised. On 15 July 2026 the European Commission also authorised two hybrid liraglutide medicines from STADA: Liraglutide STADA for type 2 diabetes and Ablymico for weight management, the latter referencing Saxenda. Liraglutide is also part of Xultophy (with insulin degludec) for adults with type 2 diabetes. All are prescription-only. The CHMP gave its opinion on both in May 2026. Ablymico differs from Saxenda in how the active substance is made, which is why it was assessed as a hybrid medicine.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/liraglutide-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/victoza","title":"Victoza: EPAR (European public assessment report)","publisher":"European Medicines Agency","date":"2026-01-16","accessed":"2026-09-29"},{"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/saxenda","title":"Saxenda: EPAR (European public assessment report)","publisher":"European Medicines Agency","date":"2025-07-31","accessed":"2026-09-29"},{"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ablymico","title":"Ablymico: EPAR (European public assessment report)","publisher":"European Medicines Agency","date":"2026-08-25","accessed":"2026-09-29"},{"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/liraglutide-stada","title":"Liraglutide STADA: EPAR (European public assessment report)","publisher":"European Medicines Agency","date":"2026-08-25","accessed":"2026-09-29"},{"url":"https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-18-21-may-2026","title":"Meeting highlights from the CHMP 18-21 May 2026","publisher":"European Medicines Agency","date":"2026-05-22","accessed":"2026-09-29"},{"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/xultophy","title":"Xultophy: EPAR (European public assessment report)","publisher":"European Medicines Agency","date":"2024-11-28","accessed":"2026-09-29"}]},{"molecule":"ll-37","moleculeName":"LL-37","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"No EU marketing authorisation; not listed in EMA or Union Register data","detail":"LL-37 does not appear in the EMA medicines dataset or the Union Register, so there is no EU-wide authorisation. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation. No EU regulator has issued an LL-37-specific decision that we found.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ll-37-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","title":"EMA medicines data (JSON report): human and veterinary medicines, with authorisation status","publisher":"European Medicines Agency","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","title":"Union Register of medicinal products for human use","publisher":"European Commission","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101","title":"Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)","publisher":"European Union (EUR-Lex)","date":"2025-01-01","accessed":"2026-09-29"}]},{"molecule":"maridebart-cafraglutide","moleculeName":"Maridebart cafraglutide (MariTide)","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"Investigational; no EU marketing authorisation and no application under evaluation","detail":"Maridebart cafraglutide does not appear in the Union Register or in EMA's September 2026 list of applications under evaluation. It has no EU authorisation. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/maridebart-cafraglutide-in-european-union","sources":[{"url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","title":"Union Register of medicinal products for human use","publisher":"European Commission","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.ema.europa.eu/en/documents/report/applications-new-human-medicines-under-evaluation-september-2026_en.xlsx","title":"Applications for new human medicines under evaluation by the CHMP (September 2026)","publisher":"European Medicines Agency","date":"2026-09-04","accessed":"2026-09-29"},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101","title":"Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)","publisher":"European Union (EUR-Lex)","date":"2025-01-01","accessed":"2026-09-29"}]},{"molecule":"mazdutide","moleculeName":"Mazdutide","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"No EU marketing authorisation and no application under evaluation","detail":"Mazdutide does not appear in the Union Register or in EMA's September 2026 list of applications under evaluation, so it has no EU authorisation. Any approval in another region does not carry over to the EU. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/mazdutide-in-european-union","sources":[{"url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","title":"Union Register of medicinal products for human use","publisher":"European Commission","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.ema.europa.eu/en/documents/report/applications-new-human-medicines-under-evaluation-september-2026_en.xlsx","title":"Applications for new human medicines under evaluation by the CHMP (September 2026)","publisher":"European Medicines Agency","date":"2026-09-04","accessed":"2026-09-29"},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101","title":"Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)","publisher":"European Union (EUR-Lex)","date":"2025-01-01","accessed":"2026-09-29"}]},{"molecule":"melanotan-ii","moleculeName":"Melanotan II","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"No EU marketing authorisation; not listed in EMA or Union Register data","detail":"Melanotan II does not appear in the EMA medicines dataset or the Union Register. Afamelanotide (Scenesse) is authorised in the EU, but it is a different molecule, approved only for a rare light-sensitivity disease (erythropoietic protoporphyria). Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation. Melanotan II products for tanning are therefore unauthorised medicines. National enforcement varies and was not surveyed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/melanotan-ii-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","title":"EMA medicines data (JSON report): human and veterinary medicines, with authorisation status","publisher":"European Medicines Agency","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","title":"Union Register of medicinal products for human use","publisher":"European Commission","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101","title":"Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)","publisher":"European Union (EUR-Lex)","date":"2025-01-01","accessed":"2026-09-29"}]},{"molecule":"mots-c","moleculeName":"MOTS-c","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"No EU marketing authorisation; named on the WADA 2026 prohibited list (S4.4.1)","detail":"MOTS-c has no EU marketing authorisation and is absent from the EMA dataset and Union Register. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation. WADA's 2026 Prohibited List names MOTS-c under S4.4.1 (metabolic modulators, AMPK activators), so it is banned in sport at all times.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/mots-c-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","title":"EMA medicines data (JSON report): human and veterinary medicines, with authorisation status","publisher":"European Medicines Agency","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101","title":"Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)","publisher":"European Union (EUR-Lex)","date":"2025-01-01","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"The 2026 Prohibited List","publisher":"World Anti-Doping Agency","date":"2025-09","accessed":"2026-09-29"}]},{"molecule":"nad-plus","moleculeName":"NAD+","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"No EU marketing authorisation for NAD+ as a medicine; not listed in EMA or Union Register data","detail":"NAD+ (nicotinamide adenine dinucleotide) does not appear in the EMA medicines dataset or the Union Register as an authorised medicine. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation. Claims that a product treats or prevents disease, or changes body functions in a pharmacological way, would bring it under the EU definition of a medicinal product. National rules on any pharmacy preparation or supplement were not surveyed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/nad-plus-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","title":"EMA medicines data (JSON report): human and veterinary medicines, with authorisation status","publisher":"European Medicines Agency","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","title":"Union Register of medicinal products for human use","publisher":"European Commission","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101","title":"Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)","publisher":"European Union (EUR-Lex)","date":"2025-01-01","accessed":"2026-09-29"}]},{"molecule":"orforglipron","moleculeName":"Orforglipron","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"under-review","statusLabel":"Under review","headline":"Under EMA evaluation for obesity and type 2 diabetes; no EU authorisation yet","detail":"EMA's list of applications under evaluation (data extracted 4 September 2026) shows orforglipron, EMEA/H/C/006632, for obesity and type 2 diabetes in adults, with evaluation started on 22 January 2026. It was not among the medicines given a positive opinion at the CHMP meeting of 14-17 September 2026. Until the European Commission issues a decision, it cannot lawfully be marketed in the EU.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/orforglipron-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/documents/report/applications-new-human-medicines-under-evaluation-september-2026_en.xlsx","title":"Applications for new human medicines under evaluation by the CHMP (September 2026)","publisher":"European Medicines Agency","date":"2026-09-04","accessed":"2026-09-29"},{"url":"https://www.ema.europa.eu/en/medicines/medicines-human-use-under-evaluation","title":"Medicines under evaluation (human use)","publisher":"European Medicines Agency","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-14-17-september-2026","title":"Meeting highlights from the CHMP 14-17 September 2026","publisher":"European Medicines Agency","date":"2026-09-18","accessed":"2026-09-29"}]},{"molecule":"pramlintide","moleculeName":"Pramlintide","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"No EU marketing authorisation; not listed in EMA or Union Register data","detail":"Pramlintide does not appear in the EMA medicines dataset or in the Union Register of centrally authorised medicines, so there is no EU-wide authorisation. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation. National registers were not searched one by one.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/pramlintide-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","title":"EMA medicines data (JSON report): human and veterinary medicines, with authorisation status","publisher":"European Medicines Agency","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","title":"Union Register of medicinal products for human use","publisher":"European Commission","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101","title":"Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)","publisher":"European Union (EUR-Lex)","date":"2025-01-01","accessed":"2026-09-29"}]},{"molecule":"retatrutide","moleculeName":"Retatrutide","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"Investigational; no EU marketing authorisation and no application under evaluation","detail":"Retatrutide is not in the Union Register and is absent from EMA's September 2026 list of applications under evaluation, so no EU authorisation exists and none is under formal review. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation. Products sold online under this name are unauthorised and not covered by any EU quality checks.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/retatrutide-in-european-union","sources":[{"url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","title":"Union Register of medicinal products for human use","publisher":"European Commission","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.ema.europa.eu/en/documents/report/applications-new-human-medicines-under-evaluation-september-2026_en.xlsx","title":"Applications for new human medicines under evaluation by the CHMP (September 2026)","publisher":"European Medicines Agency","date":"2026-09-04","accessed":"2026-09-29"},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101","title":"Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)","publisher":"European Union (EUR-Lex)","date":"2025-01-01","accessed":"2026-09-29"}]},{"molecule":"selank","moleculeName":"Selank","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"No EU marketing authorisation; not listed in EMA or Union Register data","detail":"Selank does not appear in the EMA medicines dataset or the Union Register, so there is no EU-wide authorisation. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation. Approval in another country would not make it lawful to market in the EU. National registers were not searched one by one.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/selank-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","title":"EMA medicines data (JSON report): human and veterinary medicines, with authorisation status","publisher":"European Medicines Agency","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","title":"Union Register of medicinal products for human use","publisher":"European Commission","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101","title":"Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)","publisher":"European Union (EUR-Lex)","date":"2025-01-01","accessed":"2026-09-29"}]},{"molecule":"semaglutide","moleculeName":"Semaglutide","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"approved","statusLabel":"Approved","headline":"Authorised EU-wide for type 2 diabetes, weight management and MASH (Ozempic, Rybelsus, Wegovy, Kayshild)","detail":"Semaglutide holds central EU marketing authorisations: Ozempic (2018) and Rybelsus (2020) for type 2 diabetes, Wegovy (2022) for weight management, and Kayshild (authorised 26 March 2026) for adults with MASH liver disease. Wegovy covers adults and adolescents from 12 years, and its authorisation was extended in 2026 to add an oral tablet for adults after a CHMP opinion in May 2026. Semaglutide is also part of Kyinsu (with insulin icodec, authorised 24 November 2025) for adults with type 2 diabetes. All are prescription-only. No generic semaglutide is authorised centrally; EMA's September 2026 list of applications under evaluation shows three semaglutide applications marked generic or hybrid. Reimbursement for obesity varies by country (for example, statutory health insurance in Germany excludes Wegovy for weight reduction (G-BA Annex II), while France has reimbursed Wegovy since 15 June 2026 under conditions).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/semaglutide-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/wegovy","title":"Wegovy: EPAR (European public assessment report)","publisher":"European Medicines Agency","date":"2026-09-21","accessed":"2026-09-29"},{"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ozempic","title":"Ozempic: EPAR (European public assessment report)","publisher":"European Medicines Agency","date":"2026-08-25","accessed":"2026-09-29"},{"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/kayshild","title":"Kayshild: EPAR (European public assessment report)","publisher":"European Medicines Agency","date":"2026-04-09","accessed":"2026-09-29"},{"url":"https://www.ema.europa.eu/en/news/first-oral-glp-1-treatment-weight-management","title":"First oral GLP-1 treatment for weight management","publisher":"European Medicines Agency","date":"2026-05-22","accessed":"2026-09-29"},{"url":"https://www.ema.europa.eu/en/documents/report/applications-new-human-medicines-under-evaluation-september-2026_en.xlsx","title":"Applications for new human medicines under evaluation by the CHMP (September 2026)","publisher":"European Medicines Agency","date":"2026-09-04","accessed":"2026-09-29"},{"url":"https://www.vidal.fr/actualites/37850-obesite-prise-en-charge-de-wegovy-et-mounjaro-a-partir-du-15-juin-2026-sous-conditions.html","title":"Obesite: prise en charge de Wegovy et Mounjaro a partir du 15 juin 2026, sous conditions","publisher":"Vidal","date":"2026-05-28","accessed":"2026-09-29"},{"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/kyinsu","title":"Kyinsu: EPAR (European public assessment report)","publisher":"European Medicines Agency","date":"2026-02-12","accessed":"2026-09-29"},{"url":"https://www.legifrance.gouv.fr/jorf/id/JORFTEXT000054144081","title":"Arrêté du 23 mai 2026 modifiant la liste des spécialités pharmaceutiques remboursables aux assurés sociaux (WEGOVY)","publisher":"Légifrance, Journal officiel de la République française","date":"2026-05-28","accessed":"2026-09-29"},{"url":"https://www.g-ba.de/downloads/83-691-1029/AM-RL-II-Lifestyle-2025-08-20.pdf","title":"Arzneimittel-Richtlinie Anlage II: Lifestyle-Arzneimittel (Stand 20. August 2025)","publisher":"Gemeinsamer Bundesausschuss (G-BA)","date":"2025-08-20","accessed":"2026-09-29"}]},{"molecule":"semax","moleculeName":"Semax","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"No EU marketing authorisation; not listed in EMA or Union Register data","detail":"Semax does not appear in the EMA medicines dataset or the Union Register, so there is no EU-wide authorisation. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation. Approval in another country would not make it lawful to market in the EU. National registers were not searched one by one.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/semax-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","title":"EMA medicines data (JSON report): human and veterinary medicines, with authorisation status","publisher":"European Medicines Agency","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","title":"Union Register of medicinal products for human use","publisher":"European Commission","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101","title":"Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)","publisher":"European Union (EUR-Lex)","date":"2025-01-01","accessed":"2026-09-29"}]},{"molecule":"sermorelin","moleculeName":"Sermorelin","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"No EU marketing authorisation; banned in sport (WADA S2.2.4)","detail":"Sermorelin has no EU-wide marketing authorisation and does not appear in the EMA dataset or the Union Register. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation. WADA's 2026 Prohibited List names sermorelin under S2.2.4 (growth-hormone-releasing hormone analogues).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/sermorelin-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","title":"EMA medicines data (JSON report): human and veterinary medicines, with authorisation status","publisher":"European Medicines Agency","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101","title":"Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)","publisher":"European Union (EUR-Lex)","date":"2025-01-01","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"The 2026 Prohibited List","publisher":"World Anti-Doping Agency","date":"2025-09","accessed":"2026-09-29"}]},{"molecule":"setmelanotide","moleculeName":"Setmelanotide","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"approved-restricted","statusLabel":"Approved, restricted","headline":"Authorised EU-wide as Imcivree, only for rare genetic or hypothalamic obesity","detail":"Imcivree was authorised centrally on 16 July 2021. Its EU label covers obesity and hunger control in specific rare conditions: genetic POMC/PCSK1 or LEPR deficiency, genetically confirmed Bardet-Biedl syndrome, and acquired hypothalamic obesity. It is a prescription-only specialist medicine and is not authorised for general obesity.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/setmelanotide-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/imcivree","title":"Imcivree: EPAR (European public assessment report)","publisher":"European Medicines Agency","date":"2026-05-27","accessed":"2026-09-29"},{"url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","title":"EMA medicines data (JSON report): human and veterinary medicines, with authorisation status","publisher":"European Medicines Agency","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"survodutide","moleculeName":"Survodutide","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"Investigational; no EU marketing authorisation and no application under evaluation","detail":"Survodutide does not appear in the Union Register or in EMA's September 2026 list of applications under evaluation. It has no EU authorisation. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/survodutide-in-european-union","sources":[{"url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","title":"Union Register of medicinal products for human use","publisher":"European Commission","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.ema.europa.eu/en/documents/report/applications-new-human-medicines-under-evaluation-september-2026_en.xlsx","title":"Applications for new human medicines under evaluation by the CHMP (September 2026)","publisher":"European Medicines Agency","date":"2026-09-04","accessed":"2026-09-29"},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101","title":"Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)","publisher":"European Union (EUR-Lex)","date":"2025-01-01","accessed":"2026-09-29"}]},{"molecule":"tb-500","moleculeName":"TB-500 (thymosin beta-4 fragment)","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"Not authorised as a medicine in the EU; banned in sport (WADA S2.3)","detail":"TB-500 has no EU marketing authorisation and does not appear in the EMA dataset or Union Register. If it is offered for use in people it falls within the EU definition of a medicinal product and would need authorisation first. Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation. WADA's 2026 Prohibited List names thymosin-beta4 and its derivatives, for example TB-500, under S2.3 (growth factors and modulators).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tb-500-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","title":"EMA medicines data (JSON report): human and veterinary medicines, with authorisation status","publisher":"European Medicines Agency","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101","title":"Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)","publisher":"European Union (EUR-Lex)","date":"2025-01-01","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"The 2026 Prohibited List","publisher":"World Anti-Doping Agency","date":"2025-09","accessed":"2026-09-29"}]},{"molecule":"tesamorelin","moleculeName":"Tesamorelin","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"not-approved","statusLabel":"Not approved","headline":"Not authorised in the EU: the Egrifta application was withdrawn in 2012","detail":"Tesamorelin has no EU-wide authorisation. The company Ferrer Internacional withdrew its application for Egrifta (excess abdominal fat in HIV lipodystrophy) from CHMP review on 21 June 2012. No centralised authorisation has been granted since. Tesamorelin is also on the WADA 2026 Prohibited List as a growth-hormone-releasing factor (S2.2.4).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tesamorelin-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/egrifta","title":"Egrifta: application withdrawn (tesamorelin)","publisher":"European Medicines Agency","date":"2012-07-18","accessed":"2026-09-29"},{"url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","title":"EMA medicines data (JSON report): human and veterinary medicines, with authorisation status","publisher":"European Medicines Agency","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"The 2026 Prohibited List","publisher":"World Anti-Doping Agency","date":"2025-09","accessed":"2026-09-29"}]},{"molecule":"tirzepatide","moleculeName":"Tirzepatide","country":"european-union","countryName":"European Union","countryIso2":"EU","status":"approved","statusLabel":"Approved","headline":"Authorised EU-wide as Mounjaro for type 2 diabetes and for weight management in adults","detail":"Mounjaro was authorised centrally on 15 September 2022. It is indicated for insufficiently controlled type 2 diabetes in adults, adolescents and children from 10 years, and for weight management in adults with obesity or with overweight plus a weight-related condition. It is prescription-only. Coverage depends on the member state: in Germany it is excluded from statutory health insurance when used for weight reduction (G-BA Annex II), in Italy it is reimbursed for type 2 diabetes but not for obesity, and France began reimbursing it for obesity on 15 June 2026 with strict criteria.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tirzepatide-in-european-union","sources":[{"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/mounjaro","title":"Mounjaro: EPAR (European public assessment report)","publisher":"European Medicines Agency","date":"2026-09-21","accessed":"2026-09-29"},{"url":"https://www.aifa.gov.it/en/-/nuovi-farmaci-diabete-obesita-guida-aifa","title":"New diabetes and obesity medicines: an AIFA guide","publisher":"Italian Medicines Agency (AIFA)","date":"2026-05-18","accessed":"2026-09-29"},{"url":"https://www.vidal.fr/actualites/37850-obesite-prise-en-charge-de-wegovy-et-mounjaro-a-partir-du-15-juin-2026-sous-conditions.html","title":"Obesite: prise en charge de Wegovy et Mounjaro a partir du 15 juin 2026, sous conditions","publisher":"Vidal","date":"2026-05-28","accessed":"2026-09-29"},{"url":"https://www.g-ba.de/downloads/83-691-1029/AM-RL-II-Lifestyle-2025-08-20.pdf","title":"Arzneimittel-Richtlinie Anlage II: Lifestyle-Arzneimittel (Stand 20. August 2025)","publisher":"Gemeinsamer Bundesausschuss (G-BA)","date":"2025-08-20","accessed":"2026-09-29"}]},{"molecule":"amycretin","moleculeName":"Amycretin","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India; Novo Nordisk's amycretin (code NNC0487-0111) is only in CDSCO-permitted Phase III trials","detail":"Amycretin has no CDSCO marketing permission. CDSCO expert-committee records from March and July 2026 show Phase III trial protocols for Novo Nordisk's NNC0487-0111, the development code for amycretin, being cleared or reviewed for Indian sites. Trial permission is not approval to sell. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/amycretin-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Pulmonary%2023.03.2026%20%282%29%20%282%29.pdf","title":"Recommendations of the SEC (Pulmonary) made in its 04th/26 meeting held on 23.03.2026 at CDSCO HQ","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2026-03-23","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Pulmonary%2008.07.2026.pdf","title":"Recommendations of the SEC (Pulmonary) made in its 08th/26 meeting held on 08.07.2026 at CDSCO HQ","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2026-07-17","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"}]},{"molecule":"aod-9604","moleculeName":"AOD-9604","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India: no CDSCO marketing permission found for AOD-9604; making or selling it as a medicine would be unapproved","detail":"AOD-9604 is a fragment of human growth hormone that has not been approved as a medicine. The CDSCO expert-committee records reviewed (2015 to September 2026) show no marketing application or permission for it. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026). I found no CDSCO notice naming this specific substance, so it is listed as not approved rather than prohibited. The WADA 2026 Prohibited List names AOD-9604 among banned growth hormone fragments at all times.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/aod-9604-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/","title":"CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-09-23","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Public%20Notice%20dated%2018.05.2026.pdf","title":"Public Notice dated 18 May 2026: injectable preparations do not fall under the definition of cosmetics","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-05-18","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"World Anti-Doping Code International Standard: Prohibited List 2026","publisher":"World Anti-Doping Agency","date":"2025-09","accessed":"2026-09-29"}]},{"molecule":"bpc-157","moleculeName":"BPC-157","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India: no CDSCO marketing permission found for BPC-157; making or selling it as a medicine would be unapproved","detail":"BPC-157 is a lab-made fragment of a stomach protein that has been studied mainly in animals and in very small human studies. The CDSCO expert-committee records reviewed (2015 to September 2026) show no marketing application or permission for it. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026). I found no CDSCO notice naming this specific substance, so it is listed as not approved rather than prohibited. The World Anti-Doping Agency's 2026 Prohibited List names BPC-157 as a non-approved substance banned at all times for athletes.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/bpc-157-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/","title":"CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-09-23","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Public%20Notice%20dated%2018.05.2026.pdf","title":"Public Notice dated 18 May 2026: injectable preparations do not fall under the definition of cosmetics","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-05-18","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"World Anti-Doping Code International Standard: Prohibited List 2026","publisher":"World Anti-Doping Agency","date":"2025-09","accessed":"2026-09-29"}]},{"molecule":"bremelanotide","moleculeName":"Bremelanotide (PT-141)","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India: no CDSCO marketing permission found for bremelanotide","detail":"Bremelanotide is a melanocortin-receptor drug approved in some other countries for low sexual desire in premenopausal women. The CDSCO expert-committee records reviewed (2015 to September 2026) show no marketing application or permission for it. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/bremelanotide-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/","title":"CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-09-23","accessed":"2026-09-29"}]},{"molecule":"cagrilintide","moleculeName":"Cagrilintide (and CagriSema)","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India; CagriSema is only in CDSCO-permitted Phase III trials","detail":"Cagrilintide, alone or combined with semaglutide (CagriSema), has no CDSCO marketing permission. CDSCO's expert committee recommended permission for a Novo Nordisk CagriSema Phase 3b trial in May 2024 and approved a trial protocol amendment in June 2025. In March 2026 it asked for more safety and dose-justification data, including for children and adolescents, on two Phase IIIa protocols, and in August 2026 it recommended permission for both, on condition that Indian paediatric growth charts are also used. Trial permission is not approval to sell. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/cagrilintide-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Endocrinology%20%26%20Metabolism%20dated%20on%2009.05.2024.pdf","title":"Recommendations of the SEC Endocrinology & Metabolism made in its 9th/24 meeting held on 09.05.2024 at CDSCO HQ","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2024-05-09","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendation%20E%20Metabolism%2017.06.2025.pdf","title":"Recommendations of the SEC (Endocrinology & Metabolism) made in its 13th meeting held on 17.06.2025 at CDSCO HQ New Delhi","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2025-06-17","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Endocrinology%20Metabolism%2023.03.2026%20%281%29%20%282%29.pdf","title":"Recommendations of the SEC (Endocrinology & Metabolism) made in its 06th/26 meeting held on 23.03.2026 at CDSCO HQ","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2026-03-23","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Endocrinology%20and%20Metabolism%2006.08.2026.pdf","title":"Recommendations of the SEC (Endocrinology & Metabolism) made in its 18th/26 meeting held on 06.08.2026 at CDSCO HQ","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2026-08-06","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"}]},{"molecule":"cjc-1295","moleculeName":"CJC-1295","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India: no CDSCO marketing permission found for CJC-1295; making or selling it as a medicine would be unapproved","detail":"CJC-1295 is a growth-hormone-releasing-hormone analogue that has not completed development as a medicine. The CDSCO expert-committee records reviewed (2015 to September 2026) show no marketing application or permission for it. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026). I found no CDSCO notice naming this specific substance, so it is listed as not approved rather than prohibited. The WADA 2026 Prohibited List names CJC-1295 among banned growth-hormone-releasing-hormone analogues at all times.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/cjc-1295-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/","title":"CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-09-23","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Public%20Notice%20dated%2018.05.2026.pdf","title":"Public Notice dated 18 May 2026: injectable preparations do not fall under the definition of cosmetics","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-05-18","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"World Anti-Doping Code International Standard: Prohibited List 2026","publisher":"World Anti-Doping Agency","date":"2025-09","accessed":"2026-09-29"}]},{"molecule":"dsip","moleculeName":"DSIP (delta sleep-inducing peptide)","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India: no CDSCO marketing permission found for DSIP; making or selling it as a medicine would be unapproved","detail":"DSIP is delta sleep-inducing peptide, studied mainly in animals and in small human studies. The CDSCO expert-committee records reviewed (2015 to September 2026) show no marketing application or permission for it. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026). I found no CDSCO notice naming this specific substance, so it is listed as not approved rather than prohibited.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/dsip-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/","title":"CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-09-23","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Public%20Notice%20dated%2018.05.2026.pdf","title":"Public Notice dated 18 May 2026: injectable preparations do not fall under the definition of cosmetics","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-05-18","accessed":"2026-09-29"}]},{"molecule":"dulaglutide","moleculeName":"Dulaglutide","country":"india","countryName":"India","countryIso2":"IN","status":"approved","statusLabel":"Approved","headline":"Approved in India (Eli Lilly) for type 2 diabetes; the expert committee backed adding an age-10-and-over indication in 2024","detail":"CDSCO expert-committee minutes from April 2017 describe dulaglutide as an old drug marketed in India, and Lilly's marketing authorisation carried a post-marketing study condition. In December 2020 the committee recommended approval of a new indication already approved by the US FDA, and in May 2024 it recommended adding treatment of type 2 diabetes in patients aged 10 years and older. In July 2026, reviewing a children's trial of another drug, the committee described dulaglutide as a comparator 'not approved in India' for that paediatric population, so whether the paediatric indication was finally granted is not confirmed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/dulaglutide-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/RecommendEndocrinology_25_04_2017_13.pdf","title":"SEC Metabolism and Endocrinology: 25.04.2017","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2017-04-25","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendation%20of%20SEC%20%28Endo%29%2016.12.2020.pdf","title":"Recommendations of the SEC (Endocrinology & Metabolism) made in its72nd meeting held on 16.12.2020 at CDSCO","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2020-12-16","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Endocrinology%20%26%20Metabolism%20dated%20on%2009.05.2024.pdf","title":"Recommendations of the SEC Endocrinology & Metabolism made in its 9th/24 meeting held on 09.05.2024 at CDSCO HQ","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2024-05-09","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Endocrinology%20%26%20Metabolism%2013.08.2024.pdf","title":"Recommendations of the SEC Endocrinology & Metabolism made in its 14th/24 meeting held on 13.08.24 at CDSCO HQ","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2024-08-13","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Endocrinology%20and%20Metabolism%2016.07.2026.pdf","title":"Recommendations of the SEC (Endocrinology & Metabolism) made in its 17th/26 meeting held on 16.07.2026 at CDSCO HQ","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2026-07-16","accessed":"2026-09-29"}]},{"molecule":"ecnoglutide","moleculeName":"Ecnoglutide","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India: no CDSCO marketing permission or Indian trial record found for ecnoglutide","detail":"Ecnoglutide is an investigational incretin-based drug. The CDSCO expert-committee records reviewed (2015 to September 2026) show no marketing application or permission for it. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ecnoglutide-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/","title":"CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-09-23","accessed":"2026-09-29"}]},{"molecule":"elamipretide","moleculeName":"Elamipretide (SS-31)","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India: no CDSCO marketing permission found for elamipretide","detail":"Elamipretide is a mitochondria-targeting peptide that the US regulator approved for Barth syndrome. The CDSCO expert-committee records reviewed (2015 to September 2026) show no marketing application or permission for it. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/elamipretide-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/","title":"CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-09-23","accessed":"2026-09-29"}]},{"molecule":"eloralintide","moleculeName":"Eloralintide","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India; Lilly's eloralintide (LY3841136) is only in CDSCO-permitted Phase III trials","detail":"Eloralintide has no CDSCO marketing permission. In February and March 2026 CDSCO's expert committee recommended permission for Eli Lilly Phase III trial protocols for LY3841136, the development code for eloralintide, in India. Trial permission is not approval to sell. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/eloralintide-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Endocrinology%20Metabolism%2005.02.2026.pdf","title":"Recommendations of the SEC (Endocrinology & Metabolism) made in its 03th/26 meeting held on 05.02.2026 at CDSCO HQ","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2026-02-05","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Pulmonary%2023.03.2026%20%282%29%20%282%29.pdf","title":"Recommendations of the SEC (Pulmonary) made in its 04th/26 meeting held on 23.03.2026 at CDSCO HQ","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2026-03-23","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"}]},{"molecule":"epitalon","moleculeName":"Epitalon","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India: no CDSCO marketing permission found for Epitalon; making or selling it as a medicine would be unapproved","detail":"Epitalon is a peptide studied mainly in animals and in small, older studies. The CDSCO expert-committee records reviewed (2015 to September 2026) show no marketing application or permission for it. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026). I found no CDSCO notice naming this specific substance, so it is listed as not approved rather than prohibited.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/epitalon-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/","title":"CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-09-23","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Public%20Notice%20dated%2018.05.2026.pdf","title":"Public Notice dated 18 May 2026: injectable preparations do not fall under the definition of cosmetics","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-05-18","accessed":"2026-09-29"}]},{"molecule":"exenatide","moleculeName":"Exenatide","country":"india","countryName":"India","countryIso2":"IN","status":"approved","statusLabel":"Approved","headline":"Exenatide has an older CDSCO approval; whether it is still sold in India could not be confirmed","detail":"CDSCO expert-committee minutes from April 2017 describe an AstraZeneca exenatide product as approved and marketed in India, and minutes from June 2019 record the committee noting antibody results for the early closure (pre-closure) of a Sun Pharma exenatide injection Phase III study. I found no later record of withdrawal or of new approvals, and no current product listing, so present commercial availability is not verified. It is not a weight-management product in India.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/exenatide-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/RecommendEndocrinology_25_04_2017_13.pdf","title":"SEC Metabolism and Endocrinology: 25.04.2017","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2017-04-25","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/56thEndocrinologyRecommendation.pdf","title":"Recommendations of the SEC (Endocrinology & Metabolism) made in its 56th meeting held on 20.06.2019 at CDSCO","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2019-06-20","accessed":"2026-09-29"}]},{"molecule":"ghk-cu","moleculeName":"GHK-Cu (copper peptide)","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India: no CDSCO marketing permission found for GHK-Cu; making or selling it as a medicine would be unapproved","detail":"GHK-Cu is a copper-binding peptide used as a skin-care ingredient, with little human evidence for injected use. Topical cosmetic products are regulated separately under the Cosmetics Rules, 2020, and CDSCO's May 2026 notice says no cosmetic may be injected. The CDSCO expert-committee records reviewed (2015 to September 2026) show no marketing application or permission for it. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026). I found no CDSCO notice naming this specific substance, so it is listed as not approved rather than prohibited.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ghk-cu-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/","title":"CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-09-23","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Public%20Notice%20dated%2018.05.2026.pdf","title":"Public Notice dated 18 May 2026: injectable preparations do not fall under the definition of cosmetics","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-05-18","accessed":"2026-09-29"}]},{"molecule":"ipamorelin","moleculeName":"Ipamorelin","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India: no CDSCO marketing permission found for Ipamorelin; making or selling it as a medicine would be unapproved","detail":"Ipamorelin is a growth-hormone secretagogue peptide that has not completed development as a medicine. The CDSCO expert-committee records reviewed (2015 to September 2026) show no marketing application or permission for it. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026). I found no CDSCO notice naming this specific substance, so it is listed as not approved rather than prohibited. The WADA 2026 Prohibited List names ipamorelin among banned growth hormone secretagogues at all times.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ipamorelin-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/","title":"CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-09-23","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Public%20Notice%20dated%2018.05.2026.pdf","title":"Public Notice dated 18 May 2026: injectable preparations do not fall under the definition of cosmetics","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-05-18","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"World Anti-Doping Code International Standard: Prohibited List 2026","publisher":"World Anti-Doping Agency","date":"2025-09","accessed":"2026-09-29"}]},{"molecule":"kisspeptin","moleculeName":"Kisspeptin","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India: no CDSCO marketing permission found for Kisspeptin; making or selling it as a medicine would be unapproved","detail":"Kisspeptin is a natural hormone peptide studied for reproductive conditions and not yet approved as a medicine. The CDSCO expert-committee records reviewed (2015 to September 2026) show no marketing application or permission for it. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026). I found no CDSCO notice naming this specific substance, so it is listed as not approved rather than prohibited. The WADA 2026 Prohibited List names kisspeptin and its agonist analogues as banned in males at all times.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/kisspeptin-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/","title":"CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-09-23","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Public%20Notice%20dated%2018.05.2026.pdf","title":"Public Notice dated 18 May 2026: injectable preparations do not fall under the definition of cosmetics","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-05-18","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"World Anti-Doping Code International Standard: Prohibited List 2026","publisher":"World Anti-Doping Agency","date":"2025-09","accessed":"2026-09-29"}]},{"molecule":"kpv","moleculeName":"KPV","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India: no CDSCO marketing permission found for KPV; making or selling it as a medicine would be unapproved","detail":"KPV is a short peptide fragment studied mainly in cells and animals. The CDSCO expert-committee records reviewed (2015 to September 2026) show no marketing application or permission for it. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026). I found no CDSCO notice naming this specific substance, so it is listed as not approved rather than prohibited.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/kpv-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/","title":"CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-09-23","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Public%20Notice%20dated%2018.05.2026.pdf","title":"Public Notice dated 18 May 2026: injectable preparations do not fall under the definition of cosmetics","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-05-18","accessed":"2026-09-29"}]},{"molecule":"liraglutide","moleculeName":"Liraglutide","country":"india","countryName":"India","countryIso2":"IN","status":"approved","statusLabel":"Approved","headline":"Approved in India since 2010 (Victoza) for type 2 diabetes; a weight-management version was recommended for an Indian maker in 2025","detail":"CDSCO issued marketing authorisation for Victoza on 8 February 2010, with a requirement to run a post-marketing study. A 2017 request to add weight management for the higher-strength product (Saxenda) was not accepted at that time because the company had not supplied enough Indian data. In February 2025 the expert committee recommended permission for an Indian company to make and market a liraglutide pen for weight management without a new Phase III trial, after the company said the UK regulator (MHRA) had approved it, and in November 2025 it reviewed a Phase IV protocol for Biocon's synthetic liraglutide. One other application for a weight-management indication in adults and adolescents was not recommended in February 2025.