# GLP1 Base: full reference text > 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. Source: https://glp1base.com. Generated from the site's structured dataset; data last verified 2026-09-29. Every status and claim below comes with its primary source. The structured data behind this file can be downloaded and reused under CC-BY-4.0 at https://glp1base.com/data; please attribute GLP1 Base and link the page you quote. No dosing, titration, mixing, injection or sourcing information is included, by policy. ## Molecules ### Amycretin - Page: https://glp1base.com/molecules/amycretin - Also known as: Zenagamtide, NNC0487-0111 - Class: Amylin analogue - Targets: GLP-1 receptor, Amylin receptors (calcitonin receptor with RAMP proteins), Calcitonin receptor - Route: Investigational only. In clinical trials it has been studied as a once-weekly subcutaneous injection (pre-filled pen in the phase 3 trials) and as a once-daily oral tablet. No route is approved for routine use. - Last verified: 2026-09-29 Simple: Amycretin is an experimental medicine from Novo Nordisk that copies two hormones in a single molecule: GLP-1 and amylin. Both help you feel full and help control blood sugar. It is not approved anywhere yet. Large phase 3 trials for weight loss, type 2 diabetes and heart failure are now running. Expert: Amycretin (NNC0487-0111; called zenagamtide in 2026 publications and trial records) is a unimolecular peptide agonist of the GLP-1, amylin and calcitonin receptors, developed by Novo Nordisk. It is a 68-amino-acid peptide of average molecular weight about 7,847 Da: a GLP-1 receptor agonist moiety and an amylin receptor agonist moiety are joined by a linker of four glycine residues and one glutamic acid. It carries a C18 diacid side chain on the GLP-1 lysine at position 37 (GLP-1 7-37 numbering) for reversible albumin binding, a C-terminal amide, and 2-aminoisobutyric acid in the N-terminal GLP-1 region to resist DPP-4 cleavage. Subcutaneous once-weekly and oral once-daily formulations are in clinical development. In humans, the geometric mean terminal half-life after a single subcutaneous dose was 88 hours in adults with normal kidney function, and plasma exposure was dose-proportional in phase 1. Amycretin has no marketing authorisation from any regulator as of 2026-09-29. Key published trials: a first-in-human phase 1 study (NCT05369390); a phase 1b/2a subcutaneous study in overweight or obesity (NCT06064006; body-weight change of -24.3% versus -1.1% with placebo at week 36 at the highest dose tested); and a 36-week phase 2 trial in type 2 diabetes (NCT06542874; HbA1c change from baseline up to -1.7% subcutaneous and -1.4% oral). Phase 3 trials began in 2026: the AMAZE programme (including obesity, obesity with type 2 diabetes, head-to-head trials against semaglutide, obstructive sleep apnoea, knee osteoarthritis and an oral obesity trial) and a separate heart-failure-with-obesity outcomes trial (HF-POLARIS, NCT07567001). No phase 3 efficacy results have been published. Evidence level: Phase 2 trials. Human evidence comes from phase 1 and phase 2 trials, all sponsored by Novo Nordisk: a first-in-human phase 1 trial of the oral form (144 adults with overweight or obesity), a phase 1b/2a subcutaneous trial (125 adults, up to 36 weeks), and one 36-week phase 2 trial in type 2 diabetes (NCT06542874) with subcutaneous and oral parts reported in two papers (262 and 186 randomised adults). These are placebo-controlled but small and short, and the phase 1b/2a study had many discontinuations. Phase 3 (AMAZE) trials began in 2026; no phase 3 results are published. Preclinical work in mice and rats is animal-only. - Evidence source: The Lancet (via PubMed), "Safety, tolerability, pharmacokinetics, and pharmacodynamics of the first-in-class GLP-1 and amylin receptor agonist, amycretin: a first-in-human, phase 1, double-blind, randomised, placebo-controlled trial" (2025-06-20) https://pubmed.ncbi.nlm.nih.gov/40550229/ - Evidence source: The Lancet (via PubMed), "Amycretin, a novel, unimolecular GLP-1 and amylin receptor agonist administered subcutaneously: results from a phase 1b/2a randomised controlled study" (2025-06-20) https://pubmed.ncbi.nlm.nih.gov/40550231/ - Evidence source: The Lancet (via PubMed), "Efficacy and safety of once-weekly subcutaneous zenagamtide, a novel unimolecular GLP-1 and amylin receptor agonist, in type 2 diabetes: a multicentre, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial" (2026-07-30) https://pubmed.ncbi.nlm.nih.gov/42532080/ - Evidence source: The Lancet (via PubMed), "Efficacy and safety of once-daily oral zenagamtide, a novel unimolecular GLP-1 and amylin receptor agonist, in adults with type 2 diabetes: a multicentre, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial" (2026-07-30) https://pubmed.ncbi.nlm.nih.gov/42532079/ - Evidence source: EBioMedicine (via PubMed Central), "The effect of amycretin, a unimolecular glucagon-like peptide-1 and amylin receptor agonist, on body weight and metabolic dysfunction in mice and rats" (2025-07-23) https://pmc.ncbi.nlm.nih.gov/articles/PMC12309853/ - Evidence source: ClinicalTrials.gov (Novo Nordisk A/S), "AMAZE 1: Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Obesity (NCT07339423)" (2026-01-14) https://clinicaltrials.gov/study/NCT07339423 - Evidence source: ClinicalTrials.gov (Novo Nordisk A/S), "Efficacy and Safety of NNC0487-0111 Compared to Placebo on Morbidity and Mortality in People With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity (NCT07567001)" (2026-05-05) https://clinicaltrials.gov/study/NCT07567001 - Evidence source: ClinicalTrials.gov (Novo Nordisk A/S), "AMAZE 9: Efficacy and Safety of Once-daily Oral Zenagamtide in Participants With Obesity (NCT07720271)" (2026-07-22) https://clinicaltrials.gov/study/NCT07720271 Half-life: About 88 hours (about 3.7 days): geometric mean terminal half-life after a single subcutaneous dose in adults with normal kidney function (88.1 h); 94 to 113 h across mild to end-stage kidney impairment. (source: https://pmc.ncbi.nlm.nih.gov/articles/PMC13538736/) Status by country: - Australia: Not approved. Investigational only. No amycretin product is on the ARTG and no application appears on the TGA's evaluation list. (verified 2026-09-29; source: https://www.tga.gov.au/resources/artg?keywords=amycretin) - Brazil: Not approved. Amycretin is an investigational drug with no Brazilian registration (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Not approved. Amycretin is an investigational drug with no Health Canada authorisation (verified 2026-09-29; source: https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=amycretin) - China: Not approved. Not approved in China; Novo Nordisk has only clinical-trial applications on file. (verified 2026-09-29; source: https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d) - European Union: Not approved. Investigational; no EU marketing authorisation and no application under evaluation (verified 2026-09-29; source: https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm) - India: Not approved. Not approved in India; Novo Nordisk's amycretin (code NNC0487-0111) is only in CDSCO-permitted Phase III trials (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Pulmonary%2023.03.2026%20%282%29%20%282%29.pdf) - Japan: Not approved. 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 (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. Not registered in Mexico; amycretin is an investigational Novo Nordisk medicine (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Not approved. Amycretin is an investigational medicine with no Medsafe consent in New Zealand (verified 2026-09-29; source: https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm) - United Arab Emirates: Not approved. No EDE approval found for amycretin; an investigational medicine, not marketed in the UAE (verified 2026-09-29; source: https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae) - United Kingdom: Not approved. Investigational medicine with no UK licence (verified 2026-09-29; source: https://www.gov.uk/guidance/find-product-information-about-medicines) - United States: Not approved. No FDA approval or filing; Novo Nordisk now calls it zenagamtide and has started Phase 3 trials (verified 2026-09-29; source: https://www.sec.gov/Archives/edgar/data/353278/000035327826000006/caq42025.htm) ### AOD-9604 - Page: https://glp1base.com/molecules/aod-9604 - Also known as: AOD9604, Tyr-hGH(177-191), Modified C-terminal fragment of human growth hormone (residues 177-191 plus an N-terminal tyrosine) - Class: Trending peptide - Targets: Not established. It does not bind the growth hormone receptor in cell assays; in mice its fat-burning effect depended at least in part on intact beta-3 adrenergic receptor signalling - Route: In the human studies it was given as single intravenous doses, and by mouth either as single doses or once daily for up to 24 weeks. No route is approved. FDA found no human data for subcutaneous injection or skin (transdermal) use. - Last verified: 2026-09-29 Simple: AOD-9604 is a short piece of human growth hormone that a company tested as a possible weight-loss drug. It helped obese mice and rats. But in the biggest human trial it did not cause enough weight loss, and the company stopped in 2007. It is not an approved medicine, and it is banned in sport. Expert: AOD-9604 is a synthetic hexadecapeptide: residues 177-191 of human growth hormone (hGH) with an extra N-terminal tyrosine, and a disulfide bond between the two cysteines (positions 7 and 14 of the 16-residue chain). Molecular formula C78H123N23O23S2, about 1815 Da. It was developed by Metabolic Pharmaceuticals (Australia) as an oral anti-obesity agent, on the idea that the C-terminal lipolytic region of hGH could be separated from hGH's diabetogenic and growth-promoting effects. In cell assays it neither displaces hGH from the growth hormone receptor nor stimulates receptor-driven proliferation; in obese mice and rats it increased fat oxidation and lipolysis without the hyperglycaemia seen with hGH, and mice lacking the beta-3 adrenergic receptor did not respond to chronic treatment. The molecular target has not been identified. No human pharmacokinetic study has been published: in pigs the intravenous half-life was about 3 minutes, and in rat plasma in vitro about 4 minutes, with rapid N-terminal truncation. Company-sponsored human work comprised six randomised, placebo-controlled studies (intravenous and oral, 893 participants in total by the studies' listed sizes); a 12-week phase 2 study reported only a small, non-linear effect on weight (the company later said the best dose fell short of significance on the primary analysis, p=0.1, reaching it only in women), and the 24-week phase 2b OPTIONS study (536 enrolled, 502 randomised) did not reach statistical significance on weight loss at 12 or 24 weeks, so development for obesity was terminated in February 2007. The phase 2b results were announced by the company but do not appear to have been published in a peer-reviewed journal. Later interest in joint cartilage rests on one rabbit study. No regulator among those checked has approved AOD-9604: the US FDA notes it is not a component of any FDA-approved drug; FDA staff recommended against adding it to the 503A bulk drug substances list, its Pharmacy Compounding Advisory Committee voted 12 to 0 against in December 2024, and FDA lists it among bulk substances that may present significant safety risks in compounding. It is prohibited at all times under the WADA 2026 Prohibited List (S2.2.3). Status at EMA, MHRA, PMDA, NMPA, TGA and Health Canada was not verified here. Evidence level: Phase 2 trials. The best human evidence is company-sponsored: six randomised, placebo-controlled studies in about 900 people, ending with a 24-week phase 2b obesity trial (OPTIONS, 536 enrolled) that did not show statistically significant weight loss versus placebo at 12 or 24 weeks. The company announced this in 2007 and stopped development for obesity; the phase 2b results do not appear to have been published in a peer-reviewed journal. An earlier 12-week study reported about 2.6 kg loss versus 0.8 kg with placebo in its best dose group, with a non-linear dose response; the company later stated that this difference fell short of statistical significance on the primary analysis (p=0.1) and was significant only in the female subgroup. There are no published human pharmacokinetic studies and no human data for injected (subcutaneous) or skin-applied use. Evidence for effects on fat metabolism, and on cartilage in a rabbit knee model, is animal-only. Use for osteoarthritis, muscle building or other purposes is unapproved and unsupported by human trial data. - Evidence source: U.S. Food and Drug Administration, "FDA Briefing Document: Pharmacy Compounding Advisory Committee, evaluation of AOD-9604-related bulk drug substances (AOD-9604 free base and AOD-9604 acetate) for inclusion on the 503A Bulk Drug Substances List" (2024-12) https://www.fda.gov/media/183584/download - Evidence source: Australian Securities Exchange / Metabolic Pharmaceuticals Limited, "Metabolic Pharmaceuticals Limited: ASX announcement, obesity drug Phase 2B clinical trial results (filed with the SEC as a foreign private issuer submission)" (2007-02-21) https://www.sec.gov/Archives/edgar/vprr/0702/07021963.pdf - Evidence source: Current Cardiology Reviews (via PubMed Central), "Obesity pharmacotherapy: current perspectives and future directions (Misra)" (2013) https://pmc.ncbi.nlm.nih.gov/articles/PMC3584306/ - Evidence source: Journal of Endocrinology and Metabolism, "Safety and Tolerability of the Hexadecapeptide AOD9604 in Humans (Stier, Vos, Kenley)" (2013-04) https://www.jofem.org/index.php/jofem/article/view/157 - Evidence source: Curr Opin Investig Drugs (via PubMed), "AOD-9604 Metabolic (Wilding)" (2004-04) https://pubmed.ncbi.nlm.nih.gov/15134286/ - Evidence source: Int J Obes Relat Metab Disord (via PubMed), "Increase of fat oxidation and weight loss in obese mice caused by chronic treatment with human growth hormone or a modified C-terminal fragment (Heffernan et al.)" (2001-10) https://pubmed.ncbi.nlm.nih.gov/11673763/ - Evidence source: Ann Clin Lab Sci (via PubMed), "Effect of Intra-articular Injection of AOD9604 with or without Hyaluronic Acid in Rabbit Osteoarthritis Model (Kwon and Park)" (2015) https://pubmed.ncbi.nlm.nih.gov/26275694/ Half-life: Not measured in humans. Animal and laboratory data only: about 3 minutes after an intravenous dose in pigs, and about 4 minutes when added to rat plasma in vitro. (source: https://jofem.org/index.php/jofem/article/view/213/278) Status by country: - Australia: Prohibited. Unapproved and controlled: AOD9604 is prescription-only and possession without authority is illegal under the Poisons Standard. (verified 2026-09-29; source: https://www.legislation.gov.au/F2026L00633/latest/text) - Brazil: Not approved. No Brazilian registration for AOD-9604; the unregistered-peptide rules apply (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Prohibited. Not authorised; named in Health Canada seizure notices (2025) and banned in sport (verified 2026-09-29; source: https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=aod) - China: Not approved. Not an approved medicine in China; unlawful to sell as a drug, and it is banned in sport. (verified 2026-09-29; source: https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html) - European Union: Not approved. No EU marketing authorisation; banned in sport (WADA S2.2.3) (verified 2026-09-29; source: https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json) - India: Not approved. Not approved in India: no CDSCO marketing permission found for AOD-9604; making or selling it as a medicine would be unapproved (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf) - Japan: Not approved. Not an approved medicine in Japan; sale and advertising as a drug are illegal, and WADA bans AOD-9604 in sport (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. No registration for AOD-9604 found in COFEPRIS lists (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Not approved. No Medsafe-approved medicine contains AOD-9604; it is classed as a prescription medicine (verified 2026-09-29; source: https://www.medsafe.govt.nz/profs/class/classintro.asp) - United Arab Emirates: Not approved. Not approved in the UAE: no marketing authorisation for AOD-9604; unapproved peptide products are under EDE enforcement (verified 2026-09-29; source: https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities) - United Kingdom: Not approved. AOD-9604 is not licensed in the UK (verified 2026-09-29; source: https://www.gov.uk/guidance/find-product-information-about-medicines) - United States: Not approved. No FDA approval; FDA lists AOD-9604 among withdrawn nominations after noting possible serious adverse events (verified 2026-09-29; source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) ### BPC-157 - Page: https://glp1base.com/molecules/bpc-157 - Also known as: Body Protection Compound-157, Body Protective Compound 157, Bepecin, PL 14736, PL-10, PLD-116, pentadecapeptide BPC 157 - Class: Trending peptide - Targets: No confirmed molecular target (laboratory studies report effects on VEGFR2 signalling, the nitric oxide pathway and growth-hormone-receptor expression) - Route: No approved route. In the few human studies published so far it was given as a rectal enema (ulcerative colitis and healthy volunteers), by injection into a knee joint, by injection into the bladder wall during cystoscopy, and by intravenous infusions on two consecutive days in two people. Animal studies have used injections and oral administration. Oral, subcutaneous, nasal and skin-cream products have not been studied in humans in the literature FDA reviewed. Human bioavailability is unknown. - Last verified: 2026-09-29 Simple: BPC-157 is a short chain of 15 building blocks (amino acids) made in a lab. It copies part of a protein first found in stomach juice. In rats and cells it seems to help tissue repair, but it has never been approved as a medicine anywhere, and only a handful of tiny human studies exist. Expert: BPC-157 ("body protection compound 157", PL 14736, Bepecin) is a synthetic linear pentadecapeptide, GEPPPGKPADDAGLV (C62H98N16O22, 1419.5 g/mol), reported to be a partial sequence of a gastric-juice protein and first synthesised in Croatia in the early 1990s. It is unmodified: no D-amino acids, lipidation or other half-life engineering. The name is a common name, not a USAN (US Adopted Name), and the free base and the acetate salt are distinct bulk substances. Reported preclinical effects (rats, mice and cell models) include protection against drug-induced gastric and liver lesions, faster healing of tendon injuries and colonic fistulas, and pro-angiogenic activity linked in vitro to VEGFR2-Akt-eNOS signalling and nitric oxide modulation; no molecular target has been identified and dose-response relationships have not been established. In rats and beagle dogs the elimination half-life is under 30 minutes (5.3 min in dogs, 15.2 min in rats after IV dosing); intramuscular bioavailability is about 14-19% in rats and 45-51% in dogs, and the peptide is broken down to small fragments and amino acids. Human pharmacokinetics have not been reported. FDA staff found five small human studies (rectal enema studies in healthy volunteers and in ulcerative colitis, the latter a 53-person randomised trial known only from a meeting abstract that showed no clear benefit; intra-articular use for knee pain; intravesical use for interstitial cystitis; and a two-person intravenous pilot) plus a registered phase 1 oral study with no posted results. No approved product contains it in any country. FDA staff recommended against adding it to the 503A bulks list; an advisory committee voted in July 2026 to recommend it anyway, which is advisory only. Evidence level: Animal studies only. Efficacy evidence is almost entirely from rodent and cell studies, largely from a small number of research groups. A 2025 systematic review found 36 studies, 35 preclinical and 1 human (level IV/V evidence, no randomised trials). FDA staff identified five small human studies: an 8-day rectal enema tolerability study in 24 healthy volunteers (meeting abstracts only), a two-week rectal enema study in ulcerative colitis (53 people randomised; results only in a meeting abstract, with a between-group difference of 1.6 points on a disease activity index, 95% CI -4.84 to 1.62), a retrospective chart review of knee injections, some combined with thymosin beta-4 (17 patients, 16 reached by phone; 14 reported relief), a 12-woman bladder pilot without a control group, and a two-person intravenous pilot, plus a registered phase 1 oral-tablet study planned for 42 people (NCT02637284) with no posted results. None of these can show that BPC-157 works or is safe. No phase 2 or phase 3 trial has been published. - Evidence source: HSS Journal (via PubMed), "Emerging Use of BPC-157 in Orthopaedic Sports Medicine: A Systematic Review" (2025-07-31) https://pubmed.ncbi.nlm.nih.gov/40756949/ - Evidence source: U.S. Food and Drug Administration, "FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: Evaluation of BPC-157-Related Bulk Drug Substances (BPC-157 free base and BPC-157 acetate) for the 503A Bulk Drug Substances List" (2026-07) https://www.fda.gov/media/193343/download - Evidence source: Alternative Therapies in Health and Medicine (via PubMed), "Intra-Articular Injection of BPC 157 for Multiple Types of Knee Pain" (2021-07) https://pubmed.ncbi.nlm.nih.gov/34324435/ - Evidence source: Alternative Therapies in Health and Medicine (via PubMed), "Effect of BPC-157 on Symptoms in Patients with Interstitial Cystitis: A Pilot Study" (2024-10) https://pubmed.ncbi.nlm.nih.gov/39325560/ - Evidence source: Alternative Therapies in Health and Medicine (via PubMed), "Safety of Intravenous Infusion of BPC157 in Humans: A Pilot Study" (2025-09) https://pubmed.ncbi.nlm.nih.gov/40131143/ - Evidence source: ClinicalTrials.gov, "PCO-02 - Safety and Pharmacokinetics Trial (Phase I pilot in healthy volunteers; NCT02637284)" (2015-12) https://clinicaltrials.gov/study/NCT02637284 - Evidence source: Current Reviews in Musculoskeletal Medicine (via PubMed), "Regeneration or Risk? A Narrative Review of BPC-157 for Musculoskeletal Healing" (2025-08-12) https://pubmed.ncbi.nlm.nih.gov/40789979/ Half-life: Under 30 minutes in rats and beagle dogs (5.3 min in dogs, 15.2 min in rats after an intravenous dose). Not measured in humans. (source: https://pubmed.ncbi.nlm.nih.gov/36588717/) Status by country: - Australia: Prohibited. 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. (verified 2026-09-29; source: 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) - Brazil: Not approved. Not registered in Brazil; Anvisa says injectable BPC-157 sold online is irregular and cannot be sold (verified 2026-09-29; source: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa) - Canada: Prohibited. Not authorised; seized by Health Canada and subject to a Type I recall of unauthorised powder in May 2026 (verified 2026-09-29; source: https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm) - China: Not approved. Not an approved medicine in China; producing, importing or selling it as a drug is unlawful, and it is banned in sport. (verified 2026-09-29; source: https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html) - European Union: Not approved. Not authorised as a medicine in the EU; also on the WADA prohibited list (S0) (verified 2026-09-29; source: https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json) - India: Not approved. Not approved in India: no CDSCO marketing permission found for BPC-157; making or selling it as a medicine would be unapproved (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf) - Japan: Not approved. Not an approved medicine in Japan; sale and advertising as a drug are illegal, and WADA bans BPC-157 in sport (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. Not approved in Mexico; a 2026 bill would expressly ban sale of unregistered research peptides (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Prohibited. Not approved; Medsafe names BPC-157 as an illegal unapproved peptide and says it seizes it (verified 2026-09-29; source: https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp) - United Arab Emirates: Not approved. Not approved in the UAE: no marketing authorisation for BPC-157, and the EDE is acting against unapproved peptide products (verified 2026-09-29; source: https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities) - United Kingdom: Not approved. BPC-157 is not licensed in the UK (verified 2026-09-29; source: https://www.gov.uk/guidance/find-product-information-about-medicines) - United States: Not approved. 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 (verified 2026-09-29; source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) ### Bremelanotide (PT-141) - Page: https://glp1base.com/molecules/bremelanotide - Also known as: PT-141, Bremelanotide acetate, Bremelanotida - Brand names (nominative use only): Vyleesi - Class: Approved peptide medicine - Targets: Melanocortin receptors (MC4R and MC1R most relevant at therapeutic exposure; also MC3R, MC5R, MC2R) - Route: Subcutaneous injection, self-administered with a single-dose prefilled autoinjector, used as needed ahead of anticipated sexual activity rather than as a daily medicine. It is not taken by mouth. (Earlier clinical studies also tested an intranasal form in men; that form is not approved.) - Last verified: 2026-09-29 Simple: Bremelanotide is a small ring-shaped peptide that switches on melanocortin receptors, which are docking points for a natural brain-and-skin hormone. In the US it is a prescription injection for one condition: low sexual desire that causes distress in women before menopause. Doctors do not know exactly how it works. Expert: Bremelanotide (formerly PT-141) is a synthetic cyclic heptapeptide analogue of alpha-melanocyte-stimulating hormone: Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-OH, closed by a lactam bridge between the Asp and Lys side chains (C50H68N14O10, about 1025 Da). It is a non-selective melanocortin receptor agonist with potency order MC1R > MC4R > MC3R > MC5R > MC2R; MC4R and MC1R binding is considered most relevant at therapeutic exposure, and the label states that the mechanism by which it improves HSDD is unknown. After subcutaneous injection absolute bioavailability is about 100%, median Tmax about 1 hour, protein binding 21%, and terminal half-life about 2.7 hours; it is cleared by hydrolysis of amide bonds, with radioactivity recovered mainly in urine (64.8%) and faeces (22.8%). The FDA approved Vyleesi (NDA 210557, sponsor AMAG, later Cosette) on 21 June 2019 for premenopausal women with acquired, generalized HSDD; it is not indicated for postmenopausal women, men or to enhance performance. Approval rested on the two 24-week RECONNECT phase 3 trials (n=1,267 randomised), where the desire-domain gain over placebo was 0.35 points (integrated analysis) and distress fell by 0.33 points; nausea (40% vs 1%), flushing and headache were the main adverse events. It is contraindicated in uncontrolled hypertension or known cardiovascular disease because each use transiently raises blood pressure. A cryo-EM structure of bremelanotide bound to MC4R and Gs is in the PDB (7F55). Approval status at regulators other than the FDA was not verified for this record. Evidence level: Approved. Approved by the US FDA in 2019 on the strength of two identical 24-week randomised, double-blind, placebo-controlled phase 3 trials (RECONNECT, NCT02333071 and NCT02338960; 1,267 women randomised), preceded by a 12-week phase 2 dose-finding trial (NCT01382719). Benefits were modest: the FDA reported that about 25% of treated women had a desire-score increase of 1.2 or more versus about 17% on placebo, and about 35% versus 31% had a distress-score decrease of 1 or more; there was no difference in satisfying sexual events. An intranasal form was studied earlier in healthy men and men with erectile dysfunction; use in men is not approved (the label states it is not indicated in men). The pivotal evidence is in premenopausal women only. - Evidence source: Obstetrics & Gynecology (PubMed), "Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials" (2019-11) https://pubmed.ncbi.nlm.nih.gov/31599840/ - Evidence source: U.S. Food and Drug Administration (news release distributed via PR Newswire), "FDA approves new treatment for hypoactive sexual desire disorder in premenopausal women" (2019-06-21) https://www.prnewswire.com/news-releases/fda-approves-new-treatment-for-hypoactive-sexual-desire-disorder-in-premenopausal-women-300872998.html - Evidence source: U.S. Food and Drug Administration (Drugs@FDA), "VYLEESI (bremelanotide injection) prescribing information, initial approval label (NDA 210557)" (2019-06) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210557s000lbl.pdf - Evidence source: Women's Health (London) (PubMed), "Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial" (2016-06) https://pubmed.ncbi.nlm.nih.gov/27181790/ - Evidence source: International Journal of Impotence Research (PubMed), "Double-blind, placebo-controlled evaluation of the safety, pharmacokinetic properties and pharmacodynamic effects of intranasal PT-141 in healthy males and patients with mild-to-moderate erectile dysfunction" (2004-02) https://pubmed.ncbi.nlm.nih.gov/14963471/ Half-life: About 2.7 hours after a single subcutaneous injection (range 1.9-4.0 hours); median time to peak level about 1 hour (source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf) Status by country: - Australia: Not approved. Not on the ARTG and not shown as under TGA evaluation. It is an unapproved therapeutic good in Australia. (verified 2026-09-29; source: https://www.tga.gov.au/resources/artg?keywords=bremelanotide) - Brazil: Not approved. No Brazilian registration for bremelanotide (PT-141) (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Prohibited. Not authorised; Health Canada seizure notices in 2025 name bremelanotide (PT-141) as an unauthorised injectable (verified 2026-09-29; source: https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta) - China: Not approved. Not approved in China; the only CDE record we found is a 2019 import clinical-trial application. (verified 2026-09-29; source: https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d) - European Union: Not approved. No EU marketing authorisation; not listed in EMA or Union Register data (verified 2026-09-29; source: https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json) - India: Not approved. Not approved in India: no CDSCO marketing permission found for bremelanotide (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf) - Japan: Not approved. No marketing approval in Japan; bremelanotide is not in PMDA's approved-drug lists or package-insert database (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. No registration for bremelanotide found in COFEPRIS lists (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Not approved. No bremelanotide product is approved by Medsafe; melanocortin-type peptides are prescription-only (verified 2026-09-29; source: https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm) - United Arab Emirates: Unverified. Could not confirm whether bremelanotide (Vyleesi) is registered by the EDE; no UAE-specific record was found (verified 2026-09-29; source: https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae) - United Kingdom: Not approved. No UK licence for bremelanotide (verified 2026-09-29; source: https://www.gov.uk/guidance/find-product-information-about-medicines) - United States: Approved, restricted. FDA-approved as Vyleesi (2019) only for low sexual desire in premenopausal women with a specific diagnosis (verified 2026-09-29; source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210557s002lbl.pdf) ### Cagrilintide (and CagriSema) - Page: https://glp1base.com/molecules/cagrilintide - Also known as: AM833, CagriSema (fixed-dose combination of cagrilintide and semaglutide), Cagrilintide-semaglutide - Class: Amylin analogue - Targets: Amylin receptors (AMY1R, AMY2R, AMY3R), Calcitonin receptor - Route: Investigational once-weekly subcutaneous injection in clinical trials, alone or as a fixed-dose combination with semaglutide (CagriSema). There is no approved route because there is no approved product. - Last verified: 2026-09-29 Simple: Cagrilintide is an experimental drug that copies amylin, a hormone your pancreas makes to help you feel full. It is built to stay in the body for a long time, so in studies it is given once a week. It is not approved anywhere yet. Its maker has asked the US FDA to approve it combined with semaglutide in one product, called CagriSema. Expert: Cagrilintide (AM833) is a 37-residue, C-terminally amidated, long-acting amylin analogue from Novo Nordisk. It keeps the human amylin backbone, including the Cys2-Cys7 disulfide, and differs from mature human amylin at six positions (including prolines at 25, 28 and 29 and a Glu14/Arg17 pair); its developers describe it as a stable analogue, in contrast to native amylin's strong tendency to form amyloid fibrils. In the PubChem structure, a C20 fatty diacid is attached through a gamma-glutamic acid linker to the alpha-amino group of the N-terminal lysine; this lipidation is part of what makes it long acting. It is a non-selective agonist of the calcitonin receptor and the three amylin receptors (calcitonin receptor plus RAMP1, RAMP2 or RAMP3). Elimination half-life is about 159-195 h, which supports once-weekly subcutaneous use. In a 26-week phase 2 trial, weight loss across the cagrilintide groups was 6.0%-10.8% versus 3.0% with placebo (trial product estimand). In the phase 3 REDEFINE 1 trial, cagrilintide alone gave 11.5% weight loss at 68 weeks (treatment-policy estimand) versus 3.0% with placebo, and the fixed-dose combination with semaglutide (CagriSema) gave 20.4%. We found no regulatory approval of cagrilintide, alone or combined, as of the access date. Novo Nordisk filed a US NDA for CagriSema on 2025-12-18 and on 2026-09-21 still described CagriSema as investigational, with an FDA decision expected in Q4 2026; and the cagrilintide-alone RENEW phase 3 programme began in November 2025. Evidence level: Phase 3 trials. Human evidence is from randomised phase 1b, phase 2 and phase 3 trials sponsored by Novo Nordisk. Most phase 3 data test the fixed-dose combination with semaglutide (CagriSema). Cagrilintide-alone phase 3 data come from a comparison arm inside REDEFINE 1, and the dedicated RENEW 1 and RENEW 2 phase 3 trials had not reported at the access date. Cagrilintide is not approved by any regulator. On 2026-09-21 Novo Nordisk still described CagriSema as an investigational product and said an FDA decision on its December 2025 application is expected in Q4 2026. - Evidence source: The Lancet (via PubMed), "Once-weekly cagrilintide for weight management in people with overweight and obesity: a dose-finding phase 2 trial" (2021-11-16) https://pubmed.ncbi.nlm.nih.gov/34798060/ - Evidence source: New England Journal of Medicine (via PubMed), "Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (REDEFINE 1)" (2025-06-22) https://pubmed.ncbi.nlm.nih.gov/40544433/ - Evidence source: Novo Nordisk press release (reprinted by BioSpace), "Novo Nordisk presents phase 3 data for next-generation amylin cagrilintide, leading to advancement into dedicated clinical programme" (2025-09-16) https://www.biospace.com/press-releases/novo-nordisk-presents-phase-3-data-for-next-generation-amylin-cagrilintide-leading-to-advancement-into-dedicated-clinical-programme - Evidence source: ClinicalTrials.gov, "RENEW 1: Efficacy and Safety of Cagrilintide for Weight Management in Participants With Overweight or Obesity (NCT07220642)" (2025-10-24) https://clinicaltrials.gov/study/NCT07220642 - Evidence source: Novo Nordisk (company announcement), "Novo's CagriSema delivers superior weight loss versus tirzepatide in REIMAGINE 5 trial" (2026-09-21) https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=916774 Half-life: About 159-195 hours (roughly 6.5-8 days) in a phase 1b trial where cagrilintide was given together with semaglutide (source: https://pubmed.ncbi.nlm.nih.gov/33894838/) Status by country: - Australia: Not approved. Not approved and not shown as under TGA evaluation. No cagrilintide product is on the ARTG. (verified 2026-09-29; source: https://www.tga.gov.au/resources/artg?keywords=cagrilintide) - Brazil: Not approved. Not registered in Brazil; no filing for cagrilintide or CagriSema was found (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Under review. Cagrilintide with semaglutide (CagriSema) under review since March 2026; no cagrilintide product is authorised (verified 2026-09-29; source: https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review/new-drug-submissions-under-review.html) - China: Not approved. Not approved in China; CagriSema has been tested in China but only trial-stage filings are visible. (verified 2026-09-29; source: https://clinicaltrials.gov/study/NCT05996848) - European Union: Not approved. No EU marketing authorisation; no application on EMA's September 2026 evaluation list (verified 2026-09-29; source: https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm) - India: Not approved. Not approved in India; CagriSema is only in CDSCO-permitted Phase III trials (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Endocrinology%20%26%20Metabolism%20dated%20on%2009.05.2024.pdf) - Japan: Not approved. No marketing approval in Japan; the amylin analogue cagrilintide does not appear in PMDA's approved-drug lists to September 2026 (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. Not registered in Mexico; CagriSema and cagrilintide are still investigational there (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Not approved. Cagrilintide (alone or in CagriSema) has no Medsafe consent and no data sheet in New Zealand (verified 2026-09-29; source: https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm) - United Arab Emirates: Not approved. No EDE approval found for cagrilintide or CagriSema; not marketed in the UAE (verified 2026-09-29; source: https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae) - United Kingdom: Not approved. No UK licence for cagrilintide or the cagrilintide-semaglutide combination (CagriSema) (verified 2026-09-29; source: https://www.gov.uk/guidance/find-product-information-about-medicines) - United States: Under review. Not approved alone; Novo Nordisk's CagriSema (cagrilintide plus semaglutide) is under FDA review for obesity, and cagrilintide cannot be compounded (verified 2026-09-29; source: https://www.sec.gov/Archives/edgar/data/353278/000035327826000006/caq42025.htm) ### CJC-1295 - Page: https://glp1base.com/molecules/cjc-1295 - Also known as: CJC-1295 DAC, CJC1295, DAC:GRF, Tetrasubstituted GRF(1-29), Modified GRF(1-29), Drug Affinity Complex GHRH analogue - Class: Trending peptide - Targets: Growth hormone-releasing hormone receptor (GHRHR) on pituitary somatotroph cells: the receptor the parent hormone GHRH acts on, Serum albumin (Cys34): covalent attachment site for the DAC form, shown in rats and in laboratory conjugation studies, Growth hormone (GH) and insulin-like growth factor 1 (IGF-1) axis: downstream effect measured in healthy adults - Route: Not given by any approved route, because it is not approved anywhere. In the published human studies it was given as a subcutaneous (under-the-skin) injection to healthy adult volunteers in supervised trial settings. In animal studies it was given by subcutaneous injection to rats and mice. No trial has established a route or schedule for treating any condition. - Last verified: 2026-09-29 Simple: CJC-1295 is a lab-made copy of GHRH, a brain hormone that tells the pituitary gland to release growth hormone. One version is built to stick to a blood protein so it lasts about a week. The only published human studies are small, short trials in healthy adults. No regulator has approved it as a medicine. Expert: CJC-1295 is a synthetic analogue of human GHRH(1-29), the shortest fully active fragment of growth hormone-releasing hormone. It carries substitutions at positions 2 (D-Ala, which FDA notes may make the peptide resistant to dipeptidyl peptidase-IV), 8 (Gln), 15 (Ala) and 27 (Leu) and a C-terminal amide (Jette 2005; FDA 2024). FDA distinguishes two active moieties that the literature and sellers often conflate: CJC-1295 without DAC (29 residues, C152H252N44O42, about 3368 g/mol) and CJC-1295 with the Drug Affinity Complex (DAC), which adds a C-terminal Lys carrying a 3-maleimidopropionamide group (C165H269N47O46, about 3647 g/mol). The maleimide reacts with the free thiol of Cys34 on serum albumin after injection, giving a long-lived albumin conjugate (shown in rats by Western blot). The DAC form is the one studied in humans. In two randomised, placebo-controlled, double-blind ascending-dose trials in healthy adults aged 21-61 years (Teichman 2006), single subcutaneous injections raised mean plasma GH 2- to 10-fold for 6 days or more and IGF-I 1.5- to 3-fold for 9-11 days; estimated half-life was 5.8-8.1 days and no serious adverse reactions were reported. In a follow-up study in young men (Ionescu and Frohman 2006), pulsatile GH secretion was preserved (pulse frequency and size unchanged) while trough GH rose 7.5-fold, mean GH 46% and IGF-I 45%. Animal data include normalised growth in GHRH-knockout mice with somatotroph proliferation (Alba 2006). A phase 2 trial in HIV-associated visceral obesity (NCT00267527) was terminated in 2006 and its data were never published; FDA describes anecdotal reports that a participant died of a myocardial infarction, which the attending physician attributed to underlying coronary disease. No efficacy trial in growth hormone deficiency or any other disease has been published. CJC-1295 is not a component of any FDA-approved drug and has no USP monograph. In December 2024 FDA's Pharmacy Compounding Advisory Committee voted against placing any CJC-1295 form on the 503A bulks list. Evidence level: Small human studies. Human evidence is limited to short studies in healthy adult volunteers. FDA counted 63 healthy adults across three published studies, mostly men, and most received only one injection. These studies measured hormone levels (GH and IGF-I), pharmacokinetics and short-term tolerability, not whether the peptide treats any condition. A phase 2 trial in HIV-associated visceral obesity was registered in 2005 and terminated in 2006 and has no published results. There is no published trial in people with growth hormone deficiency. Growth results come from animals only (rats and GHRH-knockout mice). Long-term safety in humans is unknown. - Evidence source: Journal of Clinical Endocrinology & Metabolism (Teichman SL et al.), "Prolonged stimulation of growth hormone (GH) and insulin-like growth factor I secretion by CJC-1295, a long-acting analog of GH-releasing hormone, in healthy adults" (2006-03) https://pubmed.ncbi.nlm.nih.gov/16352683/ - Evidence source: Journal of Clinical Endocrinology & Metabolism (Ionescu M, Frohman LA), "Pulsatile secretion of growth hormone (GH) persists during continuous stimulation by CJC-1295, a long-acting GH-releasing hormone analog" (2006-12) https://pubmed.ncbi.nlm.nih.gov/17018654/ - Evidence source: ClinicalTrials.gov (ConjuChem), "A Study to Evaluate CJC 1295 in HIV Patients With Visceral Obesity (NCT00267527)" (2005-12) https://clinicaltrials.gov/study/NCT00267527 - Evidence source: U.S. Food and Drug Administration, "FDA Briefing Document, Pharmacy Compounding Advisory Committee, December 4, 2024: CJC-1295-Related Bulk Drug Substances" (2024-12-04) https://www.fda.gov/media/183819/download Half-life: About 5.8 to 8.1 days (estimated after single injections of the DAC form in healthy adults) (source: https://pubmed.ncbi.nlm.nih.gov/16352683/) Status by country: - Australia: Prohibited. Unapproved and controlled: CJC-1295 is prescription-only, possession without authority is illegal, and the TGA has named and seized it. (verified 2026-09-29; source: https://www.legislation.gov.au/F2026L00633/latest/text) - Brazil: Not approved. Not registered in Brazil; Anvisa says injectable CJC-1295 sold online is irregular (verified 2026-09-29; source: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa) - Canada: Prohibited. Not authorised; named in seizure notices from 2025 and 2026 and banned in sport (verified 2026-09-29; source: https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm) - China: Not approved. Not an approved medicine in China; unlawful to sell as a drug, and it is banned in sport. (verified 2026-09-29; source: https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html) - European Union: Not approved. No EU marketing authorisation; banned in sport (WADA S2.2.4) (verified 2026-09-29; source: https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json) - India: Not approved. Not approved in India: no CDSCO marketing permission found for CJC-1295; making or selling it as a medicine would be unapproved (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf) - Japan: Not approved. Not an approved medicine in Japan; sale and advertising as a drug are illegal, and WADA bans CJC-1295 in sport (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. Not approved in Mexico; unregistered peptide named in a July 2026 bill and a fact-check (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Prohibited. Not approved; Medsafe names CJC-1295 as an illegal unapproved peptide and says it seizes it (verified 2026-09-29; source: https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp) - United Arab Emirates: Not approved. Not approved in the UAE: no marketing authorisation for CJC-1295; unapproved peptide products are under EDE enforcement (verified 2026-09-29; source: https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities) - United Kingdom: Not approved. CJC-1295 is not licensed in the UK (verified 2026-09-29; source: https://www.gov.uk/guidance/find-product-information-about-medicines) - United States: Not approved. No FDA approval; FDA lists CJC-1295 among withdrawn nominations and cites serious adverse events, so it is not on the 503A list (verified 2026-09-29; source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) ### DSIP (delta sleep-inducing peptide) - Page: https://glp1base.com/molecules/dsip - Also known as: Emideltide, Delta sleep-inducing peptide, Delta sleeping inducing peptide, DSIP nonapeptide, Delta sleep peptide - Class: Trending peptide - Targets: No confirmed receptor or molecular target. Animal and cell studies point to an indirect link with the opioid system (naloxone blocks some effects, but DSIP did not displace an opioid ligand from rat brain or human placental membranes in vitro) and to reported release of enkephalins in brain tissue. - Route: In every human study FDA identified, DSIP was given by intravenous injection in a clinical or laboratory setting. Animal studies also used direct infusion into the brain ventricles, and intraperitoneal or subcutaneous injection. No study of subcutaneous or nasal use in people was identified by FDA. No approved product exists and there is no approved route. - Last verified: 2026-09-29 Simple: DSIP is a tiny chain of nine amino acids (the building blocks of proteins). Scientists first found it in rabbit blood in the 1970s during sleep experiments. It is not an approved medicine anywhere we could verify. Human studies were