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/liraglutide-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/MOMof33rdSECEndocrinologyandMetabolism10_02_2017.pdf","title":"SEC-(Endocrinology): 10.02.2017","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2017-02-10","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Endocrinology%20%20Metabolism%2006.02.2025.pdf","title":"Recommendations of the SEC (Endocrinology & Metabolism) made in its 04th /25 meeting held on 06.02.2025 at CDSCO HQ","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2025-02-06","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Endocrinology%20%20Metabolism%2006.02.20251.pdf","title":"Recommendations of the SEC (Endocrinology & Metabolism) made in its 05th /25 meeting held on 20.02.2025 at CDSCO (HQ)","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2025-02-20","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Endocrinology%20Metabolism%2018.11.2025.pdf","title":"Recommendations of the SEC (Endocrinology & Metabolism) made in its 23 rd/25 meeting held on 18.11.2025 at CDSCO HQ","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2025-11-18","accessed":"2026-09-29"}]},{"molecule":"ll-37","moleculeName":"LL-37","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India: no CDSCO marketing permission found for LL-37; making or selling it as a medicine would be unapproved","detail":"LL-37 is a natural human antimicrobial peptide studied mainly in the lab and in early trials. The CDSCO expert-committee records reviewed (2015 to September 2026) show no marketing application or permission for it. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026). I found no CDSCO notice naming this specific substance, so it is listed as not approved rather than prohibited.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ll-37-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/","title":"CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-09-23","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Public%20Notice%20dated%2018.05.2026.pdf","title":"Public Notice dated 18 May 2026: injectable preparations do not fall under the definition of cosmetics","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-05-18","accessed":"2026-09-29"}]},{"molecule":"maridebart-cafraglutide","moleculeName":"Maridebart cafraglutide (MariTide)","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India: no CDSCO marketing permission or Indian trial record found for maridebart cafraglutide","detail":"Maridebart cafraglutide is an investigational incretin-based drug. The CDSCO expert-committee records reviewed (2015 to September 2026) show no marketing application or permission for it. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/maridebart-cafraglutide-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/","title":"CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-09-23","accessed":"2026-09-29"}]},{"molecule":"mazdutide","moleculeName":"Mazdutide","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India: no CDSCO marketing permission or Indian trial record found for mazdutide","detail":"Mazdutide is an investigational incretin-based drug. The CDSCO expert-committee records reviewed (2015 to September 2026) show no marketing application or permission for it. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/mazdutide-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/","title":"CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-09-23","accessed":"2026-09-29"}]},{"molecule":"melanotan-ii","moleculeName":"Melanotan II","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India: no CDSCO marketing permission found for Melanotan II; making or selling it as a medicine would be unapproved","detail":"Melanotan II is an unapproved melanocortin peptide, often associated with tanning. The CDSCO expert-committee records reviewed (2015 to September 2026) show no marketing application or permission for it. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026). I found no CDSCO notice naming this specific substance, so it is listed as not approved rather than prohibited.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/melanotan-ii-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/","title":"CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-09-23","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Public%20Notice%20dated%2018.05.2026.pdf","title":"Public Notice dated 18 May 2026: injectable preparations do not fall under the definition of cosmetics","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-05-18","accessed":"2026-09-29"}]},{"molecule":"mots-c","moleculeName":"MOTS-c","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India: no CDSCO marketing permission found for MOTS-c; making or selling it as a medicine would be unapproved","detail":"MOTS-c is a peptide encoded in mitochondrial DNA, studied mainly in cells and animals. The CDSCO expert-committee records reviewed (2015 to September 2026) show no marketing application or permission for it. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026). I found no CDSCO notice naming this specific substance, so it is listed as not approved rather than prohibited. The WADA 2026 Prohibited List names MOTS-c among banned metabolic modulators at all times.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/mots-c-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/","title":"CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-09-23","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Public%20Notice%20dated%2018.05.2026.pdf","title":"Public Notice dated 18 May 2026: injectable preparations do not fall under the definition of cosmetics","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-05-18","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"World Anti-Doping Code International Standard: Prohibited List 2026","publisher":"World Anti-Doping Agency","date":"2025-09","accessed":"2026-09-29"}]},{"molecule":"nad-plus","moleculeName":"NAD+","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India: no CDSCO marketing permission found for NAD+; making or selling it as a medicine would be unapproved","detail":"NAD+ is a coenzyme offered in some clinics as an injectable or drip. CDSCO's May 2026 notice says injectables cannot be sold as cosmetics. The CDSCO expert-committee records reviewed (2015 to September 2026) show no marketing application or permission for it. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026). I found no CDSCO notice naming this specific substance, so it is listed as not approved rather than prohibited.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/nad-plus-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/","title":"CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-09-23","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Public%20Notice%20dated%2018.05.2026.pdf","title":"Public Notice dated 18 May 2026: injectable preparations do not fall under the definition of cosmetics","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-05-18","accessed":"2026-09-29"}]},{"molecule":"orforglipron","moleculeName":"Orforglipron","country":"india","countryName":"India","countryIso2":"IN","status":"under-review","statusLabel":"Under review","headline":"Under review: CDSCO's expert committee recommended import and marketing permission for Lilly's oral orforglipron in May 2026","detail":"On 20 May 2026 CDSCO's Endocrinology and Metabolism expert committee considered Eli Lilly's application to import and market orforglipron tablets, noted it is approved in the USA, and recommended permission on conditions: retail sale only on prescription from endocrinologists or internal medicine specialists, and a Phase IV study protocol within three months. The records I could reach do not show whether the Drugs Controller has issued the final permission or whether the product is on sale, so it is listed as pending. Indian sites also take part in Lilly's orforglipron trials.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/orforglipron-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations-%20Endocrinology%20Metabolism%2020.05.2026%20%281%29.pdf","title":"Recommendations of the SEC (Endocrinology & Metabolism) made in its 13th/26 meeting held on 20.05.2026 at CDSCO HQ","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2026-05-20","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Endocrinology%20Metabolism%2020.08.2025.pdf","title":"Recommendations of the SEC (Endocrinology & Metabolism) made in its 18th/25 meeting held on 20.08.2025 at CDSCO HQ","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2025-08-20","accessed":"2026-09-29"}]},{"molecule":"pramlintide","moleculeName":"Pramlintide","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India: no CDSCO marketing permission found for pramlintide","detail":"The CDSCO expert-committee records reviewed (2015 to September 2026) show no marketing application or permission for it. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026). Pramlintide is an amylin-analogue injection used in some countries for people with diabetes who take mealtime insulin; it is not an authorised medicine in India as far as the public regulator records show.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/pramlintide-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/","title":"CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-09-23","accessed":"2026-09-29"}]},{"molecule":"retatrutide","moleculeName":"Retatrutide","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India; retatrutide is only in CDSCO-permitted Phase III trials run by Eli Lilly","detail":"Retatrutide has no CDSCO marketing permission. CDSCO's expert committee cleared Eli Lilly Phase III protocols for LY3437943 (retatrutide) from 2024, including trials reviewed by the cardiovascular committee, and a trial with a safety-reporting condition in December 2025. Trial permission is not approval to sell. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/retatrutide-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Endocrinology%20%26%20Metabolism%20dated%20on%2009.05.2024.pdf","title":"Recommendations of the SEC Endocrinology & Metabolism made in its 9th/24 meeting held on 09.05.2024 at CDSCO HQ","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2024-05-09","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Cardiovascular13.05.2025.pdf","title":"Recommendations of the SEC (Cardiovascular) made in its 07th/25 meeting held on 13.05.2025 at CDSCO HQ","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2025-05-13","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Gastroenterology%20Hepatology%2011.12.2025.pdf","title":"Recommendations of the SEC (Gastroenterology & Hepatology) made in its 16 th/25 meeting held on 11.12.2025 at CDSCO HQ","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2025-12-11","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"}]},{"molecule":"selank","moleculeName":"Selank","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India: no CDSCO marketing permission found for Selank; making or selling it as a medicine would be unapproved","detail":"Selank is a peptide drug authorised in Russia but not in India. The CDSCO expert-committee records reviewed (2015 to September 2026) show no marketing application or permission for it. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026). I found no CDSCO notice naming this specific substance, so it is listed as not approved rather than prohibited.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/selank-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/","title":"CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-09-23","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Public%20Notice%20dated%2018.05.2026.pdf","title":"Public Notice dated 18 May 2026: injectable preparations do not fall under the definition of cosmetics","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-05-18","accessed":"2026-09-29"}]},{"molecule":"semaglutide","moleculeName":"Semaglutide","country":"india","countryName":"India","countryIso2":"IN","status":"generic-available","statusLabel":"Generics available","headline":"Approved in India (Novo Nordisk's Wegovy and type 2 diabetes products); Indian generics on sale since March 2026, prescription-only","detail":"CDSCO approved Wegovy for chronic weight management in adults on 20 April 2022. Novo Nordisk has held an import and marketing permission for semaglutide since at least 2020, and its semaglutide injection for type 2 diabetes has been approved since September 2025, according to expert-committee records. Novo Nordisk's core Indian patent expired in March 2026 and several Indian companies (reported: Dr Reddy's, Zydus, Alkem, Sun Pharma, Glenmark) launched generic semaglutide from about 21 March 2026; CDSCO's expert committee has been clearing synthetic-origin versions company by company, including for weight management in May 2026. Sale is by retail on prescription from specialists (endocrinologists and internal medicine specialists; some indications also cardiologists). In March 2026 CDSCO began an enforcement drive over illegal sales and surrogate advertising, and in July 2026 a counterfeit-semaglutide alert was reported.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/semaglutide-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Endocrinology%20Metabolism%2023.04.2026%20%281%29.pdf","title":"Recommendations of the SEC (Endocrinology & Metabolism) made in its 09 th/26 meeting held on 23.04.2026 at CDSCO HQ","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2026-04-23","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendation%20of%20SEC%20%28Endo%29%2016.12.2020.pdf","title":"Recommendations of the SEC (Endocrinology & Metabolism) made in its72nd meeting held on 16.12.2020 at CDSCO","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2020-12-16","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Endocrinology%20and%20Metabolism%2016.07.2026.pdf","title":"Recommendations of the SEC (Endocrinology & Metabolism) made in its 17th/26 meeting held on 16.07.2026 at CDSCO HQ","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2026-07-16","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Endocrinology%20%20Metabolism%2011.09.2025%20%281%29.pdf","title":"Recommendations of the SEC (Endocrinology & Metabolism) made in its 19th/25 meeting held on 11.09.2025 at CDSCO (HQ","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2025-09-11","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations-%20Endocrinology%20Metabolism%2020.05.2026%20%281%29.pdf","title":"Recommendations of the SEC (Endocrinology & Metabolism) made in its 13th/26 meeting held on 20.05.2026 at CDSCO HQ","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2026-05-20","accessed":"2026-09-29"},{"url":"https://www.pearceip.law/2026/03/21/generic-semaglutide-launches-in-india-including-by-dr-reddys-zydus-alkem-sun-pharma-glenmark/","title":"Generic semaglutide launches in India, including by Dr Reddy's, Zydus, Alkem, Sun Pharma, Glenmark","publisher":"Pearce IP","date":"2026-03-21","accessed":"2026-09-29"},{"url":"https://www.newsonair.gov.in/india-tightens-surveillance-on-glp-1-weight-loss-drug-sales","title":"India Tightens Surveillance on GLP-1 Weight Loss Drug Sales","publisher":"News On AIR (All India Radio)","date":"2026-03-24","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/34801%20%282%29.pdf","title":"Strengthening Enforcement against Unauthorized Promotion and Distribution of GLP-1 Based Drugs (letter to State/UT Drug Controllers, 27 March 2026)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-03-27","accessed":"2026-09-29"}]},{"molecule":"semax","moleculeName":"Semax","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India: no CDSCO marketing permission found for Semax; making or selling it as a medicine would be unapproved","detail":"Semax is a peptide drug authorised in Russia but not in India. The CDSCO expert-committee records reviewed (2015 to September 2026) show no marketing application or permission for it. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026). I found no CDSCO notice naming this specific substance, so it is listed as not approved rather than prohibited.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/semax-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/","title":"CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-09-23","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Public%20Notice%20dated%2018.05.2026.pdf","title":"Public Notice dated 18 May 2026: injectable preparations do not fall under the definition of cosmetics","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-05-18","accessed":"2026-09-29"}]},{"molecule":"sermorelin","moleculeName":"Sermorelin","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India: no CDSCO marketing permission found for Sermorelin; making or selling it as a medicine would be unapproved","detail":"Sermorelin is a growth-hormone-releasing-hormone analogue. The CDSCO expert-committee records reviewed (2015 to September 2026) show no marketing application or permission for it. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026). I found no CDSCO notice naming this specific substance, so it is listed as not approved rather than prohibited. The WADA 2026 Prohibited List names sermorelin among banned growth-hormone-releasing-hormone analogues at all times.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/sermorelin-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/","title":"CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-09-23","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Public%20Notice%20dated%2018.05.2026.pdf","title":"Public Notice dated 18 May 2026: injectable preparations do not fall under the definition of cosmetics","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-05-18","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"World Anti-Doping Code International Standard: Prohibited List 2026","publisher":"World Anti-Doping Agency","date":"2025-09","accessed":"2026-09-29"}]},{"molecule":"setmelanotide","moleculeName":"Setmelanotide","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India: no CDSCO marketing permission found for setmelanotide","detail":"Setmelanotide is a melanocortin-4-receptor drug approved in some other countries for certain rare genetic forms of obesity. The CDSCO expert-committee records reviewed (2015 to September 2026) show no marketing application or permission for it. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/setmelanotide-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/","title":"CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-09-23","accessed":"2026-09-29"}]},{"molecule":"survodutide","moleculeName":"Survodutide","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India; survodutide (BI 456906) appears only in a CDSCO-permitted clinical trial","detail":"Survodutide has no CDSCO marketing permission. CDSCO's cardiovascular expert committee approved amendments to a Boehringer Ingelheim trial protocol (1404-0040) run through IQVIA in September 2024 and May 2025. Trial permission is not approval to sell. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/survodutide-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Cardiovascular%2011.09.2024.pdf","title":"Recommendations of the SEC (Cardiovascular) made in its 17th/24 meeting held on 11.09.2024 at CDSCO HQ","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2024-09-11","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Cardiovascular13.05.2025.pdf","title":"Recommendations of the SEC (Cardiovascular) made in its 07th/25 meeting held on 13.05.2025 at CDSCO HQ","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2025-05-13","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"}]},{"molecule":"tb-500","moleculeName":"TB-500 (thymosin beta-4 fragment)","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India: no CDSCO marketing permission found for TB-500; making or selling it as a medicine would be unapproved","detail":"TB-500 is a fragment related to thymosin beta-4 that has been studied mainly in animals; it is different from thymosin alpha-1, which is a separate peptide. The CDSCO expert-committee records reviewed (2015 to September 2026) show no marketing application or permission for it. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026). I found no CDSCO notice naming this specific substance, so it is listed as not approved rather than prohibited. The WADA 2026 Prohibited List names thymosin-beta-4 and its derivatives such as TB-500 as banned growth factor modulators at all times.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tb-500-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/","title":"CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-09-23","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Public%20Notice%20dated%2018.05.2026.pdf","title":"Public Notice dated 18 May 2026: injectable preparations do not fall under the definition of cosmetics","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-05-18","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"World Anti-Doping Code International Standard: Prohibited List 2026","publisher":"World Anti-Doping Agency","date":"2025-09","accessed":"2026-09-29"}]},{"molecule":"tesamorelin","moleculeName":"Tesamorelin","country":"india","countryName":"India","countryIso2":"IN","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in India: no CDSCO marketing permission found for tesamorelin","detail":"Tesamorelin is a growth-hormone-releasing-hormone analogue approved in some other countries for a specific fat-distribution condition. The CDSCO expert-committee records reviewed (2015 to September 2026) show no marketing application or permission for it. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026). The WADA 2026 Prohibited List names tesamorelin among banned growth-hormone-releasing-hormone analogues at all times.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tesamorelin-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf","title":"Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-08-10","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/","title":"CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)","publisher":"Central Drugs Standard Control Organisation (CDSCO)","date":"2026-09-23","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"World Anti-Doping Code International Standard: Prohibited List 2026","publisher":"World Anti-Doping Agency","date":"2025-09","accessed":"2026-09-29"}]},{"molecule":"tirzepatide","moleculeName":"Tirzepatide","country":"india","countryName":"India","countryIso2":"IN","status":"approved-restricted","statusLabel":"Approved, restricted","headline":"Approved in India (Mounjaro) for type 2 diabetes and weight management, prescription-only; no approved generic found","detail":"CDSCO's expert committee noted in February 2024 that the tirzepatide pre-filled pen was already approved, and in June 2024 recommended import and marketing permission for chronic weight management, with a Phase IV study condition. In June 2026 the committee declined a request to drop the BMI cut-off from the weight indication, saying Asian and US definitions of obesity differ, and said it does not treat tirzepatide as first-line for diabetes without other conditions. The Health Ministry says these drugs are sold by retail only on prescription from endocrinologists and internal medicine specialists. I found no CDSCO record of a generic tirzepatide being approved.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tirzepatide-in-india","sources":[{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Endocrinology%20%26%20Metabolism%20%20dated%2013.02.2024%20%26%2014.02.2024%20%283%29.pdf","title":"Recommendations of the SEC Endocrinology and Metabolism made in its 3rd/24 SEC meeting held on 13.02.2024 and 14.02.2024 at CDSCO HQ","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2024-02-13","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Endocrinology%20%26%20Metabolism%2019.06.2024.pdf","title":"Recommendations of the SEC Endocrinology & Metabolism made in its 12th/24 meeting held on 19.06.2024 at CDSCO HQ","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2024-06-19","accessed":"2026-09-29"},{"url":"https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations-%20Endocrinology%20Metabolism%2024.06.2026%20%281%29.pdf","title":"Recommendations of the SEC (Endocrinology & Metabolism) made in its 15th/26 meeting held on 24.06.2026 at CDSCO HQ","publisher":"Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee","date":"2026-07-02","accessed":"2026-09-29"},{"url":"https://www.newsonair.gov.in/india-tightens-surveillance-on-glp-1-weight-loss-drug-sales","title":"India Tightens Surveillance on GLP-1 Weight Loss Drug Sales","publisher":"News On AIR (All India Radio)","date":"2026-03-24","accessed":"2026-09-29"}]},{"molecule":"amycretin","moleculeName":"Amycretin","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"No marketing approval in Japan; the investigational amylin and GLP-1 agonist amycretin does not appear in PMDA's approved-drug lists to September 2026","detail":"PMDA's approved new drug lists (April 2004 to September 2026) and its package-insert database contain no product with this ingredient, so it cannot be marketed or prescribed as an approved medicine in Japan. It is an investigational drug. We did not verify whether an application is pending. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/amycretin-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000277965.pdf","title":"Approved new drugs list (Japanese), April 2025 to March 2026 (承認品目一覧（新医薬品：2025年4月～2026年3月）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-03","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"}]},{"molecule":"aod-9604","moleculeName":"AOD-9604","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"Not an approved medicine in Japan; sale and advertising as a drug are illegal, and WADA bans AOD-9604 in sport","detail":"AOD-9604 (a growth hormone fragment) has no approval in PMDA's approved-drug lists (April 2004 to September 2026). Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68). Individuals may import a prescription drug for their own use up to one month's supply and may not pass it on, and physicians may import an unapproved drug for a patient under their own responsibility. The WADA Prohibited List 2026 names AOD-9604 under S2 (growth hormone fragments).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/aod-9604-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/kojinyunyu/topics/tp010401-1.html","title":"Personal import of pharmaceuticals and related products (医薬品等の個人輸入について)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2025","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"World Anti-Doping Code International Standard: Prohibited List 2026","publisher":"World Anti-Doping Agency (WADA)","date":"2025-09","accessed":"2026-09-29"},{"url":"https://www.playtruejapan.org/","title":"Japan Anti-Doping Agency (JADA) website","publisher":"Japan Anti-Doping Agency (JADA)","date":"2026","accessed":"2026-09-29"}]},{"molecule":"bpc-157","moleculeName":"BPC-157","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"Not an approved medicine in Japan; sale and advertising as a drug are illegal, and WADA bans BPC-157 in sport","detail":"BPC-157 has no approval in PMDA's approved-drug lists. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68). No MHLW or PMDA notice naming BPC-157 was found, so we do not classify it as specifically banned. Individuals may import a prescription drug for their own use up to one month's supply and may not pass it on, and physicians may import an unapproved drug for a patient under their own responsibility. The WADA Prohibited List 2026 names BPC-157 as an example under S0 (non-approved substances), prohibited at all times in sport.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/bpc-157-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/kojinyunyu/topics/tp010401-1.html","title":"Personal import of pharmaceuticals and related products (医薬品等の個人輸入について)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2025","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"World Anti-Doping Code International Standard: Prohibited List 2026","publisher":"World Anti-Doping Agency (WADA)","date":"2025-09","accessed":"2026-09-29"},{"url":"https://www.playtruejapan.org/","title":"Japan Anti-Doping Agency (JADA) website","publisher":"Japan Anti-Doping Agency (JADA)","date":"2026","accessed":"2026-09-29"}]},{"molecule":"bremelanotide","moleculeName":"Bremelanotide (PT-141)","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"No marketing approval in Japan; bremelanotide is not in PMDA's approved-drug lists or package-insert database","detail":"PMDA's approved new drug lists (April 2004 to September 2026) and its package-insert database return no bremelanotide product, so it is not an approved medicine in Japan. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68). Individuals may import a prescription drug for their own use up to one month's supply and may not pass it on, and physicians may import an unapproved drug for a patient under their own responsibility.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/bremelanotide-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/kojinyunyu/topics/tp010401-1.html","title":"Personal import of pharmaceuticals and related products (医薬品等の個人輸入について)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2025","accessed":"2026-09-29"}]},{"molecule":"cagrilintide","moleculeName":"Cagrilintide (and CagriSema)","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"No marketing approval in Japan; the amylin analogue cagrilintide does not appear in PMDA's approved-drug lists to September 2026","detail":"PMDA's approved new drug lists (April 2004 to September 2026) and its package-insert database contain no product with this ingredient, so it cannot be marketed or prescribed as an approved medicine in Japan. It is an investigational drug. We did not verify whether an application is pending. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/cagrilintide-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000277965.pdf","title":"Approved new drugs list (Japanese), April 2025 to March 2026 (承認品目一覧（新医薬品：2025年4月～2026年3月）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-03","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"}]},{"molecule":"cjc-1295","moleculeName":"CJC-1295","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"Not an approved medicine in Japan; sale and advertising as a drug are illegal, and WADA bans CJC-1295 in sport","detail":"CJC-1295 has no approval in PMDA's approved-drug lists (April 2004 to September 2026). Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68). Individuals may import a prescription drug for their own use up to one month's supply and may not pass it on, and physicians may import an unapproved drug for a patient under their own responsibility. The WADA Prohibited List 2026 names CJC-1295 under S2 (growth hormone releasing hormone analogues).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/cjc-1295-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/kojinyunyu/topics/tp010401-1.html","title":"Personal import of pharmaceuticals and related products (医薬品等の個人輸入について)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2025","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"World Anti-Doping Code International Standard: Prohibited List 2026","publisher":"World Anti-Doping Agency (WADA)","date":"2025-09","accessed":"2026-09-29"},{"url":"https://www.playtruejapan.org/","title":"Japan Anti-Doping Agency (JADA) website","publisher":"Japan Anti-Doping Agency (JADA)","date":"2026","accessed":"2026-09-29"}]},{"molecule":"dsip","moleculeName":"DSIP (delta sleep-inducing peptide)","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"Not an approved medicine in Japan; DSIP (delta sleep-inducing peptide) is absent from PMDA's approved-drug lists and package-insert database","detail":"DSIP (delta sleep-inducing peptide) has no approval in PMDA's approved-drug lists (April 2004 to September 2026), and PMDA's package-insert database has no matching product. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68). No MHLW or PMDA notice naming it was found, so we do not classify it as specifically banned. Individuals may import a prescription drug for their own use up to one month's supply and may not pass it on, and physicians may import an unapproved drug for a patient under their own responsibility.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/dsip-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/kojinyunyu/topics/tp010401-1.html","title":"Personal import of pharmaceuticals and related products (医薬品等の個人輸入について)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2025","accessed":"2026-09-29"}]},{"molecule":"dulaglutide","moleculeName":"Dulaglutide","country":"japan","countryName":"Japan","countryIso2":"JP","status":"approved","statusLabel":"Approved","headline":"Approved for type 2 diabetes as Trulicity, on the NHI price list; not approved for obesity","detail":"PMDA lists Trulicity (dulaglutide) as a new active ingredient for type 2 diabetes, approved on 3 July 2015, with an additional dose form and strength approved on 24 June 2024. PMDA's package-insert database shows an updated Trulicity package insert dated 15 September 2026. Trulicity is on the NHI price list applicable from 13 August 2026. No obesity indication for dulaglutide appears in the approval lists.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/dulaglutide-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/topics/2026/04/tp20260401-01.html","title":"NHI drug price list and generic drug information, applicable from 13 August 2026 (薬価基準収載品目リスト)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2026-08-13","accessed":"2026-09-29"}]},{"molecule":"ecnoglutide","moleculeName":"Ecnoglutide","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"No marketing approval in Japan; the investigational GLP-1 agonist ecnoglutide does not appear in PMDA's approved-drug lists to September 2026","detail":"PMDA's approved new drug lists (April 2004 to September 2026) and its package-insert database contain no product with this ingredient, so it cannot be marketed or prescribed as an approved medicine in Japan. It is an investigational drug in Japan. We did not verify whether an application is pending. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ecnoglutide-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000277965.pdf","title":"Approved new drugs list (Japanese), April 2025 to March 2026 (承認品目一覧（新医薬品：2025年4月～2026年3月）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-03","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"}]},{"molecule":"elamipretide","moleculeName":"Elamipretide (SS-31)","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"No marketing approval in Japan; elamipretide is not in PMDA's approved-drug lists or package-insert database","detail":"PMDA's approved new drug lists (April 2004 to September 2026) and its package-insert database return no elamipretide product, so it is not an approved medicine in Japan. We did not verify whether an application is pending. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68). Individuals may import a prescription drug for their own use up to one month's supply and may not pass it on, and physicians may import an unapproved drug for a patient under their own responsibility.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/elamipretide-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000277965.pdf","title":"Approved new drugs list (Japanese), April 2025 to March 2026 (承認品目一覧（新医薬品：2025年4月～2026年3月）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-03","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/kojinyunyu/topics/tp010401-1.html","title":"Personal import of pharmaceuticals and related products (医薬品等の個人輸入について)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2025","accessed":"2026-09-29"}]},{"molecule":"eloralintide","moleculeName":"Eloralintide","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"No marketing approval in Japan; the investigational amylin agonist eloralintide does not appear in PMDA's approved-drug lists to September 2026","detail":"PMDA's approved new drug lists (April 2004 to September 2026) and its package-insert database contain no product with this ingredient, so it cannot be marketed or prescribed as an approved medicine in Japan. It is an investigational drug. We did not verify whether an application is pending. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/eloralintide-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000277965.pdf","title":"Approved new drugs list (Japanese), April 2025 to March 2026 (承認品目一覧（新医薬品：2025年4月～2026年3月）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-03","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"}]},{"molecule":"epitalon","moleculeName":"Epitalon","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"Not an approved medicine in Japan; epitalon is absent from PMDA's approved-drug lists and package-insert database","detail":"Epitalon has no approval in PMDA's approved-drug lists (April 2004 to September 2026), and PMDA's package-insert database has no matching product. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68). No MHLW or PMDA notice naming it was found, so we do not classify it as specifically banned. Individuals may import a prescription drug for their own use up to one month's supply and may not pass it on, and physicians may import an unapproved drug for a patient under their own responsibility.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/epitalon-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/kojinyunyu/topics/tp010401-1.html","title":"Personal import of pharmaceuticals and related products (医薬品等の個人輸入について)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2025","accessed":"2026-09-29"}]},{"molecule":"exenatide","moleculeName":"Exenatide","country":"japan","countryName":"Japan","countryIso2":"JP","status":"unknown","statusLabel":"Unverified","headline":"Byetta (2010) and Bydureon (2012) were approved, but exenatide is off the current price list and its marketing status was not confirmed","detail":"PMDA's English approval list shows Byetta (type 2 diabetes, 27 October 2010) and Bydureon (30 March 2012). PMDA's package-insert database now returns only four exenatide records, all review or re-examination reports (the latest dated 25 June 2020), with no current package insert. Exenatide products appear in neither the March 2026 nor the August 2026 NHI price lists. This suggests the products are no longer marketed, but we did not find a withdrawal notice, so we cannot say whether the approvals remain formally in force.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/countries/japan","sources":[{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/topics/2026/04/tp20260401-01.html","title":"NHI drug price list and generic drug information, applicable from 13 August 2026 (薬価基準収載品目リスト)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2026-08-13","accessed":"2026-09-29"}]},{"molecule":"ghk-cu","moleculeName":"GHK-Cu (copper peptide)","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"Not an approved medicine in Japan; GHK-Cu (copper peptide) is absent from PMDA's approved-drug lists and package-insert database","detail":"GHK-Cu (copper peptide) has no approval in PMDA's approved-drug lists (April 2004 to September 2026), and PMDA's package-insert database has no matching product. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68). No MHLW or PMDA notice naming it was found, so we do not classify it as specifically banned. Individuals may import a prescription drug for their own use up to one month's supply and may not pass it on, and physicians may import an unapproved drug for a patient under their own responsibility.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ghk-cu-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/kojinyunyu/topics/tp010401-1.html","title":"Personal import of pharmaceuticals and related products (医薬品等の個人輸入について)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2025","accessed":"2026-09-29"}]},{"molecule":"ipamorelin","moleculeName":"Ipamorelin","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"Not an approved medicine in Japan; sale and advertising as a drug are illegal, and WADA bans ipamorelin in sport","detail":"Ipamorelin has no approval in PMDA's approved-drug lists, and PMDA's package-insert database returns no ipamorelin product. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68). Individuals may import a prescription drug for their own use up to one month's supply and may not pass it on, and physicians may import an unapproved drug for a patient under their own responsibility. The WADA Prohibited List 2026 names ipamorelin under S2 (growth hormone secretagogues).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ipamorelin-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/kojinyunyu/topics/tp010401-1.html","title":"Personal import of pharmaceuticals and related products (医薬品等の個人輸入について)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2025","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"World Anti-Doping Code International Standard: Prohibited List 2026","publisher":"World Anti-Doping Agency (WADA)","date":"2025-09","accessed":"2026-09-29"},{"url":"https://www.playtruejapan.org/","title":"Japan Anti-Doping Agency (JADA) website","publisher":"Japan Anti-Doping Agency (JADA)","date":"2026","accessed":"2026-09-29"}]},{"molecule":"kisspeptin","moleculeName":"Kisspeptin","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"Not an approved medicine in Japan; kisspeptin is absent from PMDA's lists, and WADA bans it in sport","detail":"Kisspeptin has no approval in PMDA's approved-drug lists, and PMDA's package-insert database returns no kisspeptin product. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68). Individuals may import a prescription drug for their own use up to one month's supply and may not pass it on, and physicians may import an unapproved drug for a patient under their own responsibility. The WADA Prohibited List 2026 names kisspeptin and its agonist analogues under S2 (testosterone-stimulating peptides in males).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/kisspeptin-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/kojinyunyu/topics/tp010401-1.html","title":"Personal import of pharmaceuticals and related products (医薬品等の個人輸入について)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2025","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"World Anti-Doping Code International Standard: Prohibited List 2026","publisher":"World Anti-Doping Agency (WADA)","date":"2025-09","accessed":"2026-09-29"},{"url":"https://www.playtruejapan.org/","title":"Japan Anti-Doping Agency (JADA) website","publisher":"Japan Anti-Doping Agency (JADA)","date":"2026","accessed":"2026-09-29"}]},{"molecule":"kpv","moleculeName":"KPV","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"Not an approved medicine in Japan; KPV is absent from PMDA's approved-drug lists and package-insert database","detail":"KPV has no approval in PMDA's approved-drug lists (April 2004 to September 2026), and PMDA's package-insert database has no matching product. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68). No MHLW or PMDA notice naming it was found, so we do not classify it as specifically banned. Individuals may import a prescription drug for their own use up to one month's supply and may not pass it on, and physicians may import an unapproved drug for a patient under their own responsibility.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/kpv-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/kojinyunyu/topics/tp010401-1.html","title":"Personal import of pharmaceuticals and related products (医薬品等の個人輸入について)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2025","accessed":"2026-09-29"}]},{"molecule":"liraglutide","moleculeName":"Liraglutide","country":"japan","countryName":"Japan","countryIso2":"JP","status":"approved","statusLabel":"Approved","headline":"Approved for type 2 diabetes (Victoza, and Xultophy with insulin); no separate weight-loss liraglutide product found","detail":"PMDA lists Victoza (type 2 diabetes, 20 January 2010) and the insulin degludec plus liraglutide combination Xultophy (18 June 2019). PMDA's package-insert database returns only these two liraglutide products, and none is for obesity. On the NHI price list applicable from 13 August 2026, Victoza carries a transitional-use deadline of 31 March 2027, which normally signals that the product is being removed from the list, while the Xultophy combination remains listed. Generic liraglutide is not shown on the lists we checked.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/liraglutide-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/topics/2026/04/tp20260401-01.html","title":"NHI drug price list and generic drug information, applicable from 13 August 2026 (薬価基準収載品目リスト)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2026-08-13","accessed":"2026-09-29"}]},{"molecule":"ll-37","moleculeName":"LL-37","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"Not an approved medicine in Japan; LL-37 is absent from PMDA's approved-drug lists and package-insert database","detail":"LL-37 has no approval in PMDA's approved-drug lists (April 2004 to September 2026), and PMDA's package-insert database has no matching product. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68). No MHLW or PMDA notice naming it was found, so we do not classify it as specifically banned. Individuals may import a prescription drug for their own use up to one month's supply and may not pass it on, and physicians may import an unapproved drug for a patient under their own responsibility.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ll-37-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/kojinyunyu/topics/tp010401-1.html","title":"Personal import of pharmaceuticals and related products (医薬品等の個人輸入について)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2025","accessed":"2026-09-29"}]},{"molecule":"maridebart-cafraglutide","moleculeName":"Maridebart cafraglutide (MariTide)","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"No marketing approval in Japan; the investigational antibody-peptide conjugate maridebart cafraglutide does not appear in PMDA's approved-drug lists to September 2026","detail":"PMDA's approved new drug lists (April 2004 to September 2026) and its package-insert database contain no product with this ingredient, so it cannot be marketed or prescribed as an approved medicine in Japan. It is an investigational drug. We did not verify whether an application is pending. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/maridebart-cafraglutide-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000277965.pdf","title":"Approved new drugs list (Japanese), April 2025 to March 2026 (承認品目一覧（新医薬品：2025年4月～2026年3月）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-03","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"}]},{"molecule":"mazdutide","moleculeName":"Mazdutide","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"No marketing approval in Japan; the investigational GLP-1 and glucagon agonist mazdutide does not appear in PMDA's approved-drug lists to September 2026","detail":"PMDA's approved new drug lists (April 2004 to September 2026) and its package-insert database contain no product with this ingredient, so it cannot be marketed or prescribed as an approved medicine in Japan. It is an investigational drug in Japan. We did not verify whether an application is pending. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/mazdutide-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000277965.pdf","title":"Approved new drugs list (Japanese), April 2025 to March 2026 (承認品目一覧（新医薬品：2025年4月～2026年3月）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-03","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"}]},{"molecule":"melanotan-ii","moleculeName":"Melanotan II","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"Not an approved medicine in Japan; sale and advertising as a drug are illegal","detail":"Melanotan II has no approval in PMDA's approved-drug lists, and PMDA's package-insert database returns no melanotan product. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68). No MHLW or PMDA notice naming melanotan II was found, so we do not classify it as specifically banned. Individuals may import a prescription drug for their own use up to one month's supply and may not pass it on, and physicians may import an unapproved drug for a patient under their own responsibility.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/melanotan-ii-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/kojinyunyu/topics/tp010401-1.html","title":"Personal import of pharmaceuticals and related products (医薬品等の個人輸入について)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2025","accessed":"2026-09-29"}]},{"molecule":"mots-c","moleculeName":"MOTS-c","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"Not an approved medicine in Japan; MOTS-c is absent from PMDA's lists, and WADA bans it in sport","detail":"MOTS-c has no approval in PMDA's approved-drug lists (April 2004 to September 2026). Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68). No MHLW or PMDA notice naming it was found. Individuals may import a prescription drug for their own use up to one month's supply and may not pass it on, and physicians may import an unapproved drug for a patient under their own responsibility. The WADA Prohibited List 2026 names MOTS-c under S4 (hormone and metabolic modulators, AMPK activators).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/mots-c-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/kojinyunyu/topics/tp010401-1.html","title":"Personal import of pharmaceuticals and related products (医薬品等の個人輸入について)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2025","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"World Anti-Doping Code International Standard: Prohibited List 2026","publisher":"World Anti-Doping Agency (WADA)","date":"2025-09","accessed":"2026-09-29"},{"url":"https://www.playtruejapan.org/","title":"Japan Anti-Doping Agency (JADA) website","publisher":"Japan Anti-Doping Agency (JADA)","date":"2026","accessed":"2026-09-29"}]},{"molecule":"nad-plus","moleculeName":"NAD+","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"No NAD+ injection is an approved medicine in Japan; sale or advertising as a drug without approval is illegal","detail":"PMDA's package-insert database returns no product with nicotinamide adenine dinucleotide as the active ingredient, and none appears in PMDA's approved-drug lists (April 2004 to September 2026). Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68). Clinics offering NAD+ injections would be using an unapproved drug, which a doctor may import under their own responsibility for a patient, but the Medical Advertising Guidelines do not allow ordinary advertising of treatment with unapproved drugs. Individuals may import a prescription drug for their own use up to one month's supply and may not pass it on, and physicians may import an unapproved drug for a patient under their own responsibility.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/nad-plus-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/kojinyunyu/topics/tp010401-1.html","title":"Personal import of pharmaceuticals and related products (医薬品等の個人輸入について)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2025","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/content/001683594.pdf","title":"Guidelines on advertising by medical institutions (医療広告等ガイドライン), last revised 30 March 2026","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2026-03-30","accessed":"2026-09-29"}]},{"molecule":"orforglipron","moleculeName":"Orforglipron","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"No marketing approval in Japan; the oral GLP-1 orforglipron does not appear in PMDA's approved-drug lists to September 2026","detail":"PMDA's approved new drug lists (April 2004 to September 2026) and its package-insert database contain no product with this ingredient, so it cannot be marketed or prescribed as an approved medicine in Japan. Among GLP-1-based medicines, only Wegovy and Zepbound carry a Japanese obesity indication. We did not verify whether an application is pending. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/orforglipron-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000277965.pdf","title":"Approved new drugs list (Japanese), April 2025 to March 2026 (承認品目一覧（新医薬品：2025年4月～2026年3月）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-03","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"}]},{"molecule":"pramlintide","moleculeName":"Pramlintide","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"No marketing approval in Japan; pramlintide (an amylin analogue) is not in PMDA's approved-drug lists or package-insert database","detail":"PMDA's approved new drug lists (April 2004 to September 2026) and its package-insert database return no pramlintide product, so it is not an approved medicine in Japan. We did not look for an unapproved-use notice specific to pramlintide. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/pramlintide-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"}]},{"molecule":"retatrutide","moleculeName":"Retatrutide","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"No marketing approval in Japan; the investigational triple agonist retatrutide does not appear in PMDA's approved-drug lists to September 2026","detail":"PMDA's approved new drug lists (April 2004 to September 2026) and its package-insert database contain no product with this ingredient, so it cannot be marketed or prescribed as an approved medicine in Japan. It is an investigational drug. We did not verify whether an application is pending. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/retatrutide-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000277965.pdf","title":"Approved new drugs list (Japanese), April 2025 to March 2026 (承認品目一覧（新医薬品：2025年4月～2026年3月）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-03","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"}]},{"molecule":"selank","moleculeName":"Selank","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"Not an approved medicine in Japan; Selank is absent from PMDA's approved-drug lists and package-insert database","detail":"Selank has no approval in PMDA's approved-drug lists (April 2004 to September 2026), and PMDA's package-insert database returns no product. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68). No MHLW or PMDA notice naming it was found, so we do not classify it as specifically banned. Individuals may import a prescription drug for their own use up to one month's supply and may not pass it on, and physicians may import an unapproved drug for a patient under their own responsibility.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/selank-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/kojinyunyu/topics/tp010401-1.html","title":"Personal import of pharmaceuticals and related products (医薬品等の個人輸入について)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2025","accessed":"2026-09-29"}]},{"molecule":"semaglutide","moleculeName":"Semaglutide","country":"japan","countryName":"Japan","countryIso2":"JP","status":"approved","statusLabel":"Approved","headline":"Approved for type 2 diabetes (Ozempic, Rybelsus) and obesity (Wegovy); Wegovy use is limited by an MHLW guideline","detail":"PMDA lists Ozempic (type 2 diabetes, 23 March 2018), Rybelsus tablets (29 June 2020), Wegovy (obesity, 27 March 2023) and the insulin icodec plus semaglutide combination Kyinsu (19 February 2026). Wegovy gained a second indication on 19 June 2026 for metabolic dysfunction-associated steatohepatitis with moderate or advanced fibrosis. The obesity indication is limited to people with hypertension, dyslipidaemia or type 2 diabetes who have a BMI of 35 or more, or 27 or more with two or more obesity-related conditions. MHLW's Optimal Use Promotion Guideline (revised June 2026) restricts use to qualified facilities and says it must not be used for slimming or dieting. Ozempic, Rybelsus and Wegovy are on the NHI price list applicable from 13 August 2026.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/semaglutide-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281140.pdf","title":"Optimal Use Promotion Guideline: semaglutide (Wegovy), obesity (revised June 2026)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2026-06","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/topics/2026/04/tp20260401-01.html","title":"NHI drug price list and generic drug information, applicable from 13 August 2026 (薬価基準収載品目リスト)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2026-08-13","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/content/001720946.pdf","title":"Notice on proper use of GLP-1 receptor agonists and GIP/GLP-1 receptor agonists (医薬安発0616第16号)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2026-06-16","accessed":"2026-09-29"}]},{"molecule":"semax","moleculeName":"Semax","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"Not an approved medicine in Japan; Semax is absent from PMDA's approved-drug lists and package-insert database","detail":"Semax has no approval in PMDA's approved-drug lists (April 2004 to September 2026), and PMDA's package-insert database returns no product. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68). No MHLW or PMDA notice naming it was found, so we do not classify it as specifically banned. Individuals may import a prescription drug for their own use up to one month's supply and may not pass it on, and physicians may import an unapproved drug for a patient under their own responsibility.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/semax-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/kojinyunyu/topics/tp010401-1.html","title":"Personal import of pharmaceuticals and related products (医薬品等の個人輸入について)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2025","accessed":"2026-09-29"}]},{"molecule":"sermorelin","moleculeName":"Sermorelin","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"Not an approved medicine in Japan; sermorelin is absent from PMDA's lists, and WADA bans it in sport","detail":"Sermorelin has no approval in PMDA's approved-drug lists, and PMDA's package-insert database returns no sermorelin or somatorelin product. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68). Individuals may import a prescription drug for their own use up to one month's supply and may not pass it on, and physicians may import an unapproved drug for a patient under their own responsibility. The WADA Prohibited List 2026 names sermorelin under S2 (growth hormone releasing hormone analogues).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/sermorelin-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/kojinyunyu/topics/tp010401-1.html","title":"Personal import of pharmaceuticals and related products (医薬品等の個人輸入について)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2025","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"World Anti-Doping Code International Standard: Prohibited List 2026","publisher":"World Anti-Doping Agency (WADA)","date":"2025-09","accessed":"2026-09-29"},{"url":"https://www.playtruejapan.org/","title":"Japan Anti-Doping Agency (JADA) website","publisher":"Japan Anti-Doping Agency (JADA)","date":"2026","accessed":"2026-09-29"}]},{"molecule":"setmelanotide","moleculeName":"Setmelanotide","country":"japan","countryName":"Japan","countryIso2":"JP","status":"approved-restricted","statusLabel":"Approved, restricted","headline":"Approved on 24 August 2026 as Imcivree, only for acquired hypothalamic obesity; not yet on the NHI price list","detail":"MHLW approved Rhythm Pharmaceuticals' Imcivree (setmelanotide) on 24 August 2026 as a new active ingredient for acquired hypothalamic obesity, with orphan drug designation. PMDA's package-insert database now shows a package insert and review report for it. The approval covers that one indication only, and it does not extend to other forms of obesity. The product does not appear in the NHI price list applicable from 13 August 2026, which predates the approval.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/setmelanotide-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/topics/2026/04/tp20260401-01.html","title":"NHI drug price list and generic drug information, applicable from 13 August 2026 (薬価基準収載品目リスト)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2026-08-13","accessed":"2026-09-29"}]},{"molecule":"survodutide","moleculeName":"Survodutide","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"No marketing approval in Japan; the investigational GLP-1 and glucagon agonist survodutide does not appear in PMDA's approved-drug lists to September 2026","detail":"PMDA's approved new drug lists (April 2004 to September 2026) and its package-insert database contain no product with this ingredient, so it cannot be marketed or prescribed as an approved medicine in Japan. It is an investigational drug. We did not verify whether an application is pending. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/survodutide-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000277965.pdf","title":"Approved new drugs list (Japanese), April 2025 to March 2026 (承認品目一覧（新医薬品：2025年4月～2026年3月）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-03","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"}]},{"molecule":"tb-500","moleculeName":"TB-500 (thymosin beta-4 fragment)","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"Not an approved medicine in Japan; sale and advertising as a drug are illegal, and WADA bans TB-500 in sport","detail":"TB-500 (a fragment of thymosin beta-4) has no approval in PMDA's approved-drug lists, and PMDA's package-insert database has no thymosin product. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68). Individuals may import a prescription drug for their own use up to one month's supply and may not pass it on, and physicians may import an unapproved drug for a patient under their own responsibility. The WADA Prohibited List 2026 names thymosin beta-4 and its derivatives, for example TB-500, under S2 (growth factors and growth factor modulators).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tb-500-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/kojinyunyu/topics/tp010401-1.html","title":"Personal import of pharmaceuticals and related products (医薬品等の個人輸入について)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2025","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"World Anti-Doping Code International Standard: Prohibited List 2026","publisher":"World Anti-Doping Agency (WADA)","date":"2025-09","accessed":"2026-09-29"},{"url":"https://www.playtruejapan.org/","title":"Japan Anti-Doping Agency (JADA) website","publisher":"Japan Anti-Doping Agency (JADA)","date":"2026","accessed":"2026-09-29"}]},{"molecule":"tesamorelin","moleculeName":"Tesamorelin","country":"japan","countryName":"Japan","countryIso2":"JP","status":"not-approved","statusLabel":"Not approved","headline":"No marketing approval in Japan; tesamorelin is not in PMDA's approved-drug lists, and WADA prohibits it in sport","detail":"PMDA's approved new drug lists (April 2004 to September 2026) and its package-insert database return no tesamorelin product, so it is not an approved medicine in Japan. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68). Individuals may import a prescription drug for their own use up to one month's supply and may not pass it on, and physicians may import an unapproved drug for a patient under their own responsibility. In sport, the WADA Prohibited List 2026 names tesamorelin under S2 (growth hormone releasing factors).","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tesamorelin-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/PmdaSearch/iyakuSearch/","title":"Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://laws.e-gov.go.jp/law/335AC0000000145","title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text","publisher":"Digital Agency (e-Gov Law Search)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/kojinyunyu/topics/tp010401-1.html","title":"Personal import of pharmaceuticals and related products (医薬品等の個人輸入について)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2025","accessed":"2026-09-29"},{"url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","title":"World Anti-Doping Code International Standard: Prohibited List 2026","publisher":"World Anti-Doping Agency (WADA)","date":"2025-09","accessed":"2026-09-29"}]},{"molecule":"tirzepatide","moleculeName":"Tirzepatide","country":"japan","countryName":"Japan","countryIso2":"JP","status":"approved","statusLabel":"Approved","headline":"Approved for type 2 diabetes (Mounjaro) and obesity (Zepbound), plus sleep apnoea; Zepbound use is limited by an MHLW guideline","detail":"PMDA lists Mounjaro (type 2 diabetes, 26 September 2022) and Zepbound (obesity, 27 December 2024). On 18 May 2026 Zepbound gained an indication for moderate or worse obstructive sleep apnoea with a BMI of 27 or more, and its obesity wording was updated. Under the 18 May 2026 wording, the obesity indication is limited to people with hypertension, dyslipidaemia or impaired glucose metabolism (type 2 diabetes, impaired glucose tolerance and similar) who did not respond enough to diet and exercise and who have a BMI of 35 or more, or 27 or more with two or more obesity-related conditions. MHLW's Optimal Use Promotion Guideline (revised May 2026) still asks that patients have a diagnosis of hypertension, dyslipidaemia or type 2 diabetes, limits use to qualified facilities, allows at most 72 weeks in a course, and excludes slimming or cosmetic use. Both brands are on the NHI price list applicable from 13 August 2026, with new Mounjaro prices marked from 1 August 2026.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tirzepatide-in-japan","sources":[{"url":"https://www.pmda.go.jp/files/000281577.pdf","title":"Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000281190.pdf","title":"List of Approved Drugs, April 2004 to February 2026 (new drugs)","publisher":"Pharmaceuticals and Medical Devices Agency (PMDA)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.pmda.go.jp/files/000280607.pdf","title":"Optimal Use Promotion Guideline: tirzepatide (Zepbound), obesity (revised May 2026)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2026-05","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/topics/2026/04/tp20260401-01.html","title":"NHI drug price list and generic drug information, applicable from 13 August 2026 (薬価基準収載品目リスト)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2026-08-13","accessed":"2026-09-29"},{"url":"https://www.mhlw.go.jp/content/001720946.pdf","title":"Notice on proper use of GLP-1 receptor agonists and GIP/GLP-1 receptor agonists (医薬安発0616第16号)","publisher":"Ministry of Health, Labour and Welfare (MHLW)","date":"2026-06-16","accessed":"2026-09-29"}]},{"molecule":"amycretin","moleculeName":"Amycretin","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"Not registered in Mexico; amycretin is an investigational Novo Nordisk medicine","detail":"No medicine containing this ingredient appears in COFEPRIS's yearly lists of allopathic registrations issued from 2007 to 2026 that we searched, and the 2026 list of new applications (updated 31 August 2026) has no entry for it. Amycretin is still in mid-stage human trials run by Novo Nordisk; Novo Nordisk México's press centre lists 2025 phase 1b-2a and phase 2 trial news, not a marketing authorisation. COFEPRIS's alerts state that a medicine needs a sanitary registration before it can be sold in Mexico and that prescription drugs are governed by Article 226 of the Ley General de Salud.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/amycretin-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cofepris/documentos/registros-sanitarios-medicamentos","title":"Listados de registros sanitarios de medicamentos (visor y listas anuales)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-08-21","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1102317/Solicitudes_Reg_Excepto_Gen_ricos_y_Biocomp_2026.pdf","title":"Solicitudes de medicamentos (excepto genérico y biocomparable) ingresadas en 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://www.novonordisk.com.mx/center-press.html","title":"Centro de prensa de Novo Nordisk México","publisher":"Novo Nordisk México","date":"2026-04-17","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"aod-9604","moleculeName":"AOD-9604","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"No registration for AOD-9604 found in COFEPRIS lists","detail":"No medicine containing this ingredient appears in COFEPRIS's yearly lists of allopathic registrations issued from 2007 to 2026 that we searched, and the 2026 list of new applications (updated 31 August 2026) has no entry for it. AOD-9604 failed to show a significant weight-loss effect in its main phase 2b trial and has no approved use. COFEPRIS's alerts state that a medicine needs a sanitary registration before it can be sold in Mexico and that prescription drugs are governed by Article 226 of the Ley General de Salud.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/aod-9604-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cofepris/documentos/registros-sanitarios-medicamentos","title":"Listados de registros sanitarios de medicamentos (visor y listas anuales)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-08-21","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1102317/Solicitudes_Reg_Excepto_Gen_ricos_y_Biocomp_2026.pdf","title":"Solicitudes de medicamentos (excepto genérico y biocomparable) ingresadas en 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"bpc-157","moleculeName":"BPC-157","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in Mexico; a 2026 bill would expressly ban sale of unregistered research peptides","detail":"This is an unapproved peptide in Mexico. COFEPRIS lists no registration for it, and a July 2026 bill in Congress argues that Mexican law has no provision that classifies such compounds or expressly bans selling them, leaving the authority to act only after the fact. COFEPRIS's own alerts treat selling a medicine without a sanitary registration as illegal, as in its February 2026 tirzepatide alert. The bill (Movimiento Ciudadano, July 2026) names BPC-157 and would add Article 215 Bis to the Ley General de Salud; it is only a proposal, and we found no record that Congress has approved it. A fact-check of April 2026 described BPC-157 as unapproved for human use and in a legal grey area. We found no COFEPRIS alert naming it on the alert pages we could read. Human evidence is very limited and mostly from animals.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/bpc-157-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"http://sil.gobernacion.gob.mx/Archivos/Documentos/2026/07/asun_5112302_20260729_1784761524.pdf","title":"Iniciativa con proyecto de decreto por el que se adiciona un artículo 215 Bis a la Ley General de Salud, en materia de regulación de péptidos de investigación de uso estético y deportivo","publisher":"Cámara de Diputados, Sistema de Información Legislativa (dip. Ivonne Ortega Pacheco, MC)","date":"2026-07","accessed":"2026-09-29"},{"url":"https://verificado.com.mx/peptidos-influencers-autoridades-no-los-aprueban/","title":"Qué son los péptidos que usan influencers y por qué las autoridades no los aprueban","publisher":"Verificado","date":"2026-04-01","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cofepris/documentos/alertas-sanitarias-de-medicamentos","title":"Alertas sanitarias de medicamentos (índice)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-09-28","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"bremelanotide","moleculeName":"Bremelanotide (PT-141)","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"No registration for bremelanotide found in COFEPRIS lists","detail":"No medicine containing this ingredient appears in COFEPRIS's yearly lists of allopathic registrations issued from 2007 to 2026 that we searched, and the 2026 list of new applications (updated 31 August 2026) has no entry for it. Bremelanotide (PT-141) is approved in the US for low sexual desire in premenopausal women, but we found no Mexican registration or application. COFEPRIS's alerts state that a medicine needs a sanitary registration before it can be sold in Mexico and that prescription drugs are governed by Article 226 of the Ley General de Salud.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/bremelanotide-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cofepris/documentos/registros-sanitarios-medicamentos","title":"Listados de registros sanitarios de medicamentos (visor y listas anuales)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-08-21","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1102317/Solicitudes_Reg_Excepto_Gen_ricos_y_Biocomp_2026.pdf","title":"Solicitudes de medicamentos (excepto genérico y biocomparable) ingresadas en 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"cagrilintide","moleculeName":"Cagrilintide (and CagriSema)","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"Not registered in Mexico; CagriSema and cagrilintide are still investigational there","detail":"No medicine containing this ingredient appears in COFEPRIS's yearly lists of allopathic registrations issued from 2007 to 2026 that we searched, and the 2026 list of new applications (updated 31 August 2026) has no entry for it. Cagrilintide, alone or combined with semaglutide as CagriSema, is an investigational Novo Nordisk medicine. Novo Nordisk México's press centre lists trial-result news for CagriSema in 2026, not a marketing authorisation. COFEPRIS's alerts state that a medicine needs a sanitary registration before it can be sold in Mexico and that prescription drugs are governed by Article 226 of the Ley General de Salud.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/cagrilintide-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cofepris/documentos/registros-sanitarios-medicamentos","title":"Listados de registros sanitarios de medicamentos (visor y listas anuales)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-08-21","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1102317/Solicitudes_Reg_Excepto_Gen_ricos_y_Biocomp_2026.pdf","title":"Solicitudes de medicamentos (excepto genérico y biocomparable) ingresadas en 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://www.novonordisk.com.mx/center-press.html","title":"Centro de prensa de Novo Nordisk México","publisher":"Novo Nordisk México","date":"2026-04-17","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"cjc-1295","moleculeName":"CJC-1295","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in Mexico; unregistered peptide named in a July 2026 bill and a fact-check","detail":"This is an unapproved peptide in Mexico. COFEPRIS lists no registration for it, and a July 2026 bill in Congress argues that Mexican law has no provision that classifies such compounds or expressly bans selling them, leaving the authority to act only after the fact. COFEPRIS's own alerts treat selling a medicine without a sanitary registration as illegal, as in its February 2026 tirzepatide alert. The bill and an April 2026 fact-check name CJC-1295 among peptides claimed to raise growth hormone. Human data are limited to short studies in healthy volunteers. No COFEPRIS registration or alert for it was found.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/cjc-1295-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"http://sil.gobernacion.gob.mx/Archivos/Documentos/2026/07/asun_5112302_20260729_1784761524.pdf","title":"Iniciativa con proyecto de decreto por el que se adiciona un artículo 215 Bis a la Ley General de Salud, en materia de regulación de péptidos de investigación de uso estético y deportivo","publisher":"Cámara de Diputados, Sistema de Información Legislativa (dip. Ivonne Ortega Pacheco, MC)","date":"2026-07","accessed":"2026-09-29"},{"url":"https://verificado.com.mx/peptidos-influencers-autoridades-no-los-aprueban/","title":"Qué son los péptidos que usan influencers y por qué las autoridades no los aprueban","publisher":"Verificado","date":"2026-04-01","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"dsip","moleculeName":"DSIP (delta sleep-inducing peptide)","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"No registration for DSIP found in COFEPRIS lists","detail":"No medicine containing this ingredient appears in COFEPRIS's yearly lists of allopathic registrations issued from 2007 to 2026 that we searched, and the 2026 list of new applications (updated 31 August 2026) has no entry for it. DSIP (delta sleep-inducing peptide) has only small, old and mixed human studies and no approved use. COFEPRIS's alerts state that a medicine needs a sanitary registration before it can be sold in Mexico and that prescription drugs are governed by Article 226 of the Ley General de Salud.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/dsip-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cofepris/documentos/registros-sanitarios-medicamentos","title":"Listados de registros sanitarios de medicamentos (visor y listas anuales)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-08-21","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1102317/Solicitudes_Reg_Excepto_Gen_ricos_y_Biocomp_2026.pdf","title":"Solicitudes de medicamentos (excepto genérico y biocomparable) ingresadas en 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"dulaglutide","moleculeName":"Dulaglutide","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"approved","statusLabel":"Approved","headline":"Approved as Trulicity (Eli Lilly) for type 2 diabetes; listed as valid by COFEPRIS in May 2024","detail":"COFEPRIS registered Trulicity (dulaglutide) as 173M2015, held by Eli Lilly, in class IV of Article 226, a prescription-only category. COFEPRIS's reference-biologic list, version 10 of May 2024, shows it as valid and indicated for type 2 diabetes. We found no generic or biosimilar dulaglutide application in the 2026 lists of new applications. Weight loss is not part of the indication in that list.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/dulaglutide-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/303036/Alop_ticos_2015.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2015","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2018-02-23","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1030531/Listado_de_Medicamentos_Biotecnol_gicos_de_Referencia__versi_n_10__05-2024.pdf","title":"Medicamentos biotecnológicos de referencia (versión 10)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2024-05","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1102316/Solicitudes_Reg_Gen_ricos_y_Biocomparables_2026_aviso.pdf","title":"Solicitudes de medicamentos genérico o biocomparable ingresadas en 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-31","accessed":"2026-09-29"}]},{"molecule":"ecnoglutide","moleculeName":"Ecnoglutide","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"Not registered in Mexico; ecnoglutide is approved only in China","detail":"No medicine containing this ingredient appears in COFEPRIS's yearly lists of allopathic registrations issued from 2007 to 2026 that we searched, and the 2026 list of new applications (updated 31 August 2026) has no entry for it. Ecnoglutide has been approved by China's regulator, but that does not confer a Mexican authorisation. COFEPRIS's alerts state that a medicine needs a sanitary registration before it can be sold in Mexico and that prescription drugs are governed by Article 226 of the Ley General de Salud.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ecnoglutide-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cofepris/documentos/registros-sanitarios-medicamentos","title":"Listados de registros sanitarios de medicamentos (visor y listas anuales)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-08-21","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1102317/Solicitudes_Reg_Excepto_Gen_ricos_y_Biocomp_2026.pdf","title":"Solicitudes de medicamentos (excepto genérico y biocomparable) ingresadas en 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"elamipretide","moleculeName":"Elamipretide (SS-31)","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"No registration for elamipretide found in COFEPRIS lists","detail":"No medicine containing this ingredient appears in COFEPRIS's yearly lists of allopathic registrations issued from 2007 to 2026 that we searched, and the 2026 list of new applications (updated 31 August 2026) has no entry for it. Elamipretide has only a US accelerated approval, for Barth syndrome, and we found no Mexican registration or application. COFEPRIS's alerts state that a medicine needs a sanitary registration before it can be sold in Mexico and that prescription drugs are governed by Article 226 of the Ley General de Salud.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/elamipretide-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cofepris/documentos/registros-sanitarios-medicamentos","title":"Listados de registros sanitarios de medicamentos (visor y listas anuales)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-08-21","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1102317/Solicitudes_Reg_Excepto_Gen_ricos_y_Biocomp_2026.pdf","title":"Solicitudes de medicamentos (excepto genérico y biocomparable) ingresadas en 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"eloralintide","moleculeName":"Eloralintide","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"Not registered in Mexico; eloralintide is an investigational Eli Lilly medicine","detail":"No medicine containing this ingredient appears in COFEPRIS's yearly lists of allopathic registrations issued from 2007 to 2026 that we searched, and the 2026 list of new applications (updated 31 August 2026) has no entry for it. Eloralintide is an investigational amylin-type medicine from Eli Lilly, with phase 3 studies registered but no approval anywhere. COFEPRIS's alerts state that a medicine needs a sanitary registration before it can be sold in Mexico and that prescription drugs are governed by Article 226 of the Ley General de Salud.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/eloralintide-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cofepris/documentos/registros-sanitarios-medicamentos","title":"Listados de registros sanitarios de medicamentos (visor y listas anuales)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-08-21","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1102317/Solicitudes_Reg_Excepto_Gen_ricos_y_Biocomp_2026.pdf","title":"Solicitudes de medicamentos (excepto genérico y biocomparable) ingresadas en 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"epitalon","moleculeName":"Epitalon","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in Mexico; unregistered peptide named in a July 2026 bill","detail":"This is an unapproved peptide in Mexico. COFEPRIS lists no registration for it, and a July 2026 bill in Congress argues that Mexican law has no provision that classifies such compounds or expressly bans selling them, leaving the authority to act only after the fact. COFEPRIS's own alerts treat selling a medicine without a sanitary registration as illegal, as in its February 2026 tirzepatide alert. The bill names Epitalon among peptides sold on social media. Human evidence is small and comes mostly from one research network. No COFEPRIS registration or alert for it was found.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/epitalon-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"http://sil.gobernacion.gob.mx/Archivos/Documentos/2026/07/asun_5112302_20260729_1784761524.pdf","title":"Iniciativa con proyecto de decreto por el que se adiciona un artículo 215 Bis a la Ley General de Salud, en materia de regulación de péptidos de investigación de uso estético y deportivo","publisher":"Cámara de Diputados, Sistema de Información Legislativa (dip. Ivonne Ortega Pacheco, MC)","date":"2026-07","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cofepris/documentos/registros-sanitarios-medicamentos","title":"Listados de registros sanitarios de medicamentos (visor y listas anuales)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-08-21","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"exenatide","moleculeName":"Exenatide","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"unknown","statusLabel":"Unverified","headline":"Bydureon's registration was cancelled in 2025; the status of Byetta could not be confirmed","detail":"COFEPRIS registered exenatide twice: Byetta (listed as BAIETTA, 181M2008, Eli Lilly) and Bydureon (047M2013). Bydureon's registration, held by AstraZeneca and extended to January 2023, appears on COFEPRIS's 2025 list of registrations cancelled at the holder's request. The last published validity for the Byetta registration was 30 October 2018, and we found no later renewal, cancellation or revocation in the published lists. COFEPRIS's live registry viewer was not reachable, so we cannot say whether any exenatide product is currently authorised.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/countries/mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/145567/Alop_ticos2008.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2008","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2008","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/145573/Alop_ticos_2013.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2013","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2014-06-09","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/274836/Prorrogas_Aprob_A-H_13_E.pdf","title":"Registros de medicamentos prorrogados en 2013","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2013","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/542775/Pr_rrogas_Aprobadas_2018.pdf","title":"Registros de medicamentos prorrogados en 2018","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2018","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/998238/Registros_Cancelados_2025.pdf","title":"Registros sanitarios de medicamentos cancelados 2025","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-04-23","accessed":"2026-09-29"}]},{"molecule":"ghk-cu","moleculeName":"GHK-Cu (copper peptide)","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"Not approved as a medicine in Mexico; injectable copper peptide is unregistered","detail":"This is an unapproved peptide in Mexico. COFEPRIS lists no registration for it, and a July 2026 bill in Congress argues that Mexican law has no provision that classifies such compounds or expressly bans selling them, leaving the authority to act only after the fact. COFEPRIS's own alerts treat selling a medicine without a sanitary registration as illegal, as in its February 2026 tirzepatide alert. The bill and a fact-check both name GHK-Cu among peptides sold on social media. We found no COFEPRIS registration or alert for it, and did not assess how topical cosmetic uses are treated. Human evidence is small and mostly for topical use.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ghk-cu-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"http://sil.gobernacion.gob.mx/Archivos/Documentos/2026/07/asun_5112302_20260729_1784761524.pdf","title":"Iniciativa con proyecto de decreto por el que se adiciona un artículo 215 Bis a la Ley General de Salud, en materia de regulación de péptidos de investigación de uso estético y deportivo","publisher":"Cámara de Diputados, Sistema de Información Legislativa (dip. Ivonne Ortega Pacheco, MC)","date":"2026-07","accessed":"2026-09-29"},{"url":"https://verificado.com.mx/peptidos-influencers-autoridades-no-los-aprueban/","title":"Qué son los péptidos que usan influencers y por qué las autoridades no los aprueban","publisher":"Verificado","date":"2026-04-01","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"ipamorelin","moleculeName":"Ipamorelin","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in Mexico; unregistered peptide named in a July 2026 bill and a fact-check","detail":"This is an unapproved peptide in Mexico. COFEPRIS lists no registration for it, and a July 2026 bill in Congress argues that Mexican law has no provision that classifies such compounds or expressly bans selling them, leaving the authority to act only after the fact. COFEPRIS's own alerts treat selling a medicine without a sanitary registration as illegal, as in its February 2026 tirzepatide alert. The bill and an April 2026 fact-check name Ipamorelin among peptides claimed to raise growth hormone. Human evidence is thin and does not support any use. No COFEPRIS registration or alert for it was found.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ipamorelin-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"http://sil.gobernacion.gob.mx/Archivos/Documentos/2026/07/asun_5112302_20260729_1784761524.pdf","title":"Iniciativa con proyecto de decreto por el que se adiciona un artículo 215 Bis a la Ley General de Salud, en materia de regulación de péptidos de investigación de uso estético y deportivo","publisher":"Cámara de Diputados, Sistema de Información Legislativa (dip. Ivonne Ortega Pacheco, MC)","date":"2026-07","accessed":"2026-09-29"},{"url":"https://verificado.com.mx/peptidos-influencers-autoridades-no-los-aprueban/","title":"Qué son los péptidos que usan influencers y por qué las autoridades no los aprueban","publisher":"Verificado","date":"2026-04-01","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"kisspeptin","moleculeName":"Kisspeptin","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"No registration for kisspeptin found in COFEPRIS lists","detail":"No medicine containing this ingredient appears in COFEPRIS's yearly lists of allopathic registrations issued from 2007 to 2026 that we searched, and the 2026 list of new applications (updated 31 August 2026) has no entry for it. Kisspeptin has been tested only in small supervised studies and has no approved use anywhere. COFEPRIS's alerts state that a medicine needs a sanitary registration before it can be sold in Mexico and that prescription drugs are governed by Article 226 of the Ley General de Salud.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/kisspeptin-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cofepris/documentos/registros-sanitarios-medicamentos","title":"Listados de registros sanitarios de medicamentos (visor y listas anuales)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-08-21","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1102317/Solicitudes_Reg_Excepto_Gen_ricos_y_Biocomp_2026.pdf","title":"Solicitudes de medicamentos (excepto genérico y biocomparable) ingresadas en 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"kpv","moleculeName":"KPV","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"No registration for KPV found in COFEPRIS lists","detail":"No medicine containing this ingredient appears in COFEPRIS's yearly lists of allopathic registrations issued from 2007 to 2026 that we searched, and the 2026 list of new applications (updated 31 August 2026) has no entry for it. KPV is a small peptide studied only in cell and animal work, so it has no medical use in Mexico or elsewhere. COFEPRIS's alerts state that a medicine needs a sanitary registration before it can be sold in Mexico and that prescription drugs are governed by Article 226 of the Ley General de Salud.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/kpv-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cofepris/documentos/registros-sanitarios-medicamentos","title":"Listados de registros sanitarios de medicamentos (visor y listas anuales)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-08-21","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1102317/Solicitudes_Reg_Excepto_Gen_ricos_y_Biocomp_2026.pdf","title":"Solicitudes de medicamentos (excepto genérico y biocomparable) ingresadas en 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"liraglutide","moleculeName":"Liraglutide","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"approved","statusLabel":"Approved","headline":"Approved as Victoza (diabetes), Saxenda (weight) and Xultophy; several generic and biocomparable applications pending","detail":"COFEPRIS's registers list Victoza (registration 225M2009, renewed in 2019), Saxenda (333M2015) and Xultophy, a combination with insulin degludec (043M2018), all held by Novo Nordisk A/S. COFEPRIS's reference-biologic list of May 2024 shows Victoza for type 2 diabetes and Saxenda for weight management in adults and adolescents aged 12 and over, both as valid. The 2026 lists of pending applications include seven generic or biocomparable liraglutide entries (Heptapharma, Sun Pharma two, Mexicip two, Exeltis, Productos Farmacéuticos), on top of 2024 and 2025 filings. On 19 February 2026 COFEPRIS warned of counterfeit Victoza lots that were meant for the public health sector, in which no active ingredient was detected.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/liraglutide-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/542776/Pr_rrogas_Aprobadas_2019.pdf","title":"Registros de medicamentos prorrogados en 2019","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2020-03-18","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/303036/Alop_ticos_2015.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2015","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2018-02-23","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/436142/Alop_ticos_2018.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2018","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2019-01-24","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1030531/Listado_de_Medicamentos_Biotecnol_gicos_de_Referencia__versi_n_10__05-2024.pdf","title":"Medicamentos biotecnológicos de referencia (versión 10)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2024-05","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1102316/Solicitudes_Reg_Gen_ricos_y_Biocomparables_2026_aviso.pdf","title":"Solicitudes de medicamentos genérico o biocomparable ingresadas en 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1051984/Solicitudes_Reg_Gen_ricos_y_Biocomparables_2025_aviso.pdf","title":"Solicitudes de medicamentos genérico o biocomparable ingresadas en 2025","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-01-05","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1058153/Alerta_Sanitaria_Victoza_19022026.pdf","title":"Alerta sanitaria: falsificación de Victoza (liraglutida) solución inyectable","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-19","accessed":"2026-09-29"}]},{"molecule":"ll-37","moleculeName":"LL-37","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"No registration for LL-37 found in COFEPRIS lists","detail":"No medicine containing this ingredient appears in COFEPRIS's yearly lists of allopathic registrations issued from 2007 to 2026 that we searched, and the 2026 list of new applications (updated 31 August 2026) has no entry for it. LL-37 has only two small early human studies, of topical use on leg ulcers, and no approved use. COFEPRIS's alerts state that a medicine needs a sanitary registration before it can be sold in Mexico and that prescription drugs are governed by Article 226 of the Ley General de Salud.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ll-37-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cofepris/documentos/registros-sanitarios-medicamentos","title":"Listados de registros sanitarios de medicamentos (visor y listas anuales)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-08-21","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1102317/Solicitudes_Reg_Excepto_Gen_ricos_y_Biocomp_2026.pdf","title":"Solicitudes de medicamentos (excepto genérico y biocomparable) ingresadas en 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"maridebart-cafraglutide","moleculeName":"Maridebart cafraglutide (MariTide)","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"Not registered in Mexico; MariTide is an investigational Amgen medicine","detail":"No medicine containing this ingredient appears in COFEPRIS's yearly lists of allopathic registrations issued from 2007 to 2026 that we searched, and the 2026 list of new applications (updated 31 August 2026) has no entry for it. Maridebart cafraglutide (MariTide) is an investigational Amgen medicine in late-stage trials, with no approval anywhere. COFEPRIS's alerts state that a medicine needs a sanitary registration before it can be sold in Mexico and that prescription drugs are governed by Article 226 of the Ley General de Salud.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/maridebart-cafraglutide-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cofepris/documentos/registros-sanitarios-medicamentos","title":"Listados de registros sanitarios de medicamentos (visor y listas anuales)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-08-21","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1102317/Solicitudes_Reg_Excepto_Gen_ricos_y_Biocomp_2026.pdf","title":"Solicitudes de medicamentos (excepto genérico y biocomparable) ingresadas en 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"mazdutide","moleculeName":"Mazdutide","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"Not registered in Mexico; mazdutide is approved only in China","detail":"No medicine containing this ingredient appears in COFEPRIS's yearly lists of allopathic registrations issued from 2007 to 2026 that we searched, and the 2026 list of new applications (updated 31 August 2026) has no entry for it. Mazdutide has been approved by China's regulator, but that does not confer a Mexican authorisation. COFEPRIS's alerts state that a medicine needs a sanitary registration before it can be sold in Mexico and that prescription drugs are governed by Article 226 of the Ley General de Salud.