small and old, and results were mixed. Nobody has found its gene or receptor, so how it might work is still unclear. Expert: DSIP (delta sleep-inducing peptide; INN emideltide) is a linear nonapeptide, H-Trp-Ala-Gly-Gly-Asp-Ala-Ser-Gly-Glu-OH (C35H48N10O15, 848.8 g/mol; PubChem CID 68816, CAS 62568-57-4). It was isolated in 1977 by the Schoenenberger-Monnier group in Basel from cerebral venous blood dialysate of rabbits given hypnogenic thalamic stimulation; the synthetic peptide raised EEG delta and spindle activity after intraventricular infusion in rabbits, and only the alpha-aspartyl form (not the beta-Asp isomer) was active. It is unmodified: no D-amino acids, lipidation or other half-life engineering. No gene, precursor protein or receptor has been identified, and a 2006 review called the link between DSIP and sleep weakly documented. In animals the peptide crosses the blood-brain barrier and its sleep effects are inconsistent between studies; naloxone blocks some effects, but DSIP does not displace opioid ligands from receptor membranes in vitro, and enkephalin release has been reported in brain tissue. Pharmacokinetics: plasma half-life after intravenous injection is about 2 to 4 minutes in dogs, a monkey and rats (Kato 1984) and about 5 to 10 minutes in human serum in vitro (as cited by FDA), which FDA attributes mainly to rapid breakdown by peptidases starting at the N-terminal end; FDA identified no pharmacokinetic study for subcutaneous use. Human evidence is limited to 1980s to 1990s intravenous studies: small crossover and parallel-group studies in chronic insomnia with inconsistent results (the 16-patient double-blind study of Bes 1992 concluded any benefit was weak), an uncontrolled open-label report in 107 inpatients with alcohol or opiate withdrawal (Dick 1984), a 7-patient open-label opioid detoxification study (Backmund 1998, as summarised by FDA), and a single-patient narcolepsy report. No phase 2 or 3 programme was identified. No regulator among FDA, EMA, MHRA, PMDA, NMPA, TGA or Health Canada has approved a DSIP product that we could verify; there is no USP or NF monograph. FDA evaluated emideltide-related bulk substances at its own initiative for the 503A bulks list after two nominations were withdrawn, proposed not adding them (poor characterisation, insufficient evidence of effectiveness, no subcutaneous-route effectiveness or safety data, immunogenicity and impurity concerns), and the Pharmacy Compounding Advisory Committee narrowly voted against listing (6 to 7, with 1 abstention) on 24 July 2026. Evidence level: Small human studies. Human evidence is small, old and mixed, and all of it used intravenous injection. Chronic insomnia: FDA's 2026 review focused on three studies and also described several other small reports. A 6-person crossover study reported only tendencies toward fewer awakenings and higher sleep efficiency; a 14-person study without a placebo arm (compared with an external matched group) reported shorter time to fall asleep (58.4 to 27.6 minutes) and more total sleep time, but FDA judged its methods poor; and the 16-patient double-blind parallel-group study of Bes 1992 concluded that the statistically significant effects were weak and that short-term treatment is not likely to be of major therapeutic benefit. FDA also noted that a second double-blind, placebo-controlled crossover study in 6 patients (Monti 1987) found no significant differences from placebo. Withdrawal: an uncontrolled open-label report in 107 inpatients with alcohol or opiate withdrawal described improved signs and symptoms, but had no comparison group or blinding; FDA also described a 7-patient open-label opioid detoxification study (Backmund 1998) with no comparison group. Narcolepsy: a single-patient case report. FDA concluded there was insufficient evidence of effectiveness for chronic insomnia, narcolepsy or opioid withdrawal, and none for the subcutaneous route. Animal: rabbit, rat and cat EEG studies report more delta-wave activity, but findings differ between laboratories and some studies found no effect. No phase 2 or phase 3 trial was identified. - Evidence source: U.S. Food and Drug Administration, "FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: Evaluation of Emideltide-related bulk drug substances (Emideltide (free base) and Emideltide acetate) for inclusion on the 503A Bulk Drug Substances List" (2026-07) https://www.fda.gov/media/193344/download - Evidence source: Neuropsychobiology (via PubMed), "Effects of delta sleep-inducing peptide on sleep of chronic insomniac patients. A double-blind study" (1992) https://pubmed.ncbi.nlm.nih.gov/1299794/ - Evidence source: European Neurology (via PubMed), "DSIP in the treatment of withdrawal syndromes from alcohol and opiates" (1984) https://pubmed.ncbi.nlm.nih.gov/6548969/ - Evidence source: Proceedings of the National Academy of Sciences of the USA (via PubMed), "Characterization of a delta-electroencephalogram (-sleep)-inducing peptide" (1977-03) https://pubmed.ncbi.nlm.nih.gov/265572/ - Evidence source: Journal of Neurochemistry (via PubMed), "Delta sleep-inducing peptide (DSIP): a still unresolved riddle" (2006-04) https://pubmed.ncbi.nlm.nih.gov/16539679/ Half-life: Very short. In animals, about 2 to 6 minutes after intravenous injection (dogs 3 to 6 minutes; rats and a monkey about 2 to 3 minutes). FDA's 2026 review also states a plasma half-life of about 8 minutes without naming the species or study, and a half-life of about 5 to 10 minutes when the peptide was kept in human serum in a test tube. No human pharmacokinetic data exist for injection under the skin. (source: https://www.fda.gov/media/193344/download) Status by country: - Australia: Not approved. No DSIP product is on the ARTG. It counts as an unapproved peptide, and advertising or supplying it is likely unlawful. (verified 2026-09-29; source: https://www.tga.gov.au/resources/artg?keywords=DSIP) - Brazil: Not approved. No Brazilian registration for DSIP; the unregistered-peptide rules apply (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Prohibited. Not authorised; named in Health Canada's April 2026 advisory of seized unauthorised injectables (verified 2026-09-29; source: https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm) - China: Not approved. No NMPA approval found for DSIP; it cannot lawfully be sold as a medicine in China. (verified 2026-09-29; source: https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html) - European Union: Not approved. No EU marketing authorisation; not listed in EMA or Union Register data (verified 2026-09-29; source: https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json) - India: Not approved. Not approved in India: no CDSCO marketing permission found for DSIP; making or selling it as a medicine would be unapproved (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf) - Japan: Not approved. Not an approved medicine in Japan; DSIP (delta sleep-inducing peptide) is absent from PMDA's approved-drug lists and package-insert database (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. No registration for DSIP found in COFEPRIS lists (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Not approved. No Medsafe-approved medicine contains DSIP; it is not named in Medsafe's 2026 peptide advisory (verified 2026-09-29; source: https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm) - United Arab Emirates: Not approved. Not approved in the UAE: no marketing authorisation for DSIP; unapproved peptide products are under EDE enforcement (verified 2026-09-29; source: https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities) - United Kingdom: Not approved. DSIP (delta sleep-inducing peptide) is not licensed in the UK (verified 2026-09-29; source: https://www.gov.uk/guidance/find-product-information-about-medicines) - United States: Not approved. No FDA approval; advisers reviewed emideltide (DSIP) in July 2026 and, per a law-firm report, did not recommend it (verified 2026-09-29; source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) ### Dulaglutide - Page: https://glp1base.com/molecules/dulaglutide - Also known as: LY2189265, Dulaglutida - Brand names (nominative use only): Trulicity - Class: Approved GLP-1 medicine - Targets: GLP-1 receptor - Route: Subcutaneous injection, once weekly, from a single-dose pen (approved use in type 2 diabetes). - Last verified: 2026-09-29 Simple: Dulaglutide copies a gut hormone called GLP-1. It helps the pancreas release insulin when blood sugar is high and slows how fast the stomach empties. It is joined to part of an antibody, which keeps it in the body for days, so it is given once a week. It is approved for type 2 diabetes. Expert: Dulaglutide is a GLP-1 receptor agonist fusion protein: two disulfide-linked chains, each carrying a GLP-1(7-37) analogue (90% homologous to native GLP-1, with changes that resist DPP-4 cleavage) joined by a short peptide linker to a modified human IgG4 Fc fragment engineered to reduce Fc-receptor binding and half-antibody formation. It is produced in Chinese hamster ovary cells and has a molecular weight of about 63 kDa. The Fc fusion gives a much longer half-life than native GLP-1: elimination half-life is about 5 days, time to peak concentration of 24 to 72 hours and steady state after 2 to 4 weeks. It activates the GLP-1 receptor on pancreatic beta cells (cAMP-dependent, glucose-dependent insulin release), lowers glucagon and delays gastric emptying. FDA approved it on 2014-09-18 and the EU authorised it on 2014-11-21, for type 2 diabetes; the label also includes reducing major adverse cardiovascular events, based on REWIND (HR 0.88). It carries a boxed warning for thyroid C-cell tumours seen in rats. Unlike semaglutide and tirzepatide, it is not approved for chronic weight management. Evidence level: Approved. Approved on the AWARD phase 3 programme in type 2 diabetes (for example AWARD-2 versus insulin glargine), then the REWIND cardiovascular outcomes trial (9,901 participants, median follow-up 5.4 years) and the AWARD-PEDS trial in youths aged 10 to under 18. Preclinical engineering and animal studies are reported in Glaesner 2010. - Evidence source: Diabetes Care (via PubMed), "Efficacy and Safety of Once-Weekly Dulaglutide Versus Insulin Glargine in Patients With Type 2 Diabetes on Metformin and Glimepiride (AWARD-2)" (2015-12) https://pubmed.ncbi.nlm.nih.gov/26089386/ - Evidence source: The Lancet (via PubMed), "Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial" (2019-07-13) https://pubmed.ncbi.nlm.nih.gov/31189511/ - Evidence source: New England Journal of Medicine (via PubMed), "Once-Weekly Dulaglutide for the Treatment of Youths with Type 2 Diabetes" (2022-08-04) https://pubmed.ncbi.nlm.nih.gov/35658022/ Half-life: About 5 days (elimination half-life) (source: https://pi.lilly.com/us/trulicity-uspi.pdf) Status by country: - Australia: Approved. Approved as Trulicity for type 2 diabetes since January 2015 and listed on the PBS. Compounded GLP-1 copies are barred. (verified 2026-09-29; source: https://www.tga.gov.au/resources/artg/217965) - Brazil: Approved. Approved as Trulicity, registered by Anvisa in 2015 for type 2 diabetes (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Approved. Approved as Trulicity for type 2 diabetes; no generic submissions on Health Canada's list (verified 2026-09-29; source: https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=dulaglutide) - China: Approved. Approved in China and on the national insurance list for type 2 diabetes, with restrictions; a domestic biosimilar application is in review. (verified 2026-09-29; source: https://www.nhsa.gov.cn/module/download/downfile.jsp?classid=0&filename=a32f9f2f3fc046afaf08471f87456ce3.pdf) - European Union: Approved. Authorised EU-wide as Trulicity for type 2 diabetes (from age 10); no weight-management indication (verified 2026-09-29; source: https://www.ema.europa.eu/en/medicines/human/EPAR/trulicity) - India: Approved. Approved in India (Eli Lilly) for type 2 diabetes; the expert committee backed adding an age-10-and-over indication in 2024 (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/RecommendEndocrinology_25_04_2017_13.pdf) - Japan: Approved. Approved for type 2 diabetes as Trulicity, on the NHI price list; not approved for obesity (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281190.pdf) - Mexico: Approved. Approved as Trulicity (Eli Lilly) for type 2 diabetes; listed as valid by COFEPRIS in May 2024 (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/303036/Alop_ticos_2015.pdf) - New Zealand: Approved. Approved as Trulicity for type 2 diabetes and publicly funded with Special Authority criteria (verified 2026-09-29; source: https://www.medsafe.govt.nz/profs/datasheet/t/trulicityinj.pdf) - United Arab Emirates: Unverified. Could not confirm whether dulaglutide (Trulicity) is registered by the EDE; no UAE-specific record was found (verified 2026-09-29; source: https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae) - United Kingdom: Approved. Licensed in the UK as Trulicity for type 2 diabetes only; not licensed for weight loss (verified 2026-09-29; source: https://www.medicines.org.uk/emc/product/7482/smpc) - United States: Approved. FDA-approved as Trulicity for type 2 diabetes since 2014; as a biologic it cannot be compounded (verified 2026-09-29; source: http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125469s065lbl.pdf) ### Ecnoglutide - Page: https://glp1base.com/molecules/ecnoglutide - Also known as: XW003, XW-003, Ecnoglutide injection - Brand names (nominative use only): Xianyida (先颐达), Xianweiying (先维盈) - Class: Approved GLP-1 medicine - Targets: GLP-1 receptor - Route: Subcutaneous injection, given once weekly (as studied in the phase 3 trials and approved in China). Oral tablet versions are being studied separately and are investigational. - Last verified: 2026-09-29 Simple: Ecnoglutide is a once-a-week injection that copies a gut hormone called GLP-1. It helps the body release insulin and makes people feel full. China approved it in 2026 for type 2 diabetes and for weight management. No approval from the US, EU or UK regulators was found as of late September 2026. Expert: Ecnoglutide (XW003) is a once-weekly, subcutaneously administered, acylated 31-residue analogue of GLP-1(7-37), developed by Hangzhou Sciwind Biosciences (PubChem CID 162625103; C194H304N48O61, about 4,285 Da). Relative to native GLP-1(7-37) it carries Ala8Val, Gly22Glu, Lys26Arg, Ala30Lys and Lys34Arg substitutions, and a C18 diacid fatty acid attached through a gamma-Glu-2xAEEA linker to Lys30, which promotes albumin binding and extends half-life; it contains only natural amino acids. In vitro it activates cAMP signalling with an EC50 of 0.018 nM, while beta-arrestin recruitment reaches about 60% of the semaglutide maximum and receptor internalisation is much weaker than with semaglutide (EC50 above 10 uM versus 0.093 uM); the sponsor calls this a cAMP-biased profile, and its clinical significance relative to unbiased agonists has not been shown in a head-to-head human trial. In a phase 1 study in healthy adults (n=64), steady-state half-life was 124 to 138 hours. Sciwind announced China NMPA approval for glycaemic control in adults with type 2 diabetes on 2026-01-30 (brand Xianyida) and for long-term weight management in adults with overweight or obesity on 2026-03-06 (brand Xianweiying). Key phase 3 trials: SLIMMER (NCT05813795; 664 adults with overweight or obesity, placebo-controlled, weight change at week 40 of -9.1%, -10.9% and -13.2% across the three tested doses versus +0.1% on placebo); EECOH-1 (NCT05680155; HbA1c change of -1.96% and -2.43% versus -0.87% on placebo at week 24); and EECOH-2 (NCT05680129; non-inferior to dulaglutide at the comparator dose, HbA1c -1.91% and -1.89% versus -1.65% at week 32). All pivotal trials were run in Chinese adults. Pfizer China holds mainland-China commercial rights, with Sciwind as marketing authorisation holder. Regulatory approval outside China was not found as of 2026-09-29. Evidence level: Approved. Approved by China's NMPA (approvals announced by the sponsor on 2026-01-30 for type 2 diabetes and 2026-03-06 for weight management), which is a major regulator on the schema's list. The approvals rest on three randomised phase 3 trials in Chinese adults, published in peer-reviewed journals: SLIMMER (obesity, placebo-controlled, 48 weeks), EECOH-1 (type 2 diabetes, placebo-controlled, 24 weeks) and EECOH-2 (type 2 diabetes versus dulaglutide, 52 weeks). A phase 2 diabetes trial and a phase 1 study in healthy adults preceded them. No approval from the FDA, EMA, MHRA, PMDA, TGA or Health Canada was found. All the pivotal trials were sponsor-funded and done only in China, so results may not transfer to other populations. Further phase 3 studies (obstructive sleep apnoea and knee osteoarthritis in adults with obesity) are registered and recruiting, and a phase 3 study in adolescents with overweight or obesity (SLIMMER-YOUNG) is registered but not yet recruiting; those uses are investigational and not approved. - Evidence source: The Lancet Diabetes & Endocrinology (PubMed), "Efficacy and safety of a biased GLP-1 receptor agonist ecnoglutide in adults with overweight or obesity: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial (SLIMMER)" (2025-09) https://pubmed.ncbi.nlm.nih.gov/40555243/ - Evidence source: Nature Communications (PubMed), "Efficacy and safety of cAMP signalling-biased GLP-1 analogue ecnoglutide monotherapy versus placebo in patients with type 2 diabetes (EECOH-1): a multi-centre, randomised, double-blind, placebo-controlled, phase 3 trial" (2026-01-07) https://pubmed.ncbi.nlm.nih.gov/41501026/ - Evidence source: The Lancet Diabetes & Endocrinology (PubMed), "Efficacy and safety of cAMP-biased GLP-1 receptor agonist ecnoglutide versus dulaglutide in patients with type 2 diabetes and elevated glucose concentrations on metformin monotherapy (EECOH-2): a 52-week, multicentre, open-label, non-inferiority, randomised, phase 3 trial" (2025-10) https://pubmed.ncbi.nlm.nih.gov/40854315/ - Evidence source: Nature Communications (PubMed), "Efficacy and safety of GLP-1 analog ecnoglutide in adults with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 2 trial" (2024-09-27) https://pubmed.ncbi.nlm.nih.gov/39333121/ - Evidence source: Sciwind Biosciences (PR Newswire), "Sciwind Biosciences Announces Ecnoglutide Injection Approved by China's National Medical Products Administration (NMPA) for Chronic Weight Management" (2026-03-06) https://www.prnewswire.com/news-releases/sciwind-biosciences-announces-ecnoglutide-injection-approved-by-chinas-national-medical-products-administration-nmpa-for-chronic-weight-management-302706442.html - Evidence source: Sciwind Biosciences (PR Newswire), "Sciwind Biosciences Announces Ecnoglutide Injection Approved by China's National Medical Products Administration (NMPA) for Adult Type 2 Diabetes" (2026-01-30) https://www.prnewswire.com/apac/news-releases/sciwind-biosciences-announces-ecnoglutide-injection-approved-by-chinas-national-medical-products-administration-nmpa-for-adult-type-2-diabetes-302675016.html - Evidence source: ClinicalTrials.gov, "A Study of XW003 in Obese Participants With Obstructive Sleep Apnea Receiving Positive Airway Pressure Therapy, NCT07434050" (2026-02-25) https://clinicaltrials.gov/study/NCT07434050 - Evidence source: ClinicalTrials.gov, "A Study of Econoglutide Injection in Obese Participants With Knee Osteoarthritis (KOA), NCT07734311" (2026-07-29) https://clinicaltrials.gov/study/NCT07734311 - Evidence source: Hangzhou Sciwind Biosciences, "全球首个偏向型GLP-1埃诺格鲁肽注射液获批！ (Xianyida approved for type 2 diabetes)" (2026-01-30) https://www.sciwind.com.cn/portal/index/newsdetail/id/131.html - Evidence source: Hangzhou Sciwind Biosciences, "全球首个偏向型GLP-1减重药物先维盈®获批上市！ (Xianweiying approved for weight management)" (2026-03-06) https://www.sciwind.com.cn/portal/index/newsdetail/id/135.html - Evidence source: ClinicalTrials.gov, "A Study of Ecnoglutide Injection in Overweight or Obese Chinese Adolescents (SLIMMER-YOUNG), NCT07836270" (2026-09-23) https://clinicaltrials.gov/study/NCT07836270 Half-life: Steady-state half-life of about 124 to 138 hours (roughly 5 to 6 days) in healthy adults in the phase 1 multiple-dose study, supporting once-weekly injection (source: https://pubmed.ncbi.nlm.nih.gov/37364710/) Status by country: - Australia: Not approved. Not approved in Australia. No ecnoglutide product is on the ARTG and no application appears on the TGA's evaluation list. (verified 2026-09-29; source: https://www.tga.gov.au/resources/artg?keywords=ecnoglutide) - Brazil: Not approved. Ecnoglutide has no Brazilian registration and is not on the market (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Not approved. Ecnoglutide is an investigational drug with no Health Canada authorisation (verified 2026-09-29; source: https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=ecnoglutide) - China: Approved. Approved in China for type 2 diabetes (January 2026) and weight management (March 2026); Chinese-developed. (verified 2026-09-29; source: https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20260130142923121.html) - European Union: Not approved. No EU marketing authorisation and no application under evaluation (verified 2026-09-29; source: https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm) - India: Not approved. Not approved in India: no CDSCO marketing permission or Indian trial record found for ecnoglutide (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf) - Japan: Not approved. No marketing approval in Japan; the investigational GLP-1 agonist ecnoglutide does not appear in PMDA's approved-drug lists to September 2026 (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. Not registered in Mexico; ecnoglutide is approved only in China (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Not approved. Ecnoglutide is an investigational medicine with no Medsafe consent in New Zealand (verified 2026-09-29; source: https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm) - United Arab Emirates: Not approved. No EDE approval found for ecnoglutide; not marketed in the UAE (verified 2026-09-29; source: https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae) - United Kingdom: Not approved. Ecnoglutide has no UK licence (verified 2026-09-29; source: https://www.gov.uk/guidance/find-product-information-about-medicines) - United States: Not approved. Not approved in the US; only early-stage US studies of an oral form have been registered (verified 2026-09-29; source: https://clinicaltrials.gov/study/NCT07281937) ### Elamipretide (SS-31) - Page: https://glp1base.com/molecules/elamipretide - Also known as: SS-31, Bendavia, MTP-131, Szeto-Schiller peptide 31, D-Arg-Dmt-Lys-Phe-NH2, Elamipretide hydrochloride - Brand names (nominative use only): Forzinity - Class: Approved peptide medicine - Targets: Cardiolipin, a fat molecule in the inner mitochondrial membrane (the peptide binds it), Cardiolipin-binding proteins of the mitochondrial energy machinery, such as ATP synthase and the adenine nucleotide translocator (identified in mouse-heart mitochondria) - Route: Given by subcutaneous injection in its approved use (US label); it is not approved for intravenous use. In research it has also been given by intravenous infusion (for example, the EMBRACE STEMI heart-attack trial and a single-dose study in older adults); that route is not approved. - Last verified: 2026-09-29 Simple: Elamipretide is a tiny four-piece protein that gets inside cells and sticks to the inner wall of mitochondria, the parts that make energy. In September 2025 the US FDA gave it a conditional (accelerated) approval for Barth syndrome, a rare genetic muscle and heart disease. Its other tried uses are not approved. Expert: Elamipretide (SS-31, MTP-131, Bendavia) is a synthetic tetrapeptide, D-Arg-2',6'-dimethyl-Tyr-Lys-Phe-NH2, a Szeto-Schiller peptide (C32H49N9O5, 639.8 Da as the free base; the marketed hydrochloride salt is 749.2). The alternating basic and aromatic residues make it polybasic and amphipathic. The D-arginine and the non-natural dimethyltyrosine are the engineered features: dimethyltyrosine gives antioxidant properties in vitro. It is cell-permeable and concentrates in the inner mitochondrial membrane (IMM) in cell and isolated-mitochondria work. It binds the anionic phospholipid cardiolipin, alters membrane surface electrostatics and protein-lipid interactions, and, in isolated mouse-heart mitochondria, cross-links to cardiolipin-binding proteins of oxidative phosphorylation (ATP synthase, respiratory complexes III and IV, the adenine nucleotide translocator); in rodent ischaemia-reperfusion models it preserves cristae structure and ATP recovery. The FDA label calls it a mitochondrial cardiolipin binder. Pharmacokinetics (FDA label and review): after subcutaneous injection the absolute bioavailability is about 92%, Tmax 0.5-1 h, volume of distribution about 0.5 L/kg, plasma protein binding about 39%; it is cleared by C-terminal degradation to inactive tri- and dipeptide metabolites, with about 100% of a dose recovered in urine within 48 h, and a half-life of about 3-4 h; exposure rises in renal impairment. Barth syndrome is an X-linked disorder of TAFAZZIN (TAZ), the enzyme that matures cardiolipin. The FDA granted accelerated approval on 19 September 2025 (Forzinity, NDA 215244) to improve muscle strength in patients with Barth syndrome weighing at least 30 kg, based on knee-extensor strength (an intermediate endpoint) in the TAZPOWER trial: a 12-patient randomised crossover trial that missed both primary endpoints, followed by an open-label extension with no control arm in which strength rose. FDA reviewers were divided on whether this was substantial evidence. Continued approval depends on a confirmatory trial. The phase 3 MMPOWER-3 trial in primary mitochondrial myopathy missed its primary endpoints, phase 2 trials in heart failure and heart attack did not meet their main endpoints, and the phase 2 ReCLAIM-2 trial in dry AMD missed its primary endpoints; a phase 3 dry AMD trial (ReNEW) is ongoing. These other uses are unapproved. No approval outside the US was found; the sponsor reports an EU orphan designation for Barth syndrome, which is a rare-disease development status, not an approval. Evidence level: Approved. Approved only in the US, under accelerated approval (19 September 2025), for Barth syndrome. The pivotal package is very small: TAZPOWER randomised 12 people; in the randomised part neither primary endpoint (6-minute walk, fatigue score) beat placebo, and knee strength rose only in the open-label extension, which had no control group. FDA reviewers disagreed on whether this was enough. In other conditions, the phase 3 MMPOWER-3 trial (primary mitochondrial myopathy, 218 people) missed its primary endpoints, phase 2 trials in heart failure and heart attack did not meet their main endpoints, and the phase 2 dry-AMD trial ReCLAIM-2 missed its primary endpoints (a phase 3, ReNEW, is running). Those uses are not approved. - Evidence source: U.S. Food and Drug Administration (CDER), "NDA 215244 Forzinity (elamipretide) Integrated Review" (2025-09-19) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/215244Orig1s000IntegratedR.pdf - Evidence source: U.S. Food and Drug Administration (Drugs@FDA), "FORZINITY (elamipretide) injection, prescribing information (FDA label, NDA 215244)" (2025-09) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215244s000lbl.pdf - Evidence source: Genetics in Medicine, "Long-term efficacy and safety of elamipretide in patients with Barth syndrome: 168-week open-label extension results of TAZPOWER" (2024-07) https://doi.org/10.1016/j.gim.2024.101138 - Evidence source: Neurology, "Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial" (2023-07) https://doi.org/10.1212/WNL.0000000000207402 - Evidence source: Ophthalmology Science, "ReCLAIM-2: A Randomized Phase II Clinical Trial Evaluating Elamipretide in Age-related Macular Degeneration, Geographic Atrophy Growth, Visual Function, and Ellipsoid Zone Preservation" (2024-10) https://doi.org/10.1016/j.xops.2024.100628 Half-life: About 3 to 4 hours (FDA review). After a single subcutaneous dose the mean half-life was 3.16 h in healthy volunteers and 1.48 h in people with Barth syndrome. (source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/215244Orig1s000IntegratedR.pdf) Status by country: - Australia: Not approved. No elamipretide product is on the ARTG and none appears on the TGA's evaluation list. (verified 2026-09-29; source: https://www.tga.gov.au/resources/artg?keywords=elamipretide) - Brazil: Not approved. No Brazilian registration for elamipretide (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Prohibited. Not authorised; Health Canada named SS-31 (elamipretide) among unauthorised injectables it seized in April 2026 (verified 2026-09-29; source: https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm) - China: Not approved. Not approved in China; Stealth BioTherapeutics filed an import clinical-trial application in 2026. (verified 2026-09-29; source: https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d) - European Union: Not approved. No EU marketing authorisation; only EU orphan designations exist (verified 2026-09-29; source: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-21-2430) - India: Not approved. Not approved in India: no CDSCO marketing permission found for elamipretide (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf) - Japan: Not approved. No marketing approval in Japan; elamipretide is not in PMDA's approved-drug lists or package-insert database (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. No registration for elamipretide found in COFEPRIS lists (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Not approved. Elamipretide is classed as a prescription medicine but has no Medsafe consent or data sheet (verified 2026-09-29; source: https://www.medsafe.govt.nz/profs/class/classintro.asp) - United Arab Emirates: Unverified. Could not confirm whether elamipretide is registered by the EDE; no UAE-specific record was found (verified 2026-09-29; source: https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae) - United Kingdom: Not approved. No UK licence found for elamipretide (verified 2026-09-29; source: https://www.gov.uk/guidance/find-product-information-about-medicines) - United States: Approved, restricted. FDA-approved under accelerated approval on 19 September 2025 as Forzinity for Barth syndrome only (verified 2026-09-29; source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215244s000lbl.pdf) ### Eloralintide - Page: https://glp1base.com/molecules/eloralintide - Also known as: LY3841136, LY-3841136 - Class: Amylin analogue - Targets: Amylin 1 receptor (AMY1R: calcitonin receptor with RAMP1), Amylin 3 receptor (AMY3R: calcitonin receptor with RAMP3) - Route: Subcutaneous injection, once weekly, in clinical trials (investigational; not an approved medicine, so there is no approved route of use). - Last verified: 2026-09-29 Simple: Eloralintide is an experimental once-weekly injection being tested for obesity. It copies amylin, a hormone made in the pancreas after meals that helps you feel full. It is not a GLP-1 drug. In a 48-week trial of 263 adults, average weight loss ranged from 9.5% to 20.1%, versus 0.4% on placebo. It is not approved anywhere yet. Expert: Eloralintide (LY3841136, Eli Lilly) is a synthetic, C-terminally amidated 37-residue analogue of human amylin, designed as a selective amylin receptor agonist for once-weekly subcutaneous use. Engineering features: the native Cys2-Cys7 disulfide is replaced by a methylene thioacetal bridge (chemical stability); three non-coded residues (ornithine at position 11, alpha-methyl-phenylalanine at 15, N-methyl-asparagine at 22); an N-terminal gamma-glutamate; and Lys26 acylated through a gamma-Glu-gamma-Glu linker with a C20 fatty diacid to bind albumin and extend half-life. In cAMP assays it was about 12-fold more potent at human AMY1R (EC50 23.9 pM) than at the human calcitonin receptor and about 11-fold more potent than at AMY3R, unlike the non-selective dual amylin/calcitonin agonist cagrilintide. Pharmacokinetics in people with obesity: slow absorption, half-life about 14 days, dose-proportional exposure and low steady-state peak-to-trough ratios (1.28 to 1.38). Key human data: a phase 1 single-ascending-dose study in healthy adults (NCT05295940), a 12-week phase 1 multiple-ascending-dose study (100 participants; least-squares mean weight reduction 2.6% to 11.3% across dose groups), and a 48-week phase 2 trial (NCT06230523; 263 adults without type 2 diabetes; mean weight change -9% to -20% across arms versus -0.4% on placebo, efficacy estimand; most common adverse events nausea and fatigue). Phase 3 (ENLIGHTEN) began in December 2025 and is recruiting; no phase 3 efficacy results are public as of 2026-09-29. It has no marketing approval from any regulator, and Lilly describes it as investigational. Evidence level: Phase 3 trials. Phase 3 (ENLIGHTEN programme) is registered and recruiting; the first phase 3 trial (ENLIGHTEN-2, NCT07282600) started on 2025-12-15, and no phase 3 results are public as of 2026-09-29. The strongest completed human evidence is a 48-week randomised, double-blind, placebo-controlled phase 2 trial in 263 adults with obesity or overweight and no type 2 diabetes (Lancet 2025), supported by phase 1 single- and multiple-ascending-dose studies. Receptor pharmacology, pharmacokinetics in rats and monkeys, and body-composition data come from cell and animal studies. The phase 2 trial was funded by Lilly, and Lilly's summary notes that its endpoints were assessed with the efficacy estimand and not adjusted for multiplicity. - Evidence source: The Lancet (via PubMed), "Eloralintide, a selective amylin receptor agonist for the treatment of obesity: a 48-week phase 2, multicentre, double-blind, randomised, placebo-controlled trial" (2025-11-06) https://pubmed.ncbi.nlm.nih.gov/41207310/ - Evidence source: ClinicalTrials.gov (U.S. National Library of Medicine), "A Study of Eloralintide (LY3841136) in Participants With Obesity, or Overweight Without Type 2 Diabetes (ENLIGHTEN-1 phase 3 record)" (2026-09-22) https://clinicaltrials.gov/study/NCT07321886 - Evidence source: ClinicalTrials.gov (U.S. National Library of Medicine), "A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, and Type 2 Diabetes (ENLIGHTEN-2 phase 3 record)" (2026-09-22) https://clinicaltrials.gov/study/NCT07282600 - Evidence source: Diabetes, Obesity and Metabolism (via PubMed), "Eloralintide, a selective, long-acting amylin receptor agonist for treatment of obesity: Phase 1 proof of concept" (2026-01-20) https://pubmed.ncbi.nlm.nih.gov/41559929/ - Evidence source: Molecular Metabolism (via PubMed), "Eloralintide (LY3841136), a novel amylin receptor agonist for the treatment of obesity: From discovery to clinical proof of concept" (2025-10-16) https://pubmed.ncbi.nlm.nih.gov/41109426/ Half-life: About 14 days (people with obesity or overweight, reported in the phase 1 multiple-ascending-dose paper) (source: https://pubmed.ncbi.nlm.nih.gov/41559929/) Status by country: - Australia: Not approved. Investigational only. No eloralintide product is on the ARTG and no application appears on the TGA's evaluation list. (verified 2026-09-29; source: https://www.tga.gov.au/resources/artg?keywords=eloralintide) - Brazil: Not approved. Eloralintide is an investigational drug with no Brazilian registration (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Not approved. Eloralintide is an investigational drug with no Health Canada authorisation (verified 2026-09-29; source: https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=eloralintide) - China: Not approved. Not approved in China; Lilly has import clinical-trial filings and Chinese phase 3 sites, but no marketing application was found. (verified 2026-09-29; source: https://clinicaltrials.gov/study/NCT07321886) - European Union: Not approved. Investigational; no EU marketing authorisation and no application under evaluation (verified 2026-09-29; source: https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm) - India: Not approved. Not approved in India; Lilly's eloralintide (LY3841136) is only in CDSCO-permitted Phase III trials (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Endocrinology%20Metabolism%2005.02.2026.pdf) - Japan: Not approved. No marketing approval in Japan; the investigational amylin agonist eloralintide does not appear in PMDA's approved-drug lists to September 2026 (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. Not registered in Mexico; eloralintide is an investigational Eli Lilly medicine (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Not approved. Eloralintide is an investigational medicine with no Medsafe consent in New Zealand (verified 2026-09-29; source: https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm) - United Arab Emirates: Not approved. No EDE approval found for eloralintide; an investigational medicine, not marketed in the UAE (verified 2026-09-29; source: https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae) - United Kingdom: Not approved. Investigational medicine with no UK licence (verified 2026-09-29; source: https://www.gov.uk/guidance/find-product-information-about-medicines) - United States: Not approved. Investigational; Eli Lilly is running Phase 3 obesity trials and nothing is approved or filed (verified 2026-09-29; source: https://clinicaltrials.gov/study/NCT07321886) ### Epitalon - Page: https://glp1base.com/molecules/epitalon - Also known as: Epithalon, Epitalone, AEDG peptide, Ala-Glu-Asp-Gly, Tetrapeptide AEDG, AE-0 peptide - Class: Trending peptide - Targets: No confirmed molecular target (laboratory studies report effects on telomerase expression, melatonin and circadian-clock gene expression, and gene regulation) - Route: No approved route. In the few human studies it was given as a sublingual spray (women working night shifts) and as an injection beside the eye (retinitis pigmentosa, parabulbar). Animal studies used subcutaneous injection in mice and intramuscular injection in monkeys. The products FDA reviewed in 2026 were nominated for subcutaneous injection, but no human study of that route was found. Human absorption and bioavailability are unknown. - Last verified: 2026-09-29 Simple: Epitalon is a tiny lab-made chain of four amino acids (building blocks of proteins), copied from the make-up of an extract from cow pineal glands. It is not an approved medicine in the US, and we found no approval by any other regulator. Most of the research comes from one Russian group, in cells and animals, with a few small human studies. It has never been tested for safety in a proper trial. Expert: Epitalon (epithalon, AEDG) is a synthetic linear tetrapeptide, L-Ala-L-Glu-L-Asp-Gly (C14H22N4O9, 390.35 g/mol), designed by V. Khavinson's group at the St Petersburg Institute of Bioregulation and Gerontology from the amino-acid composition of epithalamin, a polypeptide extract of bovine pineal gland; FDA treats epitalon and epithalamin as different substances. It is unmodified: no D-amino acids, lipidation or other half-life engineering. Epitalon is a common name, not a USAN, and the free base (CAS 307297-39-8) and the acetate salt (CAS 307297-40-1) are distinct bulk substances. Reported effects, mostly from the originating group, include induction of telomerase catalytic-subunit expression and telomere elongation in cultured human fetal fibroblasts, increased evening melatonin and normalised cortisol rhythm in old rhesus monkeys, fewer or smaller spontaneous tumours of some types in some mouse models, and altered gene expression in several tissues. An in-vitro rat pineal perifusion study found no direct effect on melatonin release, and the mechanism in vivo is unknown. Human evidence is limited to three small reports identified by FDA: a report of benefit in retinitis pigmentosa after injection beside the eye, and two 2021 reports of sublingual use in women working night shifts, one of them a small randomised placebo-controlled study that measured a urinary melatonin metabolite and clock-gene expression. No pharmacokinetic data exist in humans or, apart from one unvalidated fluorescence-tracer report in rabbits, in animals. No approved product contains epitalon and there is no USP or NF monograph. An orphan designation for retinitis pigmentosa (FDA, 2010) was withdrawn in 2016. FDA staff recommended in 2026 against adding it to the 503A bulks list, citing weak characterisation, no effectiveness data for insomnia and no human safety data, and flagging a theoretical carcinogenicity concern from telomerase activation; the advisory committee voted 7 to 4 (1 abstention) in favour on 24 July 2026, which is advisory only. Evidence level: Small human studies. The evidence is small, mostly from a single research network, and largely not from modern controlled trials. Human: (1) a 2002 report from the originating group that injection beside the eye produced a positive clinical effect in 90% of cases in patients with degenerative retinal lesions (the abstract gives no patient numbers or comparison; a 2025 review's account describes 162 patients and a comparison group on conventional treatment, but no placebo and no between-group results); (2) a small randomised placebo-controlled sublingual study in women aged 40-50 working night shifts (Ivko 2021, 75 women, 40 with low urinary melatonin metabolite split into treatment and placebo groups for 20 days) in which the treated group's metabolite level rose 1.7-fold; sleep outcomes were not assessed and no safety data were reported; FDA noted blinding was not specified and the study was short and small. FDA also listed a related 2021 report on clock-gene expression in night-shift workers. FDA found no study in people with insomnia and no clinical safety study. Animal: monkey hormone studies and mouse lifespan and tumour studies, all with a fixed regimen and (in mice) females only. Cell: telomerase and telomere-length work in human fibroblast cultures. In-vitro rat pineal tissue showed no direct melatonin effect. No phase 2 or 3 trial exists. - Evidence source: U.S. Food and Drug Administration, "FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: Evaluation of Epitalon-Related Bulk Drug Substances (Epitalon (Free Base) and Epitalon Acetate) for the 503A Bulk Drug Substances List" (2026-07) https://www.fda.gov/media/193345/download - Evidence source: International Journal of Molecular Sciences (via PubMed Central), "Overview of Epitalon: Highly Bioactive Pineal Tetrapeptide with Promising Properties" (2025-03-17) https://pmc.ncbi.nlm.nih.gov/articles/PMC11943447/ - Evidence source: Neuroendocrinology Letters (via PubMed), "Pineal-regulating tetrapeptide epitalon improves eye retina condition in retinitis pigmentosa" (2002-08) https://pubmed.ncbi.nlm.nih.gov/12195242/ - Evidence source: Biogerontology (via PubMed), "Effect of Epitalon on biomarkers of aging, life span and spontaneous tumor incidence in female Swiss-derived SHR mice" (2003) https://pubmed.ncbi.nlm.nih.gov/14501183/ - Evidence source: Bulletin of Experimental Biology and Medicine (via PubMed), "Epithalon peptide induces telomerase activity and telomere elongation in human somatic cells" (2003-06) https://pubmed.ncbi.nlm.nih.gov/12937682/ - Evidence source: Bulletin of Experimental Biology and Medicine (via PubMed), "Regulatory effect of Epithalon on production of melatonin and cortisol in old monkeys" (2001-04) https://pubmed.ncbi.nlm.nih.gov/11550036/ - Evidence source: Journal of Endocrinological Investigation (via PubMed), "Effect of a synthetic pineal tetrapeptide (Ala-Glu-Asp-Gly) on melatonin secretion by the pineal gland of young and old rats" (2003-03) https://pubmed.ncbi.nlm.nih.gov/12809170/ Status by country: - Australia: Not approved. No epitalon product is on the ARTG. It counts as an unapproved peptide, and advertising or supplying it is likely unlawful. (verified 2026-09-29; source: https://www.tga.gov.au/resources/artg?keywords=epitalon) - Brazil: Not approved. No Brazilian registration for epitalon; the unregistered-peptide rules apply (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Prohibited. Not authorised; named in Health Canada's seizure notices from 2025 and 2026 (verified 2026-09-29; source: https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm) - China: Not approved. No NMPA approval found for epitalon; it cannot lawfully be sold as a medicine in China. (verified 2026-09-29; source: https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html) - European Union: Not approved. No EU marketing authorisation; not listed in EMA or Union Register data (verified 2026-09-29; source: https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json) - India: Not approved. Not approved in India: no CDSCO marketing permission found for Epitalon; making or selling it as a medicine would be unapproved (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf) - Japan: Not approved. Not an approved medicine in Japan; epitalon is absent from PMDA's approved-drug lists and package-insert database (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. Not approved in Mexico; unregistered peptide named in a July 2026 bill (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Not approved. No Medsafe-approved medicine contains epitalon; pineal peptides are prescription-only (verified 2026-09-29; source: https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm) - United Arab Emirates: Not approved. Not approved in the UAE: no marketing authorisation for epitalon; unapproved peptide products are under EDE enforcement (verified 2026-09-29; source: https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities) - United Kingdom: Not approved. Epitalon is not licensed in the UK (verified 2026-09-29; source: https://www.gov.uk/guidance/find-product-information-about-medicines) - United States: Not approved. No FDA approval; an advisory panel voted in July 2026 to recommend considering it, but the vote is not binding (verified 2026-09-29; source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) ### Exenatide - Page: https://glp1base.com/molecules/exenatide - Also known as: Exendin-4 (synthetic), Exendin 4, AC2993, LY2148568, Exenatide once weekly (extended-release form) - Brand names (nominative use only): Byetta, Bydureon BCise, Bydureon - Class: Approved GLP-1 medicine - Targets: GLP-1 receptor - Route: Subcutaneous injection. The original form (Byetta) is given twice a day before meals from a prefilled pen; extended-release forms (Bydureon, Bydureon BCise) are given once a week. - Last verified: 2026-09-29 Simple: Exenatide is a lab-made copy of a hormone first found in the saliva of the Gila monster, a large lizard. It acts on the same receptor as the gut hormone GLP-1: it helps the pancreas release insulin when blood sugar is high and slows the stomach. It was approved in the US in 2005 for type 2 diabetes. Expert: Exenatide is the synthetic form of exendin-4, a 39-residue peptide amide (C184H282N50O60S, 4186.6 Da) first isolated from Heloderma suspectum venom. Its sequence only partly overlaps human GLP-1; it binds and activates the human GLP-1 receptor, enhancing glucose-dependent insulin secretion, suppressing inappropriately high glucagon and slowing gastric emptying. It carries no fatty-acid chain: it is less prone to enzymatic degradation than native GLP-1 and, according to nonclinical studies, is eliminated mainly by glomerular filtration, giving a terminal half-life of about 2.4 hours (median Tmax 2.1 hours) for the twice-daily