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/mazdutide-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cofepris/documentos/registros-sanitarios-medicamentos","title":"Listados de registros sanitarios de medicamentos (visor y listas anuales)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-08-21","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1102317/Solicitudes_Reg_Excepto_Gen_ricos_y_Biocomp_2026.pdf","title":"Solicitudes de medicamentos (excepto genérico y biocomparable) ingresadas en 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"melanotan-ii","moleculeName":"Melanotan II","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in Mexico; unregistered tanning peptide named in a July 2026 bill and a fact-check","detail":"This is an unapproved peptide in Mexico. COFEPRIS lists no registration for it, and a July 2026 bill in Congress argues that Mexican law has no provision that classifies such compounds or expressly bans selling them, leaving the authority to act only after the fact. COFEPRIS's own alerts treat selling a medicine without a sanitary registration as illegal, as in its February 2026 tirzepatide alert. The bill and an April 2026 fact-check name Melanotan 2, which is claimed to speed up tanning. Human data are limited to small pilot and crossover studies. No COFEPRIS registration or alert for it was found.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/melanotan-ii-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"http://sil.gobernacion.gob.mx/Archivos/Documentos/2026/07/asun_5112302_20260729_1784761524.pdf","title":"Iniciativa con proyecto de decreto por el que se adiciona un artículo 215 Bis a la Ley General de Salud, en materia de regulación de péptidos de investigación de uso estético y deportivo","publisher":"Cámara de Diputados, Sistema de Información Legislativa (dip. Ivonne Ortega Pacheco, MC)","date":"2026-07","accessed":"2026-09-29"},{"url":"https://verificado.com.mx/peptidos-influencers-autoridades-no-los-aprueban/","title":"Qué son los péptidos que usan influencers y por qué las autoridades no los aprueban","publisher":"Verificado","date":"2026-04-01","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"mots-c","moleculeName":"MOTS-c","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"No registration for MOTS-c found in COFEPRIS lists","detail":"No medicine containing this ingredient appears in COFEPRIS's yearly lists of allopathic registrations issued from 2007 to 2026 that we searched, and the 2026 list of new applications (updated 31 August 2026) has no entry for it. MOTS-c has therapeutic evidence only from animal and cell work, and it has no approved medical use. COFEPRIS's alerts state that a medicine needs a sanitary registration before it can be sold in Mexico and that prescription drugs are governed by Article 226 of the Ley General de Salud.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/mots-c-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cofepris/documentos/registros-sanitarios-medicamentos","title":"Listados de registros sanitarios de medicamentos (visor y listas anuales)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-08-21","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1102317/Solicitudes_Reg_Excepto_Gen_ricos_y_Biocomp_2026.pdf","title":"Solicitudes de medicamentos (excepto genérico y biocomparable) ingresadas en 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"nad-plus","moleculeName":"NAD+","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"No registration for NAD+ as an injectable medicine found in COFEPRIS lists","detail":"No medicine listing NAD+ (nicotinamide adenine dinucleotide) as its active ingredient appears in COFEPRIS's yearly lists of allopathic registrations issued from 2007 to 2026 that we searched, and the 2026 list of new applications has no entry for it. We did not assess oral supplements or precursors, which fall under different rules. COFEPRIS's alerts state that a medicine needs a sanitary registration before it can be sold in Mexico and that prescription drugs are governed by Article 226 of the Ley General de Salud. Human evidence for injected NAD+ is small.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/nad-plus-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cofepris/documentos/registros-sanitarios-medicamentos","title":"Listados de registros sanitarios de medicamentos (visor y listas anuales)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-08-21","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1102317/Solicitudes_Reg_Excepto_Gen_ricos_y_Biocomp_2026.pdf","title":"Solicitudes de medicamentos (excepto genérico y biocomparable) ingresadas en 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"orforglipron","moleculeName":"Orforglipron","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"approved","statusLabel":"Approved","headline":"Registered by COFEPRIS in July 2026 as Foundayz (Eli Lilly); the register does not state the indication","detail":"COFEPRIS's 2026 list of registrations shows Foundayz (orforglipron tablets, registration 264M2026, Eli Lilly and Company) in class IV of Article 226, a prescription-only category, with validity to 20 July 2031. That is consistent with issue in July 2026. Lilly México had filed the application as a new molecule on 18 December 2025. The list does not give the approved indication, so we do not state one. It is an oral, non-peptide GLP-1 medicine.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/orforglipron-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1051987/Solicitudes_Reg_Excepto_Gen_ricos_y_Biocomp_2025.pdf","title":"Solicitudes de medicamentos (excepto genérico y biocomparable) ingresadas en 2025","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-01-05","accessed":"2026-09-29"}]},{"molecule":"pramlintide","moleculeName":"Pramlintide","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"No registration for pramlintide found in COFEPRIS lists","detail":"No medicine containing this ingredient appears in COFEPRIS's yearly lists of allopathic registrations issued from 2007 to 2026 that we searched, and the 2026 list of new applications (updated 31 August 2026) has no entry for it. Pramlintide is an amylin analogue approved in the US as an add-on for people using mealtime insulin. COFEPRIS's alerts state that a medicine needs a sanitary registration before it can be sold in Mexico and that prescription drugs are governed by Article 226 of the Ley General de Salud. Without a registration it cannot be legally marketed in Mexico.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/pramlintide-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cofepris/documentos/registros-sanitarios-medicamentos","title":"Listados de registros sanitarios de medicamentos (visor y listas anuales)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-08-21","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1102317/Solicitudes_Reg_Excepto_Gen_ricos_y_Biocomp_2026.pdf","title":"Solicitudes de medicamentos (excepto genérico y biocomparable) ingresadas en 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"retatrutide","moleculeName":"Retatrutide","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"Not registered in Mexico; retatrutide is unapproved everywhere","detail":"No medicine containing this ingredient appears in COFEPRIS's yearly lists of allopathic registrations issued from 2007 to 2026 that we searched, and the 2026 list of new applications (updated 31 August 2026) has no entry for it. Retatrutide is an investigational Eli Lilly triple-hormone medicine that no regulator has approved. We found no COFEPRIS alert naming it on the alerts pages we could read. Any product sold as retatrutide in Mexico would be unregistered. COFEPRIS's alerts state that a medicine needs a sanitary registration before it can be sold in Mexico and that prescription drugs are governed by Article 226 of the Ley General de Salud.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/retatrutide-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cofepris/documentos/registros-sanitarios-medicamentos","title":"Listados de registros sanitarios de medicamentos (visor y listas anuales)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-08-21","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1102317/Solicitudes_Reg_Excepto_Gen_ricos_y_Biocomp_2026.pdf","title":"Solicitudes de medicamentos (excepto genérico y biocomparable) ingresadas en 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cofepris/documentos/alertas-sanitarias-de-medicamentos","title":"Alertas sanitarias de medicamentos (índice)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-09-28","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"selank","moleculeName":"Selank","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"No registration for selank found in COFEPRIS lists","detail":"No medicine containing this ingredient appears in COFEPRIS's yearly lists of allopathic registrations issued from 2007 to 2026 that we searched, and the 2026 list of new applications (updated 31 August 2026) has no entry for it. Selank has been studied mainly in small Russian-language trials and has no approval from a major regulator. COFEPRIS's alerts state that a medicine needs a sanitary registration before it can be sold in Mexico and that prescription drugs are governed by Article 226 of the Ley General de Salud.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/selank-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cofepris/documentos/registros-sanitarios-medicamentos","title":"Listados de registros sanitarios de medicamentos (visor y listas anuales)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-08-21","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1102317/Solicitudes_Reg_Excepto_Gen_ricos_y_Biocomp_2026.pdf","title":"Solicitudes de medicamentos (excepto genérico y biocomparable) ingresadas en 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"semaglutide","moleculeName":"Semaglutide","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"approved","statusLabel":"Approved","headline":"Approved in Mexico as Ozempic, Rybelsus and Wegovy; generic applications are pending but none is registered","detail":"COFEPRIS's registration lists show Novo Nordisk A/S holds Ozempic (registration 096M2019), Rybelsus (135M2021) and Wegovy (006M2023), all in class IV of Article 226, a prescription-only category. Novo Nordisk México said COFEPRIS approved Wegovy for weight management in adults and in adolescents aged 12 and over, and announced its launch for April 2025. Press reports say a higher-strength injection and a liver-disease (MASH) indication were approved in July 2026, and a Wegovy tablet in August 2026; we did not find the COFEPRIS record itself for those, although COFEPRIS's 2026 list of innovator applications shows a Novo Nordisk México application for semaglutide tablets filed on 30 April 2026. The 2026 application lists (updated 31 August 2026) show six generic semaglutide applications (Amarox Pharma four, Siegfried Rhein one, Sandoz one), plus an Aspen Labs application from November 2025, but no generic registration was found. Press reports say a court extended clinical-data protection for semaglutide, which the generics association ANAFAM disputes. COFEPRIS issued counterfeit alerts for Ozempic on 17 June 2025, 26 March 2026 and 25 May 2026, and for Rybelsus on 13 April 2026.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/semaglutide-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/526719/Alop_ticos_2019.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2019","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2020-01-10","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/789641/Alop_ticos_2021.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2021","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2022-12-23","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/879176/Alop_ticos_2023.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2023","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2024-01-05","accessed":"2026-09-29"},{"url":"https://www.novonordisk.com.mx/content/dam/nncorp/mx/es/center-press/2025-02-26_novo-nordisk-anuncia-el-lanzamiento-de-semaglutida-2-4-mg-en-mexico-a-partir-de-abril-de-2025-la-unica-terapia-glp-1-de-administracion-semanal-aprobada-para-el-tra.pdf","title":"Novo Nordisk anuncia el lanzamiento de semaglutida en México a partir de abril de 2025 (comunicado de prensa)","publisher":"Novo Nordisk México","date":"2025-02-26","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1102316/Solicitudes_Reg_Gen_ricos_y_Biocomparables_2026_aviso.pdf","title":"Solicitudes de medicamentos genérico o biocomparable ingresadas en 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1051984/Solicitudes_Reg_Gen_ricos_y_Biocomparables_2025_aviso.pdf","title":"Solicitudes de medicamentos genérico o biocomparable ingresadas en 2025","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-01-05","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1070696/Alerta_Sanitaria_Rybelsus_13042026.pdf","title":"Alerta sanitaria: falsificación y comercialización de Rybelsus (semaglutida) tabletas","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-04-13","accessed":"2026-09-29"},{"url":"https://www.sumedico.com/especialidades/otras-enfermedades/2026/7/31/ozempic-los-tres-medicamentos-revividos-por-jueces-53074.html","title":"Ozempic y los medicamentos revividos por jueces: protección de datos para semaglutida","publisher":"Su Médico","date":"2026-07-31","accessed":"2026-09-29"},{"url":"https://www.saludiario.com/cofepris-aprueba-la-semaglutida-oral-25-mg-de-novo-nordisk-es-el-primer-pais-de-latam-en-autorizarla/","title":"Cofepris aprueba la semaglutida oral de Novo Nordisk, primer país de Latinoamérica en autorizarla","publisher":"Saludiario","date":"2026-08-17","accessed":"2026-09-29"},{"url":"https://cadenapolitica.com/2026/07/28/cofepris-aprueba-semaglutida-obesidad-higado-graso/","title":"Cofepris aprueba semaglutida para obesidad e hígado graso","publisher":"Cadena Política","date":"2026-07-28","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1102317/Solicitudes_Reg_Excepto_Gen_ricos_y_Biocomp_2026.pdf","title":"Solicitudes de medicamentos (excepto genérico y biocomparable) ingresadas en 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1002514/Alerta_Sanitaria_Ozempic_17062025.pdf","title":"Alerta sanitaria: falsificación y comercialización irregular de Ozempic, Wegovy y Saxenda","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-06-17","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1067535/Alerta_Sanitaria_OZEMPiC_26032026.pdf","title":"Alerta sanitaria: falsificación de OZEMPiC (semaglutida) solución inyectable en pluma precargada","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-03-26","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1080351/Alerta_Sanitaria_OZEMPiC_25052026.pdf","title":"Alerta sanitaria: falsificación de OZEMPiC 0.25 mg-0.5 mg/dosis (semaglutida) en pluma precargada","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-05-25","accessed":"2026-09-29"}]},{"molecule":"semax","moleculeName":"Semax","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"No registration for semax found in COFEPRIS lists; approved only in Russia","detail":"No medicine containing this ingredient appears in COFEPRIS's yearly lists of allopathic registrations issued from 2007 to 2026 that we searched, and the 2026 list of new applications (updated 31 August 2026) has no entry for it. Semax is registered as a drug in Russia, but that gives it no status in Mexico. COFEPRIS's alerts state that a medicine needs a sanitary registration before it can be sold in Mexico and that prescription drugs are governed by Article 226 of the Ley General de Salud.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/semax-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cofepris/documentos/registros-sanitarios-medicamentos","title":"Listados de registros sanitarios de medicamentos (visor y listas anuales)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-08-21","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1102317/Solicitudes_Reg_Excepto_Gen_ricos_y_Biocomp_2026.pdf","title":"Solicitudes de medicamentos (excepto genérico y biocomparable) ingresadas en 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"sermorelin","moleculeName":"Sermorelin","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"No current registration for sermorelin found in COFEPRIS lists","detail":"No medicine containing this ingredient appears in COFEPRIS's yearly lists of allopathic registrations issued from 2007 to 2026 that we searched, and the 2026 list of new applications (updated 31 August 2026) has no entry for it. Sermorelin has human clinical data but no current marketing authorisation from a major regulator. COFEPRIS's alerts state that a medicine needs a sanitary registration before it can be sold in Mexico and that prescription drugs are governed by Article 226 of the Ley General de Salud.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/sermorelin-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cofepris/documentos/registros-sanitarios-medicamentos","title":"Listados de registros sanitarios de medicamentos (visor y listas anuales)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-08-21","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1102317/Solicitudes_Reg_Excepto_Gen_ricos_y_Biocomp_2026.pdf","title":"Solicitudes de medicamentos (excepto genérico y biocomparable) ingresadas en 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"setmelanotide","moleculeName":"Setmelanotide","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"No registration for setmelanotide found in COFEPRIS lists","detail":"No medicine containing this ingredient appears in COFEPRIS's yearly lists of allopathic registrations issued from 2007 to 2026 that we searched, and the 2026 list of new applications (updated 31 August 2026) has no entry for it. Setmelanotide is approved in the US and EU for narrowly defined rare genetic and hypothalamic obesity conditions, but we found no Mexican registration or application. COFEPRIS's alerts state that a medicine needs a sanitary registration before it can be sold in Mexico and that prescription drugs are governed by Article 226 of the Ley General de Salud.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/setmelanotide-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cofepris/documentos/registros-sanitarios-medicamentos","title":"Listados de registros sanitarios de medicamentos (visor y listas anuales)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-08-21","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1102317/Solicitudes_Reg_Excepto_Gen_ricos_y_Biocomp_2026.pdf","title":"Solicitudes de medicamentos (excepto genérico y biocomparable) ingresadas en 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"survodutide","moleculeName":"Survodutide","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"Not registered in Mexico; survodutide is an investigational Boehringer Ingelheim medicine","detail":"No medicine containing this ingredient appears in COFEPRIS's yearly lists of allopathic registrations issued from 2007 to 2026 that we searched, and the 2026 list of new applications (updated 31 August 2026) has no entry for it. Survodutide is a dual glucagon and GLP-1 receptor medicine from Boehringer Ingelheim, still investigational and not approved anywhere we could verify. COFEPRIS's alerts state that a medicine needs a sanitary registration before it can be sold in Mexico and that prescription drugs are governed by Article 226 of the Ley General de Salud.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/survodutide-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cofepris/documentos/registros-sanitarios-medicamentos","title":"Listados de registros sanitarios de medicamentos (visor y listas anuales)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-08-21","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1102317/Solicitudes_Reg_Excepto_Gen_ricos_y_Biocomp_2026.pdf","title":"Solicitudes de medicamentos (excepto genérico y biocomparable) ingresadas en 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-31","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"tb-500","moleculeName":"TB-500 (thymosin beta-4 fragment)","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in Mexico; unregistered peptide named in a July 2026 bill","detail":"This is an unapproved peptide in Mexico. COFEPRIS lists no registration for it, and a July 2026 bill in Congress argues that Mexican law has no provision that classifies such compounds or expressly bans selling them, leaving the authority to act only after the fact. COFEPRIS's own alerts treat selling a medicine without a sanitary registration as illegal, as in its February 2026 tirzepatide alert. The bill names TB-500 among peptides promoted on social media, and a fact-check of April 2026 says it has no scientific backing for the claims made. No COFEPRIS alert naming it was found on the pages we could read. There are no published studies of it in people.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tb-500-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2026","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"http://sil.gobernacion.gob.mx/Archivos/Documentos/2026/07/asun_5112302_20260729_1784761524.pdf","title":"Iniciativa con proyecto de decreto por el que se adiciona un artículo 215 Bis a la Ley General de Salud, en materia de regulación de péptidos de investigación de uso estético y deportivo","publisher":"Cámara de Diputados, Sistema de Información Legislativa (dip. Ivonne Ortega Pacheco, MC)","date":"2026-07","accessed":"2026-09-29"},{"url":"https://verificado.com.mx/peptidos-influencers-autoridades-no-los-aprueban/","title":"Qué son los péptidos que usan influencers y por qué las autoridades no los aprueban","publisher":"Verificado","date":"2026-04-01","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"tesamorelin","moleculeName":"Tesamorelin","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"unknown","statusLabel":"Unverified","headline":"COFEPRIS registered Egrifta (tesamorelin) in 2015; whether the registration is still valid could not be confirmed","detail":"COFEPRIS's 2015 list shows Egrifta (tesamorelin, registration 202M2015, Sanofi-Aventis de México) in class IV of Article 226, with validity to 6 July 2020. We found no renewal for it in COFEPRIS's 2019 list of extended registrations, and it is not on the 2025 list of registrations cancelled. Renewals after 2020 are not published in the lists we could read, and COFEPRIS's live registry viewer was not reachable. Current authorisation is therefore unconfirmed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/countries/mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/303036/Alop_ticos_2015.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2015","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2018-02-23","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cofepris/documentos/registros-sanitarios-medicamentos","title":"Listados de registros sanitarios de medicamentos (visor y listas anuales)","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-08-21","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/998238/Registros_Cancelados_2025.pdf","title":"Registros sanitarios de medicamentos cancelados 2025","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-04-23","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/542776/Pr_rrogas_Aprobadas_2019.pdf","title":"Prórrogas de registros sanitarios de medicamentos aprobadas 2019","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2020-03-18","accessed":"2026-09-29"}]},{"molecule":"tirzepatide","moleculeName":"Tirzepatide","country":"mexico","countryName":"Mexico","countryIso2":"MX","status":"approved","statusLabel":"Approved","headline":"Approved as Mounjaro (Eli Lilly), registered in 2024; COFEPRIS has warned about unregistered tirzepatide sold online","detail":"COFEPRIS's 2024 list shows Mounjaro (registration 313M2024, Eli Lilly and Company) in class IV of Article 226, a prescription-only category, valid to 21 November 2029. Lilly México filed in April 2024 under the route for active ingredients already approved in the EU, Switzerland, the US, Canada and Australia. The indication text was not in the sources we could read. On 9 February 2026 COFEPRIS issued an alert about tirzepatide products without registration sold through e-commerce sites and apps in several forms; it said one relabelled cartridge sold as tirzepatide was found by analysis to contain semaglutide and bacterial growth. The alert says tirzepatide must be used under prescription.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tirzepatide-in-mexico","sources":[{"url":"https://www.gob.mx/cms/uploads/attachment/file/969390/Alop_ticos_2024.pdf","title":"Registros sanitarios de medicamentos alopáticos expedidos 2024","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-01-15","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1031012/Solicitudes_Reg_Excepto_Gen_ricos_y_Biocomp_2024.pdf","title":"Solicitudes de medicamentos (excepto genérico y biocomparable) ingresadas en 2024","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2025-01-06","accessed":"2026-09-29"},{"url":"https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf","title":"Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario","publisher":"COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)","date":"2026-02-09","accessed":"2026-09-29"}]},{"molecule":"amycretin","moleculeName":"Amycretin","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"not-approved","statusLabel":"Not approved","headline":"Amycretin is an investigational medicine with no Medsafe consent in New Zealand","detail":"Medsafe's index of data sheets for consented medicines, revised 29 September 2026, lists no amycretin product, and the Medsafe classification database has no amycretin entry that could be found. Under the Medicines Act 1981 a new medicine cannot be sold, supplied or advertised without ministerial consent (delegated to Medsafe). Medsafe also states that clinical trials of new medicines need Medsafe and ethics committee approval.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/amycretin-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp","title":"Consumer advisory: Unapproved peptide products health warning","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-05-21","accessed":"2026-09-29"}]},{"molecule":"aod-9604","moleculeName":"AOD-9604","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"not-approved","statusLabel":"Not approved","headline":"No Medsafe-approved medicine contains AOD-9604; it is classed as a prescription medicine","detail":"AOD-9604 appears by name in the Medsafe classification database as a prescription medicine. Medsafe's index of data sheets for consented medicines, revised 29 September 2026, lists no AOD-9604 product. Medsafe's weight-loss guidance says any product claimed or implied to cause weight loss must have consent to be distributed as a medicine before it can be supplied. AOD-9604 is not named in the May 2026 advisory, which says its list is not complete.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/aod-9604-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/regulatory/weight/weightloss.asp","title":"Weight Management / Weight Loss Products","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2019-12-19","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp","title":"Consumer advisory: Unapproved peptide products health warning","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-05-21","accessed":"2026-09-29"}]},{"molecule":"bpc-157","moleculeName":"BPC-157","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"prohibited","statusLabel":"Prohibited","headline":"Not approved; Medsafe names BPC-157 as an illegal unapproved peptide and says it seizes it","detail":"Medsafe's consumer advisory of 21 May 2026 names BPC-157 among products promoted by online sellers. It says it is illegal to import, sell or use such products outside the regulated medicines system, that Medsafe continues to seize them, and that 'for research purposes only' labels have no legal effect. 'Body protective compound 157 and its analogues' is a listed prescription medicine class in the Medsafe classification database. No BPC-157 medicine has Medsafe consent, and Medsafe says it has not assessed such products for quality, safety or effectiveness.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/bpc-157-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp","title":"Consumer advisory: Unapproved peptide products health warning","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"}]},{"molecule":"bremelanotide","moleculeName":"Bremelanotide (PT-141)","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"not-approved","statusLabel":"Not approved","headline":"No bremelanotide product is approved by Medsafe; melanocortin-type peptides are prescription-only","detail":"Medsafe's index of data sheets for consented medicines, revised 29 September 2026, lists no bremelanotide product (no Vyleesi entry). The Medsafe classification database has a group entry for melanocyte-stimulating compounds as prescription medicines, which is a classification and not an approval. Without ministerial consent it cannot lawfully be sold, supplied or advertised outside narrow prescriber exemptions. Medsafe's product search showed no bremelanotide product on 29 September 2026.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/bremelanotide-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/RIss/unapp.asp","title":"Use of Unapproved Medicines and Use of approved Medicines for an unapproved purpose","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2025-12-12","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/DbSearch/","title":"Product/Application Search (product and application records searched by ingredient on 29 September 2026)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-07-07","accessed":"2026-09-29"}]},{"molecule":"cagrilintide","moleculeName":"Cagrilintide (and CagriSema)","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"not-approved","statusLabel":"Not approved","headline":"Cagrilintide (alone or in CagriSema) has no Medsafe consent and no data sheet in New Zealand","detail":"Medsafe's index of data sheets for consented medicines, revised 29 September 2026, lists no cagrilintide or CagriSema product. It is an investigational medicine here, and Medsafe notes that any clinical trial of a new medicine in New Zealand needs Medsafe and ethics committee approval. Without ministerial consent it cannot lawfully be sold, supplied or advertised outside narrow prescriber exemptions. Medsafe's Product/Application Search showed no cagrilintide product or application on 29 September 2026.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/cagrilintide-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp","title":"Consumer advisory: Unapproved peptide products health warning","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/DbSearch/","title":"Product/Application Search (product and application records searched by ingredient on 29 September 2026)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-07-07","accessed":"2026-09-29"}]},{"molecule":"cjc-1295","moleculeName":"CJC-1295","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"prohibited","statusLabel":"Prohibited","headline":"Not approved; Medsafe names CJC-1295 as an illegal unapproved peptide and says it seizes it","detail":"Medsafe's consumer advisory of 21 May 2026 names CJC-1295 among products promoted by online sellers. It says it is illegal to import, sell or use such products outside the regulated medicines system, that Medsafe continues to seize them, and that 'for research purposes only' labels have no legal effect. CJC-1295 appears by name as a prescription medicine in the Medsafe classification database, and no CJC-1295 medicine has Medsafe consent.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/cjc-1295-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp","title":"Consumer advisory: Unapproved peptide products health warning","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"}]},{"molecule":"dsip","moleculeName":"DSIP (delta sleep-inducing peptide)","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"not-approved","statusLabel":"Not approved","headline":"No Medsafe-approved medicine contains DSIP; it is not named in Medsafe's 2026 peptide advisory","detail":"Medsafe's index of data sheets for consented medicines, revised 29 September 2026, lists no DSIP (delta sleep-inducing peptide) product, and the classification database has no DSIP entry that could be found. Medsafe's May 2026 advisory does not name it but says its list is not complete. A DSIP product supplied for use in people would need ministerial consent as a medicine, and products sold outside the regulated system are illegal however they are labelled.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/dsip-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp","title":"Consumer advisory: Unapproved peptide products health warning","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"}]},{"molecule":"dulaglutide","moleculeName":"Dulaglutide","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"approved","statusLabel":"Approved","headline":"Approved as Trulicity for type 2 diabetes and publicly funded with Special Authority criteria","detail":"Medsafe's data sheet for Trulicity gives 12 August 2021 as the date of first approval. It is approved for improving blood sugar control in adults with type 2 diabetes and for reducing the risk of major cardiovascular events in adults with type 2 diabetes who have heart disease or several cardiovascular risk factors. Pharmac funds it through a Special Authority: the person must have type 2 diabetes and must not have reached their HbA1c target despite regular use of empagliflozin, metformin and vildagliptin for at least 6 months where clinically appropriate. It is not approved for weight management, and Pharmac describes it as one of two funded GLP-1 medicines for type 2 diabetes, alongside Victoza.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/dulaglutide-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/profs/datasheet/t/trulicityinj.pdf","title":"Trulicity (dulaglutide) solution for injection: New Zealand Data Sheet","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-07-13","accessed":"2026-09-29"},{"url":"https://schedule.pharmac.govt.nz/2026/10/01/Schedule.pdf","title":"Pharmaceutical Schedule, October 2026 (Volume 33)","publisher":"Pharmac (Pharmaceutical Management Agency)","date":"2026-10","accessed":"2026-09-29"},{"url":"https://www.pharmac.govt.nz/news-and-resources/news/semaglutide-wegovy-ozempic","title":"Wegovy and Mounjaro for weight loss not funded","publisher":"Pharmac (Pharmaceutical Management Agency)","date":"2026-05-14","accessed":"2026-09-29"}]},{"molecule":"ecnoglutide","moleculeName":"Ecnoglutide","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"not-approved","statusLabel":"Not approved","headline":"Ecnoglutide is an investigational medicine with no Medsafe consent in New Zealand","detail":"Medsafe's index of data sheets for consented medicines, revised 29 September 2026, lists no ecnoglutide product. Under the Medicines Act 1981 a new medicine cannot be sold, supplied or advertised without ministerial consent (delegated to Medsafe). Medsafe states that clinical trials of new medicines need Medsafe and ethics committee approval. The classification database has a group entry for GLP-1 receptor agonists as prescription medicines, which is not an approval.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ecnoglutide-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp","title":"Consumer advisory: Unapproved peptide products health warning","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"}]},{"molecule":"elamipretide","moleculeName":"Elamipretide (SS-31)","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"not-approved","statusLabel":"Not approved","headline":"Elamipretide is classed as a prescription medicine but has no Medsafe consent or data sheet","detail":"Elamipretide appears by name in the Medsafe classification database as a prescription medicine. That is a classification only: Medsafe's index of data sheets for consented medicines, revised 29 September 2026, lists no elamipretide product. Without ministerial consent it cannot lawfully be sold, supplied or advertised, apart from narrow exemptions such as a prescriber obtaining an unapproved medicine for a named patient. Medsafe's product search showed no elamipretide product on 29 September 2026.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/elamipretide-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/RIss/unapp.asp","title":"Use of Unapproved Medicines and Use of approved Medicines for an unapproved purpose","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2025-12-12","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/DbSearch/","title":"Product/Application Search (product and application records searched by ingredient on 29 September 2026)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-07-07","accessed":"2026-09-29"}]},{"molecule":"eloralintide","moleculeName":"Eloralintide","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"not-approved","statusLabel":"Not approved","headline":"Eloralintide is an investigational medicine with no Medsafe consent in New Zealand","detail":"Medsafe's index of data sheets for consented medicines, revised 29 September 2026, lists no eloralintide product, and the Medsafe classification database has no eloralintide entry that could be found. Under the Medicines Act 1981 a new medicine cannot be sold, supplied or advertised without ministerial consent (delegated to Medsafe). Medsafe also states that clinical trials of new medicines need Medsafe and ethics committee approval.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/eloralintide-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp","title":"Consumer advisory: Unapproved peptide products health warning","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-05-21","accessed":"2026-09-29"}]},{"molecule":"epitalon","moleculeName":"Epitalon","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"not-approved","statusLabel":"Not approved","headline":"No Medsafe-approved medicine contains epitalon; pineal peptides are prescription-only","detail":"Medsafe's index of data sheets for consented medicines, revised 29 September 2026, lists no epitalon product. The Medsafe classification database lists 'pineal gland peptides and their analogues' as a prescription medicine class, a group entry that may capture epitalon; epitalon is not listed by name. Epitalon is not named in Medsafe's May 2026 advisory, which says its list is not complete. Products sold outside the regulated system are illegal however they are labelled.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/epitalon-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp","title":"Consumer advisory: Unapproved peptide products health warning","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"}]},{"molecule":"exenatide","moleculeName":"Exenatide","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"not-approved","statusLabel":"Not approved","headline":"Byetta and Bydureon approvals have lapsed; no exenatide product is currently approved or funded","detail":"Medsafe's product records show that Byetta (first approved 31 May 2007) and Bydureon (first approved 8 September 2016) once had consent, but both are now listed as 'approval lapsed'. Medsafe says a lapsed product needs new consent before it can return to the market. Medsafe's data sheet index, revised 29 September 2026, has no exenatide entry, and the October 2026 Pharmaceutical Schedule lists no funded exenatide product. Exenatide is classified as a prescription medicine. Any supply without Medsafe consent would rely on the narrow exemptions in the Medicines Act, such as a prescriber obtaining an unapproved medicine for a named patient.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/exenatide-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/DbSearch/","title":"Product/Application Search (product and application records searched by ingredient on 29 September 2026)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-07-07","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://schedule.pharmac.govt.nz/2026/10/01/Schedule.pdf","title":"Pharmaceutical Schedule, October 2026 (Volume 33)","publisher":"Pharmac (Pharmaceutical Management Agency)","date":"2026-10","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"}]},{"molecule":"ghk-cu","moleculeName":"GHK-Cu (copper peptide)","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"not-approved","statusLabel":"Not approved","headline":"No Medsafe-approved medicine contains GHK-Cu; it is not named in Medsafe's 2026 peptide advisory","detail":"Medsafe's index of data sheets for consented medicines, revised 29 September 2026, lists no GHK-Cu product, and the classification database has no GHK-Cu entry that could be found. Medsafe's May 2026 peptide advisory does not name it, but says its list of unapproved peptides is not complete. Any GHK-Cu product supplied for a therapeutic purpose in people, such as an injection, would need ministerial consent as a medicine. Cosmetic products fall under separate rules that this record does not assess.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ghk-cu-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp","title":"Consumer advisory: Unapproved peptide products health warning","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"}]},{"molecule":"ipamorelin","moleculeName":"Ipamorelin","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"prohibited","statusLabel":"Prohibited","headline":"Not approved; Medsafe names ipamorelin as an illegal unapproved peptide and says it seizes it","detail":"Medsafe's consumer advisory of 21 May 2026 names ipamorelin among products promoted by online sellers. It says it is illegal to import, sell or use such products outside the regulated medicines system, that Medsafe continues to seize them, and that 'for research purposes only' labels have no legal effect. Ipamorelin appears by name as a prescription medicine in the Medsafe classification database, and no ipamorelin medicine has Medsafe consent.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ipamorelin-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp","title":"Consumer advisory: Unapproved peptide products health warning","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"}]},{"molecule":"kisspeptin","moleculeName":"Kisspeptin","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"prohibited","statusLabel":"Prohibited","headline":"Not approved; Medsafe names kisspeptin as an illegal unapproved peptide and says it seizes it","detail":"Medsafe's consumer advisory of 21 May 2026 names kisspeptin among products promoted by online sellers. It says it is illegal to import, sell or use such products outside the regulated medicines system, that Medsafe continues to seize them, and that 'for research purposes only' labels have no legal effect. 'Kisspeptins' are listed as a prescription medicine class in the Medsafe classification database, and no kisspeptin medicine has Medsafe consent.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/kisspeptin-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp","title":"Consumer advisory: Unapproved peptide products health warning","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"}]},{"molecule":"kpv","moleculeName":"KPV","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"not-approved","statusLabel":"Not approved","headline":"No Medsafe-approved medicine contains KPV; unapproved peptide products are unlawful to supply","detail":"Medsafe's index of data sheets for consented medicines, revised 29 September 2026, lists no KPV product, and KPV is not named in Medsafe's May 2026 advisory, which says its list is not complete. The classification database has a group entry for melanocyte-stimulating compounds as prescription medicines; Medsafe has not said whether it covers KPV. Medsafe states that products sold outside the regulated system are illegal however they are labelled, and that 'for research purposes only' has no legal effect.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/kpv-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp","title":"Consumer advisory: Unapproved peptide products health warning","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"}]},{"molecule":"liraglutide","moleculeName":"Liraglutide","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"approved","statusLabel":"Approved","headline":"Victoza and Saxenda approved; three generics have consent but are not marketed; Victoza funded for type 2 diabetes","detail":"Medsafe lists Victoza (first approved 24 June 2010, for type 2 diabetes and reducing cardiovascular events) and Saxenda (first approved 10 March 2016, for weight management) as having consent. Three generic weight-management liraglutide products, Benedo, Liraglutide RBX and Liraglutide SUN, received consent in August 2025 (the RBX and SUN data sheets give 15 August 2025), but Medsafe's product records list all three as 'not available', meaning the sponsor has told Medsafe it does not market or supply them. Three further generic liraglutide applications were still being evaluated in September 2026. Pharmac funds the Victoza pen for people with type 2 diabetes who meet its Special Authority criteria, according to the October 2026 Pharmaceutical Schedule. No liraglutide for weight management is listed as funded there. Liraglutide is a prescription medicine.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/liraglutide-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/DbSearch/","title":"Product/Application Search (product and application records searched by ingredient on 29 September 2026)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-07-07","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/datasheet/v/Victozainj.pdf","title":"Victoza (liraglutide) solution for injection: New Zealand Data Sheet","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-08-27","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/datasheet/s/saxendainj.pdf","title":"Saxenda (liraglutide) solution for injection: New Zealand Data Sheet","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-08-27","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/datasheet/L/LiraglutideRBXinj.pdf","title":"Liraglutide RBX solution for injection: New Zealand Data Sheet","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2025-08-15","accessed":"2026-09-29"},{"url":"https://schedule.pharmac.govt.nz/2026/10/01/Schedule.pdf","title":"Pharmaceutical Schedule, October 2026 (Volume 33)","publisher":"Pharmac (Pharmaceutical Management Agency)","date":"2026-10","accessed":"2026-09-29"},{"url":"https://www.pharmac.govt.nz/news-and-resources/news/semaglutide-wegovy-ozempic","title":"Wegovy and Mounjaro for weight loss not funded","publisher":"Pharmac (Pharmaceutical Management Agency)","date":"2026-05-14","accessed":"2026-09-29"}]},{"molecule":"ll-37","moleculeName":"LL-37","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"not-approved","statusLabel":"Not approved","headline":"No Medsafe-approved medicine contains LL-37; antimicrobial peptides are prescription-only","detail":"Medsafe's index of data sheets for consented medicines, revised 29 September 2026, lists no LL-37 product. The Medsafe classification database lists 'anti-microbial peptides and their precursors' as a prescription medicine class, a group entry that may capture LL-37; LL-37 is not listed by name. LL-37 is not named in Medsafe's May 2026 advisory, which says its list is not complete. Products sold outside the regulated system are illegal however they are labelled.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ll-37-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp","title":"Consumer advisory: Unapproved peptide products health warning","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"}]},{"molecule":"maridebart-cafraglutide","moleculeName":"Maridebart cafraglutide (MariTide)","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"not-approved","statusLabel":"Not approved","headline":"Maridebart cafraglutide (MariTide) is investigational with no Medsafe consent in New Zealand","detail":"Medsafe's index of data sheets for consented medicines, revised 29 September 2026, lists no maridebart cafraglutide product, and the classification database has no entry for it that could be found. Under the Medicines Act 1981 a new medicine cannot be sold, supplied or advertised without ministerial consent (delegated to Medsafe). Medsafe also states that clinical trials of new medicines need Medsafe and ethics committee approval.