immediate-release form, Byetta. Extended-release once-weekly forms (Bydureon, Bydureon BCise) use poly(D,L-lactide-co-glycolide) microspheres to sustain release. FDA first approved Byetta on 28 April 2005 and the EU authorised it on 20 November 2006. In the US, AstraZeneca notified FDA on 16 August 2024 of plans to discontinue Byetta and Bydureon BCise (Bydureon itself left the market in March 2021); FDA approved Amneal's generic exenatide injection (ANDA 206697) on 19 November 2024. Placebo-controlled 16- to 30-week trials showed HbA1c reductions when added to oral agents; EXSCEL (14,752 patients) found the once-weekly form non-inferior to placebo for major cardiovascular events but not superior (HR 0.91, 95% CI 0.83 to 1.00). It has no approved use outside type 2 diabetes; a phase 3 trial in Parkinson's disease reported no benefit and its paper now carries a journal Expression of Concern. Evidence level: Approved. Approved on the basis of phase 3 programmes in type 2 diabetes: placebo-controlled trials of the twice-daily form added to oral drugs (label section 14), DURATION-1 (once-weekly form gave a larger HbA1c fall than twice-daily, -1.9% vs -1.5%), and DURATION-6 (once-weekly exenatide failed non-inferiority against once-daily liraglutide, HbA1c -1.28% vs -1.48%). EXSCEL, a large cardiovascular outcomes trial, found no significant difference in major cardiovascular events (HR 0.91, 95% CI 0.83 to 1.00). Use in Parkinson's disease is unapproved: the UK phase 3 Exenatide-PD3 trial (194 people) found no benefit on motor scores at 96 weeks, and in June 2026 The Lancet published an Expression of Concern about that paper. - Evidence source: U.S. Food and Drug Administration, "BYETTA (exenatide) injection prescribing information (revised 09/2025)" (2025-09) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021773Orig1s051correctedlbl.pdf - Evidence source: The Lancet, "Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study (DURATION-1)" (2008-09-07) https://doi.org/10.1016/s0140-6736(08)61206-4 - Evidence source: The Lancet, "Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (DURATION-6): a randomised, open-label study" (2012-11-07) https://doi.org/10.1016/s0140-6736(12)61267-7 - Evidence source: New England Journal of Medicine, "Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes (EXSCEL)" (2017-09-14) https://www.nejm.org/doi/full/10.1056/NEJMoa1612917 - Evidence source: The Lancet, "Exenatide once a week versus placebo as a potential disease-modifying treatment for people with Parkinson's disease in the UK: a phase 3 trial" (2025-02-04) https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02808-3/fulltext - Evidence source: The Lancet (via PubMed), "Expression of Concern: Exenatide once a week versus placebo ... Parkinson's disease in the UK (Lancet 2025;405:627-636)" (2026-06-22) https://pubmed.ncbi.nlm.nih.gov/42330995/ Half-life: About 2.4 hours (terminal half-life of the twice-daily immediate-release form) (source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021773Orig1s051correctedlbl.pdf) Status by country: - Australia: Not approved. TGA assessed Byetta and Bydureon (2013), but a search of the ARTG on 29 Sep 2026 finds no current exenatide entry. (verified 2026-09-29; source: https://www.tga.gov.au/resources/auspar/auspar-exenatide) - Brazil: Not approved. No active registration: the Byetta and Bydureon registrations show as inactive in Anvisa's register (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Not approved. No exenatide product is authorised on the market; Byetta and Bydureon were cancelled in 2022 (verified 2026-09-29; source: https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=exenatide) - China: Generics available. Approved, with a domestic generic approved in 2025; insurance covers it for type 2 diabetes. (verified 2026-09-29; source: http://static.cninfo.com.cn/finalpage/2025-07-01/1224037851.PDF) - European Union: Approved. Authorised EU-wide for type 2 diabetes as Byetta (2006) and Bydureon (2011) (verified 2026-09-29; source: https://www.ema.europa.eu/en/medicines/human/EPAR/byetta) - India: Approved. Exenatide has an older CDSCO approval; whether it is still sold in India could not be confirmed (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/RecommendEndocrinology_25_04_2017_13.pdf) - Japan: Unverified. Byetta (2010) and Bydureon (2012) were approved, but exenatide is off the current price list and its marketing status was not confirmed (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281190.pdf) - Mexico: Unverified. Bydureon's registration was cancelled in 2025; the status of Byetta could not be confirmed (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/145567/Alop_ticos2008.pdf) - New Zealand: Not approved. Byetta and Bydureon approvals have lapsed; no exenatide product is currently approved or funded (verified 2026-09-29; source: https://www.medsafe.govt.nz/DbSearch/) - United Arab Emirates: Unverified. Could not confirm whether exenatide (Byetta, Bydureon) is registered by the EDE; no UAE-specific record was found (verified 2026-09-29; source: https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae) - United Kingdom: Unverified. EU authorisations exist for Byetta and Bydureon; we could not confirm a current UK licence or availability (verified 2026-09-29; source: https://www.ema.europa.eu/en/medicines/human/EPAR/byetta) - United States: Generics available. Byetta and Bydureon BCISE are listed as discontinued; an FDA-approved generic exenatide (Amneal) is on the market (verified 2026-09-29; source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021773s050lbl.pdf) ### GHK-Cu (copper peptide) - Page: https://glp1base.com/molecules/ghk-cu - Also known as: Copper tripeptide-1, Copper tripeptide, GHK copper, Glycyl-L-histidyl-L-lysine copper, Prezatide copper, Cu-GHK - Class: Trending peptide - Targets: No single receptor has been established, Copper(II) transport and binding (competes with albumin for the metal), Fibroblast extracellular-matrix genes (collagen, glycosaminoglycans, matrix metalloproteinases) in cell and animal studies, TGF-beta pathway gene signatures (cell and gene-expression studies) - Route: No approved drug route. In human studies GHK-Cu has been tested as a topical gel or cream applied to the skin or to wounds. In animal research it has also been given by injection into wound chambers, into the abdominal cavity and through the nose. Injectable, oral and nasal uses in people are unapproved and have not been studied in controlled human trials that were verified for this record. - Last verified: 2026-09-29 Simple: GHK-Cu is a tiny protein piece made of three building blocks (glycine, histidine, lysine) holding onto a copper atom. Our blood contains a little of it naturally. It is used in some skin creams. Human studies are few and small, and mostly test creams. Most other claims come from cells or animals. No drug regulator has approved it as a medicine. Expert: GHK-Cu is the copper(II) complex of the endogenous tripeptide glycyl-L-histidyl-L-lysine (Gly-His-Lys, GHK; peptide C14H24N6O4, 340.38 Da; the 1:1 copper complex is about 403 Da; INCI copper tripeptide-1, also named prezatide copper). GHK was reported as a growth-promoting tripeptide from human serum in 1973 (Pickart and Thaler). It is a small, unmodified, naturally occurring sequence with no engineering features; copper is coordinated by the N-terminal amine, a deprotonated amide nitrogen and the histidine imidazole, and the solid-state complex is dimeric (Hureau 2011). In equilibrium-dialysis experiments GHK competed with albumin for Cu(II) (about 42% of the copper on the peptide at equimolar concentrations; Lau 1981), consistent with a proposed role in copper transport. No receptor has been established. Proposed actions come from cell culture (stimulation of fibroblast collagen and glycosaminoglycan synthesis, modulation of MMPs and integrins), rodent wound models (effects in dogs, mice and pigs are described in reviews by the discoverer's group), a mouse lung-fibrosis model, a mouse Alzheimer's model, and Connectivity Map gene-expression analyses; the largest claims (for example regulation of thousands of genes, plasma decline with age from about 200 to 80 ng/mL between ages 20 and 60) come mainly from reviews by the discoverer's group and should be read as hypotheses. No human pharmacokinetic or half-life data were verified for this record. Approval status: no major regulator (FDA, EMA, MHRA, PMDA, NMPA, TGA, Health Canada) has approved a GHK-Cu medicine; it is used as a cosmetic ingredient (assessed by the Cosmetic Ingredient Review in 2018 at very low use concentrations). Human evidence is limited to small topical studies: a multicentre randomised trial of a GHK-copper gel in diabetic neuropathic foot ulcers (Mulder 1994, 98.5% vs 60.8% median area closure) and a 13-patient randomised trial after CO2 laser resurfacing that found no significant objective differences (Miller 2006). Injectable and other systemic uses are unapproved and lack controlled human safety data; FDA states (page current as of April 2026) that compounded injectable GHK-Cu may pose immunogenicity risk from aggregation and peptide-related impurities. FDA's May 2026 503A update says GHK-Cu for non-injectable routes will be added back to Category 1 (bulk substances under evaluation); that is not an approval. Evidence level: Small human studies. Best available evidence is small, mostly topical, and largely old. Human: a 1994 multicentre randomised, vehicle-controlled trial of a topical GHK-copper gel in diabetic neuropathic plantar ulcers (median area closure 98.5% vs 60.8% for vehicle) and a 2006 randomised trial of 13 patients after CO2 laser resurfacing, which found no statistically significant objective differences in redness resolution, wrinkles or skin quality, only better self-rated skin quality with GHK-Cu (P = .04). Cosmetic-cream studies (12-week facial and eye creams of 41 to 71 women) are reported in review articles by the peptide's discoverer and are not independently verified here. Animal: accelerated wound healing and matrix build-up in rat models (including ischemic wounds), with effects in dogs, mice and pigs described in reviews by the discoverer's group; reduced fibrosis and inflammation in a mouse lung-fibrosis model (GHK peptide); intranasal GHK-Cu in a mouse Alzheimer's model (animal-only). Cell/computational: collagen and glycosaminoglycan synthesis in fibroblasts, Connectivity Map gene signatures. No phase 2 or phase 3 programme for a GHK-Cu drug was found, and no controlled human data for injectable or oral GHK-Cu were verified. - Evidence source: Wound Repair and Regeneration (PubMed), "Enhanced healing of ulcers in patients with diabetes by topical treatment with glycyl-l-histidyl-l-lysine copper" (1994-10) https://pubmed.ncbi.nlm.nih.gov/17147644/ - Evidence source: Archives of Facial Plastic Surgery (PubMed), "Effects of topical copper tripeptide complex on CO2 laser-resurfaced skin" (2006-07) https://pubmed.ncbi.nlm.nih.gov/16847171/ - Evidence source: BioMed Research International (PubMed), "GHK Peptide as a Natural Modulator of Multiple Cellular Pathways in Skin Regeneration" (2015-07-07) https://pubmed.ncbi.nlm.nih.gov/26236730/ - Evidence source: Veterinary Surgery (PubMed), "The effect of topical tripeptide-copper complex on healing of ischemic open wounds" (2003-11) https://pubmed.ncbi.nlm.nih.gov/14648529/ - Evidence source: Journal of Clinical Investigation (PubMed), "In vivo stimulation of connective tissue accumulation by the tripeptide-copper complex glycyl-L-histidyl-L-lysine-Cu2+ in rat experimental wounds" (1993-11) https://pubmed.ncbi.nlm.nih.gov/8227353/ - Evidence source: Aging Pathobiology and Therapeutics (PubMed), "Behavioral and neuropathological features of Alzheimer's disease are attenuated in 5xFAD mice treated with intranasal GHK peptide" (2024-09-30) https://pubmed.ncbi.nlm.nih.gov/40766919/ Status by country: - Australia: Not approved. Not on the ARTG. The TGA names GHK-Cu as an unapproved peptide product and warns against importing or advertising it. (verified 2026-09-29; source: https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/understanding-your-responsibilities-when-importing-compounding-and-supplying-unapproved-peptide-products) - Brazil: Not approved. Injectable GHK-Cu is unregistered in Brazil and has been among goods seized by Anvisa (verified 2026-09-29; source: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa) - Canada: Prohibited. Not authorised as an injectable drug; named in Health Canada's 2026 seizure advisory and a May 2026 Type I recall (verified 2026-09-29; source: https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm) - China: Not approved. No NMPA drug approval found for GHK-Cu; it cannot lawfully be sold as a medicine in China. (verified 2026-09-29; source: https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html) - European Union: Not approved. No EU marketing authorisation as a medicine; no specific EU medicines rule beyond the general one (verified 2026-09-29; source: https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json) - India: Not approved. Not approved in India: no CDSCO marketing permission found for GHK-Cu; making or selling it as a medicine would be unapproved (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf) - Japan: Not approved. Not an approved medicine in Japan; GHK-Cu (copper peptide) is absent from PMDA's approved-drug lists and package-insert database (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. Not approved as a medicine in Mexico; injectable copper peptide is unregistered (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Not approved. No Medsafe-approved medicine contains GHK-Cu; it is not named in Medsafe's 2026 peptide advisory (verified 2026-09-29; source: https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm) - United Arab Emirates: Not approved. Not approved as a medicine in the UAE: no marketing authorisation found for injectable or medicinal GHK-Cu (verified 2026-09-29; source: https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities) - United Kingdom: Not approved. GHK-Cu is not licensed in the UK (verified 2026-09-29; source: https://www.gov.uk/guidance/find-product-information-about-medicines) - United States: Compounding restricted. Not approved as a drug; FDA treats non-injectable GHK-Cu as under evaluation (Category 1) but the injectable route is not covered (verified 2026-09-29; source: https://www.fda.gov/media/94155/download?attachment) ### Ipamorelin - Page: https://glp1base.com/molecules/ipamorelin - Also known as: NNC 26-0161, Aib-His-D-2Nal-D-Phe-Lys-NH2, ipamorelin acetate, ipamorelin free base - Class: Trending peptide - Targets: Ghrelin receptor (growth hormone secretagogue receptor type 1a, GHSR-1a), agonist - Route: Not approved for any route. In published human studies it was given by intravenous infusion (healthy volunteers, and hospital patients after bowel surgery). In animal studies it has been given by injection into a vein or under the skin, and by nasal application in rats (about 20% nasal bioavailability). Human pharmacokinetic data for other routes were not identified by FDA in its 2024 review. - Last verified: 2026-09-29 Simple: Ipamorelin is a tiny lab-made protein piece (five building blocks) that acts like the hunger hormone ghrelin, even though it is not built like ghrelin. It makes the pituitary gland release a short burst of growth hormone. It is not an approved medicine anywhere we could verify. The one published trial in patients tested gut recovery after bowel surgery and found no clear benefit. Expert: Ipamorelin (NNC 26-0161) is a synthetic pentapeptide, H-Aib-His-D-2Nal-D-Phe-Lys-NH2 (C38H49N9O5, 711.9 g/mol), discovered at Novo Nordisk in the 1990s in a series derived from GHRP-1 by removing its central Ala-Trp dipeptide. It is a ghrelin-receptor (GHSR-1a) agonist. Engineering features are a C-terminal amide and three unnatural residues (alpha-aminoisobutyric acid, D-2-naphthylalanine, D-phenylalanine); the peptide is moderately resistant to metabolism, with 60-80% of an intravenous dose recovered intact in bile and urine in rats. In swine, unlike GHRP-2 and GHRP-6, it released GH without raising ACTH or cortisol, even at doses over 200 times the GH ED50. In healthy men, intravenous infusion produced dose-proportional (linear) two-compartment pharmacokinetics with a terminal half-life of about 2 h, clearance 0.078 L/h/kg and steady-state volume 0.22 L/kg, and a single GH pulse peaking near 0.67 h that fell to very low levels by 6 h. The only published efficacy trial is a phase 2 study in postoperative ileus after bowel resection (117 enrolled), which showed no significant difference from placebo; a second, larger phase 2 study (NCT01280344, 320 participants) is registered as completed without posted results. We found no regulator that has approved ipamorelin as a medicine; FDA states it is not a component of any FDA-approved drug and has no USP monograph. In October 2024 FDA's Pharmacy Compounding Advisory Committee voted 0 yes, 12 no, 1 abstain against placing ipamorelin (free base or acetate) on the 503A bulks list, and ipamorelin acetate has been in Category 2 (may present significant safety risks) of FDA's interim 503B bulks policy since 29 September 2023. Evidence level: Phase 2 trials. Human evidence is thin and does not support any use. (1) An intravenous pharmacokinetic and pharmacodynamic study in healthy men (1999) showed GH release and a roughly 2-hour half-life. (2) A phase 2 randomised, double-blind, placebo-controlled trial in postoperative ileus after bowel resection (NCT00672074; 117 enrolled, 114 analysed) found no significant difference: median time to first tolerated solid meal was 25.3 h with ipamorelin versus 32.6 h with placebo (p = 0.15). (3) A second phase 2 dose-finding study in the same condition (NCT01280344; 320 participants) is registered as completed, and no results were posted on the registry record. No controlled trial of ipamorelin in growth hormone deficiency, body composition, sleep, ageing or recovery from injury was found on ClinicalTrials.gov, and no phase 3 trial was found. Apart from the gut-recovery trial, the only efficacy data are from rodent studies (for example bone growth and bone mineral content in rats), which are animal-only evidence. - Evidence source: Pharmaceutical Research (via PubMed), "Pharmacokinetic-pharmacodynamic modeling of ipamorelin, a growth hormone releasing peptide, in human volunteers" (1999-09) https://pubmed.ncbi.nlm.nih.gov/10496658/ - Evidence source: International Journal of Colorectal Disease (via PubMed), "Prospective, randomized, controlled, proof-of-concept study of the Ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients" (2014-12) https://pubmed.ncbi.nlm.nih.gov/25331030/ - Evidence source: ClinicalTrials.gov (Helsinn Therapeutics), "Safety and Efficacy of Ipamorelin for Management of Post-Operative Ileus (NCT00672074)" (2017-04) https://clinicaltrials.gov/study/NCT00672074 - Evidence source: ClinicalTrials.gov (Helsinn Therapeutics), "Safety and Efficacy of Ipamorelin Compared to Placebo for the Recovery of Gastrointestinal Function (NCT01280344)" (2017-04) https://clinicaltrials.gov/study/NCT01280344 - Evidence source: U.S. Food and Drug Administration, "FDA Briefing Document, Pharmacy Compounding Advisory Committee, October 29, 2024: Evaluation of Ipamorelin-related Bulk Drug Substances for Inclusion on the 503A Bulk Drug Substances List" (2024-10) https://www.fda.gov/media/182088/download Half-life: About 2 hours (terminal half-life after intravenous infusion in healthy men) (source: https://pubmed.ncbi.nlm.nih.gov/10496658/) Status by country: - Australia: Prohibited. Unapproved and controlled: ipamorelin is prescription-only and possession without authority is illegal under the Poisons Standard. (verified 2026-09-29; source: https://www.legislation.gov.au/F2026L00633/latest/text) - Brazil: Not approved. Not registered in Brazil; Anvisa says injectable ipamorelin sold online is irregular (verified 2026-09-29; source: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa) - Canada: Prohibited. Not authorised; named in seizure notices from 2025 and 2026 and banned in sport (verified 2026-09-29; source: https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm) - China: Not approved. Not an approved medicine in China; unlawful to sell as a drug, and it is banned in sport. (verified 2026-09-29; source: https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html) - European Union: Not approved. No EU marketing authorisation; banned in sport (WADA S2.2.4) (verified 2026-09-29; source: https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json) - India: Not approved. Not approved in India: no CDSCO marketing permission found for Ipamorelin; making or selling it as a medicine would be unapproved (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf) - Japan: Not approved. Not an approved medicine in Japan; sale and advertising as a drug are illegal, and WADA bans ipamorelin in sport (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. Not approved in Mexico; unregistered peptide named in a July 2026 bill and a fact-check (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Prohibited. Not approved; Medsafe names ipamorelin as an illegal unapproved peptide and says it seizes it (verified 2026-09-29; source: https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp) - United Arab Emirates: Not approved. Not approved in the UAE: no marketing authorisation for ipamorelin; unapproved peptide products are under EDE enforcement (verified 2026-09-29; source: https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities) - United Kingdom: Not approved. Ipamorelin is not licensed in the UK (verified 2026-09-29; source: https://www.gov.uk/guidance/find-product-information-about-medicines) - United States: Not approved. No FDA approval; FDA keeps ipamorelin in Category 2 for 503B outsourcing facilities because of immunogenicity and safety concerns (verified 2026-09-29; source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) ### Kisspeptin - Page: https://glp1base.com/molecules/kisspeptin - Also known as: Kisspeptin-54, KP-54, KP54, Metastin, Metastin (1-54), KISS1 peptide, Kisspeptin-10, KP-10, Metastin 45-54 - Class: Trending peptide - Targets: KISS1R (kisspeptin receptor, also called GPR54): a Gq/11-coupled receptor on GnRH neurons; loss-of-function variants cause hypogonadotropic hypogonadism in people, and cryo-EM structures of the receptor bound to kisspeptin-54 and kisspeptin-10 have been solved, GnRH neurons of the hypothalamus: kisspeptin activates them directly (shown in mice and sheep; supported by human genetics and human hormone responses), Pituitary gonadotropes (indirectly): LH and FSH release follows the GnRH signal, shown in human studies - Route: Not given by any approved route, because no kisspeptin product is approved anywhere. In published clinical research, kisspeptin-54 has been given by intravenous infusion or bolus and by subcutaneous injection under medical supervision, and intranasally in one 2025 crossover study. Kisspeptin-10 has been studied by intravenous and subcutaneous routes. FDA's 2024 review found no human study of intramuscular kisspeptin-10. The synthetic analogue MVT-602 (previously TAK-448) has been studied by subcutaneous injection. - Last verified: 2026-09-29 Simple: Kisspeptin is a natural hormone that acts like a starter switch for the body's reproductive system. It tells a small group of brain cells to send a signal to the pituitary gland. It has been given to volunteers and IVF patients in small, supervised studies. No regulator has approved it as a medicine. Expert: Kisspeptin is the family of peptides encoded by KISS1 and processed from a precursor into kisspeptin-54 (metastin, precursor residues 68-121), -14, -13 and -10. They share a C-terminal Arg-Phe-NH2 end, and the shortest active form is kisspeptin-10. Kisspeptin-54 (about 5.8 kDa) was first isolated from human placenta as the endogenous ligand of the orphan receptor now called KISS1R (GPR54) (Ohtaki 2001). The receptor is Gq/11-coupled. Inactivating KISS1R variants cause congenital hypogonadotropic hypogonadism in humans and Gpr54-null mice (Seminara 2003; de Roux 2003), which established kisspeptin as an upstream gatekeeper of pulsatile GnRH secretion. Infundibular (arcuate) kisspeptin neurons that co-express neurokinin B and dynorphin are thought to drive the GnRH pulse generator, and in rodents a rostral (AVPV) kisspeptin population drives the pre-ovulatory LH surge. The molecule discussed here is the unmodified, native peptide, with no engineered half-life extension: kisspeptin-54 has a plasma half-life of about 28 minutes after intravenous infusion in men (Dhillo 2005) and kisspeptin-10 about 4 minutes (Jayasena 2011, as summarised by FDA). The synthetic analogue MVT-602 (previously TAK-448), a modified nonapeptide based on kisspeptin-10, is a separate substance: in two phase 1 studies sustained exposure lowered testosterone to the castration range in men (MacLean 2014), and in phase 1 and 2a trials in women its mean elimination half-life was 1.3-2.2 h (Abbara 2024). In humans, acute intravenous or subcutaneous kisspeptin-54 raises LH, FSH and, in men, testosterone (Dhillo 2005), with the largest LH response in the pre-ovulatory phase in women (Dhillo 2007). Repeated dosing over two weeks in women with hypothalamic amenorrhoea caused tachyphylaxis (Jayasena 2009), matching continuous-infusion desensitisation in monkeys (Seminara 2006). Phase 2 IVF studies at one London centre used a single injection of kisspeptin-54 to trigger oocyte maturation, including in women at high risk of ovarian hyperstimulation syndrome (Jayasena 2014; Abbara 2015, 2017). Intranasal kisspeptin-54 raised LH in a 2025 crossover study. No phase 3 trial exists. No product containing kisspeptin is approved by any regulator. FDA's October 2024 briefing found no approved product containing kisspeptin-10 in any country, and its 503A list, updated 14 May 2026, places kisspeptin-10 in Category 2 (substances raising significant safety concerns). Evidence level: Phase 2 trials. Native kisspeptin-54 has been tested in small, supervised human studies: physiology studies in healthy volunteers and patients (usually 5 to 40 people), a few small randomised trials, and single-centre phase 2 IVF trials (53 and 60 women, plus a 62-woman randomised second-dose trial) in which one injection triggered egg maturation. A 2025 crossover study tested a nasal spray. There is no phase 3 trial and no regulatory approval for any indication. Repeated dosing has shown loss of response (tachyphylaxis) in women with hypothalamic amenorrhoea. FDA's 2024 review found the evidence insufficient to judge kisspeptin-10 for male hypogonadism, and no published clinical trial of kisspeptin-10 given for more than one day. Popular claims about weight loss, libido or fertility outside these studies are not established by trials. - Evidence source: Journal of Clinical Endocrinology and Metabolism (Dhillo WS et al.), "Kisspeptin-54 stimulates the hypothalamic-pituitary gonadal axis in human males" (2005-12) https://pubmed.ncbi.nlm.nih.gov/16174713/ - Evidence source: Journal of Clinical Investigation (Jayasena CN et al.), "Kisspeptin-54 triggers egg maturation in women undergoing in vitro fertilization" (2014-08) https://pubmed.ncbi.nlm.nih.gov/25036713/ - Evidence source: Journal of Clinical Endocrinology and Metabolism (Abbara A et al.), "Efficacy of Kisspeptin-54 to Trigger Oocyte Maturation in Women at High Risk of Ovarian Hyperstimulation Syndrome (OHSS) During In Vitro Fertilization (IVF) Therapy" (2015-09) https://pubmed.ncbi.nlm.nih.gov/26192876/ - Evidence source: Human Reproduction (Abbara A et al.), "A second dose of kisspeptin-54 improves oocyte maturation in women at high risk of ovarian hyperstimulation syndrome: a Phase 2 randomized controlled trial" (2017-09-01) https://pubmed.ncbi.nlm.nih.gov/28854728/ - Evidence source: eBioMedicine (Mills EG et al.), "Intranasal kisspeptin administration rapidly stimulates gonadotropin release in humans" (2025-05) https://pubmed.ncbi.nlm.nih.gov/40215751/ - Evidence source: U.S. Food and Drug Administration, "FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, October 29, 2024: Evaluation of Kisspeptin-10 for Inclusion on the 503A Bulk Drug Substances List" (2024-10) https://www.fda.gov/media/182089/download Half-life: About 28 minutes for kisspeptin-54 in the blood of healthy men (27.6 +/- 1.1 min, intravenous infusion). Kisspeptin-10 is cleared faster, at about 4 minutes. (source: https://pubmed.ncbi.nlm.nih.gov/16174713/) Status by country: - Australia: Not approved. No kisspeptin product is on the ARTG. It counts as an unapproved peptide, and advertising or supplying it is likely unlawful. (verified 2026-09-29; source: https://www.tga.gov.au/resources/artg?keywords=kisspeptin) - Brazil: Not approved. No Brazilian registration for kisspeptin; the unregistered-peptide rules apply (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Prohibited. Not authorised; named in three Health Canada seizure notices (2025) and banned in sport (verified 2026-09-29; source: https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=kisspeptin) - China: Not approved. No NMPA approval found for kisspeptin; it cannot lawfully be sold as a medicine in China. (verified 2026-09-29; source: https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html) - European Union: Not approved. No EU marketing authorisation; in sport, banned for males (WADA S2.2.1) (verified 2026-09-29; source: https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json) - India: Not approved. Not approved in India: no CDSCO marketing permission found for Kisspeptin; making or selling it as a medicine would be unapproved (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf) - Japan: Not approved. Not an approved medicine in Japan; kisspeptin is absent from PMDA's lists, and WADA bans it in sport (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. No registration for kisspeptin found in COFEPRIS lists (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Prohibited. Not approved; Medsafe names kisspeptin as an illegal unapproved peptide and says it seizes it (verified 2026-09-29; source: https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp) - United Arab Emirates: Not approved. Not approved in the UAE: no marketing authorisation for kisspeptin; unapproved peptide products are under EDE enforcement (verified 2026-09-29; source: https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities) - United Kingdom: Not approved. Kisspeptin is not licensed in the UK (verified 2026-09-29; source: https://www.gov.uk/guidance/find-product-information-about-medicines) - United States: Not approved. No FDA approval; kisspeptin-10 is in FDA's 503A Category 2 because of immunogenicity and missing safety data (verified 2026-09-29; source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) ### KPV - Page: https://glp1base.com/molecules/kpv - Also known as: Lys-Pro-Val, Lysyl-prolyl-valine, alpha-MSH(11-13), alpha-MSH 11-13, H-Lys-Pro-Val-OH, KPV acetate - Class: Trending peptide - Targets: PepT1 (SLC15A1, di/tripeptide transporter): proposed route into cells, shown in human cell lines and mice, NF-kB and MAP kinase inflammatory signalling: proposed downstream effect, shown in cell studies, Interleukin-1 beta signalling: proposed in a mouse study, Melanocortin receptors: studies indicate they are probably not the main target - Route: Not given by any approved route, because it is not approved anywhere. In research it has been studied by adding it to drinking water in mice (colitis models), by systemic injection in mouse inflammation models, in nanoparticle or hydrogel carriers designed for oral delivery to the colon in mice, and, in the laboratory only, across excised human skin. No human route has been studied in a published trial. - Last verified: 2026-09-29 Simple: KPV is a tiny protein piece made of three building blocks. It is the last three letters of a natural hormone called alpha-MSH. In lab dishes and mice it calmed inflammation. No human studies have been found and no regulator has approved it as a medicine. Expert: KPV (Lys-Pro-Val, C16H30N4O4, 342.43 g/mol) is the C-terminal tripeptide of alpha-melanocyte-stimulating hormone (residues 11-13). It is a linear, unmodified, unconjugated tripeptide with no engineered stabilising features; native alpha-MSH is C-terminally amidated, whereas the form FDA and PubChem describe is the free acid, and the acetate salt, N-acetylated KPV, the KdPT analogue and the (CKPV)2 dimer are different substances that the literature sometimes conflates. An early report of anti-inflammatory activity for the alpha-MSH(11-13) fragment came from a mouse ear-swelling model (Hiltz and Lipton, 1989). It does not appear to work through the melanocortin receptors that mediate alpha-MSH's pigmentary and many of its anti-inflammatory effects: it did not raise cAMP in macrophages and it acted in mice with a non-functional MC1R (Getting 2003; Kannengiesser 2008). Proposed mechanisms are uptake by the transporter PepT1 followed by inhibition of NF-kB and MAP-kinase signalling (human Caco2-BBE, HT29-Cl.19A and Jurkat cells) and interference with IL-1 beta effects; the molecular target remains unidentified. In mice, KPV reduced DSS- and TNBS-induced colitis and CD45RBhi transfer colitis, and rodent wound-healing models have been reported. FDA identified no pharmacokinetic study in any species, so there is no half-life. In vitro, KPV did not cross human skin by passive diffusion at detectable levels (Pawar 2017). KPV is not a component of any approved drug, and it has no USAN, USP monograph or UNII. FDA found no study of KPV given to humans, and its search of FAERS and the medical literature for adverse events through 3 December 2025 found no reports. FDA's briefing document (12 May 2026), prepared for the 23-24 July 2026 Pharmacy Compounding Advisory Committee, judged KPV not well characterised and proposed against adding it to the 503A bulks list. The committee voted 8-6 with one abstention to recommend adding it; the vote is advisory only and needs notice-and-comment rulemaking. Evidence level: Animal studies only. The evidence is cell and animal work only. Human intestinal and T-cell lines and mouse colitis models (DSS, TNBS and T-cell transfer colitis) support an anti-inflammatory effect. A mouse peritonitis model and rodent wound models add to this. FDA's 2026 review states that neither the nomination nor its own searches of PubMed, Embase and ClinicalTrials.gov found any study of KPV given to humans by any route. Animal and cell results often do not carry over to people. The oral delivery work in mice is early-stage and used nanoparticle or hydrogel carriers. - Evidence source: Gastroenterology (Dalmasso G et al.), "PepT1-mediated tripeptide KPV uptake reduces intestinal inflammation" (2008-01) https://pubmed.ncbi.nlm.nih.gov/18061177/ - Evidence source: Inflammatory Bowel Diseases (Kannengiesser K et al.), "Melanocortin-derived tripeptide KPV has anti-inflammatory potential in murine models of inflammatory bowel disease" (2008-03) https://pubmed.ncbi.nlm.nih.gov/18092346/ - Evidence source: Journal of Pharmacology and Experimental Therapeutics (Getting SJ et al.), "Dissection of the anti-inflammatory effect of the core and C-terminal (KPV) alpha-melanocyte-stimulating hormone peptides" (2003-08) https://pubmed.ncbi.nlm.nih.gov/12750433/ - Evidence source: U.S. Food and Drug Administration (Pharmacy Compounding Advisory Committee), "FDA Briefing Document: Evaluation of KPV-related Bulk Drug Substances (KPV (free base) and KPV acetate) for Inclusion on the 503A Bulk Drug Substances List" (2026-05-12) https://www.fda.gov/media/193346/download Status by country: - Australia: Not approved. No KPV product is on the ARTG. It counts as an unapproved peptide, and advertising or supplying it is likely unlawful. (verified 2026-09-29; source: https://www.tga.gov.au/resources/artg?keywords=KPV) - Brazil: Not approved. No Brazilian registration for KPV; the same unregistered-peptide rules apply (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Prohibited. Not authorised; named in Health Canada's April 2026 advisory of seized unauthorised injectables (verified 2026-09-29; source: https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm) - China: Not approved. No NMPA approval found for KPV; it cannot lawfully be sold as a medicine in China. (verified 2026-09-29; source: https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html) - European Union: Not approved. No EU marketing authorisation; not listed in EMA or Union Register data (verified 2026-09-29; source: https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json) - India: Not approved. Not approved in India: no CDSCO marketing permission found for KPV; making or selling it as a medicine would be unapproved (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf) - Japan: Not approved. Not an approved medicine in Japan; KPV is absent from PMDA's approved-drug lists and package-insert database (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. No registration for KPV found in COFEPRIS lists (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Not approved. No Medsafe-approved medicine contains KPV; unapproved peptide products are unlawful to supply (verified 2026-09-29; source: https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm) - United Arab Emirates: Not approved. Not approved in the UAE: no marketing authorisation for KPV; unapproved peptide products are under EDE enforcement (verified 2026-09-29; source: https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities) - United Kingdom: Not approved. KPV is not licensed in the UK (verified 2026-09-29; source: https://www.gov.uk/guidance/find-product-information-about-medicines) - United States: Not approved. No FDA approval; FDA found no human exposure data for KPV, and an advisory panel recommended considering it in July 2026 (non-binding) (verified 2026-09-29; source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) ### Liraglutide - Page: https://glp1base.com/molecules/liraglutide - Also known as: NN2211, Liraglutide (rDNA origin) - Brand names (nominative use only): Victoza, Saxenda - Class: Approved GLP-1 medicine - Targets: GLP-1 receptor - Route: Subcutaneous injection, once daily (pre-filled pen, used under a prescriber's supervision) - Last verified: 2026-09-29 Simple: Liraglutide copies a gut hormone called GLP-1. It helps the pancreas release insulin when blood sugar is high, slows the stomach, and turns down hunger signals. A small fatty chain helps it stick to a blood protein, so one daily injection is enough. Its maker says it was the first once-daily GLP-1 medicine for obesity. Expert: Liraglutide is an acylated GLP-1 receptor agonist with 97% sequence homology to human GLP-1(7-37): Lys34 is replaced by Arg, and a C16 fatty acid (palmitic acid) is attached to Lys26 through a glutamic acid spacer. Self-association at the injection site, more than 98% plasma protein binding and resistance to DPP-4 and neutral endopeptidase give a plasma half-life of about 13 hours after subcutaneous injection (endogenous GLP-1: 1.5-2 minutes), supporting once-daily use; Tmax is about 11 hours and absolute bioavailability about 55%. Molecular weight is 3751.2 Da (C172H265N43O51). Mechanism: GLP-1R activation raises cAMP via Gs, stimulating insulin and suppressing glucagon secretion in a glucose-dependent manner, delaying gastric emptying and lowering calorie intake without raising 24-hour energy expenditure. Marketed by Novo Nordisk as Victoza (type 2 diabetes; LEADER cardiovascular outcomes trial) and Saxenda (chronic weight management; SCALE programme). It carries a boxed warning for thyroid C-cell tumours seen in rodents. Generic versions have been approved in the US. Evidence level: Approved. Approved by major regulators (FDA, EMA and others) on the basis of large phase 3 programmes: LEAD (type 2 diabetes), LEADER (cardiovascular outcomes, 9,340 participants) and SCALE (weight management), plus a 56-week adolescent trial (251 participants). - Evidence source: The Lancet, "Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6)" (2009-07-04) https://doi.org/10.1016/S0140-6736(09)60659-0 - Evidence source: New England Journal of Medicine, "Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes" (2016-07-28) https://doi.org/10.1056/NEJMoa1603827 - Evidence source: New England Journal of Medicine, "A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management" (2015-07-02) https://doi.org/10.1056/NEJMoa1411892 - Evidence source: New England Journal of Medicine, "A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity" (2020-05-28) https://doi.org/10.1056/NEJMoa1916038 Half-life: About 13 hours after subcutaneous administration (source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/206321s020lbl.pdf) Status by country: - Australia: Generics available. Approved as Victoza and Saxenda; generic liraglutide pens were added to the ARTG from March 2025. Compounded versions barred since 1 October 2024. (verified 2026-09-29; source: https://www.tga.gov.au/resources/artg/153980) - Brazil: Approved. Approved as Victoza (diabetes) and Saxenda (weight), with Brazilian versions and new generics (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Approved. Approved as Victoza (type 2 diabetes) and Saxenda (weight management); no generic listed yet, 11 submissions pending (verified 2026-09-29; source: https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=liraglutide) - China: Generics available. Approved, with Chinese-made biosimilar versions on the market since 2023 and insurance cover for type 2 diabetes. (verified 2026-09-29; source: http://static.cninfo.com.cn/finalpage/2023-12-05/1218507445.PDF) - European Union: Approved. Authorised EU-wide (Victoza, Saxenda) plus two STADA liraglutide products authorised in July 2026 (verified 2026-09-29; source: https://www.ema.europa.eu/en/medicines/human/EPAR/victoza) - India: Approved. Approved in India since 2010 (Victoza) for type 2 diabetes; a weight-management version was recommended for an Indian maker in 2025 (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/MOMof33rdSECEndocrinologyandMetabolism10_02_2017.pdf) - Japan: Approved. Approved for type 2 diabetes (Victoza, and Xultophy with insulin); no separate weight-loss liraglutide product found (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281190.pdf) - Mexico: Approved. Approved as Victoza (diabetes), Saxenda (weight) and Xultophy; several generic and biocomparable applications pending (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/542776/Pr_rrogas_Aprobadas_2019.pdf) - New Zealand: Approved. Victoza and Saxenda approved; three generics have consent but are not marketed; Victoza funded for type 2 diabetes (verified 2026-09-29; source: https://www.medsafe.govt.nz/DbSearch/) - United Arab Emirates: Approved. Marketed in the UAE as Saxenda for obesity care according to Novo Nordisk's UAE professional portal; EDE register entry not verified (verified 2026-09-29; source: https://pro.novonordisk.ae/products/saxenda.html) - United Kingdom: Generics available. Licensed in the UK (Saxenda, plus generic liraglutide for weight management and type 2 diabetes since 2024) (verified 2026-09-29; source: https://www.gov.uk/government/publications/glp-1-medicines-for-weight-loss-and-diabetes-what-you-need-to-know) - United States: Generics available. Brand Victoza and Saxenda plus several FDA-approved generics; liraglutide is still on FDA's shortage list and Saxenda is being discontinued (verified 2026-09-29; source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022341s046lbl.pdf) ### LL-37 - Page: https://glp1base.com/molecules/ll-37 - Also known as: Ropocamptide, Cathelicidin LL-37, Human cathelicidin antimicrobial peptide LL-37, hCAP18(134-170), CAMP peptide - Class: Trending peptide - Targets: Anionic bacterial membranes and lipopolysaccharide: direct antimicrobial action, shown in laboratory studies, Formyl peptide receptor-like 1 (FPRL1, also called FPR2): white-blood-cell recruitment, shown in human cells in the laboratory, P2X7 receptor: interleukin-1 beta release, shown in human monocytes in the laboratory, Epidermal growth factor receptor (transactivated indirectly): epithelial cell signalling, shown in human airway cells in the laboratory, Self-DNA complexes sensed by Toll-like receptor 9 in plasmacytoid dendritic cells: shown in human psoriasis skin and human cells - Route: Not given by any approved route, because it is not approved. In clinical studies it has been tested as a topical preparation applied to venous leg ulcers, as injections directly into melanoma skin tumours (intratumoral) at a cancer centre, and, in a registered trial with unknown status, as a cream on diabetic foot ulcers. Systemic use has not been studied in a published human trial that I found. - Last verified: 2026-09-29 Simple: LL-37 is a small protein piece that the human body makes itself to fight germs and help skin heal. It has been tested in only a few small human studies, on leg ulcers and on melanoma skin tumours. No regulator has approved it as a medicine, and there is no proof that it works or is safe when used outside a trial. Expert: LL-37 (INN ropocamptide; C205H340N60O53, about 4,493 Da) is the 37-residue, C-terminal antimicrobial peptide (LLGDFFRKSKEKIGKEFKRIVQRIKDFLRNLVPRTES) of hCAP-18, the only human cathelicidin, encoded by CAMP. It corresponds to residues 134-170 of the 170-residue precursor (UniProt P49913). hCAP-18 is stored in neutrophil peroxidase-negative (specific) granules and made by epithelial cells; after release, proteinase 3 cleaves off LL-37 (Sørensen 2001), and the CAMP promoter carries a vitamin D response element, conserved in primates, through which 1,25-dihydroxyvitamin D3 induced CAMP in human myeloid and keratinocyte cell lines (Gombart 2005). The native peptide is unmodified and has no engineered stabilising groups. It is cationic and amphipathic, disordered in water, and forms an alpha-helix with a bend near Gly14-Glu16 in the presence of anions, lipid micelles or membranes; it also oligomerises (Johansson 1998; Wang 2008). Antibacterial activity is membrane-directed; the same peptide was cytotoxic to several eukaryotic cell types at 13-25 micromolar in vitro, and human serum inhibited that activity (Johansson 1998). It is also a signalling molecule: it chemoattracts neutrophils, monocytes and T cells through FPRL1 (Yang 2000), promotes P2X7-dependent IL-1 beta release (Elssner 2004), transactivates EGFR in airway epithelial cells (Tjabringa 2003), and binds self-DNA to trigger TLR9-driven interferon production in plasmacytoid dendritic cells in psoriasis (Lande 2007). I found no published human pharmacokinetic study and no half-life. It is not approved by any regulator I checked. Clinical experience is limited to two small studies: a 34-participant first-in-man randomised, placebo-controlled topical dose-ranging trial in hard-to-heal venous leg ulcers (Grönberg 2014) and a phase 1/2 intratumoral melanoma study (NCT02225366) that enrolled 4 people. FDA lists cathelicidin LL-37 among bulk substances that were nominated for compounding and then withdrawn, and states concerns about immunogenicity for some routes, peptide impurities and characterisation, and nonclinical signals of harm to male reproduction and of tumour promotion in some tissues. Evidence level: Small human studies. Human data are limited to two small, early studies. (1) A