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/maridebart-cafraglutide-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp","title":"Consumer advisory: Unapproved peptide products health warning","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-05-21","accessed":"2026-09-29"}]},{"molecule":"mazdutide","moleculeName":"Mazdutide","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"not-approved","statusLabel":"Not approved","headline":"Mazdutide is an investigational medicine with no Medsafe consent in New Zealand","detail":"Medsafe's index of data sheets for consented medicines, revised 29 September 2026, lists no mazdutide product. Under the Medicines Act 1981 a new medicine cannot be sold, supplied or advertised without ministerial consent (delegated to Medsafe). Medsafe states that clinical trials of new medicines need Medsafe and ethics committee approval. The classification database has a group entry for GLP-1 receptor agonists as prescription medicines, which is not an approval.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/mazdutide-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp","title":"Consumer advisory: Unapproved peptide products health warning","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"}]},{"molecule":"melanotan-ii","moleculeName":"Melanotan II","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"prohibited","statusLabel":"Prohibited","headline":"Not approved; Medsafe names melanotan II as an illegal unapproved product and says it seizes it","detail":"Medsafe's consumer advisory of 21 May 2026 names melanotan II among products promoted by online sellers. It says it is illegal to import, sell or use such products outside the regulated medicines system, that Medsafe continues to seize them, and that 'for research purposes only' labels have no legal effect. The Medsafe classification database lists 'melanocyte stimulating compounds' as prescription medicines, and no melanotan II medicine has Medsafe consent.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/melanotan-ii-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp","title":"Consumer advisory: Unapproved peptide products health warning","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"}]},{"molecule":"mots-c","moleculeName":"MOTS-c","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"not-approved","statusLabel":"Not approved","headline":"No Medsafe-approved medicine contains MOTS-c; mitochondria-derived peptides are prescription-only","detail":"Medsafe's index of data sheets for consented medicines, revised 29 September 2026, lists no MOTS-c product. The Medsafe classification database lists 'mitochondria-derived peptides and their analogues' as a prescription medicine class, a group entry that may capture MOTS-c; MOTS-c is not listed by name. It is not named in Medsafe's May 2026 advisory, which says its list of unapproved peptides is not complete. Products sold outside the regulated system are illegal however they are labelled.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/mots-c-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp","title":"Consumer advisory: Unapproved peptide products health warning","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"}]},{"molecule":"nad-plus","moleculeName":"NAD+","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"not-approved","statusLabel":"Not approved","headline":"No Medsafe-approved medicine contains NAD+; the record covers NAD+ as a medicine, not supplements","detail":"Medsafe's index of data sheets for consented medicines, revised 29 September 2026, lists no NAD+ product, and NAD+ is not named in Medsafe's May 2026 advisory. Any NAD+ product supplied for a therapeutic purpose, such as an injection or infusion, would need ministerial consent as a medicine under the Medicines Act 1981. Supplement-type products containing NAD+ or its precursors fall under separate dietary supplement rules that this record does not assess.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/nad-plus-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp","title":"Consumer advisory: Unapproved peptide products health warning","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/RIss/unapp.asp","title":"Use of Unapproved Medicines and Use of approved Medicines for an unapproved purpose","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2025-12-12","accessed":"2026-09-29"}]},{"molecule":"orforglipron","moleculeName":"Orforglipron","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"not-approved","statusLabel":"Not approved","headline":"No Medsafe data sheet listed for orforglipron; not approved for use in New Zealand","detail":"Medsafe's index of consented medicines and data sheets, revised 29 September 2026, contains no orforglipron product, and Medsafe's Product/Application Search showed no orforglipron product or application on 29 September 2026. Under the Medicines Act 1981 it cannot be sold, supplied or advertised without Medsafe consent. The Medsafe classification database has a group entry for GLP-1 receptor agonists as prescription medicines, but that does not mean any product is approved. Since November 2025 the law has allowed consent by verification for a medicine already fully approved by two recognised overseas regulators, and Medsafe published the guideline for this route in June 2026.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/orforglipron-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/DbSearch/","title":"Product/Application Search (product and application records searched by ingredient on 29 September 2026)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-07-07","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/PUArticles/March2026/Medicines-Amendment-Act-2025.html","title":"Medicines Amendment Act 2025 (Prescriber Update, March 2026)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-03","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/other/new.asp","title":"What's New (29 June 2026: Verification Pathway for New Medicine Applications guideline and consent-by-verification application form)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-08-24","accessed":"2026-09-29"}]},{"molecule":"pramlintide","moleculeName":"Pramlintide","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"not-approved","statusLabel":"Not approved","headline":"No pramlintide product is approved, listed by Medsafe or funded in New Zealand","detail":"Medsafe's index of data sheets for consented medicines, revised 29 September 2026, lists no pramlintide product, and the October 2026 Pharmaceutical Schedule has no funded pramlintide. The Medsafe classification database has no separate pramlintide entry that could be found. Without ministerial consent (delegated to Medsafe), pramlintide cannot lawfully be sold, supplied or advertised, apart from narrow exemptions such as a prescriber obtaining it for a named patient. Medsafe's product search showed no pramlintide product on 29 September 2026.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/pramlintide-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://schedule.pharmac.govt.nz/2026/10/01/Schedule.pdf","title":"Pharmaceutical Schedule, October 2026 (Volume 33)","publisher":"Pharmac (Pharmaceutical Management Agency)","date":"2026-10","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/RIss/unapp.asp","title":"Use of Unapproved Medicines and Use of approved Medicines for an unapproved purpose","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2025-12-12","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/DbSearch/","title":"Product/Application Search (product and application records searched by ingredient on 29 September 2026)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-07-07","accessed":"2026-09-29"}]},{"molecule":"retatrutide","moleculeName":"Retatrutide","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"prohibited","statusLabel":"Prohibited","headline":"Not approved; Medsafe says retatrutide sold to the public is black-market and is being seized","detail":"Medsafe's consumer advisory of 21 May 2026 names retatrutide as a product it is seeing imported and sold online. It states that retatrutide is still being studied, has not been approved by any trusted regulator apart from overseas clinical trials, and that any retatrutide sold to the public is sourced from the black market. Medsafe says it continues to seize such products and that it is illegal to import, supply or possess prescription medicines without authorisation. Retatrutide is listed by name as a prescription medicine in the Medsafe classification database. 'For research purposes only' labels have no legal effect. Medsafe's Product/Application Search showed no retatrutide product or application on 29 September 2026.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/retatrutide-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp","title":"Consumer advisory: Unapproved peptide products health warning","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/DbSearch/","title":"Product/Application Search (product and application records searched by ingredient on 29 September 2026)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-07-07","accessed":"2026-09-29"}]},{"molecule":"selank","moleculeName":"Selank","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"not-approved","statusLabel":"Not approved","headline":"No Medsafe-approved medicine contains Selank; Medsafe's advisory lists a misspelt 'sealank'","detail":"Medsafe's May 2026 advisory on unapproved peptides lists 'sealank' and 'seamax' among products sold online, which appear to be misspellings of Selank and Semax. Medsafe says such products are illegal to import, supply or possess without authorisation, and that 'for research purposes only' labels have no legal effect. Medsafe's index of consented medicines, revised 29 September 2026, lists no Selank product. The classification database lists 'tuftsin and its analogues' as a prescription class, which may capture it.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/selank-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp","title":"Consumer advisory: Unapproved peptide products health warning","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"}]},{"molecule":"semaglutide","moleculeName":"Semaglutide","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"approved","statusLabel":"Approved","headline":"Approved as Wegovy for weight management and heart-risk reduction; not publicly funded","detail":"Medsafe's data sheet for Wegovy gives 20 March 2025 as the date of first approval. It covers chronic weight management in adults with obesity, or overweight plus a weight-related condition, weight management in adolescents aged 12 and over with obesity, and reducing major cardiovascular events in adults with established cardiovascular disease, a BMI of 27 or more and no diabetes. Pharmac does not fund Wegovy; it sits on Pharmac's Options for Investment list after an advisory group rated it high priority in December 2025. Ozempic (semaglutide for type 2 diabetes) has had Medsafe consent since 16 March 2023, but Medsafe's product records list it as 'not available', meaning the company has told Medsafe it does not market or supply it; it has no data sheet in Medsafe's index. Pharmac's December 2025 advisory record notes an Ozempic funding application for type 2 diabetes that its pharmacology committee rated high priority. Semaglutide is a prescription medicine, so unapproved versions can only be supplied through the narrow prescriber and pharmacist exemptions.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/semaglutide-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/profs/datasheet/w/wegovyinjection.pdf","title":"Wegovy (semaglutide) solution for injection: New Zealand Data Sheet","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-06-22","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/DbSearch/","title":"Product/Application Search (product and application records searched by ingredient on 29 September 2026)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-07-07","accessed":"2026-09-29"},{"url":"https://www.pharmac.govt.nz/news-and-resources/news/semaglutide-wegovy-ozempic","title":"Wegovy and Mounjaro for weight loss not funded","publisher":"Pharmac (Pharmaceutical Management Agency)","date":"2026-05-14","accessed":"2026-09-29"},{"url":"https://www.pharmac.govt.nz/assets/2025-12-11-Obesity-Treatments-Advisory-Group-record.pdf","title":"Record of the Obesity Treatments Advisory Group meeting, December 2025","publisher":"Pharmac (Pharmaceutical Management Agency)","date":"2025-12","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"semax","moleculeName":"Semax","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"not-approved","statusLabel":"Not approved","headline":"No Medsafe-approved medicine contains Semax; Medsafe's advisory lists a misspelt 'seamax'","detail":"Medsafe's May 2026 advisory on unapproved peptides lists 'sealank' and 'seamax' among products sold online, which appear to be misspellings of Selank and Semax. Medsafe says such products are illegal to import, supply or possess without authorisation, and that 'for research purposes only' labels have no legal effect. Medsafe's index of consented medicines, revised 29 September 2026, lists no Semax product. The classification database lists 'adrenocorticotropic hormone analogues' as a prescription class, which may capture it.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/semax-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp","title":"Consumer advisory: Unapproved peptide products health warning","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"}]},{"molecule":"sermorelin","moleculeName":"Sermorelin","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"not-approved","statusLabel":"Not approved","headline":"No Medsafe-approved medicine contains sermorelin; it is classed as a prescription medicine","detail":"Sermorelin appears by name in the Medsafe classification database as a prescription medicine, alongside a class entry for growth hormone releasing hormones. Medsafe's index of data sheets for consented medicines, revised 29 September 2026, lists no sermorelin product, and sermorelin is not named in Medsafe's May 2026 advisory, which says its list is not complete. Without ministerial consent it cannot lawfully be sold, supplied or advertised outside narrow prescriber exemptions.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/sermorelin-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp","title":"Consumer advisory: Unapproved peptide products health warning","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"}]},{"molecule":"setmelanotide","moleculeName":"Setmelanotide","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"not-approved","statusLabel":"Not approved","headline":"No setmelanotide product is approved by Medsafe or listed with a data sheet","detail":"Medsafe's index of data sheets for consented medicines, revised 29 September 2026, lists no setmelanotide product (no Imcivree entry), and the Pharmaceutical Schedule has no funded setmelanotide. The Medsafe classification database has a group entry for melanocyte-stimulating compounds as prescription medicines, which is not an approval. A prescriber could only obtain it for a named patient under the narrow unapproved-medicine exemptions. Medsafe's Product/Application Search showed no setmelanotide product or application on 29 September 2026.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/setmelanotide-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://schedule.pharmac.govt.nz/2026/10/01/Schedule.pdf","title":"Pharmaceutical Schedule, October 2026 (Volume 33)","publisher":"Pharmac (Pharmaceutical Management Agency)","date":"2026-10","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/RIss/unapp.asp","title":"Use of Unapproved Medicines and Use of approved Medicines for an unapproved purpose","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2025-12-12","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/DbSearch/","title":"Product/Application Search (product and application records searched by ingredient on 29 September 2026)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-07-07","accessed":"2026-09-29"}]},{"molecule":"survodutide","moleculeName":"Survodutide","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"not-approved","statusLabel":"Not approved","headline":"Survodutide is an investigational medicine with no Medsafe consent in New Zealand","detail":"Medsafe's index of data sheets for consented medicines, revised 29 September 2026, lists no survodutide product. Under the Medicines Act 1981 a new medicine cannot be sold, supplied or advertised without ministerial consent (delegated to Medsafe). Medsafe states that clinical trials of new medicines need Medsafe and ethics committee approval. The classification database has a group entry for GLP-1 receptor agonists as prescription medicines, which is not an approval.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/survodutide-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp","title":"Consumer advisory: Unapproved peptide products health warning","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"}]},{"molecule":"tb-500","moleculeName":"TB-500 (thymosin beta-4 fragment)","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"prohibited","statusLabel":"Prohibited","headline":"Not approved; Medsafe names TB-500 and thymosin peptides as illegal unapproved products","detail":"Medsafe's consumer advisory of 21 May 2026 names TB-500 and thymosin among products promoted online. It says it is illegal to import, sell or use these products outside the regulated system and that Medsafe continues to seize them. TB-500 and thymosin beta-4 both appear by name as prescription medicines in the Medsafe classification database. No medicine containing them has Medsafe consent, and 'for research purposes only' labels have no legal effect.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tb-500-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp","title":"Consumer advisory: Unapproved peptide products health warning","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-05-21","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"}]},{"molecule":"tesamorelin","moleculeName":"Tesamorelin","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"not-approved","statusLabel":"Not approved","headline":"No tesamorelin product is approved by Medsafe; it is classed as a prescription medicine","detail":"Tesamorelin appears by name in the Medsafe classification database as a prescription medicine, but Medsafe's index of data sheets for consented medicines, revised 29 September 2026, lists no tesamorelin product (no Egrifta entry). Without ministerial consent it cannot lawfully be sold, supplied or advertised, apart from narrow exemptions such as a prescriber obtaining an unapproved medicine for a named patient. Medsafe's product search showed no tesamorelin product on 29 September 2026.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tesamorelin-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm","title":"Data sheets index (medicines with consent to be distributed in New Zealand)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html","title":"Medicines Act 1981 (version as at 10 July 2026)","publisher":"New Zealand Parliamentary Counsel Office","date":"2026-07-10","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/RIss/unapp.asp","title":"Use of Unapproved Medicines and Use of approved Medicines for an unapproved purpose","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2025-12-12","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/DbSearch/","title":"Product/Application Search (product and application records searched by ingredient on 29 September 2026)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-07-07","accessed":"2026-09-29"}]},{"molecule":"tirzepatide","moleculeName":"Tirzepatide","country":"new-zealand","countryName":"New Zealand","countryIso2":"NZ","status":"approved","statusLabel":"Approved","headline":"Approved as Mounjaro for type 2 diabetes, weight management and sleep apnoea; weight loss not funded","detail":"Medsafe's data sheet for Mounjaro gives 22 December 2025 as the date of first approval. It covers adults with insufficiently controlled type 2 diabetes, chronic weight management in adults with obesity or overweight plus a weight-related condition, and moderate to severe obstructive sleep apnoea in adults with obesity. Pharmac has had no funding application for weight loss; it is assessing an application for type 2 diabetes, which its advisers rated medium priority in August 2025. People prescribed Mounjaro pay the private price. Tirzepatide is a prescription medicine in the Medsafe classification database.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tirzepatide-in-new-zealand","sources":[{"url":"https://www.medsafe.govt.nz/profs/datasheet/m/MounjaroInj.pdf","title":"Mounjaro (tirzepatide) solution for injection: New Zealand Data Sheet","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-10","accessed":"2026-09-29"},{"url":"https://www.pharmac.govt.nz/news-and-resources/news/semaglutide-wegovy-ozempic","title":"Wegovy and Mounjaro for weight loss not funded","publisher":"Pharmac (Pharmaceutical Management Agency)","date":"2026-05-14","accessed":"2026-09-29"},{"url":"https://www.pharmac.govt.nz/assets/2025-12-11-Obesity-Treatments-Advisory-Group-record.pdf","title":"Record of the Obesity Treatments Advisory Group meeting, December 2025","publisher":"Pharmac (Pharmaceutical Management Agency)","date":"2025-12","accessed":"2026-09-29"},{"url":"https://www.medsafe.govt.nz/profs/class/classintro.asp","title":"Medicines Classification Database (Schedule 1, Medicines Regulations 1984)","publisher":"Medsafe (New Zealand Medicines and Medical Devices Safety Authority)","date":"2026-09-25","accessed":"2026-09-29"}]},{"molecule":"amycretin","moleculeName":"Amycretin","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"not-approved","statusLabel":"Not approved","headline":"No EDE approval found for amycretin; an investigational medicine, not marketed in the UAE","detail":"Amycretin is an investigational Novo Nordisk medicine that acts on two hormone pathways, and it is not an approved product in the UAE as far as the sources I checked show. Under Federal Decree-Law 38/2024 no medical product may be circulated or sold in the UAE without EDE marketing approval, and the sources I checked show no EDE approval for it. It cannot lawfully be marketed without that approval, and I found no UAE marketing notice for it.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/amycretin-in-united-arab-emirates","sources":[{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/documents/d/ede/-38-2024-pdf","title":"Federal Decree-Law No. (38) of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments (Arabic text)","publisher":"Emirates Drug Establishment (EDE)","date":"2024-10-01","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/en/legislations","title":"Legislations (Federal Decree-Law 38/2024 and other instruments)","publisher":"Emirates Drug Establishment (EDE)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"aod-9604","moleculeName":"AOD-9604","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in the UAE: no marketing authorisation for AOD-9604; unapproved peptide products are under EDE enforcement","detail":"AOD-9604 is an experimental peptide promoted online for weight loss, and I found no EDE approval for it as a human medicine. In July 2026 the EDE said that calling a product a peptide does not make it an approved medicine, and it took action against 71 sources selling or promoting unapproved peptide products. Federal Decree-Law 38/2024 says no medical product may be circulated or sold in the UAE without EDE marketing approval, and I found no approval for this substance. The decree-law exempts products made in licensed compounding pharmacies from marketing approval, but I found no rule saying whether this peptide may be compounded; the EDE is inspecting compounding pharmacies, and Abu Dhabi's health department says peptides may only be prescribed for appropriate cases supported by scientific evidence.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/aod-9604-in-united-arab-emirates","sources":[{"url":"https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities","title":"UAE cracks down on illegal weight-loss products, targets 71 violators","publisher":"Khaleej Times","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://gulfnews.com/uae/health/uae-weight-loss-drug-crackdown-71-sources-14-influencers-face-action-1.500619741","title":"UAE weight-loss drug crackdown: 71 sources, 14 influencers face action","publisher":"Gulf News","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.emirates247.com/uae/abu-dhabi-health-authority-launches-online-form-for-reporting-side-effects-from-peptide-products/6023","title":"Abu Dhabi health authority launches online form for reporting side effects from peptide products","publisher":"Emirates 24|7","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/documents/d/ede/-38-2024-pdf","title":"Federal Decree-Law No. (38) of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments (Arabic text)","publisher":"Emirates Drug Establishment (EDE)","date":"2024-10-01","accessed":"2026-09-29"}]},{"molecule":"bpc-157","moleculeName":"BPC-157","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in the UAE: no marketing authorisation for BPC-157, and the EDE is acting against unapproved peptide products","detail":"BPC-157 is an experimental peptide, and it is not an approved medicine in the UAE. Evidence for it comes mainly from animal studies (animal-only); USADA says no human clinical trials have shown it works for any condition. In July 2026 the EDE said that calling a product a peptide does not make it an approved medicine, and it took action against 71 sources selling or promoting unapproved peptide products. Federal Decree-Law 38/2024 says no medical product may be circulated or sold in the UAE without EDE marketing approval, and I found no approval for this substance. The decree-law exempts products made in licensed compounding pharmacies from marketing approval, but I found no rule saying whether this peptide may be compounded; the EDE is inspecting compounding pharmacies, and Abu Dhabi's health department says peptides may only be prescribed for appropriate cases supported by scientific evidence. USADA notes BPC-157 is on the WADA Prohibited List under S0 (non-approved substances), which matters for athletes.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/bpc-157-in-united-arab-emirates","sources":[{"url":"https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities","title":"UAE cracks down on illegal weight-loss products, targets 71 violators","publisher":"Khaleej Times","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://gulfnews.com/uae/health/uae-weight-loss-drug-crackdown-71-sources-14-influencers-face-action-1.500619741","title":"UAE weight-loss drug crackdown: 71 sources, 14 influencers face action","publisher":"Gulf News","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.emirates247.com/uae/abu-dhabi-health-authority-launches-online-form-for-reporting-side-effects-from-peptide-products/6023","title":"Abu Dhabi health authority launches online form for reporting side effects from peptide products","publisher":"Emirates 24|7","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.usada.org/spirit-of-sport/bpc-157-peptide-prohibited/","title":"BPC-157: Experimental Peptide Creates Risk for Athletes (updated August 2026)","publisher":"U.S. Anti-Doping Agency","date":"2020-03-03","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/documents/d/ede/-38-2024-pdf","title":"Federal Decree-Law No. (38) of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments (Arabic text)","publisher":"Emirates Drug Establishment (EDE)","date":"2024-10-01","accessed":"2026-09-29"}]},{"molecule":"bremelanotide","moleculeName":"Bremelanotide (PT-141)","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"unknown","statusLabel":"Unverified","headline":"Could not confirm whether bremelanotide (Vyleesi) is registered by the EDE; no UAE-specific record was found","detail":"Bremelanotide is an approved prescription medicine in some countries, but I found no EDE announcement, register entry or company page showing it in the UAE. The EDE's public drug directory could not be used to check it. Any product would need EDE marketing approval under Federal Decree-Law 38/2024, so the status is left unknown rather than guessed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/countries/united-arab-emirates","sources":[{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/en/legislations","title":"Legislations (Federal Decree-Law 38/2024 and other instruments)","publisher":"Emirates Drug Establishment (EDE)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"cagrilintide","moleculeName":"Cagrilintide (and CagriSema)","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"not-approved","statusLabel":"Not approved","headline":"No EDE approval found for cagrilintide or CagriSema; not marketed in the UAE","detail":"Cagrilintide is an amylin-type medicine being developed by Novo Nordisk, alone and combined with semaglutide as CagriSema. I found no EDE approval announcement for either. Under Federal Decree-Law 38/2024 no medical product may be circulated or sold in the UAE without EDE marketing approval, and the sources I checked show no EDE approval for it. It cannot lawfully be marketed without that approval, and I found no UAE marketing notice for it.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/cagrilintide-in-united-arab-emirates","sources":[{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/documents/d/ede/-38-2024-pdf","title":"Federal Decree-Law No. (38) of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments (Arabic text)","publisher":"Emirates Drug Establishment (EDE)","date":"2024-10-01","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/en/legislations","title":"Legislations (Federal Decree-Law 38/2024 and other instruments)","publisher":"Emirates Drug Establishment (EDE)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"cjc-1295","moleculeName":"CJC-1295","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in the UAE: no marketing authorisation for CJC-1295; unapproved peptide products are under EDE enforcement","detail":"CJC-1295 is a growth-hormone-releasing peptide sold online, and I found no EDE approval for it as a human medicine. In July 2026 the EDE said that calling a product a peptide does not make it an approved medicine, and it took action against 71 sources selling or promoting unapproved peptide products. Federal Decree-Law 38/2024 says no medical product may be circulated or sold in the UAE without EDE marketing approval, and I found no approval for this substance. The decree-law exempts products made in licensed compounding pharmacies from marketing approval, but I found no rule saying whether this peptide may be compounded; the EDE is inspecting compounding pharmacies, and Abu Dhabi's health department says peptides may only be prescribed for appropriate cases supported by scientific evidence.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/cjc-1295-in-united-arab-emirates","sources":[{"url":"https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities","title":"UAE cracks down on illegal weight-loss products, targets 71 violators","publisher":"Khaleej Times","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://gulfnews.com/uae/health/uae-weight-loss-drug-crackdown-71-sources-14-influencers-face-action-1.500619741","title":"UAE weight-loss drug crackdown: 71 sources, 14 influencers face action","publisher":"Gulf News","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.emirates247.com/uae/abu-dhabi-health-authority-launches-online-form-for-reporting-side-effects-from-peptide-products/6023","title":"Abu Dhabi health authority launches online form for reporting side effects from peptide products","publisher":"Emirates 24|7","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/documents/d/ede/-38-2024-pdf","title":"Federal Decree-Law No. (38) of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments (Arabic text)","publisher":"Emirates Drug Establishment (EDE)","date":"2024-10-01","accessed":"2026-09-29"}]},{"molecule":"dsip","moleculeName":"DSIP (delta sleep-inducing peptide)","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in the UAE: no marketing authorisation for DSIP; unapproved peptide products are under EDE enforcement","detail":"DSIP (delta sleep-inducing peptide) is a research-stage peptide promoted online, and I found no EDE approval for it as a human medicine. In July 2026 the EDE said that calling a product a peptide does not make it an approved medicine, and it took action against 71 sources selling or promoting unapproved peptide products. Federal Decree-Law 38/2024 says no medical product may be circulated or sold in the UAE without EDE marketing approval, and I found no approval for this substance. The decree-law exempts products made in licensed compounding pharmacies from marketing approval, but I found no rule saying whether this peptide may be compounded; the EDE is inspecting compounding pharmacies, and Abu Dhabi's health department says peptides may only be prescribed for appropriate cases supported by scientific evidence.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/dsip-in-united-arab-emirates","sources":[{"url":"https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities","title":"UAE cracks down on illegal weight-loss products, targets 71 violators","publisher":"Khaleej Times","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://gulfnews.com/uae/health/uae-weight-loss-drug-crackdown-71-sources-14-influencers-face-action-1.500619741","title":"UAE weight-loss drug crackdown: 71 sources, 14 influencers face action","publisher":"Gulf News","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.emirates247.com/uae/abu-dhabi-health-authority-launches-online-form-for-reporting-side-effects-from-peptide-products/6023","title":"Abu Dhabi health authority launches online form for reporting side effects from peptide products","publisher":"Emirates 24|7","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/documents/d/ede/-38-2024-pdf","title":"Federal Decree-Law No. (38) of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments (Arabic text)","publisher":"Emirates Drug Establishment (EDE)","date":"2024-10-01","accessed":"2026-09-29"}]},{"molecule":"dulaglutide","moleculeName":"Dulaglutide","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"unknown","statusLabel":"Unverified","headline":"Could not confirm whether dulaglutide (Trulicity) is registered by the EDE; no UAE-specific record was found","detail":"I found no EDE announcement, register entry or company page for dulaglutide in the UAE. The EDE's public drug directory could not be used to check it, and press coverage of UAE GLP-1 medicines names semaglutide, tirzepatide and orforglipron rather than dulaglutide. Any product would need EDE marketing approval under Federal Decree-Law 38/2024, so status is left unknown rather than guessed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/countries/united-arab-emirates","sources":[{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/en/legislations","title":"Legislations (Federal Decree-Law 38/2024 and other instruments)","publisher":"Emirates Drug Establishment (EDE)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"ecnoglutide","moleculeName":"Ecnoglutide","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"not-approved","statusLabel":"Not approved","headline":"No EDE approval found for ecnoglutide; not marketed in the UAE","detail":"Ecnoglutide is a GLP-1 medicine developed by a Chinese company, and I found no EDE approval announcement for it. Under Federal Decree-Law 38/2024 no medical product may be circulated or sold in the UAE without EDE marketing approval, and the sources I checked show no EDE approval for it. It cannot lawfully be marketed without that approval, and I found no UAE marketing notice for it.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ecnoglutide-in-united-arab-emirates","sources":[{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/documents/d/ede/-38-2024-pdf","title":"Federal Decree-Law No. (38) of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments (Arabic text)","publisher":"Emirates Drug Establishment (EDE)","date":"2024-10-01","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/en/legislations","title":"Legislations (Federal Decree-Law 38/2024 and other instruments)","publisher":"Emirates Drug Establishment (EDE)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"elamipretide","moleculeName":"Elamipretide (SS-31)","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"unknown","statusLabel":"Unverified","headline":"Could not confirm whether elamipretide is registered by the EDE; no UAE-specific record was found","detail":"Elamipretide has been approved in the United States for a rare mitochondrial disease, but I found no EDE announcement, register entry or company page showing it in the UAE. The EDE's public drug directory could not be used to check it. Any product would need EDE marketing approval under Federal Decree-Law 38/2024, so the status is left unknown rather than guessed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/countries/united-arab-emirates","sources":[{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/en/legislations","title":"Legislations (Federal Decree-Law 38/2024 and other instruments)","publisher":"Emirates Drug Establishment (EDE)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"eloralintide","moleculeName":"Eloralintide","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"not-approved","statusLabel":"Not approved","headline":"No EDE approval found for eloralintide; an investigational medicine, not marketed in the UAE","detail":"Eloralintide is an investigational amylin-type medicine from Eli Lilly, and it is not an approved product in the UAE as far as the sources I checked show. Under Federal Decree-Law 38/2024 no medical product may be circulated or sold in the UAE without EDE marketing approval, and the sources I checked show no EDE approval for it. It cannot lawfully be marketed without that approval, and I found no UAE marketing notice for it.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/eloralintide-in-united-arab-emirates","sources":[{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/documents/d/ede/-38-2024-pdf","title":"Federal Decree-Law No. (38) of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments (Arabic text)","publisher":"Emirates Drug Establishment (EDE)","date":"2024-10-01","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/en/legislations","title":"Legislations (Federal Decree-Law 38/2024 and other instruments)","publisher":"Emirates Drug Establishment (EDE)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"epitalon","moleculeName":"Epitalon","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in the UAE: no marketing authorisation for epitalon; unapproved peptide products are under EDE enforcement","detail":"Epitalon is a short synthetic peptide promoted online for ageing-related claims, and I found no EDE approval for it as a human medicine. In July 2026 the EDE said that calling a product a peptide does not make it an approved medicine, and it took action against 71 sources selling or promoting unapproved peptide products. Federal Decree-Law 38/2024 says no medical product may be circulated or sold in the UAE without EDE marketing approval, and I found no approval for this substance. The decree-law exempts products made in licensed compounding pharmacies from marketing approval, but I found no rule saying whether this peptide may be compounded; the EDE is inspecting compounding pharmacies, and Abu Dhabi's health department says peptides may only be prescribed for appropriate cases supported by scientific evidence.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/epitalon-in-united-arab-emirates","sources":[{"url":"https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities","title":"UAE cracks down on illegal weight-loss products, targets 71 violators","publisher":"Khaleej Times","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://gulfnews.com/uae/health/uae-weight-loss-drug-crackdown-71-sources-14-influencers-face-action-1.500619741","title":"UAE weight-loss drug crackdown: 71 sources, 14 influencers face action","publisher":"Gulf News","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.emirates247.com/uae/abu-dhabi-health-authority-launches-online-form-for-reporting-side-effects-from-peptide-products/6023","title":"Abu Dhabi health authority launches online form for reporting side effects from peptide products","publisher":"Emirates 24|7","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/documents/d/ede/-38-2024-pdf","title":"Federal Decree-Law No. (38) of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments (Arabic text)","publisher":"Emirates Drug Establishment (EDE)","date":"2024-10-01","accessed":"2026-09-29"}]},{"molecule":"exenatide","moleculeName":"Exenatide","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"unknown","statusLabel":"Unverified","headline":"Could not confirm whether exenatide (Byetta, Bydureon) is registered by the EDE; no UAE-specific record was found","detail":"I found no EDE announcement, register entry or company page for exenatide in the UAE, and the EDE's public drug directory could not be used to check it. Any product would need EDE marketing approval under Federal Decree-Law 38/2024, so the status is left unknown rather than guessed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/countries/united-arab-emirates","sources":[{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/en/legislations","title":"Legislations (Federal Decree-Law 38/2024 and other instruments)","publisher":"Emirates Drug Establishment (EDE)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"ghk-cu","moleculeName":"GHK-Cu (copper peptide)","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"not-approved","statusLabel":"Not approved","headline":"Not approved as a medicine in the UAE: no marketing authorisation found for injectable or medicinal GHK-Cu","detail":"GHK-Cu is a copper-binding peptide, and I found no EDE approval for medicinal or injectable use in the UAE; I did not assess its use as a cosmetic ingredient. In July 2026 the EDE said that calling a product a peptide does not make it an approved medicine, and it took action against 71 sources selling or promoting unapproved peptide products. Federal Decree-Law 38/2024 says no medical product may be circulated or sold in the UAE without EDE marketing approval, and I found no approval for this substance. The decree-law exempts products made in licensed compounding pharmacies from marketing approval, but I found no rule saying whether this peptide may be compounded; the EDE is inspecting compounding pharmacies, and Abu Dhabi's health department says peptides may only be prescribed for appropriate cases supported by scientific evidence.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ghk-cu-in-united-arab-emirates","sources":[{"url":"https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities","title":"UAE cracks down on illegal weight-loss products, targets 71 violators","publisher":"Khaleej Times","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://gulfnews.com/uae/health/uae-weight-loss-drug-crackdown-71-sources-14-influencers-face-action-1.500619741","title":"UAE weight-loss drug crackdown: 71 sources, 14 influencers face action","publisher":"Gulf News","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.emirates247.com/uae/abu-dhabi-health-authority-launches-online-form-for-reporting-side-effects-from-peptide-products/6023","title":"Abu Dhabi health authority launches online form for reporting side effects from peptide products","publisher":"Emirates 24|7","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/documents/d/ede/-38-2024-pdf","title":"Federal Decree-Law No. (38) of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments (Arabic text)","publisher":"Emirates Drug Establishment (EDE)","date":"2024-10-01","accessed":"2026-09-29"}]},{"molecule":"ipamorelin","moleculeName":"Ipamorelin","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in the UAE: no marketing authorisation for ipamorelin; unapproved peptide products are under EDE enforcement","detail":"Ipamorelin is a growth-hormone-releasing peptide sold online, and I found no EDE approval for it as a human medicine. In July 2026 the EDE said that calling a product a peptide does not make it an approved medicine, and it took action against 71 sources selling or promoting unapproved peptide products. Federal Decree-Law 38/2024 says no medical product may be circulated or sold in the UAE without EDE marketing approval, and I found no approval for this substance. The decree-law exempts products made in licensed compounding pharmacies from marketing approval, but I found no rule saying whether this peptide may be compounded; the EDE is inspecting compounding pharmacies, and Abu Dhabi's health department says peptides may only be prescribed for appropriate cases supported by scientific evidence.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ipamorelin-in-united-arab-emirates","sources":[{"url":"https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities","title":"UAE cracks down on illegal weight-loss products, targets 71 violators","publisher":"Khaleej Times","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://gulfnews.com/uae/health/uae-weight-loss-drug-crackdown-71-sources-14-influencers-face-action-1.500619741","title":"UAE weight-loss drug crackdown: 71 sources, 14 influencers face action","publisher":"Gulf News","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.emirates247.com/uae/abu-dhabi-health-authority-launches-online-form-for-reporting-side-effects-from-peptide-products/6023","title":"Abu Dhabi health authority launches online form for reporting side effects from peptide products","publisher":"Emirates 24|7","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/documents/d/ede/-38-2024-pdf","title":"Federal Decree-Law No. (38) of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments (Arabic text)","publisher":"Emirates Drug Establishment (EDE)","date":"2024-10-01","accessed":"2026-09-29"}]},{"molecule":"kisspeptin","moleculeName":"Kisspeptin","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in the UAE: no marketing authorisation for kisspeptin; unapproved peptide products are under EDE enforcement","detail":"Kisspeptin is a hormone-signalling peptide studied in research settings, and I found no EDE approval for it as a marketed medicine. In July 2026 the EDE said that calling a product a peptide does not make it an approved medicine, and it took action against 71 sources selling or promoting unapproved peptide products. Federal Decree-Law 38/2024 says no medical product may be circulated or sold in the UAE without EDE marketing approval, and I found no approval for this substance. The decree-law exempts products made in licensed compounding pharmacies from marketing approval, but I found no rule saying whether this peptide may be compounded; the EDE is inspecting compounding pharmacies, and Abu Dhabi's health department says peptides may only be prescribed for appropriate cases supported by scientific evidence.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/kisspeptin-in-united-arab-emirates","sources":[{"url":"https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities","title":"UAE cracks down on illegal weight-loss products, targets 71 violators","publisher":"Khaleej Times","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://gulfnews.com/uae/health/uae-weight-loss-drug-crackdown-71-sources-14-influencers-face-action-1.500619741","title":"UAE weight-loss drug crackdown: 71 sources, 14 influencers face action","publisher":"Gulf News","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.emirates247.com/uae/abu-dhabi-health-authority-launches-online-form-for-reporting-side-effects-from-peptide-products/6023","title":"Abu Dhabi health authority launches online form for reporting side effects from peptide products","publisher":"Emirates 24|7","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/documents/d/ede/-38-2024-pdf","title":"Federal Decree-Law No. (38) of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments (Arabic text)","publisher":"Emirates Drug Establishment (EDE)","date":"2024-10-01","accessed":"2026-09-29"}]},{"molecule":"kpv","moleculeName":"KPV","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in the UAE: no marketing authorisation for KPV; unapproved peptide products are under EDE enforcement","detail":"KPV is a short peptide fragment promoted online, and I found no EDE approval for it as a human medicine. In July 2026 the EDE said that calling a product a peptide does not make it an approved medicine, and it took action against 71 sources selling or promoting unapproved peptide products. Federal Decree-Law 38/2024 says no medical product may be circulated or sold in the UAE without EDE marketing approval, and I found no approval for this substance. The decree-law exempts products made in licensed compounding pharmacies from marketing approval, but I found no rule saying whether this peptide may be compounded; the EDE is inspecting compounding pharmacies, and Abu Dhabi's health department says peptides may only be prescribed for appropriate cases supported by scientific evidence.