first-in-man trial in 34 people with hard-to-heal venous leg ulcers: 3-week placebo run-in, then a 4-week randomised, double-blind treatment phase with topical LL-37 or placebo, and 4 weeks of follow-up. The lower two of three strengths healed faster than placebo (healing rate constants about six- and three-fold higher; p = 0.003 and p = 0.088), the highest strength did not differ from placebo, and no safety concerns were reported. (2) A phase 1/2 single-arm study of injections into melanoma skin tumours at MD Anderson (NCT02225366), which enrolled only 4 people; posted results cover 3 and are too small to judge efficacy. A randomised phase 2 diabetic-foot-ulcer cream trial (NCT04098562, planned 40 participants) is registered with unknown status (last known: not yet recruiting, 2019) and no results. Everything else, including the antimicrobial, immune and wound-healing mechanisms, comes from cell, tissue and animal experiments. There is no phase 3 trial and no regulatory approval. - Evidence source: Wound Repair and Regeneration (Grönberg A et al.), "Treatment with LL-37 is safe and effective in enhancing healing of hard-to-heal venous leg ulcers: a randomized, placebo-controlled clinical trial" (2014-09) https://pubmed.ncbi.nlm.nih.gov/25041740/ - Evidence source: ClinicalTrials.gov (M.D. Anderson Cancer Center), "Intratumoral Injections of LL37 for Melanoma (NCT02225366)" (2021-12-09) https://clinicaltrials.gov/study/NCT02225366 - Evidence source: ClinicalTrials.gov (Universitas Indonesia), "Efficacy of LL-37 Cream on Bacteria Colonization, Inflammation Response and Healing Rate of Diabetic Foot Ulcers (NCT04098562)" (2019-09) https://clinicaltrials.gov/study/NCT04098562 Status by country: - Australia: Not approved. No LL-37 product is on the ARTG. It counts as an unapproved peptide, and advertising or supplying it is likely unlawful. (verified 2026-09-29; source: https://www.tga.gov.au/resources/artg?keywords=LL-37) - Brazil: Not approved. No Brazilian registration for LL-37; the unregistered-peptide rules apply (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Prohibited. Not authorised; named in Health Canada's 2025 Canada Peptide seizure notice (verified 2026-09-29; source: https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=ll-37) - China: Not approved. No NMPA approval found for LL-37; it cannot lawfully be sold as a medicine in China. (verified 2026-09-29; source: https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html) - European Union: Not approved. No EU marketing authorisation; not listed in EMA or Union Register data (verified 2026-09-29; source: https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json) - India: Not approved. Not approved in India: no CDSCO marketing permission found for LL-37; making or selling it as a medicine would be unapproved (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf) - Japan: Not approved. Not an approved medicine in Japan; LL-37 is absent from PMDA's approved-drug lists and package-insert database (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. No registration for LL-37 found in COFEPRIS lists (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Not approved. No Medsafe-approved medicine contains LL-37; antimicrobial peptides are prescription-only (verified 2026-09-29; source: https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm) - United Arab Emirates: Not approved. Not approved in the UAE: no marketing authorisation for LL-37; unapproved peptide products are under EDE enforcement (verified 2026-09-29; source: https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities) - United Kingdom: Not approved. LL-37 is not licensed in the UK (verified 2026-09-29; source: https://www.gov.uk/guidance/find-product-information-about-medicines) - United States: Not approved. 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 (verified 2026-09-29; source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) ### Maridebart cafraglutide (MariTide) - Page: https://glp1base.com/molecules/maridebart-cafraglutide - Also known as: MariTide, AMG 133, AMG133, maridebart - Class: In clinical trials - Targets: GIP receptor (antagonist antibody), GLP-1 receptor (agonist peptides) - Route: Investigational subcutaneous (under-the-skin) injection. In the phase 1 and phase 2 studies it was given every 4 weeks, and in one phase 2 group every 8 weeks. Amgen states that the long-acting design supports starting monthly and later staying on treatment with fewer doses per year; this is being tested in phase 3 and is not an approved regimen. - Last verified: 2026-09-29 Simple: MariTide is an experimental weight-loss medicine from Amgen. It is built from an antibody that blocks one gut-hormone receptor (GIP) and two small peptides that switch on another (GLP-1). It stays in the body a long time: about three weeks after a dose, roughly half of it is still in the blood. That is why it was tested once a month. It is not approved anywhere yet. Big phase 3 trials are still running. Expert: Maridebart cafraglutide (AMG 133, MariTide) is an antibody-peptide conjugate: a fully human IgG1 monoclonal antibody that antagonises the glucose-dependent insulinotropic polypeptide receptor (GIPR), covalently linked at engineered cysteines (E384C) through amino-acid linkers to two GLP-1 receptor agonist peptide analogues (average molecular weight 153,514 Da for the whole conjugate). In cell assays it fully agonised the human GLP-1 receptor (EC50 24.4 pM vs 4.1 pM for native GLP-1) and antagonised human GIPR (IC50 42.4 nM). Attaching the peptides to the antibody gives a mean half-life of about 21 days in humans (phase 1), which the authors link to the every-4-week subcutaneous dosing used in the multiple-dose study. Evidence: first-in-human phase 1 (NCT04478708; 49 participants in single-dose and 26 in multiple-dose cohorts) showed dose-dependent weight loss that persisted for months after the last dose; the 52-week phase 2 trial in obesity (NCT05669599, n=592, NEJM 2025) showed mean weight change of -12.3% to -16.2% (treatment-policy estimand) versus -2.5% with placebo, and HbA1c falls of 1.2 to 1.6 percentage points in the diabetes cohort. Gastrointestinal adverse events were common and, per the trial authors, less frequent with dose escalation and a lower starting dose. It is investigational and not approved by any regulator. As of 2026-09-29, Amgen reports ongoing phase 3 studies (MARITIME-1 and -2 in weight management, plus cardiovascular outcomes, heart failure, sleep apnoea and switch studies); no phase 3 efficacy results were found. Evidence level: Phase 2 trials. Best human efficacy data: a randomised, double-blind, placebo-controlled phase 2 trial of 592 adults for 52 weeks, sponsored by Amgen and published in the New England Journal of Medicine (2025), plus a phase 1 first-in-human study (Nature Metabolism 2024). Animal data (obese mice using a mouse-specific surrogate, and obese cynomolgus monkeys) support the design and are animal-only. Phase 3 trials (MARITIME-1, n=3,853; MARITIME-2, n=1,105; primary endpoint body-weight change at week 72) are running with estimated primary completion in early 2027 on ClinicalTrials.gov; no phase 3 results were found as of 2026-09-29. Not approved by any regulator. - Evidence source: New England Journal of Medicine (PubMed), "Once-Monthly Maridebart Cafraglutide for the Treatment of Obesity - A Phase 2 Trial" (2025-06-23) https://pubmed.ncbi.nlm.nih.gov/40549887/ - Evidence source: Nature Metabolism (PubMed), "A GIPR antagonist conjugated to GLP-1 analogues promotes weight loss with improved metabolic parameters in preclinical and phase 1 settings" (2024-02) https://pubmed.ncbi.nlm.nih.gov/38316982/ - Evidence source: ClinicalTrials.gov, "Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-1, NCT06858839)" (2025-03-05) https://clinicaltrials.gov/study/NCT06858839 - Evidence source: ClinicalTrials.gov, "Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-2, NCT06858878)" (2025-03-05) https://clinicaltrials.gov/study/NCT06858878 - Evidence source: Amgen (PR Newswire), "Amgen reports second quarter 2026 financial results" (2026-08-04) https://www.prnewswire.com/news-releases/amgen-reports-second-quarter-2026-financial-results-302842890.html Half-life: About 21 days (mean, first-in-human phase 1 study in people with obesity; about 21 to 24 days for total drug and 14 to 16 days for the intact conjugate across single-dose cohorts) (source: https://pmc.ncbi.nlm.nih.gov/articles/PMC10896721/) Status by country: - Australia: Not approved. Investigational only. No maridebart cafraglutide product is on the ARTG and no application appears on the TGA's evaluation list. (verified 2026-09-29; source: https://www.tga.gov.au/resources/artg?keywords=maridebart) - Brazil: Not approved. Maridebart cafraglutide has no Brazilian registration and is not on the market (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Not approved. Maridebart cafraglutide (MariTide) is an investigational drug with no Health Canada authorisation (verified 2026-09-29; source: https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=maridebart-cafraglutide) - China: Not approved. Not approved in China; Amgen has trial-stage filings and Chinese sites in its outcomes trial. (verified 2026-09-29; source: https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d) - European Union: Not approved. Investigational; no EU marketing authorisation and no application under evaluation (verified 2026-09-29; source: https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm) - India: Not approved. Not approved in India: no CDSCO marketing permission or Indian trial record found for maridebart cafraglutide (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf) - Japan: Not approved. No marketing approval in Japan; the investigational antibody-peptide conjugate maridebart cafraglutide does not appear in PMDA's approved-drug lists to September 2026 (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. Not registered in Mexico; MariTide is an investigational Amgen medicine (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Not approved. Maridebart cafraglutide (MariTide) is investigational with no Medsafe consent in New Zealand (verified 2026-09-29; source: https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm) - United Arab Emirates: Not approved. No EDE approval found for maridebart cafraglutide (MariTide); an investigational medicine, not marketed in the UAE (verified 2026-09-29; source: https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae) - United Kingdom: Not approved. Maridebart cafraglutide has no UK licence (verified 2026-09-29; source: https://www.gov.uk/guidance/find-product-information-about-medicines) - United States: Not approved. Investigational; Amgen is running Phase 3 trials (MARITIME programme) and no FDA approval or filing has been reported (verified 2026-09-29; source: https://clinicaltrials.gov/study/NCT07037433) ### Mazdutide - Page: https://glp1base.com/molecules/mazdutide - Also known as: IBI362, LY3305677 - Brand names (nominative use only): Xinermei - Class: Approved GLP-1 medicine - Targets: GLP-1 receptor, Glucagon receptor - Route: Once-weekly subcutaneous injection, as used in the approved Chinese indications and in all published clinical trials. - Last verified: 2026-09-29 Simple: Mazdutide is a once-a-week injected medicine that switches on the body's receptors for two hormones: GLP-1, which lowers appetite and helps control blood sugar, and glucagon, which acts mainly on the liver and may help the body use more energy (shown mostly in animals). China approved it in 2025 for weight management and type 2 diabetes. We found no US, EU or UK approval as of September 2026. Expert: Mazdutide (IBI362, LY3305677) is a synthetic 33-residue peptide analogue of mammalian oxyntomodulin that acts as a dual agonist of the GLP-1 receptor and the glucagon receptor (GCGR). It carries an Aib substitution at position 2 and a C20 fatty diacid attached through a gamma-Glu and two short PEG-like (OEG) spacers to the epsilon-amine of Lys20 (C207H317N45O65, about 4,476 Da), a fatty-acyl modification intended to extend its time in the body; the C-terminus is amidated. After subcutaneous injection in a phase 1b multiple-ascending-dose study, median Tmax was 72 hours and terminal half-life ranged from 150.9 to 403.5 hours, which supports once-weekly administration. Innovent Biologics develops it in China under an exclusive licence agreement with Eli Lilly (Lilly code LY3305677). China's NMPA approved it on 2025-06-27 for chronic weight management in adults (BMI 28 or more, or 24 or more with at least one weight-related comorbidity) and in September 2025 for glycaemic control in adults with type 2 diabetes. Key trials are GLORY-1 (phase 3, n=610, NEJM), GLORY-2 (higher-dose phase 3, JAMA), DREAMS-1 and DREAMS-2 (phase 3 in type 2 diabetes, Nature) and a US phase 2 trial run by Lilly. No FDA, EMA, MHRA or PMDA approval was found on 2026-09-29. Most efficacy data come from Chinese adults, and long-term cardiovascular outcome data are not yet available. Evidence level: Approved. Approved by China's NMPA (weight management 2025-06-27; type 2 diabetes September 2025). Pivotal evidence is from Chinese adults: GLORY-1 (phase 3, 610 adults with overweight or obesity, 48 weeks), GLORY-2 (phase 3, 461 adults with obesity, 60 weeks) and DREAMS-1 and DREAMS-2 (phase 3, type 2 diabetes). In the US, a completed phase 2 trial in obesity (179 adults, run by Eli Lilly) has been published; no approval by the FDA or other non-Chinese regulators was found in our search. - Evidence source: New England Journal of Medicine (PubMed), "Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight (GLORY-1)" (2025-06-12) https://pubmed.ncbi.nlm.nih.gov/40421736/ - Evidence source: JAMA (PubMed), "Treatment With 9-mg Mazdutide for Weight Reduction in Chinese Adults With Obesity: The GLORY-2 Randomized Clinical Trial" (2026-08-04) https://pubmed.ncbi.nlm.nih.gov/42251595/ - Evidence source: Nature (PubMed), "Mazdutide versus placebo in Chinese adults with type 2 diabetes (DREAMS-1)" (2026-04) https://pubmed.ncbi.nlm.nih.gov/41407859/ - Evidence source: Nature (PubMed), "Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes (DREAMS-2)" (2026-04) https://pubmed.ncbi.nlm.nih.gov/41407860/ - Evidence source: The Lancet Diabetes & Endocrinology (PubMed), "Efficacy and safety of mazdutide in adults with obesity or overweight: a US-based, multicentre, phase 2, randomised, placebo-controlled clinical trial" (2026-08-21) https://pubmed.ncbi.nlm.nih.gov/42628555/ - Evidence source: Drugs (PubMed), "Mazdutide: First Approval" (2025-12) https://pubmed.ncbi.nlm.nih.gov/41028652/ Half-life: About 6.3 to 16.8 days (150.9 to 403.5 hours) in Chinese adults with overweight or obesity (phase 1b multiple-ascending-dose study, pharmacokinetics measured in 24 participants given mazdutide) (source: https://pubmed.ncbi.nlm.nih.gov/34430840/) Status by country: - Australia: Not approved. Not approved in Australia. No mazdutide product is on the ARTG and no application appears on the TGA's evaluation list. (verified 2026-09-29; source: https://www.tga.gov.au/resources/artg?keywords=mazdutide) - Brazil: Not approved. Mazdutide has no Brazilian registration and is not on the market (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Not approved. Mazdutide is an investigational drug with no Health Canada authorisation (verified 2026-09-29; source: https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=mazdutide) - China: Approved. Approved in China (first in the world) for weight management and type 2 diabetes; a higher-strength application is under review. (verified 2026-09-29; source: https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20250627145044169.html) - European Union: Not approved. No EU marketing authorisation and no application under evaluation (verified 2026-09-29; source: https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm) - India: Not approved. Not approved in India: no CDSCO marketing permission or Indian trial record found for mazdutide (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf) - Japan: Not approved. 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 (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. Not registered in Mexico; mazdutide is approved only in China (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Not approved. Mazdutide is an investigational medicine with no Medsafe consent in New Zealand (verified 2026-09-29; source: https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm) - United Arab Emirates: Not approved. No EDE approval found for mazdutide; not marketed in the UAE (verified 2026-09-29; source: https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae) - United Kingdom: Not approved. Mazdutide has no UK licence (verified 2026-09-29; source: https://www.gov.uk/guidance/find-product-information-about-medicines) - United States: Not approved. Not approved by FDA; Eli Lilly has run US Phase 2 studies of the medicine (LY3305677) but no application has been reported (verified 2026-09-29; source: https://clinicaltrials.gov/study/NCT06124807) ### Melanotan II - Page: https://glp1base.com/molecules/melanotan-ii - Also known as: MT-II, MT2, MTII, Melanotan 2, Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-NH2 - Class: Trending peptide - Targets: Melanocortin receptors (non-selective agonist; MC1R, MC3R and MC4R are the best-documented targets) - Route: In the human studies it was given by subcutaneous injection under medical supervision; in the mouse feeding experiments it was injected directly into the brain (intracerebroventricular). It has no approved route because it has no approved use. Regulators describe the unapproved products sold for tanning as injectables and nasal sprays whose contents are not verified. - Last verified: 2026-09-29 Simple: Melanotan II is a small lab-made peptide that copies a natural hormone which darkens skin and acts in the brain. It was tested in a few small human studies between 1996 and 2000, and we found no regulator that has approved it. In Australia and the UK it is sold illegally as a tanning product, and regulators warn about its side effects. Expert: Melanotan II (MT-II) is a synthetic cyclic heptapeptide analogue of alpha-melanocyte-stimulating hormone (alpha-MSH): Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-NH2, closed by a lactam bridge between the Asp and Lys side chains (C50H69N15O9, about 1,024 Da). It came from a 1989 design programme that cyclised the alpha-MSH 4-10 core by lactam bridging with Nle4 and D-Phe7 substitutions; the 23-membered-ring analogues were about 90-100-fold more potent than alpha-MSH in a lizard-skin bioassay and showed prolonged residual activity. It is a non-selective melanocortin receptor agonist: MC1R activation on melanocytes explains skin darkening, while activation of central MC3R/MC4R is thought to underlie appetite suppression in mice and, in men, penile erection and increased sexual desire. We found no published human pharmacokinetic study, so no half-life is stated. Human evidence is limited to a 3-volunteer pilot phase 1 study (1996), two small double-blind placebo-controlled crossover studies in men with erectile dysfunction (1998 and 2000; 10 men each), and a 2000 review by the same group summarising its experience in 20 men with psychogenic or organic erectile dysfunction; nausea, yawning and stretching were common. We found no later phase 2 or 3 trial and no marketing approval from any regulator. The TGA states it is a prescription-only medicine in Australia with no product on the Australian register, and the MHRA treats Melanotan II as a medicine (unauthorised) when it is sold as an injectable or pen. Case reports link unregulated products to eruptive or atypical naevi, melanoma, priapism, rhabdomyolysis, renal infarction and posterior reversible encephalopathy syndrome; causality for melanoma is unproven. In the US it was removed from FDA's 503A Category 2 list in April 2026 after its nomination was withdrawn (FDA now lists it under 'nominated but withdrawn'), and the Pharmacy Compounding Advisory Committee is due to consider it before the end of February 2027; removal from Category 2 does not make it an approved drug and does not automatically give it Category 1 status. Bremelanotide (Vyleesi) is a closely related analogue that differs at the C-terminus (free acid rather than amide). Evidence level: Small human studies. The best available human data are a 3-volunteer pilot phase 1 study (skin darkening, spontaneous erections, nausea) and two small double-blind, placebo-controlled crossover studies in men with erectile dysfunction (10 men with psychogenic ED and 10 men with organic risk factors), plus a 2000 review by the same group summarising its results in 20 men; all were published between 1996 and 2000. They showed erections and higher sexual desire but were tiny, short, and proof-of-concept only. We found no large randomised trial for tanning, sexual dysfunction or any other use, and we found no regulator that has approved it. The appetite-suppression findings come from mouse experiments in which the peptide was injected directly into the brain; this is animal-only evidence and has not been shown to work as a treatment in people. - Evidence source: Life Sciences (PubMed), "Evaluation of melanotan-II, a superpotent cyclic melanotropic peptide in a pilot phase-I clinical study" (1996) https://pubmed.ncbi.nlm.nih.gov/8637402/ - Evidence source: The Journal of Urology (PubMed), "Synthetic melanotropic peptide initiates erections in men with psychogenic erectile dysfunction: double-blind, placebo controlled crossover study" (1998-08) https://pubmed.ncbi.nlm.nih.gov/9679884/ - Evidence source: Urology (PubMed), "Effect of an alpha-melanocyte stimulating hormone analog on penile erection and sexual desire in men with organic erectile dysfunction" (2000-10) https://pubmed.ncbi.nlm.nih.gov/11018622/ - Evidence source: International Journal of Impotence Research (PubMed), "Melanocortin receptor agonists, penile erection, and sexual motivation: human studies with Melanotan II" (2000-10) https://pubmed.ncbi.nlm.nih.gov/11035391/ - Evidence source: Nature (PubMed), "Role of melanocortinergic neurons in feeding and the agouti obesity syndrome" (1997-01-09) https://pubmed.ncbi.nlm.nih.gov/8990120/ Status by country: - Australia: Prohibited. 