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/kpv-in-united-arab-emirates","sources":[{"url":"https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities","title":"UAE cracks down on illegal weight-loss products, targets 71 violators","publisher":"Khaleej Times","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://gulfnews.com/uae/health/uae-weight-loss-drug-crackdown-71-sources-14-influencers-face-action-1.500619741","title":"UAE weight-loss drug crackdown: 71 sources, 14 influencers face action","publisher":"Gulf News","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.emirates247.com/uae/abu-dhabi-health-authority-launches-online-form-for-reporting-side-effects-from-peptide-products/6023","title":"Abu Dhabi health authority launches online form for reporting side effects from peptide products","publisher":"Emirates 24|7","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/documents/d/ede/-38-2024-pdf","title":"Federal Decree-Law No. (38) of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments (Arabic text)","publisher":"Emirates Drug Establishment (EDE)","date":"2024-10-01","accessed":"2026-09-29"}]},{"molecule":"liraglutide","moleculeName":"Liraglutide","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"approved","statusLabel":"Approved","headline":"Marketed in the UAE as Saxenda for obesity care according to Novo Nordisk's UAE professional portal; EDE register entry not verified","detail":"Novo Nordisk's UAE portal for healthcare professionals lists Saxenda (liraglutide) as an obesity-care product, which indicates it is marketed here as a prescription medicine. I could not open the EDE register or find an approval date, exact indication wording, or a Victoza entry, so treat these details as unconfirmed. Under the earlier 2019 medicines law, promotion of prescription-only medicines was limited to healthcare professionals, and the 2024 decree-law requires EDE approval for any advertising.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/liraglutide-in-united-arab-emirates","sources":[{"url":"https://pro.novonordisk.ae/products/saxenda.html","title":"Saxenda by Novo Nordisk | Obesity Care for Professionals (Novo Nordisk UAE portal for healthcare professionals)","publisher":"Novo Nordisk UAE","date":"2026","accessed":"2026-09-29"},{"url":"https://cms.law/en/int/expert-guides/cms-expert-guide-to-advertising-of-medicines-and-medical-devices/united-arab-emirates","title":"CMS Expert Guide to advertising of medicines and medical devices: United Arab Emirates","publisher":"CMS","date":"2024-05-08","accessed":"2026-09-29"},{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"}]},{"molecule":"ll-37","moleculeName":"LL-37","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in the UAE: no marketing authorisation for LL-37; unapproved peptide products are under EDE enforcement","detail":"LL-37 is a natural antimicrobial peptide studied in research settings, and I found no EDE approval for it as a marketed medicine. In July 2026 the EDE said that calling a product a peptide does not make it an approved medicine, and it took action against 71 sources selling or promoting unapproved peptide products. Federal Decree-Law 38/2024 says no medical product may be circulated or sold in the UAE without EDE marketing approval, and I found no approval for this substance. The decree-law exempts products made in licensed compounding pharmacies from marketing approval, but I found no rule saying whether this peptide may be compounded; the EDE is inspecting compounding pharmacies, and Abu Dhabi's health department says peptides may only be prescribed for appropriate cases supported by scientific evidence.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ll-37-in-united-arab-emirates","sources":[{"url":"https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities","title":"UAE cracks down on illegal weight-loss products, targets 71 violators","publisher":"Khaleej Times","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://gulfnews.com/uae/health/uae-weight-loss-drug-crackdown-71-sources-14-influencers-face-action-1.500619741","title":"UAE weight-loss drug crackdown: 71 sources, 14 influencers face action","publisher":"Gulf News","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.emirates247.com/uae/abu-dhabi-health-authority-launches-online-form-for-reporting-side-effects-from-peptide-products/6023","title":"Abu Dhabi health authority launches online form for reporting side effects from peptide products","publisher":"Emirates 24|7","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/documents/d/ede/-38-2024-pdf","title":"Federal Decree-Law No. (38) of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments (Arabic text)","publisher":"Emirates Drug Establishment (EDE)","date":"2024-10-01","accessed":"2026-09-29"}]},{"molecule":"maridebart-cafraglutide","moleculeName":"Maridebart cafraglutide (MariTide)","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"not-approved","statusLabel":"Not approved","headline":"No EDE approval found for maridebart cafraglutide (MariTide); an investigational medicine, not marketed in the UAE","detail":"Maridebart cafraglutide is an investigational Amgen medicine, and I found no EDE approval or marketing notice for it. Under Federal Decree-Law 38/2024 no medical product may be circulated or sold in the UAE without EDE marketing approval, and the sources I checked show no EDE approval for it. It cannot lawfully be marketed without that approval, and I found no UAE marketing notice for it.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/maridebart-cafraglutide-in-united-arab-emirates","sources":[{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/documents/d/ede/-38-2024-pdf","title":"Federal Decree-Law No. (38) of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments (Arabic text)","publisher":"Emirates Drug Establishment (EDE)","date":"2024-10-01","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/en/legislations","title":"Legislations (Federal Decree-Law 38/2024 and other instruments)","publisher":"Emirates Drug Establishment (EDE)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"mazdutide","moleculeName":"Mazdutide","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"not-approved","statusLabel":"Not approved","headline":"No EDE approval found for mazdutide; not marketed in the UAE","detail":"Mazdutide is a dual glucagon and GLP-1 medicine developed with Chinese partners, and I found no EDE approval announcement for it. Under Federal Decree-Law 38/2024 no medical product may be circulated or sold in the UAE without EDE marketing approval, and the sources I checked show no EDE approval for it. It cannot lawfully be marketed without that approval, and I found no UAE marketing notice for it.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/mazdutide-in-united-arab-emirates","sources":[{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/documents/d/ede/-38-2024-pdf","title":"Federal Decree-Law No. (38) of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments (Arabic text)","publisher":"Emirates Drug Establishment (EDE)","date":"2024-10-01","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/en/legislations","title":"Legislations (Federal Decree-Law 38/2024 and other instruments)","publisher":"Emirates Drug Establishment (EDE)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"melanotan-ii","moleculeName":"Melanotan II","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in the UAE: no marketing authorisation for melanotan II; unapproved peptide products are under EDE enforcement","detail":"Melanotan II is an unapproved tanning peptide with no marketing authorisation as a medicine, and I found no EDE approval for it. In July 2026 the EDE said that calling a product a peptide does not make it an approved medicine, and it took action against 71 sources selling or promoting unapproved peptide products. Federal Decree-Law 38/2024 says no medical product may be circulated or sold in the UAE without EDE marketing approval, and I found no approval for this substance. The decree-law exempts products made in licensed compounding pharmacies from marketing approval, but I found no rule saying whether this peptide may be compounded; the EDE is inspecting compounding pharmacies, and Abu Dhabi's health department says peptides may only be prescribed for appropriate cases supported by scientific evidence.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/melanotan-ii-in-united-arab-emirates","sources":[{"url":"https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities","title":"UAE cracks down on illegal weight-loss products, targets 71 violators","publisher":"Khaleej Times","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://gulfnews.com/uae/health/uae-weight-loss-drug-crackdown-71-sources-14-influencers-face-action-1.500619741","title":"UAE weight-loss drug crackdown: 71 sources, 14 influencers face action","publisher":"Gulf News","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.emirates247.com/uae/abu-dhabi-health-authority-launches-online-form-for-reporting-side-effects-from-peptide-products/6023","title":"Abu Dhabi health authority launches online form for reporting side effects from peptide products","publisher":"Emirates 24|7","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/documents/d/ede/-38-2024-pdf","title":"Federal Decree-Law No. (38) of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments (Arabic text)","publisher":"Emirates Drug Establishment (EDE)","date":"2024-10-01","accessed":"2026-09-29"}]},{"molecule":"mots-c","moleculeName":"MOTS-c","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in the UAE: no marketing authorisation for MOTS-c; unapproved peptide products are under EDE enforcement","detail":"MOTS-c is a research-stage peptide encoded in mitochondrial DNA, and I found no EDE approval for it as a human medicine. In July 2026 the EDE said that calling a product a peptide does not make it an approved medicine, and it took action against 71 sources selling or promoting unapproved peptide products. Federal Decree-Law 38/2024 says no medical product may be circulated or sold in the UAE without EDE marketing approval, and I found no approval for this substance. The decree-law exempts products made in licensed compounding pharmacies from marketing approval, but I found no rule saying whether this peptide may be compounded; the EDE is inspecting compounding pharmacies, and Abu Dhabi's health department says peptides may only be prescribed for appropriate cases supported by scientific evidence.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/mots-c-in-united-arab-emirates","sources":[{"url":"https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities","title":"UAE cracks down on illegal weight-loss products, targets 71 violators","publisher":"Khaleej Times","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://gulfnews.com/uae/health/uae-weight-loss-drug-crackdown-71-sources-14-influencers-face-action-1.500619741","title":"UAE weight-loss drug crackdown: 71 sources, 14 influencers face action","publisher":"Gulf News","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.emirates247.com/uae/abu-dhabi-health-authority-launches-online-form-for-reporting-side-effects-from-peptide-products/6023","title":"Abu Dhabi health authority launches online form for reporting side effects from peptide products","publisher":"Emirates 24|7","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/documents/d/ede/-38-2024-pdf","title":"Federal Decree-Law No. (38) of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments (Arabic text)","publisher":"Emirates Drug Establishment (EDE)","date":"2024-10-01","accessed":"2026-09-29"}]},{"molecule":"nad-plus","moleculeName":"NAD+","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"unknown","statusLabel":"Unverified","headline":"Could not determine a UAE rule specific to NAD+; no registration, ban or guidance naming it was found","detail":"I found no EDE or health-authority notice naming NAD+ as a medicine, supplement or injectable. Its legal position would depend on how a product is presented: anything sold or used to treat or prevent disease is a medical product needing EDE marketing approval under Federal Decree-Law 38/2024, and supplements are also covered by that law. Because I could not confirm a specific rule, the status is left unknown rather than guessed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/countries/united-arab-emirates","sources":[{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/documents/d/ede/-38-2024-pdf","title":"Federal Decree-Law No. (38) of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments (Arabic text)","publisher":"Emirates Drug Establishment (EDE)","date":"2024-10-01","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/en/legislations","title":"Legislations (Federal Decree-Law 38/2024 and other instruments)","publisher":"Emirates Drug Establishment (EDE)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"orforglipron","moleculeName":"Orforglipron","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"approved","statusLabel":"Approved","headline":"Approved by the EDE in April 2026 as Foundayo, a daily pill for chronic weight management; UAE was the second country to approve it","detail":"The Emirates Drug Establishment announced approval of Foundayo (orforglipron), an oral GLP-1 medicine from Eli Lilly, on 3 April 2026 for chronic weight management in adults, and it became available from May 2026. Khaleej Times names endocrinologists, obesity specialists and internal medicine specialists as the recommended prescribers. Abu Dhabi's Department of Health said on 24 April 2026 that it will be covered for adults eligible for its Personalised Weight Management Programme; elsewhere insurance coverage is unclear. The EDE's own announcement page could not be retrieved; the approval is confirmed by TradeArabia and Khaleej Times reports and by the EDE's first-half 2026 report carried by the state news agency WAM.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/orforglipron-in-united-arab-emirates","sources":[{"url":"https://www.tradearabia.com/News/413619/Emirates-Drug-Establishment-approves-oral-obesity-treatment","title":"Emirates Drug Establishment approves oral obesity treatment","publisher":"TradeArabia","date":"2026-04-03","accessed":"2026-09-29"},{"url":"https://www.khaleejtimes.com/uae/new-oral-obesity-treatment-approval","title":"UAE authority approves new oral obesity treatment to be available from May","publisher":"Khaleej Times","date":"2026-04-03","accessed":"2026-09-29"},{"url":"https://www.khaleejtimes.com/lifestyle/health/uae-foundayo-obesity-pill-approved-prescription-eligibility-availability","title":"New obesity pill approved in UAE: Who can get it, availability, prescription explained","publisher":"Khaleej Times","date":"2026-04-17","accessed":"2026-09-29"},{"url":"https://www.doh.gov.ae/en/news/ad-expands-access-to-innovative-daily-oral-obesity-treatment","title":"Abu Dhabi Expands Access to Innovative Daily Oral Obesity Treatment, Enhancing Outcomes and Quality of Life","publisher":"Department of Health Abu Dhabi","date":"2026-04-24","accessed":"2026-09-29"},{"url":"https://www.khaleejtimes.com/lifestyle/health/uae-new-obesity-pills-foundayo-wegovy-insurance-cover","title":"New obesity pills soon in UAE: Will your insurance cover Foundayo or Wegovy?","publisher":"Khaleej Times","date":"2026-04-23","accessed":"2026-09-29"},{"url":"https://wam.ae/article/17ft72p-emirates-drug-establishment-boosts-pharmaceutical","title":"Emirates Drug Establishment boosts pharmaceutical readiness in H1 2026","publisher":"Emirates News Agency (WAM)","date":"2026-09-22","accessed":"2026-09-29"}]},{"molecule":"pramlintide","moleculeName":"Pramlintide","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"unknown","statusLabel":"Unverified","headline":"Could not confirm whether pramlintide (Symlin) is registered by the EDE; no UAE-specific record was found","detail":"I found no EDE announcement, register entry or company page for pramlintide in the UAE, and the EDE's public drug directory could not be used to check it. Any product would need EDE marketing approval under Federal Decree-Law 38/2024, so the status is left unknown rather than guessed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/countries/united-arab-emirates","sources":[{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/en/legislations","title":"Legislations (Federal Decree-Law 38/2024 and other instruments)","publisher":"Emirates Drug Establishment (EDE)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"retatrutide","moleculeName":"Retatrutide","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"prohibited","statusLabel":"Prohibited","headline":"Not approved; the EDE named retatrutide in July 2026 when it acted against 71 sources marketing or selling unapproved peptide products","detail":"The Emirates Drug Establishment said in July 2026 that retatrutide is still in clinical trials and has not been approved for use or distribution in the UAE, and it warned residents against products promoted online. The same action covered 71 sources: 14 registered facilities were cited and 14 social media influencers were referred to the National Media Office, and the EDE said it is working with other authorities to block offending accounts. The EDE said it found no unapproved peptides in licensed pharmaceutical warehouses and is inspecting compounding pharmacies. I found no approved route of supply outside clinical trials.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/retatrutide-in-united-arab-emirates","sources":[{"url":"https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities","title":"UAE cracks down on illegal weight-loss products, targets 71 violators","publisher":"Khaleej Times","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://gulfnews.com/uae/health/uae-weight-loss-drug-crackdown-71-sources-14-influencers-face-action-1.500619741","title":"UAE weight-loss drug crackdown: 71 sources, 14 influencers face action","publisher":"Gulf News","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://filipinotimes.net/latest-news/2026/07/25/uae-cracks-down-on-unapproved-peptide-weight-loss-products-refers-influencers-for-violations/","title":"UAE cracks down on unapproved peptide weight-loss products, refers influencers for violations","publisher":"The Filipino Times","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"}]},{"molecule":"selank","moleculeName":"Selank","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in the UAE: no marketing authorisation found for Selank; unapproved peptide products are under EDE enforcement","detail":"Selank is a synthetic peptide promoted online for anxiety and mood uses, and I found no EDE approval for it in the UAE. In July 2026 the EDE said that calling a product a peptide does not make it an approved medicine, and it took action against 71 sources selling or promoting unapproved peptide products. Federal Decree-Law 38/2024 says no medical product may be circulated or sold in the UAE without EDE marketing approval, and I found no approval for this substance. The decree-law exempts products made in licensed compounding pharmacies from marketing approval, but I found no rule saying whether this peptide may be compounded; the EDE is inspecting compounding pharmacies, and Abu Dhabi's health department says peptides may only be prescribed for appropriate cases supported by scientific evidence.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/selank-in-united-arab-emirates","sources":[{"url":"https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities","title":"UAE cracks down on illegal weight-loss products, targets 71 violators","publisher":"Khaleej Times","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://gulfnews.com/uae/health/uae-weight-loss-drug-crackdown-71-sources-14-influencers-face-action-1.500619741","title":"UAE weight-loss drug crackdown: 71 sources, 14 influencers face action","publisher":"Gulf News","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.emirates247.com/uae/abu-dhabi-health-authority-launches-online-form-for-reporting-side-effects-from-peptide-products/6023","title":"Abu Dhabi health authority launches online form for reporting side effects from peptide products","publisher":"Emirates 24|7","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/documents/d/ede/-38-2024-pdf","title":"Federal Decree-Law No. (38) of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments (Arabic text)","publisher":"Emirates Drug Establishment (EDE)","date":"2024-10-01","accessed":"2026-09-29"}]},{"molecule":"semaglutide","moleculeName":"Semaglutide","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"approved","statusLabel":"Approved","headline":"Approved: Wegovy (injection and, since June 2026, a daily pill) for weight management, Ozempic for type 2 diabetes; prescription-only","detail":"The Emirates Drug Establishment approved oral Wegovy on 1 June 2026 for long-term weight management in adults with obesity or overweight, and for reducing major cardiovascular events in high-risk patients; it said the UAE was the second country to authorise it. Wegovy injection was reported as available for weight loss in the UAE by May 2024, and Novo Nordisk's UAE professional portal lists it for chronic obesity; a paediatric endocrinologist quoted in July 2026 said it is approved for adolescents aged 12 and over under medical criteria. Ozempic is listed on the same portal for type 2 diabetes. All are prescription medicines, and insurance cover for the weight-management use is limited in most plans. In March 2026 Novo Nordisk UAE said it was engaging with regulators on the higher-dose Wegovy injection approved in Europe; I found no report of UAE approval since. I could not check an EDE product register, so approval dates for the injectable products rest on company and press reports.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/semaglutide-in-united-arab-emirates","sources":[{"url":"https://www.ede.gov.ae/en/w/emirates-drug-establishment-approves-oral-wegovy%C2%AE-semaglutide-for-weight-management-and-cardiovascular-risk-reduction","title":"Emirates Drug Establishment approves oral Wegovy (semaglutide) for weight management and cardiovascular risk reduction","publisher":"Emirates Drug Establishment (EDE)","date":"2026-06-01","accessed":"2026-09-29"},{"url":"https://www.globenewswire.com/news-release/2026/06/03/3305784/0/en/wegovy-pill-launches-in-the-uae-as-novo-nordisk-expands-global-access-to-obesity-care.html","title":"Wegovy pill launches in the UAE as Novo Nordisk expands global access to obesity care","publisher":"Novo Nordisk (via GlobeNewswire)","date":"2026-06-03","accessed":"2026-09-29"},{"url":"https://www.thenationalnews.com/health/2024/05/22/ozempic-maker-urges-uae-users-to-switch-to-wegovy-for-weight-loss/","title":"Ozempic maker urges UAE users to switch to Wegovy for weight loss","publisher":"The National","date":"2024-05-22","accessed":"2026-09-29"},{"url":"https://www.khaleejtimes.com/uae/uae-parents-seek-weight-loss-injections-for-children-glp-1-pills-medication","title":"UAE parents increasingly seek weight-loss injections for children amid GLP-1 buzz","publisher":"Khaleej Times","date":"2026-07-14","accessed":"2026-09-29"},{"url":"https://www.khaleejtimes.com/lifestyle/health/uae-is-ozempic-mounjaro-wegovy-covered-by-insurance","title":"Are Ozempic, Mounjaro, other weight-loss drugs covered by insurance in the UAE?","publisher":"Khaleej Times","date":"2026-02-27","accessed":"2026-09-29"},{"url":"https://gulfnews.com/uae/health/higher-maintenance-dose-of-weight-loss-drug-wegovy-approved-in-eu-when-will-uae-get-it-1.500457281","title":"Higher maintenance dose of weight-loss drug Wegovy approved in EU. When will UAE get it?","publisher":"Gulf News","date":"2026-03-02","accessed":"2026-09-29"},{"url":"https://pro.novonordisk.ae/products/wegovy.html","title":"Wegovy by Novo Nordisk: treatment for chronic obesity (UAE healthcare professional portal)","publisher":"Novo Nordisk UAE","date":"2026","accessed":"2026-09-29"},{"url":"https://pro.novonordisk.ae/products/ozempic.html","title":"Ozempic by Novo Nordisk: GLP-1 for type 2 diabetes care (UAE healthcare professional portal)","publisher":"Novo Nordisk UAE","date":"2026","accessed":"2026-09-29"}]},{"molecule":"semax","moleculeName":"Semax","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in the UAE: no marketing authorisation found for Semax; unapproved peptide products are under EDE enforcement","detail":"Semax is a synthetic peptide promoted online for brain-related uses, and I found no EDE approval for it in the UAE. In July 2026 the EDE said that calling a product a peptide does not make it an approved medicine, and it took action against 71 sources selling or promoting unapproved peptide products. Federal Decree-Law 38/2024 says no medical product may be circulated or sold in the UAE without EDE marketing approval, and I found no approval for this substance. The decree-law exempts products made in licensed compounding pharmacies from marketing approval, but I found no rule saying whether this peptide may be compounded; the EDE is inspecting compounding pharmacies, and Abu Dhabi's health department says peptides may only be prescribed for appropriate cases supported by scientific evidence.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/semax-in-united-arab-emirates","sources":[{"url":"https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities","title":"UAE cracks down on illegal weight-loss products, targets 71 violators","publisher":"Khaleej Times","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://gulfnews.com/uae/health/uae-weight-loss-drug-crackdown-71-sources-14-influencers-face-action-1.500619741","title":"UAE weight-loss drug crackdown: 71 sources, 14 influencers face action","publisher":"Gulf News","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.emirates247.com/uae/abu-dhabi-health-authority-launches-online-form-for-reporting-side-effects-from-peptide-products/6023","title":"Abu Dhabi health authority launches online form for reporting side effects from peptide products","publisher":"Emirates 24|7","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/documents/d/ede/-38-2024-pdf","title":"Federal Decree-Law No. (38) of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments (Arabic text)","publisher":"Emirates Drug Establishment (EDE)","date":"2024-10-01","accessed":"2026-09-29"}]},{"molecule":"sermorelin","moleculeName":"Sermorelin","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"unknown","statusLabel":"Unverified","headline":"Could not determine sermorelin's UAE status; no registration or enforcement record was found","detail":"I found no EDE announcement, register entry or enforcement notice that names sermorelin. Sermorelin is a growth-hormone-releasing peptide that is not a widely marketed approved product today. Any medicine needs EDE marketing approval under Federal Decree-Law 38/2024, and the EDE has warned that peptide products are not approved just because they are called peptides, so the status is left unknown rather than guessed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/countries/united-arab-emirates","sources":[{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities","title":"UAE cracks down on illegal weight-loss products, targets 71 violators","publisher":"Khaleej Times","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/en/legislations","title":"Legislations (Federal Decree-Law 38/2024 and other instruments)","publisher":"Emirates Drug Establishment (EDE)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"setmelanotide","moleculeName":"Setmelanotide","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"unknown","statusLabel":"Unverified","headline":"Could not confirm whether setmelanotide (Imcivree) is registered by the EDE; no UAE-specific record was found","detail":"Setmelanotide is approved in some countries for rare genetic causes of obesity, but I found no EDE announcement, register entry or company page showing it in the UAE. The EDE's public drug directory could not be used to check it. Any product would need EDE marketing approval under Federal Decree-Law 38/2024, so the status is left unknown rather than guessed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/countries/united-arab-emirates","sources":[{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/en/legislations","title":"Legislations (Federal Decree-Law 38/2024 and other instruments)","publisher":"Emirates Drug Establishment (EDE)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"survodutide","moleculeName":"Survodutide","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"not-approved","statusLabel":"Not approved","headline":"No EDE approval found for survodutide; an investigational medicine, not marketed in the UAE","detail":"Survodutide is an investigational medicine from Boehringer Ingelheim that acts on glucagon and GLP-1 receptors, and I found no EDE approval for it. Under Federal Decree-Law 38/2024 no medical product may be circulated or sold in the UAE without EDE marketing approval, and the sources I checked show no EDE approval for it. It cannot lawfully be marketed without that approval, and I found no UAE marketing notice for it.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/survodutide-in-united-arab-emirates","sources":[{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/documents/d/ede/-38-2024-pdf","title":"Federal Decree-Law No. (38) of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments (Arabic text)","publisher":"Emirates Drug Establishment (EDE)","date":"2024-10-01","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/en/legislations","title":"Legislations (Federal Decree-Law 38/2024 and other instruments)","publisher":"Emirates Drug Establishment (EDE)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"tb-500","moleculeName":"TB-500 (thymosin beta-4 fragment)","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in the UAE: no marketing authorisation for TB-500; unapproved peptide products are under EDE enforcement","detail":"TB-500 is a synthetic fragment related to thymosin beta-4, promoted online, and has no marketing authorisation as a human medicine in the UAE. In July 2026 the EDE said that calling a product a peptide does not make it an approved medicine, and it took action against 71 sources selling or promoting unapproved peptide products. Federal Decree-Law 38/2024 says no medical product may be circulated or sold in the UAE without EDE marketing approval, and I found no approval for this substance. The decree-law exempts products made in licensed compounding pharmacies from marketing approval, but I found no rule saying whether this peptide may be compounded; the EDE is inspecting compounding pharmacies, and Abu Dhabi's health department says peptides may only be prescribed for appropriate cases supported by scientific evidence.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tb-500-in-united-arab-emirates","sources":[{"url":"https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities","title":"UAE cracks down on illegal weight-loss products, targets 71 violators","publisher":"Khaleej Times","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://gulfnews.com/uae/health/uae-weight-loss-drug-crackdown-71-sources-14-influencers-face-action-1.500619741","title":"UAE weight-loss drug crackdown: 71 sources, 14 influencers face action","publisher":"Gulf News","date":"2026-07-25","accessed":"2026-09-29"},{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.emirates247.com/uae/abu-dhabi-health-authority-launches-online-form-for-reporting-side-effects-from-peptide-products/6023","title":"Abu Dhabi health authority launches online form for reporting side effects from peptide products","publisher":"Emirates 24|7","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/documents/d/ede/-38-2024-pdf","title":"Federal Decree-Law No. (38) of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments (Arabic text)","publisher":"Emirates Drug Establishment (EDE)","date":"2024-10-01","accessed":"2026-09-29"}]},{"molecule":"tesamorelin","moleculeName":"Tesamorelin","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"unknown","statusLabel":"Unverified","headline":"Could not confirm whether tesamorelin (Egrifta) is registered by the EDE; no UAE-specific record was found","detail":"Tesamorelin is an approved prescription medicine in some countries, but I found no EDE announcement, register entry or company page showing it in the UAE. The EDE's public drug directory could not be used to check it. Any product would need EDE marketing approval under Federal Decree-Law 38/2024, so the status is left unknown rather than guessed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/countries/united-arab-emirates","sources":[{"url":"https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae","title":"Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)","publisher":"Kayrouz and Associates","date":"2026-03-18","accessed":"2026-09-29"},{"url":"https://www.ede.gov.ae/en/legislations","title":"Legislations (Federal Decree-Law 38/2024 and other instruments)","publisher":"Emirates Drug Establishment (EDE)","date":"2026-09-29","accessed":"2026-09-29"}]},{"molecule":"tirzepatide","moleculeName":"Tirzepatide","country":"united-arab-emirates","countryName":"United Arab Emirates","countryIso2":"AE","status":"approved","statusLabel":"Approved","headline":"On the market as Mounjaro by prescription; UAE doctors describe use for type 2 diabetes and weight management; EDE register entry not checked","detail":"UAE press describes Mounjaro (tirzepatide) as widely prescribed. Doctors quoted in July 2024 said it is used for type 2 diabetes and for obesity in adults with a BMI over 30, or over 27 with risk factors. A paediatric endocrinologist quoted in July 2026 said it is approved for type 2 diabetes in children aged 10 and over, but not for weight loss in that age group. Gulf News reported in February 2026 that it typically costs more than Dh1,700, and insurance often covers it for diabetes but rarely for weight management. A Sharjah court fined defendants in July 2026 for selling Mounjaro without a licence. I could not open the EDE register, so the approval date is unconfirmed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tirzepatide-in-united-arab-emirates","sources":[{"url":"https://www.khaleejtimes.com/lifestyle/health/mounjaro-safety-side-effects-3-things-to-know-about-this-new-weight-loss-drug","title":"Mounjaro safety, side effects: 3 things to know about this new weight loss drug","publisher":"Khaleej Times","date":"2024-07-31","accessed":"2026-09-29"},{"url":"https://www.khaleejtimes.com/uae/uae-parents-seek-weight-loss-injections-for-children-glp-1-pills-medication","title":"UAE parents increasingly seek weight-loss injections for children amid GLP-1 buzz","publisher":"Khaleej Times","date":"2026-07-14","accessed":"2026-09-29"},{"url":"https://gulfnews.com/your-money/saving-investment/anti-obesity-drugs-ozempic-wegovy-mounjaro-are-they-getting-cheaper-1.500433563","title":"Anti-obesity drugs Ozempic, Wegovy, Mounjaro: Are they getting cheaper?","publisher":"Gulf News","date":"2026-02-07","accessed":"2026-09-29"},{"url":"https://www.khaleejtimes.com/lifestyle/health/uae-is-ozempic-mounjaro-wegovy-covered-by-insurance","title":"Are Ozempic, Mounjaro, other weight-loss drugs covered by insurance in the UAE?","publisher":"Khaleej Times","date":"2026-02-27","accessed":"2026-09-29"},{"url":"https://gulfnews.com/uae/crime/dh10000-fine-for-selling-mounjaro-injections-without-a-licence-in-sharjah-1.500626515","title":"Dh10,000 fine for selling Mounjaro injections without a licence in Sharjah","publisher":"Gulf News","date":"2026-07-31","accessed":"2026-09-29"}]},{"molecule":"amycretin","moleculeName":"Amycretin","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"Investigational medicine with no UK licence","detail":"Amycretin is an investigational medicine and has no UK marketing authorisation that we could find. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience. Anyone offering it for sale in the UK is offering an unauthorised medicine.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/amycretin-in-united-kingdom","sources":[{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine","title":"Borderline products: how to tell if your product is a medicine","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-02","accessed":"2026-09-29"}]},{"molecule":"aod-9604","moleculeName":"AOD-9604","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"AOD-9604 is not licensed in the UK","detail":"AOD-9604 has no UK marketing authorisation that we could find. It is an experimental fragment of growth hormone. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience. The MHRA says illicit sites it raided in February and May 2026 are believed to have been used to make unlicensed weight-loss medicines as well as 'peptide products'. UKAD lists peptide hormones among the substances banned at all times in sport, and athletes are strictly liable for anything found in their system; we did not verify how this specific substance is listed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/aod-9604-in-united-kingdom","sources":[{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine","title":"Borderline products: how to tell if your product is a medicine","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-02","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines","title":"Two arrested during the MHRA's largest ever seizure of unlicensed weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-05-29","accessed":"2026-09-29"},{"url":"https://www.ukad.org.uk/athletes/whats-banned-sport-prohibited-list","title":"What's banned in sport - the Prohibited List","publisher":"UK Anti-Doping (UKAD)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/mhra-disrupts-second-manufacturing-facility-suspected-to-be-involved-in-the-manufacture-of-illegal-weight-loss-medicines-in-latest-blow-to-criminal-ne","title":"MHRA disrupts second manufacturing facility suspected to be involved in the manufacture of illegal weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-02-25","accessed":"2026-09-29"}]},{"molecule":"bpc-157","moleculeName":"BPC-157","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"BPC-157 is not licensed in the UK","detail":"BPC-157 has no UK marketing authorisation that we could find. It is an experimental peptide, and most of the evidence for it comes from animal studies rather than proven human treatment. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience. The MHRA says illicit sites it raided in February and May 2026 are believed to have been used to make unlicensed weight-loss medicines as well as 'peptide products'. UKAD lists peptide hormones among the substances banned at all times in sport, and athletes are strictly liable for anything found in their system; we did not verify how this specific substance is listed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/bpc-157-in-united-kingdom","sources":[{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine","title":"Borderline products: how to tell if your product is a medicine","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-02","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines","title":"Two arrested during the MHRA's largest ever seizure of unlicensed weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-05-29","accessed":"2026-09-29"},{"url":"https://www.ukad.org.uk/athletes/whats-banned-sport-prohibited-list","title":"What's banned in sport - the Prohibited List","publisher":"UK Anti-Doping (UKAD)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/mhra-disrupts-second-manufacturing-facility-suspected-to-be-involved-in-the-manufacture-of-illegal-weight-loss-medicines-in-latest-blow-to-criminal-ne","title":"MHRA disrupts second manufacturing facility suspected to be involved in the manufacture of illegal weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-02-25","accessed":"2026-09-29"}]},{"molecule":"bremelanotide","moleculeName":"Bremelanotide (PT-141)","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"No UK licence for bremelanotide","detail":"Bremelanotide has no UK marketing authorisation that we could find. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/bremelanotide-in-united-kingdom","sources":[{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine","title":"Borderline products: how to tell if your product is a medicine","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-02","accessed":"2026-09-29"}]},{"molecule":"cagrilintide","moleculeName":"Cagrilintide (and CagriSema)","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"No UK licence for cagrilintide or the cagrilintide-semaglutide combination (CagriSema)","detail":"We found no UK marketing authorisation for cagrilintide alone or for the combination product with semaglutide. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/cagrilintide-in-united-kingdom","sources":[{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine","title":"Borderline products: how to tell if your product is a medicine","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-02","accessed":"2026-09-29"}]},{"molecule":"cjc-1295","moleculeName":"CJC-1295","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"CJC-1295 is not licensed in the UK","detail":"CJC-1295 has no UK marketing authorisation that we could find. It is a growth hormone releasing hormone analogue and is not an authorised medicine. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience. The MHRA says illicit sites it raided in February and May 2026 are believed to have been used to make unlicensed weight-loss medicines as well as 'peptide products'. UKAD lists peptide hormones among the substances banned at all times in sport, and athletes are strictly liable for anything found in their system; we did not verify how this specific substance is listed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/cjc-1295-in-united-kingdom","sources":[{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine","title":"Borderline products: how to tell if your product is a medicine","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-02","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines","title":"Two arrested during the MHRA's largest ever seizure of unlicensed weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-05-29","accessed":"2026-09-29"},{"url":"https://www.ukad.org.uk/athletes/whats-banned-sport-prohibited-list","title":"What's banned in sport - the Prohibited List","publisher":"UK Anti-Doping (UKAD)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/mhra-disrupts-second-manufacturing-facility-suspected-to-be-involved-in-the-manufacture-of-illegal-weight-loss-medicines-in-latest-blow-to-criminal-ne","title":"MHRA disrupts second manufacturing facility suspected to be involved in the manufacture of illegal weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-02-25","accessed":"2026-09-29"}]},{"molecule":"dsip","moleculeName":"DSIP (delta sleep-inducing peptide)","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"DSIP (delta sleep-inducing peptide) is not licensed in the UK","detail":"DSIP (delta sleep-inducing peptide) has no UK marketing authorisation that we could find. It is an experimental peptide. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience. The MHRA says illicit sites it raided in February and May 2026 are believed to have been used to make unlicensed weight-loss medicines as well as 'peptide products'.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/dsip-in-united-kingdom","sources":[{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine","title":"Borderline products: how to tell if your product is a medicine","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-02","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines","title":"Two arrested during the MHRA's largest ever seizure of unlicensed weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-05-29","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/mhra-disrupts-second-manufacturing-facility-suspected-to-be-involved-in-the-manufacture-of-illegal-weight-loss-medicines-in-latest-blow-to-criminal-ne","title":"MHRA disrupts second manufacturing facility suspected to be involved in the manufacture of illegal weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-02-25","accessed":"2026-09-29"}]},{"molecule":"dulaglutide","moleculeName":"Dulaglutide","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"approved","statusLabel":"Approved","headline":"Licensed in the UK as Trulicity for type 2 diabetes only; not licensed for weight loss","detail":"Trulicity (dulaglutide, Eli Lilly) has a UK licence for insufficiently controlled type 2 diabetes in people aged 10 and over, as monotherapy where metformin is unsuitable or added to other diabetes medicines. Its Summary of Product Characteristics was last revised on 25 February 2026. It has no weight-management indication in the UK, and using it for weight loss alone would be outside its licence. It is prescription-only.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/dulaglutide-in-united-kingdom","sources":[{"url":"https://www.medicines.org.uk/emc/product/7482/smpc","title":"TRULICITY 0.75 mg solution for injection in pre-filled pen: Summary of Product Characteristics","publisher":"electronic medicines compendium (emc), Eli Lilly and Company Limited","date":"2026-02-25","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/publications/glp-1-medicines-for-weight-loss-and-diabetes-what-you-need-to-know","title":"GLP-1 medicines for weight loss and diabetes: what you need to know","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-02-05","accessed":"2026-09-29"}]},{"molecule":"ecnoglutide","moleculeName":"Ecnoglutide","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"Ecnoglutide has no UK licence","detail":"Ecnoglutide is an investigational or non-UK medicine and has no UK marketing authorisation that we could find. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ecnoglutide-in-united-kingdom","sources":[{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine","title":"Borderline products: how to tell if your product is a medicine","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-02","accessed":"2026-09-29"}]},{"molecule":"elamipretide","moleculeName":"Elamipretide (SS-31)","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"No UK licence found for elamipretide","detail":"We found no UK marketing authorisation for elamipretide, a mitochondria-targeting peptide studied for Barth syndrome. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/elamipretide-in-united-kingdom","sources":[{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine","title":"Borderline products: how to tell if your product is a medicine","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-02","accessed":"2026-09-29"}]},{"molecule":"eloralintide","moleculeName":"Eloralintide","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"Investigational medicine with no UK licence","detail":"Eloralintide is an investigational medicine and has no UK marketing authorisation that we could find. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/eloralintide-in-united-kingdom","sources":[{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine","title":"Borderline products: how to tell if your product is a medicine","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-02","accessed":"2026-09-29"}]},{"molecule":"epitalon","moleculeName":"Epitalon","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"Epitalon is not licensed in the UK","detail":"Epitalon has no UK marketing authorisation that we could find. It is an experimental peptide. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience. The MHRA says illicit sites it raided in February and May 2026 are believed to have been used to make unlicensed weight-loss medicines as well as 'peptide products'.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/epitalon-in-united-kingdom","sources":[{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine","title":"Borderline products: how to tell if your product is a medicine","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-02","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines","title":"Two arrested during the MHRA's largest ever seizure of unlicensed weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-05-29","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/mhra-disrupts-second-manufacturing-facility-suspected-to-be-involved-in-the-manufacture-of-illegal-weight-loss-medicines-in-latest-blow-to-criminal-ne","title":"MHRA disrupts second manufacturing facility suspected to be involved in the manufacture of illegal weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-02-25","accessed":"2026-09-29"}]},{"molecule":"exenatide","moleculeName":"Exenatide","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"unknown","statusLabel":"Unverified","headline":"EU authorisations exist for Byetta and Bydureon; we could not confirm a current UK licence or availability","detail":"The European Medicines Agency still lists Byetta and Bydureon (exenatide, AstraZeneca) as authorised in the EU, with product information updated in November 2024. We could not confirm the current UK licence status, because the MHRA Products register was unavailable when we checked. The UK electronic medicines compendium (emc) returned no product information for exenatide, Byetta or Bydureon on 29 September 2026, which suggests they may not currently be marketed in the UK, but this does not show whether a licence is still in force. We have therefore left the UK status as unknown rather than guess.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/countries/united-kingdom","sources":[{"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/byetta","title":"Byetta (exenatide): EPAR","publisher":"European Medicines Agency (EMA)","date":"2024-11-06","accessed":"2026-09-29"},{"url":"https://www.ema.europa.eu/en/medicines/human/EPAR/bydureon","title":"Bydureon (exenatide): EPAR","publisher":"European Medicines Agency (EMA)","date":"2024-11-21","accessed":"2026-09-29"},{"url":"https://www.medicines.org.uk/emc/search?q=exenatide","title":"emc search results for exenatide","publisher":"Datapharm (electronic medicines compendium, emc)","date":"2026-09-29","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"}]},{"molecule":"ghk-cu","moleculeName":"GHK-Cu (copper peptide)","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"GHK-Cu is not licensed in the UK","detail":"GHK-Cu has no UK marketing authorisation that we could find. Cosmetics are regulated separately from medicines, but the MHRA decides whether a product is a medicine based on its claims, how it is used and how it acts, so an injected product or one sold with medical claims is likely to fall under medicines law. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience. The MHRA says illicit sites it raided in February and May 2026 are believed to have been used to make unlicensed weight-loss medicines as well as 'peptide products'.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ghk-cu-in-united-kingdom","sources":[{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine","title":"Borderline products: how to tell if your product is a medicine","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-02","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines","title":"Two arrested during the MHRA's largest ever seizure of unlicensed weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-05-29","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/mhra-disrupts-second-manufacturing-facility-suspected-to-be-involved-in-the-manufacture-of-illegal-weight-loss-medicines-in-latest-blow-to-criminal-ne","title":"MHRA disrupts second manufacturing facility suspected to be involved in the manufacture of illegal weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-02-25","accessed":"2026-09-29"}]},{"molecule":"ipamorelin","moleculeName":"Ipamorelin","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"Ipamorelin is not licensed in the UK","detail":"Ipamorelin has no UK marketing authorisation that we could find. It is a growth hormone secretagogue and is not an authorised medicine. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience. The MHRA says illicit sites it raided in February and May 2026 are believed to have been used to make unlicensed weight-loss medicines as well as 'peptide products'. UKAD lists peptide hormones among the substances banned at all times in sport, and athletes are strictly liable for anything found in their system; we did not verify how this specific substance is listed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ipamorelin-in-united-kingdom","sources":[{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine","title":"Borderline products: how to tell if your product is a medicine","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-02","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines","title":"Two arrested during the MHRA's largest ever seizure of unlicensed weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-05-29","accessed":"2026-09-29"},{"url":"https://www.ukad.org.uk/athletes/whats-banned-sport-prohibited-list","title":"What's banned in sport - the Prohibited List","publisher":"UK Anti-Doping (UKAD)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/mhra-disrupts-second-manufacturing-facility-suspected-to-be-involved-in-the-manufacture-of-illegal-weight-loss-medicines-in-latest-blow-to-criminal-ne","title":"MHRA disrupts second manufacturing facility suspected to be involved in the manufacture of illegal weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-02-25","accessed":"2026-09-29"}]},{"molecule":"kisspeptin","moleculeName":"Kisspeptin","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"Kisspeptin is not licensed in the UK","detail":"Kisspeptin has no UK marketing authorisation that we could find. It is an experimental peptide. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience. The MHRA says illicit sites it raided in February and May 2026 are believed to have been used to make unlicensed weight-loss medicines as well as 'peptide products'.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/kisspeptin-in-united-kingdom","sources":[{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine","title":"Borderline products: how to tell if your product is a medicine","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-02","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines","title":"Two arrested during the MHRA's largest ever seizure of unlicensed weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-05-29","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/mhra-disrupts-second-manufacturing-facility-suspected-to-be-involved-in-the-manufacture-of-illegal-weight-loss-medicines-in-latest-blow-to-criminal-ne","title":"MHRA disrupts second manufacturing facility suspected to be involved in the manufacture of illegal weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-02-25","accessed":"2026-09-29"}]},{"molecule":"kpv","moleculeName":"KPV","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"KPV is not licensed in the UK","detail":"KPV has no UK marketing authorisation that we could find. It is an experimental peptide. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience. The MHRA says illicit sites it raided in February and May 2026 are believed to have been used to make unlicensed weight-loss medicines as well as 'peptide products'.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/kpv-in-united-kingdom","sources":[{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine","title":"Borderline products: how to tell if your product is a medicine","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-02","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines","title":"Two arrested during the MHRA's largest ever seizure of unlicensed weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-05-29","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/mhra-disrupts-second-manufacturing-facility-suspected-to-be-involved-in-the-manufacture-of-illegal-weight-loss-medicines-in-latest-blow-to-criminal-ne","title":"MHRA disrupts second manufacturing facility suspected to be involved in the manufacture of illegal weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-02-25","accessed":"2026-09-29"}]},{"molecule":"liraglutide","moleculeName":"Liraglutide","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"generic-available","statusLabel":"Generics available","headline":"Licensed in the UK (Saxenda, plus generic liraglutide for weight management and type 2 diabetes since 2024)","detail":"Liraglutide is licensed in the UK for type 2 diabetes and for weight management; the MHRA's guidance notes that the licensed use depends on the brand. Generic liraglutide pens were authorised in 2024, for example Nevolat (Zentiva, first authorised 27 March 2024) and Biolide (Biocon, April 2024) for weight management, and Diavic (Sun Pharma, June 2024) for type 2 diabetes. NICE guidance TA664 (2020) recommends Saxenda on the NHS only in specialist (tier 3) weight services for people who meet its criteria.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/liraglutide-in-united-kingdom","sources":[{"url":"https://www.gov.uk/government/publications/glp-1-medicines-for-weight-loss-and-diabetes-what-you-need-to-know","title":"GLP-1 medicines for weight loss and diabetes: what you need to know","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-02-05","accessed":"2026-09-29"},{"url":"https://www.medicines.org.uk/emc/product/100226/smpc","title":"Nevolat 6 mg/ml solution for injection in pre-filled pen (liraglutide): Summary of Product Characteristics","publisher":"electronic medicines compendium (emc), Zentiva Pharma UK Limited","date":"2025-12-15","accessed":"2026-09-29"},{"url":"https://www.medicines.org.uk/emc/product/100249/smpc","title":"BIOLIDE 6 mg/ml solution for injection in pre-filled pen (liraglutide): Summary of Product Characteristics","publisher":"electronic medicines compendium (emc), Biocon Pharma UK Limited","date":"2024-04-12","accessed":"2026-09-29"},{"url":"https://www.medicines.org.uk/emc/product/100178/smpc","title":"Diavic 6 mg/1 ml solution for injection in pre-filled pen (liraglutide): Summary of Product Characteristics","publisher":"electronic medicines compendium (emc), Ranbaxy (UK) Limited","date":"2025-08-12","accessed":"2026-09-29"},{"url":"https://www.nice.org.uk/guidance/ta664","title":"Liraglutide for managing overweight and obesity (TA664)","publisher":"National Institute for Health and Care Excellence (NICE)","date":"2020-12-09","accessed":"2026-09-29"}]},{"molecule":"ll-37","moleculeName":"LL-37","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"LL-37 is not licensed in the UK","detail":"LL-37 has no UK marketing authorisation that we could find. It is an experimental antimicrobial peptide. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience. The MHRA says illicit sites it raided in February and May 2026 are believed to have been used to make unlicensed weight-loss medicines as well as 'peptide products'.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ll-37-in-united-kingdom","sources":[{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine","title":"Borderline products: how to tell if your product is a medicine","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-02","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines","title":"Two arrested during the MHRA's largest ever seizure of unlicensed weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-05-29","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/mhra-disrupts-second-manufacturing-facility-suspected-to-be-involved-in-the-manufacture-of-illegal-weight-loss-medicines-in-latest-blow-to-criminal-ne","title":"MHRA disrupts second manufacturing facility suspected to be involved in the manufacture of illegal weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-02-25","accessed":"2026-09-29"}]},{"molecule":"maridebart-cafraglutide","moleculeName":"Maridebart cafraglutide (MariTide)","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"Maridebart cafraglutide has no UK licence","detail":"Maridebart cafraglutide is an investigational or non-UK medicine and has no UK marketing authorisation that we could find. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/maridebart-cafraglutide-in-united-kingdom","sources":[{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine","title":"Borderline products: how to tell if your product is a medicine","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-02","accessed":"2026-09-29"}]},{"molecule":"mazdutide","moleculeName":"Mazdutide","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"Mazdutide has no UK licence","detail":"Mazdutide is an investigational or non-UK medicine and has no UK marketing authorisation that we could find. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/mazdutide-in-united-kingdom","sources":[{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine","title":"Borderline products: how to tell if your product is a medicine","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-02","accessed":"2026-09-29"}]},{"molecule":"melanotan-ii","moleculeName":"Melanotan II","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"Melanotan II is not licensed in the UK","detail":"Melanotan II has no UK marketing authorisation that we could find. It is sold for tanning, which is not an approved medical use in the UK. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience. The MHRA says illicit sites it raided in February and May 2026 are believed to have been used to make unlicensed weight-loss medicines as well as 'peptide products'.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/melanotan-ii-in-united-kingdom","sources":[{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine","title":"Borderline products: how to tell if your product is a medicine","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-02","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines","title":"Two arrested during the MHRA's largest ever seizure of unlicensed weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-05-29","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/mhra-disrupts-second-manufacturing-facility-suspected-to-be-involved-in-the-manufacture-of-illegal-weight-loss-medicines-in-latest-blow-to-criminal-ne","title":"MHRA disrupts second manufacturing facility suspected to be involved in the manufacture of illegal weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-02-25","accessed":"2026-09-29"}]},{"molecule":"mots-c","moleculeName":"MOTS-c","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"MOTS-c is not licensed in the UK","detail":"MOTS-c has no UK marketing authorisation that we could find. It is an experimental peptide. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience. The MHRA says illicit sites it raided in February and May 2026 are believed to have been used to make unlicensed weight-loss medicines as well as 'peptide products'.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/mots-c-in-united-kingdom","sources":[{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine","title":"Borderline products: how to tell if your product is a medicine","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-02","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines","title":"Two arrested during the MHRA's largest ever seizure of unlicensed weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-05-29","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/mhra-disrupts-second-manufacturing-facility-suspected-to-be-involved-in-the-manufacture-of-illegal-weight-loss-medicines-in-latest-blow-to-criminal-ne","title":"MHRA disrupts second manufacturing facility suspected to be involved in the manufacture of illegal weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-02-25","accessed":"2026-09-29"}]},{"molecule":"nad-plus","moleculeName":"NAD+","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"NAD+ is not licensed in the UK","detail":"NAD+ has no UK marketing authorisation that we could find. The MHRA says food supplements are generally regulated as food unless presented for medicinal uses, and it decides case by case based on claims and ingredients; an injected NAD+ product presented as treating or preventing disease would be a medicine needing a licence. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/nad-plus-in-united-kingdom","sources":[{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine","title":"Borderline products: how to tell if your product is a medicine","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-02","accessed":"2026-09-29"}]},{"molecule":"orforglipron","moleculeName":"Orforglipron","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"approved","statusLabel":"Approved","headline":"Licensed by the MHRA on 10 August 2026 as Foundayo, a once-daily tablet for weight management and type 2 diabetes","detail":"The MHRA authorised orforglipron (Foundayo, Eli Lilly) on 10 August 2026, the first authorisation in Europe. It is licensed for weight loss and weight maintenance in adults with a BMI of 30 or more, or 27 to 30 with at least one weight-related condition, and for type 2 diabetes that is not well controlled. It is prescription-only and was not available on the NHS when authorised; the MHRA said NHS use will follow an evaluation by NICE. In June 2026, before it was licensed, the MHRA, ASA and GPhC warned businesses that promoting pipeline weight-management medicines (including waiting lists) and newly licensed oral GLP-1s to the public is likely to break the advertising rules. The MHRA's additional monitoring list shows Foundayo tablets under UK product licences held by Eli Lilly.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/orforglipron-in-united-kingdom","sources":[{"url":"https://www.gov.uk/government/news/uk-first-in-europe-to-authorise-orforglipron-for-weight-management-and-type-2-diabetes","title":"UK first in Europe to authorise orforglipron for weight management and type 2 diabetes","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-08-10","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/warning-on-promoting-newly-licensed-prescription-only-medicines-and-unlicensed-medicines-for-weight-management","title":"Warning on promoting newly licensed prescription-only medicines and unlicensed medicines for weight management","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-06-18","accessed":"2026-09-29"},{"url":"https://assets.publishing.service.gov.uk/media/6ab64daafceb6fb3a650120d/Additional_Monitoring_August_2026.xlsx","title":"UK additional monitoring list, August 2026","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-08","accessed":"2026-09-29"}]},{"molecule":"pramlintide","moleculeName":"Pramlintide","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"Not licensed in the UK","detail":"Pramlintide has no UK marketing authorisation that we could find. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/pramlintide-in-united-kingdom","sources":[{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine","title":"Borderline products: how to tell if your product is a medicine","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-02","accessed":"2026-09-29"}]},{"molecule":"retatrutide","moleculeName":"Retatrutide","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"prohibited","statusLabel":"Prohibited","headline":"Not authorised in the UK; the MHRA says selling it is illegal and has raided sites making and supplying it","detail":"The MHRA states that retatrutide is a medicine still in clinical development that has not been authorised for use in the UK; outside authorised clinical trials, products sold as retatrutide are likely to be illegal. It says anyone selling it is doing so illegally and that such products are untested for safety, quality or effectiveness. The MHRA's Criminal Enforcement Unit seized more than 2,000 unlicensed retatrutide and tirzepatide pens in Northampton in October 2025, raided two premises in February 2026 believed to have been used to make retatrutide, tirzepatide and peptide products, and arrested two people in a raid near Northampton in May 2026 that recovered around 12,000 doses of unlicensed weight loss products.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/retatrutide-in-united-kingdom","sources":[{"url":"https://www.gov.uk/government/news/no-summer-shortcut-for-safe-weight-loss","title":"No summer shortcut for safe weight loss","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-24","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/mhra-smashes-majorillicitweight-loss-medicine-production-facility-in-record-seizure","title":"MHRA smashes major illicit weight loss medicine production facility in record seizure","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2025-10-24","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/mhra-disrupts-second-manufacturing-facility-suspected-to-be-involved-in-the-manufacture-of-illegal-weight-loss-medicines-in-latest-blow-to-criminal-ne","title":"MHRA disrupts second manufacturing facility suspected to be involved in the manufacture of illegal weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-02-25","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines","title":"Two arrested during the MHRA's largest ever seizure of unlicensed weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-05-29","accessed":"2026-09-29"}]},{"molecule":"selank","moleculeName":"Selank","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"Selank is not licensed in the UK","detail":"Selank has no UK marketing authorisation that we could find. It is not an authorised medicine in the UK. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/selank-in-united-kingdom","sources":[{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine","title":"Borderline products: how to tell if your product is a medicine","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-02","accessed":"2026-09-29"}]},{"molecule":"semaglutide","moleculeName":"Semaglutide","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"approved","statusLabel":"Approved","headline":"Licensed in the UK: Ozempic and Rybelsus for type 2 diabetes, Wegovy for weight management (now also as a tablet)","detail":"The MHRA lists semaglutide as licensed in the UK. Ozempic and Rybelsus are licensed for type 2 diabetes, and Wegovy for weight management and for lowering the risk of serious heart problems in people with obesity or overweight. In April 2026 the MHRA approved a single-dose pen at the highest weekly strength for adults with obesity. On 11 June 2026 the MHRA approved a Wegovy tablet for adults with a BMI of 30 or more, or 27 to 30 with a weight-related condition; it was not available on the NHS when approved. On 3 July 2026 Wegovy also received a conditional licence for liver disease (MASH) with moderate to advanced scarring; NICE is still appraising it for this use, so it is not yet available on the NHS for MASH. It is prescription-only. NICE (TA875) recommends the Wegovy injection on the NHS only through specialist weight management services for up to two years.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/semaglutide-in-united-kingdom","sources":[{"url":"https://www.gov.uk/government/publications/glp-1-medicines-for-weight-loss-and-diabetes-what-you-need-to-know","title":"GLP-1 medicines for weight loss and diabetes: what you need to know","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-02-05","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/single-dose-72mg-semaglutide-wegovy-pen-approved-to-treat-adult-patients-with-obesity","title":"Single-dose 7.2mg semaglutide (Wegovy) pen approved to treat adult patients with obesity","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-04-14","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/first-glp-1-tablet-for-weight-loss-approved-in-the-uk","title":"First GLP-1 tablet for weight loss approved in the UK","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-06-11","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/semaglutide-wegovy-approved-to-treat-form-of-liver-disease","title":"Semaglutide (Wegovy) approved to treat form of liver disease","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-03","accessed":"2026-09-29"},{"url":"https://www.nice.org.uk/guidance/ta875","title":"Semaglutide for managing overweight and obesity (TA875)","publisher":"National Institute for Health and Care Excellence (NICE)","date":"2023-03-08","accessed":"2026-09-29"}]},{"molecule":"semax","moleculeName":"Semax","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"Semax is not licensed in the UK","detail":"Semax has no UK marketing authorisation that we could find. It is not an authorised medicine in the UK. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/semax-in-united-kingdom","sources":[{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine","title":"Borderline products: how to tell if your product is a medicine","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-02","accessed":"2026-09-29"}]},{"molecule":"sermorelin","moleculeName":"Sermorelin","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"Sermorelin is not licensed in the UK","detail":"Sermorelin has no UK marketing authorisation that we could find. It is a growth hormone releasing hormone analogue. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience. UKAD lists peptide hormones among the substances banned at all times in sport, and athletes are strictly liable for anything found in their system; we did not verify how this specific substance is listed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/sermorelin-in-united-kingdom","sources":[{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine","title":"Borderline products: how to tell if your product is a medicine","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-02","accessed":"2026-09-29"},{"url":"https://www.ukad.org.uk/athletes/whats-banned-sport-prohibited-list","title":"What's banned in sport - the Prohibited List","publisher":"UK Anti-Doping (UKAD)","date":"2026","accessed":"2026-09-29"}]},{"molecule":"setmelanotide","moleculeName":"Setmelanotide","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"approved-restricted","statusLabel":"Approved, restricted","headline":"Licensed in the UK as Imcivree for rare genetic and hypothalamic obesity; NICE funds it for POMC or LEPR deficiency","detail":"Setmelanotide (Imcivree, Rhythm Pharmaceuticals) has a UK marketing authorisation (PLGB 55587/0001). The MHRA's orphan register (September 2026) lists it for obesity and hunger caused by genetically confirmed POMC (including PCSK1) or LEPR deficiency and for Bardet-Biedl syndrome, in people aged 2 and over, and for acquired hypothalamic obesity in people aged 4 and over. NICE highly specialised technologies guidance HST21 (July 2022) recommends it on the NHS, within its marketing authorisation, for POMC (including PCSK1) or LEPR deficiency in people aged 6 and over, only under the company's commercial arrangement. It is a prescription-only treatment for these rare conditions, not a general weight-loss medicine. We did not check NICE guidance for its other licensed uses.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/setmelanotide-in-united-kingdom","sources":[{"url":"https://assets.publishing.service.gov.uk/media/6ab5418d997a4b2950cceed1/Orphan_Register_Ver1_Sep_2026.csv","title":"Orphan registered medicinal products (Orphan Register, September 2026)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-24","accessed":"2026-09-29"},{"url":"https://www.nice.org.uk/guidance/hst21","title":"Setmelanotide for treating obesity caused by LEPR or POMC deficiency (HST21)","publisher":"National Institute for Health and Care Excellence (NICE)","date":"2022-07-06","accessed":"2026-09-29"}]},{"molecule":"survodutide","moleculeName":"Survodutide","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"Survodutide has no UK licence","detail":"Survodutide is an investigational or non-UK medicine and has no UK marketing authorisation that we could find. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/survodutide-in-united-kingdom","sources":[{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine","title":"Borderline products: how to tell if your product is a medicine","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-02","accessed":"2026-09-29"}]},{"molecule":"tb-500","moleculeName":"TB-500 (thymosin beta-4 fragment)","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"TB-500 is not licensed in the UK","detail":"TB-500 has no UK marketing authorisation that we could find. It is a synthetic fragment related to thymosin beta-4 and is not an authorised medicine. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience. The MHRA says illicit sites it raided in February and May 2026 are believed to have been used to make unlicensed weight-loss medicines as well as 'peptide products'. UKAD lists peptide hormones among the substances banned at all times in sport, and athletes are strictly liable for anything found in their system; we did not verify how this specific substance is listed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tb-500-in-united-kingdom","sources":[{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine","title":"Borderline products: how to tell if your product is a medicine","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-07-02","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines","title":"Two arrested during the MHRA's largest ever seizure of unlicensed weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-05-29","accessed":"2026-09-29"},{"url":"https://www.ukad.org.uk/athletes/whats-banned-sport-prohibited-list","title":"What's banned in sport - the Prohibited List","publisher":"UK Anti-Doping (UKAD)","date":"2026","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/mhra-disrupts-second-manufacturing-facility-suspected-to-be-involved-in-the-manufacture-of-illegal-weight-loss-medicines-in-latest-blow-to-criminal-ne","title":"MHRA disrupts second manufacturing facility suspected to be involved in the manufacture of illegal weight loss medicines","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-02-25","accessed":"2026-09-29"}]},{"molecule":"tesamorelin","moleculeName":"Tesamorelin","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"not-approved","statusLabel":"Not approved","headline":"No UK licence for tesamorelin; the EU application was withdrawn in 2012","detail":"We found no UK marketing authorisation for tesamorelin. In the EU, the company withdrew its application (on 21 June 2012) for a licence for excess abdominal fat in HIV-related lipodystrophy. We found no UK marketing authorisation and no MHRA approval announcement for it. The MHRA Products register could not be queried directly on the day of checking, so this rests on MHRA guidance and the absence of any approval notice. UK law does not allow an unauthorised medicine to be sold or supplied, and the MHRA treats a product as a medicine if it is presented as treating disease or acts on the body through a pharmacological effect. Unlicensed 'specials' may only be supplied for an individual patient's clinical need that a licensed product cannot meet, and not for cost or convenience. Tesamorelin is similar to the body's growth hormone-releasing hormone. UKAD lists peptide hormones among the substances banned at all times in sport; we did not verify how tesamorelin is listed.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tesamorelin-in-united-kingdom","sources":[{"url":"https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/egrifta","title":"Egrifta: withdrawn application (tesamorelin)","publisher":"European Medicines Agency (EMA)","date":"2012-06-21","accessed":"2026-09-29"},{"url":"https://www.gov.uk/guidance/find-product-information-about-medicines","title":"Find product information about medicines (MHRA Products register)","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-09-25","accessed":"2026-09-29"},{"url":"https://www.legislation.gov.uk/uksi/2012/1916/regulation/46","title":"The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)","publisher":"UK Government (legislation.gov.uk)","date":"2012","accessed":"2026-09-29"},{"url":"https://www.ukad.org.uk/athletes/whats-banned-sport-prohibited-list","title":"What's banned in sport - the Prohibited List","publisher":"UK Anti-Doping (UKAD)","date":"2026","accessed":"2026-09-29"}]},{"molecule":"tirzepatide","moleculeName":"Tirzepatide","country":"united-kingdom","countryName":"United Kingdom","countryIso2":"GB","status":"approved","statusLabel":"Approved","headline":"Licensed in the UK as Mounjaro for type 2 diabetes and for weight management; NHS access is being phased in","detail":"Mounjaro (tirzepatide) is licensed in the UK for type 2 diabetes. The MHRA added weight management for adults on 8 November 2023 (BMI of 30 or more, or 27 to 30 with a weight-related condition). It is prescription-only. NICE guidance TA1026 (December 2024) recommends it on the NHS in England, with a phased roll-out over several years and a commercial arrangement. The NHS reimbursement prices for it were raised in September 2025. The MHRA also warned in February 2026 about fake Mounjaro pens dispensed by one pharmacy.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tirzepatide-in-united-kingdom","sources":[{"url":"https://www.gov.uk/government/news/mhra-authorises-diabetes-drug-mounjaro-tirzepatide-for-weight-management-and-weight-loss","title":"MHRA authorises diabetes drug Mounjaro (tirzepatide) for weight management and weight loss","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2023-11-08","accessed":"2026-09-29"},{"url":"https://www.nice.org.uk/guidance/ta1026","title":"Tirzepatide for managing overweight and obesity (TA1026)","publisher":"National Institute for Health and Care Excellence (NICE)","date":"2024-12-23","accessed":"2026-09-29"},{"url":"https://www.nhsbsa.nhs.uk/mounjaro-tirzepatide-price-increase-drug-tariff-redetermination","title":"Mounjaro (tirzepatide) price increase: Drug Tariff redetermination","publisher":"NHS Business Services Authority (NHSBSA)","date":"2025-09","accessed":"2026-09-29"},{"url":"https://www.gov.uk/government/news/fake-mounjaro-tirzepatide-kwikpen-15mg-pre-filled-pens","title":"Fake Mounjaro (tirzepatide) KwikPen 15mg pre-filled pens","publisher":"Medicines and Healthcare products Regulatory Agency (MHRA)","date":"2026-02-24","accessed":"2026-09-29"}]},{"molecule":"amycretin","moleculeName":"Amycretin","country":"united-states","countryName":"United States","countryIso2":"US","status":"not-approved","statusLabel":"Not approved","headline":"No FDA approval or filing; Novo Nordisk now calls it zenagamtide and has started Phase 3 trials","detail":"Amycretin is an investigational Novo Nordisk medicine that is not approved anywhere in the US and has no application under FDA review. Novo's February 2026 report refers to it as zenagamtide (previously amycretin) after a completed phase 2 trial in type 2 diabetes, and its August 2026 report says the AMAZE phase 3 programme has started, including a heart failure outcomes trial (HF-POLARIS). Any product sold as amycretin outside a clinical trial would be an unapproved new drug under FDA rules.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/amycretin-in-united-states","sources":[{"url":"https://www.sec.gov/Archives/edgar/data/353278/000035327826000006/caq42025.htm","title":"Novo Nordisk financial report for 2025 (Form 6-K, company announcement)","publisher":"Novo Nordisk A/S (SEC filing)","date":"2026-02-03","accessed":"2026-09-29"},{"url":"https://www.sec.gov/Archives/edgar/data/353278/000035327826000023/caq22026.htm","title":"Novo Nordisk financial report for the period 1 January to 30 June 2026 (Form 6-K)","publisher":"Novo Nordisk A/S (SEC filing)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"https://www.fda.gov/drugs/development-approval-process-drugs","title":"Development & Approval Process | Drugs","publisher":"U.S. Food and Drug Administration","date":"2022-08-08","accessed":"2026-09-29"}]},{"molecule":"aod-9604","moleculeName":"AOD-9604","country":"united-states","countryName":"United States","countryIso2":"US","status":"not-approved","statusLabel":"Not approved","headline":"No FDA approval; FDA lists AOD-9604 among withdrawn nominations after noting possible serious adverse events","detail":"AOD-9604 is not approved for any use. FDA's Category 2 page lists it among withdrawn nominations and states that FDA found little safety information, a risk of immunogenicity for some routes, and serious adverse events that may be associated with the drug, though causality is unclear. It was not on the July 2026 advisory committee agenda and is not on the 503A bulks list, so it is an unapproved drug with no FDA compounding policy behind it.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/aod-9604-in-united-states","sources":[{"url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","title":"Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 and withdrawn nominations)","publisher":"U.S. Food and Drug Administration","date":"2026-04-22","accessed":"2026-09-29"},{"url":"https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026","title":"July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee","publisher":"U.S. Food and Drug Administration","date":"2026-08-06","accessed":"2026-09-29"},{"url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","title":"Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act","publisher":"U.S. Food and Drug Administration","date":"2026-05-14","accessed":"2026-09-29"}]},{"molecule":"bpc-157","moleculeName":"BPC-157","country":"united-states","countryName":"United States","countryIso2":"US","status":"not-approved","statusLabel":"Not approved","headline":"No FDA approval and not on the 503A list; an FDA advisory panel recommended considering it in July 2026, but that vote is not binding","detail":"BPC-157 is not approved for any use. FDA's Category 2 page lists it among substances whose bulk-substance nomination was withdrawn (after FDA had flagged immunogenicity risk and limited safety data); leaving Category 2 does not authorise compounding. FDA's Pharmacy Compounding Advisory Committee reviewed BPC-157 for ulcerative colitis on 23 July 2026 and, according to a law-firm report, voted 8 to 6 with one abstention to recommend it for the 503A bulks list; FDA must still decide and use rulemaking. The human evidence is very limited (mostly animal studies), and BPC-157 is prohibited in sport under the WADA list category S0, according to USADA.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/bpc-157-in-united-states","sources":[{"url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","title":"Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 and withdrawn nominations)","publisher":"U.S. Food and Drug Administration","date":"2026-04-22","accessed":"2026-09-29"},{"url":"https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026","title":"July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee","publisher":"U.S. Food and Drug Administration","date":"2026-08-06","accessed":"2026-09-29"},{"url":"https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/","title":"Bulk list bound? PCAC backs majority of peptides in two-day public meeting","publisher":"McDermott Will & Schulte","date":"2026-07-27","accessed":"2026-09-29"},{"url":"https://www.mintz.com/insights-center/viewpoints/2146/2026-07-29-fdas-advisory-committee-votes-peptides-what-it-does-and","title":"FDA's Advisory Committee Votes on Peptides: What It Does and Does Not Mean","publisher":"Mintz","date":"2026-07-29","accessed":"2026-09-29"},{"url":"https://www.usada.org/spirit-of-sport/education/bpc-157/","title":"BPC-157: What Athletes Should Know About the Prohibited Experimental Peptide","publisher":"U.S. Anti-Doping Agency","date":"2026-08-10","accessed":"2026-09-29"}]},{"molecule":"bremelanotide","moleculeName":"Bremelanotide (PT-141)","country":"united-states","countryName":"United States","countryIso2":"US","status":"approved-restricted","statusLabel":"Approved, restricted","headline":"FDA-approved as Vyleesi (2019) only for low sexual desire in premenopausal women with a specific diagnosis","detail":"Bremelanotide (also called PT-141) is FDA-approved as Vyleesi, first approved 21 June 2019, for premenopausal women with acquired, generalized hypoactive sexual desire disorder that is not explained by another medical or psychiatric condition, relationship problems or a medicine. The label says it is not indicated for postmenopausal women. Bremelanotide products sold as 'PT-141' with research-use-only labels have no approval and FDA cited such a seller in an August 2026 warning letter.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/bremelanotide-in-united-states","sources":[{"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210557s002lbl.pdf","title":"VYLEESI (bremelanotide) injection prescribing information","publisher":"U.S. Food and Drug Administration","date":"2020-10","accessed":"2026-09-29"},{"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026","title":"FDA warning letter 735127 to an online seller of retatrutide, semaglutide, SS-31, PT-141 and tesamorelin labelled 'research use only'","publisher":"U.S. Food and Drug Administration","date":"2026-08-24","accessed":"2026-09-29"}]},{"molecule":"cagrilintide","moleculeName":"Cagrilintide (and CagriSema)","country":"united-states","countryName":"United States","countryIso2":"US","status":"under-review","statusLabel":"Under review","headline":"Not approved alone; Novo Nordisk's CagriSema (cagrilintide plus semaglutide) is under FDA review for obesity, and cagrilintide cannot be compounded","detail":"Novo Nordisk reported in February 2026 that it had submitted a New Drug Application to FDA for CagriSema for adults with overweight or obesity, and its August 2026 report lists a US decision on CagriSema among its anticipated 2026 regulatory milestones. Nothing is approved yet. FDA states that cagrilintide cannot be used in compounding under federal law and is not a component of any FDA-approved drug. US customs officers also seized cagrilintide among unapproved peptide shipments in 2026.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/cagrilintide-in-united-states","sources":[{"url":"https://www.sec.gov/Archives/edgar/data/353278/000035327826000006/caq42025.htm","title":"Novo Nordisk financial report for 2025 (Form 6-K, company announcement)","publisher":"Novo Nordisk A/S (SEC filing)","date":"2026-02-03","accessed":"2026-09-29"},{"url":"https://www.sec.gov/Archives/edgar/data/353278/000035327826000023/caq22026.htm","title":"Novo Nordisk financial report for the period 1 January to 30 June 2026 (Form 6-K)","publisher":"Novo Nordisk A/S (SEC filing)","date":"2026-08-04","accessed":"2026-09-29"},{"url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss","title":"FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss","publisher":"U.S. Food and Drug Administration","date":"2026-09-01","accessed":"2026-09-29"},{"url":"https://www.cbp.gov/newsroom/local-media-release/cincinnati-cbp-foils-scheme-smuggle-over-5000-unapproved-peptides-us","title":"Cincinnati CBP foils scheme to smuggle over 5,000 unapproved peptides into the U.S.","publisher":"U.S. Customs and Border Protection","date":"2026-03-31","accessed":"2026-09-29"}]},{"molecule":"cjc-1295","moleculeName":"CJC-1295","country":"united-states","countryName":"United States","countryIso2":"US","status":"not-approved","statusLabel":"Not approved","headline":"No FDA approval; FDA lists CJC-1295 among withdrawn nominations and cites serious adverse events, so it is not on the 503A list","detail":"CJC-1295 is not approved for any use. FDA's Category 2 page lists it among withdrawn nominations and states that FDA identified serious adverse events associated with CJC-1295, including increased heart rate and a systemic vasodilatory reaction, with limited clinical data. It was not on the July 2026 advisory committee agenda and is not on the 503A bulks list, so there is no FDA policy protecting compounding of it.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/cjc-1295-in-united-states","sources":[{"url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","title":"Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 and withdrawn nominations)","publisher":"U.S. Food and Drug Administration","date":"2026-04-22","accessed":"2026-09-29"},{"url":"https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026","title":"July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee","publisher":"U.S. Food and Drug Administration","date":"2026-08-06","accessed":"2026-09-29"},{"url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","title":"Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act","publisher":"U.S. Food and Drug Administration","date":"2026-05-14","accessed":"2026-09-29"}]},{"molecule":"dsip","moleculeName":"DSIP (delta sleep-inducing peptide)","country":"united-states","countryName":"United States","countryIso2":"US","status":"not-approved","statusLabel":"Not approved","headline":"No FDA approval; advisers reviewed emideltide (DSIP) in July 2026 and, per a law-firm report, did not recommend it","detail":"DSIP is called emideltide on FDA's lists and is not approved for any use. FDA's Category 2 page lists it among withdrawn nominations. The Pharmacy Compounding Advisory Committee reviewed emideltide for opioid withdrawal, chronic insomnia and narcolepsy on 24 July 2026 and, according to a law-firm report, voted against recommending it (6 yes, 7 no, 1 abstention). It is not on the 503A bulks list.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/dsip-in-united-states","sources":[{"url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","title":"Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 and withdrawn nominations)","publisher":"U.S. Food and Drug Administration","date":"2026-04-22","accessed":"2026-09-29"},{"url":"https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026","title":"July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee","publisher":"U.S. Food and Drug Administration","date":"2026-08-06","accessed":"2026-09-29"},{"url":"https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/","title":"Bulk list bound? PCAC backs majority of peptides in two-day public meeting","publisher":"McDermott Will & Schulte","date":"2026-07-27","accessed":"2026-09-29"}]},{"molecule":"dulaglutide","moleculeName":"Dulaglutide","country":"united-states","countryName":"United States","countryIso2":"US","status":"approved","statusLabel":"Approved","headline":"FDA-approved as Trulicity for type 2 diabetes since 2014; as a biologic it cannot be compounded","detail":"Dulaglutide is FDA-approved (Biologics License Application, first approved 18 September 2014) as an adjunct to diet and exercise for glycaemic control in adults and children aged 10 and over with type 2 diabetes, and to reduce major cardiovascular events in adults with type 2 diabetes and established cardiovascular disease or multiple risk factors. It is not approved for weight loss. FDA states that biological products are not eligible for the compounding exemptions in sections 503A and 503B, so there is no compounding pathway for dulaglutide.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/dulaglutide-in-united-states","sources":[{"url":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125469s065lbl.pdf","title":"TRULICITY (dulaglutide) injection prescribing information","publisher":"U.S. Food and Drug Administration","date":"2026-03","accessed":"2026-09-29"},{"url":"https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers","title":"Compounding and the FDA: Questions and Answers","publisher":"U.S. Food and Drug Administration","date":"2025-09-16","accessed":"2026-09-29"}]},{"molecule":"ecnoglutide","moleculeName":"Ecnoglutide","country":"united-states","countryName":"United States","countryIso2":"US","status":"not-approved","statusLabel":"Not approved","headline":"Not approved in the US; only early-stage US studies of an oral form have been registered","detail":"Ecnoglutide (developed by Sciwind Biosciences) has no FDA approval and no reported US application. The US-registered study in ClinicalTrials.gov is a completed Phase 2 trial of a weekly oral version (VRB-101, run by a licensee) in adults with obesity or overweight. Any approval or trials of the injectable form in China do not give it US status, so it is an investigational drug here.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ecnoglutide-in-united-states","sources":[{"url":"https://clinicaltrials.gov/study/NCT07281937","title":"A Study of Weekly Oral Ecnoglutide (VRB-101) in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities, NCT07281937","publisher":"U.S. National Library of Medicine (ClinicalTrials.gov)","date":"2026-08","accessed":"2026-09-29"},{"url":"https://www.fda.gov/drugs/development-approval-process-drugs","title":"Development & Approval Process | Drugs","publisher":"U.S. Food and Drug Administration","date":"2022-08-08","accessed":"2026-09-29"}]},{"molecule":"elamipretide","moleculeName":"Elamipretide (SS-31)","country":"united-states","countryName":"United States","countryIso2":"US","status":"approved-restricted","statusLabel":"Approved, restricted","headline":"FDA-approved under accelerated approval on 19 September 2025 as Forzinity for Barth syndrome only","detail":"Elamipretide (also known as SS-31) is FDA-approved as Forzinity to improve muscle strength in adults and children with Barth syndrome who weigh at least 30 kg. It was approved under accelerated approval, based on an intermediate endpoint (knee muscle strength), and continued approval may depend on a confirmatory trial. It is not approved for any other condition; in August 2026 FDA cited a seller marketing 'SS-31' with research-use-only labels as offering an unapproved new drug.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/elamipretide-in-united-states","sources":[{"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215244s000lbl.pdf","title":"FORZINITY (elamipretide) prescribing information (original approval)","publisher":"U.S. Food and Drug Administration","date":"2025-09","accessed":"2026-09-29"},{"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026","title":"FDA warning letter 735127 to an online seller of retatrutide, semaglutide, SS-31, PT-141 and tesamorelin labelled 'research use only'","publisher":"U.S. Food and Drug Administration","date":"2026-08-24","accessed":"2026-09-29"}]},{"molecule":"eloralintide","moleculeName":"Eloralintide","country":"united-states","countryName":"United States","countryIso2":"US","status":"not-approved","statusLabel":"Not approved","headline":"Investigational; Eli Lilly is running Phase 3 obesity trials and nothing is approved or filed","detail":"Eloralintide (Eli Lilly code LY3841136) is an investigational amylin-pathway medicine. Lilly's June 2026 quarterly filing reports that Phase 3 trials started for obesity add-on use, obstructive sleep apnea and osteoarthritis pain, and the ClinicalTrials.gov record for the Phase 3 obesity study without type 2 diabetes shows it recruiting. No marketing application has been reported, so it has no FDA approval and any sale outside a trial would be of an unapproved drug.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/eloralintide-in-united-states","sources":[{"url":"https://clinicaltrials.gov/study/NCT07321886","title":"A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight Without Type 2 Diabetes, NCT07321886","publisher":"U.S. National Library of Medicine (ClinicalTrials.gov)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.sec.gov/Archives/edgar/data/59478/000005947826000081/lly-20260630.htm","title":"Eli Lilly and Company Form 10-Q for the quarter ended 30 June 2026","publisher":"Eli Lilly and Company (SEC filing)","date":"2026-08-05","accessed":"2026-09-29"},{"url":"https://www.fda.gov/drugs/development-approval-process-drugs","title":"Development & Approval Process | Drugs","publisher":"U.S. Food and Drug Administration","date":"2022-08-08","accessed":"2026-09-29"}]},{"molecule":"epitalon","moleculeName":"Epitalon","country":"united-states","countryName":"United States","countryIso2":"US","status":"not-approved","statusLabel":"Not approved","headline":"No FDA approval; an advisory panel voted in July 2026 to recommend considering it, but the vote is not binding","detail":"Epitalon is not approved for any use. FDA's Category 2 page lists it among withdrawn nominations and says FDA has no safety information on the proposed route. The Pharmacy Compounding Advisory Committee reviewed epitalon for insomnia on 24 July 2026 and, per a law-firm report, voted 7 to 4 with one abstention to recommend it for the 503A bulks list. FDA has not acted, so epitalon is not on the list and cannot rely on FDA's Category 1 policy.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/epitalon-in-united-states","sources":[{"url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","title":"Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 and withdrawn nominations)","publisher":"U.S. Food and Drug Administration","date":"2026-04-22","accessed":"2026-09-29"},{"url":"https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026","title":"July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee","publisher":"U.S. Food and Drug Administration","date":"2026-08-06","accessed":"2026-09-29"},{"url":"https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/","title":"Bulk list bound? PCAC backs majority of peptides in two-day public meeting","publisher":"McDermott Will & Schulte","date":"2026-07-27","accessed":"2026-09-29"}]},{"molecule":"exenatide","moleculeName":"Exenatide","country":"united-states","countryName":"United States","countryIso2":"US","status":"generic-available","statusLabel":"Generics available","headline":"Byetta and Bydureon BCISE are listed as discontinued; an FDA-approved generic exenatide (Amneal) is on the market","detail":"Exenatide, the first GLP-1 medicine, was FDA-approved as Byetta in April 2005 (and later as extended-release Bydureon and Bydureon BCISE) for type 2 diabetes. FDA's Drugs@FDA data now lists Byetta and the Bydureon products as discontinued, while a generic synthetic exenatide from Amneal (approved 19 November 2024) is listed as marketed. Exenatide is not approved for weight loss. No compounding-specific FDA statement was found for exenatide; the general 503A and 503B rules on essentially-copy products apply.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/exenatide-in-united-states","sources":[{"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021773s050lbl.pdf","title":"BYETTA (exenatide) injection prescribing information","publisher":"U.S. Food and Drug Administration","date":"2025-06","accessed":"2026-09-29"},{"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209210s025lbl.pdf","title":"BYDUREON BCISE (exenatide extended-release) prescribing information","publisher":"U.S. Food and Drug Administration","date":"2025-06","accessed":"2026-09-29"},{"url":"https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:exenatide&limit=30","title":"Drugs@FDA data via openFDA: exenatide applications (Byetta, Bydureon, generic)","publisher":"U.S. Food and Drug Administration","date":"2026-09-24","accessed":"2026-09-29"}]},{"molecule":"ghk-cu","moleculeName":"GHK-Cu (copper peptide)","country":"united-states","countryName":"United States","countryIso2":"US","status":"compounding-restricted","statusLabel":"Compounding restricted","headline":"Not approved as a drug; FDA treats non-injectable GHK-Cu as under evaluation (Category 1) but the injectable route is not covered","detail":"GHK-Cu (copper peptide) has no FDA-approved drug product. FDA's 503A category list, updated 14 May 2026, puts GHK-Cu 'except for injectable routes of administration' back in Category 1 (under evaluation, with enforcement discretion under FDA's interim policy) after one nominator kept its non-injectable nomination; the injectable nomination was withdrawn and FDA lists injectable GHK-Cu among withdrawn Category 2 nominations, so it has no protection. FDA plans to ask the Pharmacy Compounding Advisory Committee about GHK-Cu before the end of February 2027.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ghk-cu-in-united-states","sources":[{"url":"https://www.fda.gov/media/94155/download?attachment","title":"Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (Categories 1, 2 and 3)","publisher":"U.S. Food and Drug Administration","date":"2026-05-14","accessed":"2026-09-29"},{"url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","title":"Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 and withdrawn nominations)","publisher":"U.S. Food and Drug Administration","date":"2026-04-22","accessed":"2026-09-29"},{"url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","title":"Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act","publisher":"U.S. Food and Drug Administration","date":"2026-05-14","accessed":"2026-09-29"}]},{"molecule":"ipamorelin","moleculeName":"Ipamorelin","country":"united-states","countryName":"United States","countryIso2":"US","status":"not-approved","statusLabel":"Not approved","headline":"No FDA approval; FDA keeps ipamorelin in Category 2 for 503B outsourcing facilities because of immunogenicity and safety concerns","detail":"Ipamorelin is not approved for any use. FDA added ipamorelin acetate to the 503B Category 2 list on 29 September 2023, citing immunogenicity risk for some routes, its unnatural amino acids, and a published study that found serious adverse events including death when it was given intravenously. FDA also lists it among 503A nominations that were withdrawn, so it is not on the 503A bulks list either and is not in the Category 1 policy. FDA could consider enforcement against compounders under its general policies.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ipamorelin-in-united-states","sources":[{"url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","title":"Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 and withdrawn nominations)","publisher":"U.S. Food and Drug Administration","date":"2026-04-22","accessed":"2026-09-29"},{"url":"https://www.fda.gov/media/94155/download?attachment","title":"Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (Categories 1, 2 and 3)","publisher":"U.S. Food and Drug Administration","date":"2026-05-14","accessed":"2026-09-29"},{"url":"https://www.fda.gov/media/94164/download?attachment","title":"Bulk Drug Substances Nominated for Use in Compounding Under Section 503B (Categories 1, 2 and 3)","publisher":"U.S. Food and Drug Administration","date":"2025-03-21","accessed":"2026-09-29"}]},{"molecule":"kisspeptin","moleculeName":"Kisspeptin","country":"united-states","countryName":"United States","countryIso2":"US","status":"not-approved","statusLabel":"Not approved","headline":"No FDA approval; kisspeptin-10 is in FDA's 503A Category 2 because of immunogenicity and missing safety data","detail":"Kisspeptin is not approved for any use. FDA added kisspeptin-10 to the 503A Category 2 list on 29 September 2023, saying compounded versions may pose immunogenicity risk for some routes and that FDA has little or no safety information for the proposed routes. Category 2 means FDA does not extend its Category 1 policy and could consider action against compounders under its general enforcement policies. It remains on the 503A Category 2 list as of the 14 May 2026 update.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/kisspeptin-in-united-states","sources":[{"url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","title":"Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 and withdrawn nominations)","publisher":"U.S. Food and Drug Administration","date":"2026-04-22","accessed":"2026-09-29"},{"url":"https://www.fda.gov/media/94155/download?attachment","title":"Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (Categories 1, 2 and 3)","publisher":"U.S. Food and Drug Administration","date":"2026-05-14","accessed":"2026-09-29"},{"url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","title":"Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act","publisher":"U.S. Food and Drug Administration","date":"2026-05-14","accessed":"2026-09-29"}]},{"molecule":"kpv","moleculeName":"KPV","country":"united-states","countryName":"United States","countryIso2":"US","status":"not-approved","statusLabel":"Not approved","headline":"No FDA approval; FDA found no human exposure data for KPV, and an advisory panel recommended considering it in July 2026 (non-binding)","detail":"KPV is not approved for any use. FDA's Category 2 page lists it among withdrawn nominations and says FDA identified no human exposure data for KPV drug products by any route. The Pharmacy Compounding Advisory Committee reviewed KPV for wound healing and inflammatory conditions on 23 July 2026 and, per a law-firm report, voted 8 to 6 with one abstention to recommend it for the 503A bulks list. That vote is advisory, so KPV is not currently on the list.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/kpv-in-united-states","sources":[{"url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","title":"Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 and withdrawn nominations)","publisher":"U.S. Food and Drug Administration","date":"2026-04-22","accessed":"2026-09-29"},{"url":"https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026","title":"July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee","publisher":"U.S. Food and Drug Administration","date":"2026-08-06","accessed":"2026-09-29"},{"url":"https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/","title":"Bulk list bound? PCAC backs majority of peptides in two-day public meeting","publisher":"McDermott Will & Schulte","date":"2026-07-27","accessed":"2026-09-29"},{"url":"https://www.mintz.com/insights-center/viewpoints/2146/2026-07-29-fdas-advisory-committee-votes-peptides-what-it-does-and","title":"FDA's Advisory Committee Votes on Peptides: What It Does and Does Not Mean","publisher":"Mintz","date":"2026-07-29","accessed":"2026-09-29"}]},{"molecule":"liraglutide","moleculeName":"Liraglutide","country":"united-states","countryName":"United States","countryIso2":"US","status":"generic-available","statusLabel":"Generics available","headline":"Brand Victoza and Saxenda plus several FDA-approved generics; liraglutide is still on FDA's shortage list and Saxenda is being discontinued","detail":"Liraglutide is FDA-approved as Victoza for type 2 diabetes (approved 2010) and as Saxenda for chronic weight management (approved 2014). Since December 2024 FDA has approved multiple generic liraglutide injections, including from Hikma, Lupin, Teva and others. FDA's shortage database still lists several liraglutide presentations as current shortages, and Novo Nordisk has notified FDA that Saxenda will be discontinued in January 2027. FDA's 1 May 2026 proposal not to list liraglutide on the 503B bulks list is open to comment; the shortage listing means compounding eligibility should be checked case by case.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/liraglutide-in-united-states","sources":[{"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022341s046lbl.pdf","title":"VICTOZA (liraglutide) injection prescribing information","publisher":"U.S. Food and Drug Administration","date":"2025-10","accessed":"2026-09-29"},{"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/206321s025lbl.pdf","title":"SAXENDA (liraglutide) injection prescribing information","publisher":"U.S. Food and Drug Administration","date":"2026-03","accessed":"2026-09-29"},{"url":"https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:liraglutide&limit=30","title":"Drugs@FDA data via openFDA: liraglutide applications (brands and generics)","publisher":"U.S. Food and Drug Administration","date":"2026-09-24","accessed":"2026-09-29"},{"url":"https://api.fda.gov/drug/shortages.json?search=generic_name:liraglutide&limit=20","title":"FDA Drug Shortages data via openFDA: liraglutide injection","publisher":"U.S. Food and Drug Administration","date":"2026-09-22","accessed":"2026-09-29"},{"url":"https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal","title":"List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B (proposal not to include semaglutide, tirzepatide, liraglutide)","publisher":"Federal Register (FDA)","date":"2026-05-01","accessed":"2026-09-29"}]},{"molecule":"ll-37","moleculeName":"LL-37","country":"united-states","countryName":"United States","countryIso2":"US","status":"not-approved","statusLabel":"Not approved","headline":"No FDA approval; FDA notes lab findings of possible harm to male reproduction and tumour promotion, and its advisers will look at it by February 2027","detail":"LL-37 (cathelicidin) is not approved for any use. FDA's Category 2 page lists it among withdrawn nominations and says FDA lacks safety information in humans, with non-clinical findings that suggest detrimental effects on male reproduction and possible tumour-promoting effects in some tissues. A law-firm report says the Pharmacy Compounding Advisory Committee will consider LL-37 before the end of February 2027. It is not on the 503A bulks list today.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/ll-37-in-united-states","sources":[{"url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","title":"Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 and withdrawn nominations)","publisher":"U.S. Food and Drug Administration","date":"2026-04-22","accessed":"2026-09-29"},{"url":"https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/","title":"Bulk list bound? PCAC backs majority of peptides in two-day public meeting","publisher":"McDermott Will & Schulte","date":"2026-07-27","accessed":"2026-09-29"},{"url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","title":"Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act","publisher":"U.S. Food and Drug Administration","date":"2026-05-14","accessed":"2026-09-29"}]},{"molecule":"maridebart-cafraglutide","moleculeName":"Maridebart cafraglutide (MariTide)","country":"united-states","countryName":"United States","countryIso2":"US","status":"not-approved","statusLabel":"Not approved","headline":"Investigational; Amgen is running Phase 3 trials (MARITIME programme) and no FDA approval or filing has been reported","detail":"Maridebart cafraglutide (MariTide, Amgen) is an antibody-peptide conjugate that blocks the GIP receptor and activates the GLP-1 receptor. Amgen has US Phase 3 trials registered, including one on cardiovascular outcomes in adults with atherosclerotic disease and overweight or obesity, which is recruiting. No marketing application is public, so it is not approved and can be obtained lawfully only through trials.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/maridebart-cafraglutide-in-united-states","sources":[{"url":"https://clinicaltrials.gov/study/NCT07037433","title":"Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity, NCT07037433","publisher":"U.S. National Library of Medicine (ClinicalTrials.gov)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.fda.gov/drugs/development-approval-process-drugs","title":"Development & Approval Process | Drugs","publisher":"U.S. Food and Drug Administration","date":"2022-08-08","accessed":"2026-09-29"}]},{"molecule":"mazdutide","moleculeName":"Mazdutide","country":"united-states","countryName":"United States","countryIso2":"US","status":"not-approved","statusLabel":"Not approved","headline":"Not approved by FDA; Eli Lilly has run US Phase 2 studies of the medicine (LY3305677) but no application has been reported","detail":"Mazdutide (Eli Lilly code LY3305677, developed with Innovent in China) has no FDA approval and no reported US application. Lilly has registered US Phase 2 trials, for example in adults with obesity or overweight. Mazdutide's regulatory status elsewhere, including China, does not change its status here: in the US it is an investigational drug that can lawfully be supplied only in trials. FDA says it has warned companies that illegally sold mazdutide falsely labelled 'for research purposes' or 'not for human consumption'.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/mazdutide-in-united-states","sources":[{"url":"https://clinicaltrials.gov/study/NCT06124807","title":"A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight, NCT06124807","publisher":"U.S. National Library of Medicine (ClinicalTrials.gov)","date":"2026-04","accessed":"2026-09-29"},{"url":"https://www.fda.gov/drugs/development-approval-process-drugs","title":"Development & Approval Process | Drugs","publisher":"U.S. Food and Drug Administration","date":"2022-08-08","accessed":"2026-09-29"},{"url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss","title":"FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss","publisher":"U.S. Food and Drug Administration","date":"2026-09-01","accessed":"2026-09-29"}]},{"molecule":"melanotan-ii","moleculeName":"Melanotan II","country":"united-states","countryName":"United States","countryIso2":"US","status":"not-approved","statusLabel":"Not approved","headline":"No FDA approval; FDA cites reports of melanoma and other serious events, and its advisers will consider it before the end of February 2027","detail":"Melanotan II is not approved for any use. FDA's Category 2 page lists it among withdrawn nominations and cites published case reports of serious adverse events including melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome and priapism. According to a law-firm report, FDA has said the Pharmacy Compounding Advisory Committee will consider Melanotan II before the end of February 2027; until FDA acts it is not on the 503A bulks list.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/melanotan-ii-in-united-states","sources":[{"url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","title":"Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 and withdrawn nominations)","publisher":"U.S. Food and Drug Administration","date":"2026-04-22","accessed":"2026-09-29"},{"url":"https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/","title":"Bulk list bound? PCAC backs majority of peptides in two-day public meeting","publisher":"McDermott Will & Schulte","date":"2026-07-27","accessed":"2026-09-29"},{"url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","title":"Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act","publisher":"U.S. Food and Drug Administration","date":"2026-05-14","accessed":"2026-09-29"}]},{"molecule":"mots-c","moleculeName":"MOTS-c","country":"united-states","countryName":"United States","countryIso2":"US","status":"not-approved","statusLabel":"Not approved","headline":"No FDA approval; FDA found no human exposure data, and a July 2026 advisory vote to consider it is non-binding","detail":"MOTS-c is not approved for any use. FDA's Category 2 page lists it among withdrawn nominations and says FDA has no human exposure data for MOTS-c drug products. The Pharmacy Compounding Advisory Committee reviewed it for obesity and osteoporosis on 23 July 2026 and, according to a law-firm report, voted 7 to 5 with two abstentions to recommend it for the 503A bulks list; FDA has not acted. US customs officers reported seizing MOTS-c among unapproved peptide shipments in 2026.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/mots-c-in-united-states","sources":[{"url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","title":"Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 and withdrawn nominations)","publisher":"U.S. Food and Drug Administration","date":"2026-04-22","accessed":"2026-09-29"},{"url":"https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026","title":"July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee","publisher":"U.S. Food and Drug Administration","date":"2026-08-06","accessed":"2026-09-29"},{"url":"https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/","title":"Bulk list bound? PCAC backs majority of peptides in two-day public meeting","publisher":"McDermott Will & Schulte","date":"2026-07-27","accessed":"2026-09-29"},{"url":"https://www.cbp.gov/newsroom/local-media-release/cincinnati-cbp-foils-scheme-smuggle-over-5000-unapproved-peptides-us","title":"Cincinnati CBP foils scheme to smuggle over 5,000 unapproved peptides into the U.S.","publisher":"U.S. Customs and Border Protection","date":"2026-03-31","accessed":"2026-09-29"}]},{"molecule":"nad-plus","moleculeName":"NAD+","country":"united-states","countryName":"United States","countryIso2":"US","status":"compounding-restricted","statusLabel":"Compounding restricted","headline":"No FDA-approved NAD+ drug; FDA lists NAD in Category 1 (under evaluation), which lets 503A pharmacies compound it under FDA's interim policy","detail":"NAD+ (nicotinamide adenine dinucleotide) is on FDA's 503A Category 1 list, updated 14 May 2026, and beta-NAD is in Category 1 on FDA's 503B list (March 2025 version). Category 1 means FDA does not intend to act against compounders who meet the conditions in its interim policy while it evaluates the substance; it is not an approval and it is not the final 503A bulks list. FDA has warned telehealth firms not to claim that a compounded drug is FDA-approved, generic, or the same as an approved drug.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/nad-plus-in-united-states","sources":[{"url":"https://www.fda.gov/media/94155/download?attachment","title":"Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (Categories 1, 2 and 3)","publisher":"U.S. Food and Drug Administration","date":"2026-05-14","accessed":"2026-09-29"},{"url":"https://www.fda.gov/media/94164/download?attachment","title":"Bulk Drug Substances Nominated for Use in Compounding Under Section 503B (Categories 1, 2 and 3)","publisher":"U.S. Food and Drug Administration","date":"2025-03-21","accessed":"2026-09-29"},{"url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","title":"Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act","publisher":"U.S. Food and Drug Administration","date":"2026-05-14","accessed":"2026-09-29"},{"url":"https://www.fda.gov/drugs/human-drug-compounding/fda-telehealth-companies-what-know-when-promoting-compounded-drugs","title":"FDA to Telehealth Companies: What to Know When Promoting Compounded Drugs","publisher":"U.S. Food and Drug Administration","date":"2026-06-15","accessed":"2026-09-29"}]},{"molecule":"orforglipron","moleculeName":"Orforglipron","country":"united-states","countryName":"United States","countryIso2":"US","status":"approved","statusLabel":"Approved","headline":"FDA-approved on 1 April 2026 as Foundayo, a tablet for obesity, or overweight with a weight-related condition","detail":"Orforglipron (brand Foundayo, Eli Lilly) received FDA approval on 1 April 2026 as a GLP-1 receptor agonist tablet to reduce excess body weight and maintain weight reduction long term in adults with obesity, or with overweight plus at least one weight-related condition. Lilly reported in its June 2026 quarterly filing that it has also submitted orforglipron for type 2 diabetes in the US, EU and Japan; that use is not yet approved. Foundayo is one of the drugs covered by the temporary Medicare GLP-1 Bridge that began on 1 July 2026.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/orforglipron-in-united-states","sources":[{"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf","title":"FOUNDAYO (orforglipron) tablets prescribing information (original approval)","publisher":"U.S. Food and Drug Administration","date":"2026-04","accessed":"2026-09-29"},{"url":"https://www.sec.gov/Archives/edgar/data/59478/000005947826000081/lly-20260630.htm","title":"Eli Lilly and Company Form 10-Q for the quarter ended 30 June 2026","publisher":"Eli Lilly and Company (SEC filing)","date":"2026-08-05","accessed":"2026-09-29"},{"url":"https://www.medicare.gov/glp1bridge","title":"Medicare GLP-1 Bridge: who is eligible and which drugs are covered","publisher":"Medicare.gov (CMS)","date":"2026","accessed":"2026-09-29"}]},{"molecule":"pramlintide","moleculeName":"Pramlintide","country":"united-states","countryName":"United States","countryIso2":"US","status":"approved-restricted","statusLabel":"Approved, restricted","headline":"Approved as Symlin in 2005 for mealtime insulin users with diabetes, but the maker has notified FDA it is discontinuing the product","detail":"Pramlintide (Symlin, AstraZeneca) was FDA-approved on 16 March 2005 as an add-on for people with type 1 or type 2 diabetes who use mealtime insulin. Drugs@FDA now lists Symlin as discontinued, and FDA's shortage database has a notice dated 27 October 2025 that manufacture of the SymlinPen products is being discontinued. It has never been approved as a weight-loss drug. No generic pramlintide product was found in FDA data.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/pramlintide-in-united-states","sources":[{"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021332s028lbl.pdf","title":"SYMLIN (pramlintide acetate) injection prescribing information","publisher":"U.S. Food and Drug Administration","date":"2019-12","accessed":"2026-09-29"},{"url":"https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:pramlintide&limit=30","title":"Drugs@FDA data via openFDA: pramlintide application (Symlin, marketing status)","publisher":"U.S. Food and Drug Administration","date":"2026-09-24","accessed":"2026-09-29"},{"url":"https://api.fda.gov/drug/shortages.json?search=generic_name:pramlintide&limit=5","title":"FDA Drug Shortages data via openFDA: pramlintide acetate injection (to be discontinued)","publisher":"U.S. Food and Drug Administration","date":"2025-10-27","accessed":"2026-09-29"}]},{"molecule":"retatrutide","moleculeName":"Retatrutide","country":"united-states","countryName":"United States","countryIso2":"US","status":"prohibited","statusLabel":"Prohibited","headline":"Not approved; FDA says retatrutide cannot be compounded and has warned sellers, so lawful access is limited to trials and expanded access","detail":"Retatrutide is an investigational Eli Lilly medicine; Lilly's June 2026 filing says its Phase 3 obesity and type 2 diabetes trials met their primary endpoints, but no approval exists. FDA states that retatrutide cannot be used in compounding under federal law and has sent warning letters to telehealth firms, ingredient distributors, outsourcing facilities and online sellers, including sellers using 'research use only' labels. US customs seized retatrutide in shipments of unapproved peptides in 2026. The only lawful routes are clinical trials and Lilly's single-patient expanded access programme for adults with severe obesity and serious complications.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/retatrutide-in-united-states","sources":[{"url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss","title":"FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss","publisher":"U.S. Food and Drug Administration","date":"2026-09-01","accessed":"2026-09-29"},{"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gram-peptides-721806-03312026","title":"FDA warning letter 721806 to an online seller of retatrutide, tirzepatide and bacteriostatic water labelled 'research use only'","publisher":"U.S. Food and Drug Administration","date":"2026-03-31","accessed":"2026-09-29"},{"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026","title":"FDA warning letter 735127 to an online seller of retatrutide, semaglutide, SS-31, PT-141 and tesamorelin labelled 'research use only'","publisher":"U.S. Food and Drug Administration","date":"2026-08-24","accessed":"2026-09-29"},{"url":"https://www.cbp.gov/newsroom/local-media-release/cincinnati-cbp-foils-scheme-smuggle-over-5000-unapproved-peptides-us","title":"Cincinnati CBP foils scheme to smuggle over 5,000 unapproved peptides into the U.S.","publisher":"U.S. Customs and Border Protection","date":"2026-03-31","accessed":"2026-09-29"},{"url":"https://www.sec.gov/Archives/edgar/data/59478/000005947826000081/lly-20260630.htm","title":"Eli Lilly and Company Form 10-Q for the quarter ended 30 June 2026","publisher":"Eli Lilly and Company (SEC filing)","date":"2026-08-05","accessed":"2026-09-29"},{"url":"https://clinicaltrials.gov/study/NCT07629401","title":"Pre-approval Expanded Access of Retatrutide (LY3437943), NCT07629401","publisher":"U.S. National Library of Medicine (ClinicalTrials.gov)","date":"2026-08","accessed":"2026-09-29"},{"url":"https://clinicaltrials.gov/study/NCT05929066","title":"A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight, NCT05929066","publisher":"U.S. National Library of Medicine (ClinicalTrials.gov)","date":"2026-08","accessed":"2026-09-29"}]},{"molecule":"selank","moleculeName":"Selank","country":"united-states","countryName":"United States","countryIso2":"US","status":"not-approved","statusLabel":"Not approved","headline":"No FDA approval; FDA lists Selank among withdrawn nominations and it was not on the July 2026 advisory agenda","detail":"Selank (selank acetate, TP-7) is not approved for any use in the US. FDA's Category 2 page lists it among withdrawn nominations and says FDA lacks important information on safety in humans, with a risk of immunogenicity for some routes. It was not among the peptides reviewed at the July 2026 Pharmacy Compounding Advisory Committee meeting or scheduled for the next one, so it is not on the 503A bulks list.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/selank-in-united-states","sources":[{"url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","title":"Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 and withdrawn nominations)","publisher":"U.S. Food and Drug Administration","date":"2026-04-22","accessed":"2026-09-29"},{"url":"https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026","title":"July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee","publisher":"U.S. Food and Drug Administration","date":"2026-08-06","accessed":"2026-09-29"},{"url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","title":"Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act","publisher":"U.S. Food and Drug Administration","date":"2026-05-14","accessed":"2026-09-29"}]},{"molecule":"semaglutide","moleculeName":"Semaglutide","country":"united-states","countryName":"United States","countryIso2":"US","status":"approved","statusLabel":"Approved","headline":"FDA-approved as Ozempic, Rybelsus and Wegovy; compounded copies lost their shortage cover in 2025 and 503B is proposing a formal exclusion","detail":"Semaglutide is FDA-approved for type 2 diabetes (Ozempic injection, Ozempic and Rybelsus tablets) and, as Wegovy, for weight reduction and long-term weight maintenance, for reducing cardiovascular events in adults with heart disease plus obesity or overweight, and for non-cirrhotic MASH. Wegovy became available as a tablet after FDA approval on 22 December 2025. FDA declared the semaglutide injection shortage resolved on 21 February 2025, so the shortage-based compounding cover ended (April 2025 for 503A pharmacies and May 2025 for 503B outsourcing facilities). On 1 May 2026 FDA proposed not to put semaglutide on the 503B bulks list, and it says it knows of no lawful basis to compound semaglutide salt forms; 503A pharmacies may still not routinely make essentially-copy versions.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/semaglutide-in-united-states","sources":[{"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209637Orig1s039lbl.pdf","title":"OZEMPIC (semaglutide) injection prescribing information","publisher":"U.S. Food and Drug Administration","date":"2026-05","accessed":"2026-09-29"},{"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213051Orig1s030lbl.pdf","title":"RYBELSUS / OZEMPIC (semaglutide) tablets prescribing information","publisher":"U.S. Food and Drug Administration","date":"2026-07","accessed":"2026-09-29"},{"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s031,218316s00lbl.pdf","title":"WEGOVY (semaglutide) injection and tablets prescribing information","publisher":"U.S. Food and Drug Administration","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.sec.gov/Archives/edgar/data/353278/000117184325008080/f6k_122225.htm","title":"Novo Nordisk announcement: FDA approves the Wegovy pill (Form 6-K)","publisher":"Novo Nordisk A/S (SEC filing)","date":"2025-12-22","accessed":"2026-09-29"},{"url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize","title":"FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize","publisher":"U.S. Food and Drug Administration","date":"2026-04-01","accessed":"2026-09-29"},{"url":"https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal","title":"List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B (proposal not to include semaglutide, tirzepatide, liraglutide)","publisher":"Federal Register (FDA)","date":"2026-05-01","accessed":"2026-09-29"},{"url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss","title":"FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss","publisher":"U.S. Food and Drug Administration","date":"2026-09-01","accessed":"2026-09-29"}]},{"molecule":"semax","moleculeName":"Semax","country":"united-states","countryName":"United States","countryIso2":"US","status":"not-approved","statusLabel":"Not approved","headline":"No FDA approval; an advisory panel voted in July 2026 to recommend considering it for the 503A list, but FDA has not acted","detail":"Semax is not approved as a drug in the US. FDA's Category 2 page lists it among withdrawn nominations and notes little or no safety information for the proposed routes. The Pharmacy Compounding Advisory Committee reviewed it for cerebral ischemia, migraine and trigeminal neuralgia on 24 July 2026 and, per a law-firm report, voted 8 to 5 with one abstention to recommend it. The committee's advice is non-binding and listing would need FDA action; US customs also reported seizing semax among unapproved peptide shipments.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/semax-in-united-states","sources":[{"url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","title":"Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 and withdrawn nominations)","publisher":"U.S. Food and Drug Administration","date":"2026-04-22","accessed":"2026-09-29"},{"url":"https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026","title":"July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee","publisher":"U.S. Food and Drug Administration","date":"2026-08-06","accessed":"2026-09-29"},{"url":"https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/","title":"Bulk list bound? PCAC backs majority of peptides in two-day public meeting","publisher":"McDermott Will & Schulte","date":"2026-07-27","accessed":"2026-09-29"},{"url":"https://www.cbp.gov/newsroom/local-media-release/cincinnati-cbp-foils-scheme-smuggle-over-5000-unapproved-peptides-us","title":"Cincinnati CBP foils scheme to smuggle over 5,000 unapproved peptides into the U.S.","publisher":"U.S. Customs and Border Protection","date":"2026-03-31","accessed":"2026-09-29"}]},{"molecule":"sermorelin","moleculeName":"Sermorelin","country":"united-states","countryName":"United States","countryIso2":"US","status":"compounding-restricted","statusLabel":"Compounding restricted","headline":"Previously FDA-approved as Geref (now discontinued, not for safety reasons); sermorelin acetate can be compounded only under 503A/503B conditions","detail":"Sermorelin acetate was FDA-approved as Geref, but Drugs@FDA lists Geref as discontinued, and in 2013 FDA determined it was not withdrawn for reasons of safety or effectiveness. Because it is a component of a previously approved drug, sermorelin acetate can be used by 503A pharmacies without being on the bulks list, and FDA's March 2025 503B list includes it in Category 1 (marked as a component of an approved drug). Compounders must still meet the other 503A and 503B conditions, and promotion of compounded products as approved or equivalent is a target of FDA enforcement.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/sermorelin-in-united-states","sources":[{"url":"https://api.fda.gov/drug/drugsfda.json?search=products.brand_name:GEREF&limit=30","title":"Drugs@FDA data via openFDA: GEREF (sermorelin acetate) applications, marketing status","publisher":"U.S. Food and Drug Administration","date":"2026-09-24","accessed":"2026-09-29"},{"url":"https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-05-milligrams-basevial-and-10-milligrams","title":"Determination That GEREF (Sermorelin Acetate) Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness","publisher":"Federal Register (FDA)","date":"2013-03-04","accessed":"2026-09-29"},{"url":"https://www.fda.gov/media/94164/download?attachment","title":"Bulk Drug Substances Nominated for Use in Compounding Under Section 503B (Categories 1, 2 and 3)","publisher":"U.S. Food and Drug Administration","date":"2025-03-21","accessed":"2026-09-29"},{"url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","title":"Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act","publisher":"U.S. Food and Drug Administration","date":"2026-05-14","accessed":"2026-09-29"},{"url":"https://www.fda.gov/drugs/human-drug-compounding/fda-telehealth-companies-what-know-when-promoting-compounded-drugs","title":"FDA to Telehealth Companies: What to Know When Promoting Compounded Drugs","publisher":"U.S. Food and Drug Administration","date":"2026-06-15","accessed":"2026-09-29"}]},{"molecule":"setmelanotide","moleculeName":"Setmelanotide","country":"united-states","countryName":"United States","countryIso2":"US","status":"approved-restricted","statusLabel":"Approved, restricted","headline":"FDA-approved as Imcivree (2020) for specific rare genetic or hypothalamic forms of obesity, not for general obesity","detail":"Setmelanotide is FDA-approved as Imcivree (first approved 25 November 2020) to reduce excess body weight and maintain weight reduction in specific patient groups. The current label covers acquired hypothalamic obesity in people aged 4 and over, and obesity due to Bardet-Biedl syndrome or to confirmed POMC, PCSK1 or LEPR gene variants in people aged 2 and over. It is not approved for common obesity or other uses.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/setmelanotide-in-united-states","sources":[{"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213793s009lbl.pdf","title":"IMCIVREE (setmelanotide) injection prescribing information","publisher":"U.S. Food and Drug Administration","date":"2026-03","accessed":"2026-09-29"}]},{"molecule":"survodutide","moleculeName":"Survodutide","country":"united-states","countryName":"United States","countryIso2":"US","status":"not-approved","statusLabel":"Not approved","headline":"Investigational; Boehringer Ingelheim has US Phase 3 trials running and no FDA approval exists","detail":"Survodutide (BI 456906) is a Boehringer Ingelheim glucagon and GLP-1 receptor dual agonist under study for obesity and liver disease. US-registered Phase 3 trials include LIVERAGE for MASH with fibrosis (recruiting) and the SYNCHRONIZE programme for obesity. No FDA approval exists, so it is classed as not approved, and any product sold as survodutide outside trials is an unapproved drug. FDA says it has warned companies that illegally sold survodutide falsely labelled 'for research purposes' or 'not for human consumption'.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/survodutide-in-united-states","sources":[{"url":"https://clinicaltrials.gov/study/NCT06632444","title":"LIVERAGE: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis, NCT06632444","publisher":"U.S. National Library of Medicine (ClinicalTrials.gov)","date":"2026-09","accessed":"2026-09-29"},{"url":"https://clinicaltrials.gov/study/NCT06309992","title":"A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With NASH to Reduce Liver Fat and to Lose Weight (SYNCHRONIZE-MASLD), NCT06309992","publisher":"U.S. National Library of Medicine (ClinicalTrials.gov)","date":"2026-04","accessed":"2026-09-29"},{"url":"https://www.fda.gov/drugs/development-approval-process-drugs","title":"Development & Approval Process | Drugs","publisher":"U.S. Food and Drug Administration","date":"2022-08-08","accessed":"2026-09-29"},{"url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss","title":"FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss","publisher":"U.S. Food and Drug Administration","date":"2026-09-01","accessed":"2026-09-29"}]},{"molecule":"tb-500","moleculeName":"TB-500 (thymosin beta-4 fragment)","country":"united-states","countryName":"United States","countryIso2":"US","status":"not-approved","statusLabel":"Not approved","headline":"No FDA approval; FDA lists TB-500 (thymosin beta-4 fragment) as having no identified human exposure data, and a July 2026 advisory vote is non-binding","detail":"TB-500, described by FDA as thymosin beta-4 fragment (LKKTETQ), is not approved for any use. FDA's Category 2 page lists it among withdrawn nominations and states FDA found no human exposure data for it. The Pharmacy Compounding Advisory Committee reviewed it for wound healing on 23 July 2026 and, per a law-firm report, voted 8 to 6 with one abstention to recommend it for the 503A bulks list; the vote is advisory and FDA has taken no listing action. Until FDA acts, it is not on the 503A bulks list.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tb-500-in-united-states","sources":[{"url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","title":"Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 and withdrawn nominations)","publisher":"U.S. Food and Drug Administration","date":"2026-04-22","accessed":"2026-09-29"},{"url":"https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026","title":"July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee","publisher":"U.S. Food and Drug Administration","date":"2026-08-06","accessed":"2026-09-29"},{"url":"https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/","title":"Bulk list bound? PCAC backs majority of peptides in two-day public meeting","publisher":"McDermott Will & Schulte","date":"2026-07-27","accessed":"2026-09-29"},{"url":"https://www.mintz.com/insights-center/viewpoints/2146/2026-07-29-fdas-advisory-committee-votes-peptides-what-it-does-and","title":"FDA's Advisory Committee Votes on Peptides: What It Does and Does Not Mean","publisher":"Mintz","date":"2026-07-29","accessed":"2026-09-29"}]},{"molecule":"tesamorelin","moleculeName":"Tesamorelin","country":"united-states","countryName":"United States","countryIso2":"US","status":"approved-restricted","statusLabel":"Approved, restricted","headline":"FDA-approved since 2010 as Egrifta only for extra belly fat in adults with HIV and lipodystrophy; not for weight loss","detail":"Tesamorelin is FDA-approved (Egrifta SV and Egrifta WR, first approved 10 November 2010) to reduce excess abdominal fat in HIV-infected adults with lipodystrophy. The label states it is not indicated for weight loss and that long-term cardiovascular safety has not been established. It is regulated as a biologic under a Biologics License Application, and FDA says biologics are not eligible for compounding exemptions. In August 2026 FDA warned an online seller that tesamorelin sold with 'research use only' labels is an unapproved new drug.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tesamorelin-in-united-states","sources":[{"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022505s020lbl.pdf","title":"EGRIFTA (tesamorelin) prescribing information","publisher":"U.S. Food and Drug Administration","date":"2025-03","accessed":"2026-09-29"},{"url":"https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers","title":"Compounding and the FDA: Questions and Answers","publisher":"U.S. Food and Drug Administration","date":"2025-09-16","accessed":"2026-09-29"},{"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026","title":"FDA warning letter 735127 to an online seller of retatrutide, semaglutide, SS-31, PT-141 and tesamorelin labelled 'research use only'","publisher":"U.S. Food and Drug Administration","date":"2026-08-24","accessed":"2026-09-29"}]},{"molecule":"tirzepatide","moleculeName":"Tirzepatide","country":"united-states","countryName":"United States","countryIso2":"US","status":"approved","statusLabel":"Approved","headline":"FDA-approved as Mounjaro (type 2 diabetes) and Zepbound (weight management, sleep apnea); shortage over since December 2024","detail":"Tirzepatide is FDA-approved as Mounjaro for type 2 diabetes (approved 13 May 2022) and as Zepbound for chronic weight management and for moderate to severe obstructive sleep apnea in adults with obesity (first approved 8 November 2023; the sleep apnea use was added later). FDA re-determined on 19 December 2024 that the tirzepatide injection shortage was resolved, and its enforcement-discretion periods for compounders ended in March 2025 (on 5 March for 503A pharmacies, when a court denied an injunction, and on 19 March for 503B outsourcing facilities). On 1 May 2026 FDA proposed not to add tirzepatide to the 503B bulks list; 503A pharmacies remain barred from routinely making essentially-copy products. FDA has logged more than 730 adverse event reports for compounded tirzepatide as of 31 May 2026.","verifiedAt":"2026-09-29","pageUrl":"https://glp1base.com/legal/tirzepatide-in-united-states","sources":[{"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215866s044s045lbl.pdf","title":"MOUNJARO (tirzepatide) injection prescribing information","publisher":"U.S. Food and Drug Administration","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806Orig1s050lbl.pdf","title":"ZEPBOUND (tirzepatide) injection prescribing information","publisher":"U.S. Food and Drug Administration","date":"2026-09","accessed":"2026-09-29"},{"url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize","title":"FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize","publisher":"U.S. Food and Drug Administration","date":"2026-04-01","accessed":"2026-09-29"},{"url":"https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal","title":"List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B (proposal not to include semaglutide, tirzepatide, liraglutide)","publisher":"Federal Register (FDA)","date":"2026-05-01","accessed":"2026-09-29"},{"url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss","title":"FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss","publisher":"U.S. Food and Drug Administration","date":"2026-09-01","accessed":"2026-09-29"}]}]}