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). (verified 2026-09-29; source: https://www.tga.gov.au/news/media-releases/individual-issued-27-infringement-notices-allegedly-supplying-melanotan-ii) - Brazil: Not approved. No Brazilian registration for melanotan II; a pharmacy-education institute says it is sold illegally online (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Prohibited. Not authorised; Health Canada has seized melanotan I and II products (2025 and 2026 notices) (verified 2026-09-29; source: https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm) - China: Not approved. No NMPA approval found for melanotan II; it cannot lawfully be sold as a medicine in China. (verified 2026-09-29; source: https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html) - European Union: Not approved. No EU marketing authorisation; not listed in EMA or Union Register data (verified 2026-09-29; source: https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json) - India: Not approved. Not approved in India: no CDSCO marketing permission found for Melanotan II; making or selling it as a medicine would be unapproved (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf) - Japan: Not approved. Not an approved medicine in Japan; sale and advertising as a drug are illegal (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. Not approved in Mexico; unregistered tanning peptide named in a July 2026 bill and a fact-check (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Prohibited. Not approved; Medsafe names melanotan II as an illegal unapproved product and says it seizes it (verified 2026-09-29; source: https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp) - United Arab Emirates: Not approved. Not approved in the UAE: no marketing authorisation for melanotan II; unapproved peptide products are under EDE enforcement (verified 2026-09-29; source: https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities) - United Kingdom: Not approved. Melanotan II is not licensed in the UK (verified 2026-09-29; source: https://www.gov.uk/guidance/find-product-information-about-medicines) - United States: Not approved. No FDA approval; FDA cites reports of melanoma and other serious events, and its advisers will consider it before the end of February 2027 (verified 2026-09-29; source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) ### MOTS-c - Page: https://glp1base.com/molecules/mots-c - Also known as: Mitochondrial open reading frame of the 12S rRNA-c, Mitochondrial-derived peptide MOTS-c, MOTSC - Class: Trending peptide - Targets: No confirmed receptor. Reported to act inside cells: folate cycle and purine synthesis inhibition leading to AMPK activation, and nuclear gene regulation (including NRF2-linked antioxidant response genes) after entering the nucleus - Route: No approved route because there is no approved product. In published animal studies MOTS-c has been given by injection (for example into the abdominal cavity of mice). The completed human trial of the analogue CB4211 and the registered phase 2a trial of MOTS-c both list subcutaneous injection. FDA's 2026 review found no clinical studies or human exposure data for MOTS-c by any route, including by mouth. - Last verified: 2026-09-29 Simple: MOTS-c is a tiny protein piece that your own cells make from their mitochondria, the parts that produce energy. In mice and cell studies it changes how muscle handles sugar and fat. It is not an approved medicine anywhere we could verify, and there are no published results from trials of MOTS-c itself in people. Expert: MOTS-c (mitochondrial open reading frame of the 12S rRNA-c) is a 16-residue peptide, MRWQEMGYIFYPRKLR (C101H152N28O22S2, 2174.6 Da), encoded by a short open reading frame inside the mitochondrial MT-RNR1 (12S rRNA) gene; it was described in 2015 (Lee et al., Cell Metab). It is a natural, unmodified linear peptide; FDA notes it can be made by standard solid-phase peptide synthesis. Proposed mechanism: in cells it inhibits the folate cycle and de novo purine biosynthesis, raising AICAR and activating AMPK; under metabolic stress it translocates to the nucleus in an AMPK-dependent way and interacts with stress-responsive transcription factors such as NRF2 (Kim et al., 2018). No cell-surface receptor has been established, and FDA reviewers noted that the molecular target remains unknown. In mice, injected MOTS-c reduced diet-induced obesity and insulin resistance and improved physical performance in young, middle-aged and old animals; rodent and cell work also reports effects on bone cells, vascular calcification and pancreatic islet senescence. No in-vivo pharmacokinetic study was identified by FDA; the only pharmacokinetic-type data found was in-vitro degradation in human whole blood, which is rapid. In humans, endogenous MOTS-c rose in skeletal muscle (11.9-fold after exercise) and plasma (1.6-fold during exercise) in 10 healthy young men, and circulating levels are reported lower in type 2 diabetes, but these are observations rather than treatment trials. MOTS-c has no approval from any regulator we verified. The only completed clinical trial linked to the peptide used CB4211, a modified analogue (CohBar phase 1a/1b, NCT03998514, 88 enrolled), which the sponsor reported as well tolerated, with a liver-fat reduction similar to placebo in its small phase 1b portion. A phase 2a trial of MOTS-c in prediabetes with overweight or obesity (NCT07505745) is registered as recruiting, with no results. In the US, MOTS-c is a non-approved substance; the FDA's Pharmacy Compounding Advisory Committee voted 7-5 (2 abstentions) on 23 July 2026 to recommend it for the 503A Bulks List (as reported by AJMC), against FDA staff's written proposal not to add it. That vote is non-binding and no final FDA decision had been verified. Evidence level: Animal studies only. For MOTS-c itself the published therapeutic evidence is animal (mainly mice and rats) and cell work, plus human observational data (levels rise with exercise and are reported lower in type 2 diabetes). FDA's 2026 briefing document states it identified no clinical studies or human exposure data for MOTS-c by any route. The only completed human trial connected to the peptide tested CB4211, a modified analogue, in a phase 1a/1b safety study (NCT03998514); the sponsor reported acceptable tolerability, and although liver enzymes (ALT, AST) and glucose fell more than on placebo in the 20-person phase 1b portion, the reported drop in liver fat (MRI-PDFF) was about the same as placebo (5.03% vs 4.88%). A phase 2a trial of MOTS-c in prediabetes (NCT07505745, sponsor Hudson Biotech, estimated 120 participants) began in February 2026 and has no results yet. Animal effects should not be assumed to carry over to people. - Evidence source: Cell Metabolism (via PubMed), "The mitochondrial-derived peptide MOTS-c promotes metabolic homeostasis and reduces obesity and insulin resistance" (2015-03-03) https://pubmed.ncbi.nlm.nih.gov/25738459/ - Evidence source: Nature Communications (via PubMed), "MOTS-c is an exercise-induced mitochondrial-encoded regulator of age-dependent physical decline and muscle homeostasis" (2021-01-20) https://pubmed.ncbi.nlm.nih.gov/33473109/ - Evidence source: US Food and Drug Administration, "FDA Briefing Document for MOTS-c-Related Bulk Drug Substances (MOTS-c (free base) and MOTS-c acetate), Pharmacy Compounding Advisory Committee, July 23-24, 2026" (2026-05-11) https://www.fda.gov/media/193347/download - Evidence source: ClinicalTrials.gov (CohBar, Inc.), "A Phase 1a/1b Study of CB4211 in Healthy Non-obese Subjects and Subjects With Nonalcoholic Fatty Liver Disease (NCT03998514)" (2021-05-11) https://clinicaltrials.gov/study/NCT03998514 - Evidence source: CohBar, Inc. (GlobeNewswire), "CohBar Announces Positive Topline Results from the Phase 1a/1b Study of CB4211 Under Development for NASH and Obesity" (2021-08-10) https://www.globenewswire.com/news-release/2021/08/10/2278324/0/en/CohBar-Announces-Positive-Topline-Results-from-the-Phase-1a-1b-Study-of-CB4211-Under-Development-for-NASH-and-Obesity.html - Evidence source: ClinicalTrials.gov (Hudson Biotech), "MOTS-c for Improving Insulin Sensitivity in Adults With Prediabetes and Overweight/Obesity (NCT07505745)" (2026-04-01) https://clinicaltrials.gov/study/NCT07505745 Status by country: - Australia: Not approved. No MOTS-c product is on the ARTG. It counts as an unapproved peptide, and advertising or supplying it is likely unlawful. (verified 2026-09-29; source: https://www.tga.gov.au/resources/artg?keywords=MOTS-c) - Brazil: Not approved. No Brazilian registration for MOTS-c; the unregistered-peptide rules apply (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Prohibited. Not authorised; named in Health Canada's April 2026 seizure advisory and banned in sport (verified 2026-09-29; source: https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm) - China: Not approved. Not an approved medicine in China; unlawful to sell as a drug, and it is named on the WADA banned list. (verified 2026-09-29; source: https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html) - European Union: Not approved. No EU marketing authorisation; named on the WADA 2026 prohibited list (S4.4.1) (verified 2026-09-29; source: https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json) - India: Not approved. Not approved in India: no CDSCO marketing permission found for MOTS-c; making or selling it as a medicine would be unapproved (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf) - Japan: Not approved. Not an approved medicine in Japan; MOTS-c is absent from PMDA's lists, and WADA bans it in sport (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. No registration for MOTS-c found in COFEPRIS lists (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Not approved. No Medsafe-approved medicine contains MOTS-c; mitochondria-derived peptides are prescription-only (verified 2026-09-29; source: https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm) - United Arab Emirates: Not approved. Not approved in the UAE: no marketing authorisation for MOTS-c; unapproved peptide products are under EDE enforcement (verified 2026-09-29; source: https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities) - United Kingdom: Not approved. MOTS-c is not licensed in the UK (verified 2026-09-29; source: https://www.gov.uk/guidance/find-product-information-about-medicines) - United States: Not approved. No FDA approval; FDA found no human exposure data, and a July 2026 advisory vote to consider it is non-binding (verified 2026-09-29; source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) ### NAD+ - Page: https://glp1base.com/molecules/nad-plus - Also known as: Nicotinamide adenine dinucleotide, Nadide, NAD, Coenzyme I, Diphosphopyridine nucleotide (DPN, older name) - Class: Other - Targets: Not a receptor-targeted drug. NAD+ is a coenzyme used by hundreds of enzymes: dehydrogenases (as an electron carrier, cycling with NADH) and NAD+-consuming enzymes such as sirtuins, poly(ADP-ribose) polymerases (PARPs) and the NADases CD38 and CD157 - Route: In the human studies identified, NAD+ itself was given by intravenous infusion: a 7-day course in the Chinese heart-failure trial and a single 6-hour infusion in the healthy-volunteer pharmacokinetic pilot. Wellness-clinic intravenous and injectable NAD+ is not an approved use we could verify anywhere. Oral NAD+ has not been established as a way to raise NAD+; the oral studies in humans used the precursors nicotinamide riboside or nicotinamide mononucleotide instead. - Last verified: 2026-09-29 Simple: NAD+ is a helper molecule that every cell in your body already makes and uses, to turn food into energy and to run repair jobs. Some clinics sell NAD+ drips as wellness treatments. Studies in people are few and small, and we found no US FDA approval. Whether drips help healthy people has not been shown. Expert: NAD+ (nicotinamide adenine dinucleotide; INN nadide) is an endogenous dinucleotide coenzyme: two nucleotides (adenosine monophosphate and nicotinamide mononucleotide) joined through their phosphate groups. It is not a peptide. PubChem lists the oxidised form as C21H28N7O14P2+ (664.4 g/mol; the neutral inner-salt record is 663.4 g/mol). Biology: NAD+/NADH shuttle electrons in glycolysis, the TCA cycle and oxidative phosphorylation, and NAD+ is also consumed as a substrate by sirtuins, PARPs and CD38/CD157. Cells make it from tryptophan (de novo), from nicotinic acid (Preiss-Handler pathway), from nicotinamide (salvage) and from the precursors nicotinamide riboside (NR) and nicotinamide mononucleotide (NMN). Pharmacology of the exogenous molecule: it is a large, highly polar, charged molecule. In the only human intravenous pharmacokinetic pilot identified (Grant et al., 2019; 8 infused, 3 saline controls), infused NAD+ was completely removed from plasma for at least the first 2 hours, which the authors attribute to tissue uptake and/or metabolism; plasma NAD+ and metabolites then rose by the end of the 6-hour infusion, and the metabolite pattern was consistent with NAD+ glycohydrolase and pyrophosphatase activity. Breakdown to smaller molecules (nicotinamide, ADP-ribose, NMN and others) therefore appears to be a major fate, but how much intact NAD+ reaches cells in humans is unresolved. Some intact uptake has been shown in cultured cells (Billington et al., 2008). No human half-life was identified. Evidence: oral NR and NMN reliably raise blood NAD+ metabolites in humans and are generally well tolerated, but functional outcomes are heterogeneous or null; a 2026 PRISMA systematic review found no eligible outcome trials of intravenous or intramuscular NAD+ itself for anti-ageing or wellness use. The main randomised, placebo-controlled trial of intravenous NAD+ identified is a single-centre Chinese trial in 180 patients with ischaemic heart failure (LVEF at 1 month 45.44% vs 42.44%, p=0.024; clinical event differences not significant; ChiCTR2200059169). A 2026 multi-cohort study found human whole-blood NAD+ does not fall with age, which weakens the rationale for using blood NAD+ as an ageing biomarker. Status: the trial paper reports that the NAD+ it used carried a Chinese drug approval number (SFDA H41024721); we could not independently confirm its approved indications on the NMPA database. We found no US FDA (Drugs@FDA) approval, and no approval by EMA, MHRA, TGA, Health Canada or PMDA was verified. In the US, NAD and NADH are listed in FDA's 503A Category 1 (bulk substances under evaluation, with interim enforcement discretion for compounding) as of the 14 May 2026 update; this is not an approval and not a final bulks-list decision. Health Canada named NAD+ among unauthorized injectable products in an April 2026 advisory. Evidence level: Small human studies. For NAD+ itself the human evidence is small. The main randomised, placebo-controlled trial identified is in 180 adults with heart failure from ischaemic cardiomyopathy, intravenous NAD+ for 7 days on top of standard care; single centre in China; primary endpoint LVEF at 1 month improved, 45.44 +/- 8.55% vs 42.44 +/- 9.09%, p=0.024; NT-proBNP, 6-month cardiac events and NYHA class showed non-significant trends; the authors note the trial was underpowered for clinical events; the trial paper also cites a smaller Chinese pilot randomised trial in older heart-failure patients). There is also one small randomised, saline-controlled pilot of the blood and urine fate of an infusion in healthy volunteers (Grant et al., 2019; 8 infused, 3 controls), plus uncontrolled series and case reports summarised in 2026 reviews. A 2026 systematic review found no eligible outcome trials of intravenous or intramuscular NAD+ for anti-ageing or wellness; a 2026 critical review calls IV longevity therapy experimental. Most of the wider 'NAD+ boosting' evidence concerns oral precursors (NR, NMN), which raise blood NAD+ metabolites in humans with mixed functional results, and is not evidence about NAD+ drips. Mechanistic claims about ageing come largely from mice and cell studies. - Evidence source: American Journal of Cardiovascular Drugs (via PubMed), "Effect of Nicotinamide Adenine Dinucleotide on Heart Failure Caused by Ischemic Cardiomyopathy: A Randomized, Placebo-Controlled Trial (Yu et al.)" (2026-01) https://pubmed.ncbi.nlm.nih.gov/40954388/ - Evidence source: Frontiers in Aging Neuroscience (via PubMed), "A Pilot Study Investigating Changes in the Human Plasma and Urine NAD+ Metabolome During a 6 Hour Intravenous Infusion of NAD+ (Grant et al.)" (2019) https://pubmed.ncbi.nlm.nih.gov/31572171/ - Evidence source: Ageing Research Reviews (via PubMed), "NAD+ supplementation for anti-aging and wellness: A PRISMA-guided systematic review of preclinical and clinical evidence (Gallagher et al.)" (2026-04) https://pubmed.ncbi.nlm.nih.gov/41655607/ - Evidence source: Frontiers in Aging (via PubMed), "Narrative review of intravenous NAD+ and NAD+ precursors in wellness and translational medicine (Alangari et al.)" (2026) https://pubmed.ncbi.nlm.nih.gov/42787547/ - Evidence source: Acta Dermatovenerologica Alpina, Pannonica et Adriatica (via PubMed), "Intravenous longevity therapy: a critical review of evidence, mechanisms, and clinical utility (Godic et al.)" (2026-03) https://pubmed.ncbi.nlm.nih.gov/41915584/ - Evidence source: Nature Communications (via PubMed), "Nicotinamide riboside is uniquely and orally bioavailable in mice and humans (Trammell et al.)" (2016-10-10) https://pubmed.ncbi.nlm.nih.gov/27721479/ - Evidence source: Nature Communications (via PubMed), "Chronic nicotinamide riboside supplementation is well-tolerated and elevates NAD+ in healthy middle-aged and older adults (Martens et al.)" (2018-03-29) https://pubmed.ncbi.nlm.nih.gov/29599478/ Status by country: - Australia: Not approved. No injectable NAD+ product is approved. ARTG entries that name NAD (nadide) are export-only listings that must not be supplied in Australia. (verified 2026-09-29; source: https://www.tga.gov.au/resources/artg?keywords=nadide) - Brazil: Not approved. No registered NAD+ medicine in Brazil; Anvisa says no supplement may be injectable (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Prohibited. Injectable NAD+ is not authorised; named in Health Canada's April 2026 advisory of seized unauthorised injectables (verified 2026-09-29; source: https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm) - China: Approved, restricted. Coenzyme I (NAD) for injection has domestic prescription-drug filings; wellness or anti-ageing use is not an approved purpose. (verified 2026-09-29; source: https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d) - European Union: Not approved. No EU marketing authorisation for NAD+ as a medicine; not listed in EMA or Union Register data (verified 2026-09-29; source: https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json) - India: Not approved. Not approved in India: no CDSCO marketing permission found for NAD+; making or selling it as a medicine would be unapproved (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf) - Japan: Not approved. No NAD+ injection is an approved medicine in Japan; sale or advertising as a drug without approval is illegal (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. No registration for NAD+ as an injectable medicine found in COFEPRIS lists (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Not approved. No Medsafe-approved medicine contains NAD+; the record covers NAD+ as a medicine, not supplements (verified 2026-09-29; source: https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm) - United Arab Emirates: Unverified. Could not determine a UAE rule specific to NAD+; no registration, ban or guidance naming it was found (verified 2026-09-29; source: https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae) - United Kingdom: Not approved. NAD+ is not licensed in the UK (verified 2026-09-29; source: https://www.gov.uk/guidance/find-product-information-about-medicines) - United States: Compounding restricted. No FDA-approved NAD+ drug; FDA lists NAD in Category 1 (under evaluation), which lets 503A pharmacies compound it under FDA's interim policy (verified 2026-09-29; source: https://www.fda.gov/media/94155/download?attachment) ### Orforglipron - Page: https://glp1base.com/molecules/orforglipron - Also known as: LY3502970, OWL833 - Brand names (nominative use only): Foundayo - Class: Oral GLP-1 - Targets: GLP-1 receptor - Route: Oral tablet taken once daily, with or without food, swallowed whole (from the approved US label). - Last verified: 2026-09-29 Simple: Orforglipron is a once-a-day tablet that copies a gut hormone called GLP-1. Most drugs like it are peptides that must be injected. This one is a small, non-peptide molecule that survives being swallowed. It is approved in the US and UK for weight management. The UK has also approved it for type 2 diabetes. Expert: Orforglipron (LY3502970, OWL833) is an orally available, non-peptide, small-molecule agonist of the human GLP-1 receptor (free base C48H48F2N10O5, about 883 Da; the marketed drug substance is the calcium salt). It binds a pocket in the upper helical bundle formed by the extracellular domain, extracellular loop 2 and transmembrane helices 1, 2, 3 and 7. It is a partial agonist biased toward G-protein activation over beta-arrestin recruitment. Its interaction with the primate-specific Trp33 of the receptor's extracellular domain explains its species selectivity, and the label states it is not pharmacologically active in rats or mice. After oral dosing, maximum concentration is reached in 4 to 8 hours, absolute bioavailability is about 77 to 79%, plasma protein binding exceeds 99%, and elimination half-life is about 29 to 49 hours, supporting once-daily use with or without food. It is cleared mainly by hepatic CYP3A4 oxidation and faecal excretion. The FDA approved it as Foundayo on 2026-04-01 for chronic weight management, based on the phase 3 ATTAIN-1 (NCT05869903) and ATTAIN-2 (NCT05872620) trials; the MHRA authorised it on 2026-08-10 for weight management and type 2 diabetes. ACHIEVE-1 (NCT05971940) is a key phase 3 diabetes trial. It carries the class boxed warning for thyroid C-cell tumours. Evidence level: Approved. Approved by the US FDA (2026-04-01, weight management) and the UK MHRA (2026-08-10, weight management and type 2 diabetes). The US approval rests on two 72-week randomised, double-blind, placebo-controlled phase 3 trials (ATTAIN-1 in adults without diabetes, n=3,127; ATTAIN-2 in adults with type 2 diabetes, n=1,613). Phase 3 work continues in other conditions. A July 2026 review in Drugs reported submissions for regulatory review in the EU, Japan and Canada; no decision there was found. - Evidence source: New England Journal of Medicine, "Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist for Obesity Treatment (ATTAIN-1)" (2025-09-16) https://www.nejm.org/doi/abs/10.1056/NEJMoa2511774 - Evidence source: New England Journal of Medicine (PubMed), "Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist, in Early Type 2 Diabetes (ACHIEVE-1)" (2025-09-18) https://pubmed.ncbi.nlm.nih.gov/40544435/ - Evidence source: U.S. Food and Drug Administration, "FOUNDAYO (orforglipron) tablets, for oral use: prescribing information" (2026-04) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf - Evidence source: Drugs (PubMed), "Orforglipron: First Approval" (2026-07-21) https://pubmed.ncbi.nlm.nih.gov/42479349/ Half-life: About 29 to 49 hours after an oral dose (source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf) Status by country: - Australia: Under review. 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. (verified 2026-09-29; source: https://www.tga.gov.au/resources/prescription-medicines-under-evaluation/tba-eli-lilly-australia-pty-ltd) - Brazil: Under review. Reported as filed with Anvisa by Lilly; no public Anvisa decision yet (verified 2026-09-29; source: https://panoramafarmaceutico.com.br/pilula-emagrecedora-da-lilly-ja-tem-data-para-chegar-no-brasil/) - Canada: Under review. Under review at Health Canada since January 2026 (Eli Lilly, new active substance); not yet authorised (verified 2026-09-29; source: https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review/new-drug-submissions-under-review.html) - China: Not approved. Not approved in China; Lilly has clinical-trial filings and Chinese trial sites, but we found no marketing application. (verified 2026-09-29; source: https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d) - European Union: Under review. Under EMA evaluation for obesity and type 2 diabetes; no EU authorisation yet (verified 2026-09-29; source: https://www.ema.europa.eu/en/documents/report/applications-new-human-medicines-under-evaluation-september-2026_en.xlsx) - India: Under review. Under review: CDSCO's expert committee recommended import and marketing permission for Lilly's oral orforglipron in May 2026 (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations-%20Endocrinology%20Metabolism%2020.05.2026%20%281%29.pdf) - Japan: Not approved. No marketing approval in Japan; the oral GLP-1 orforglipron does not appear in PMDA's approved-drug lists to September 2026 (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Approved. Registered by COFEPRIS in July 2026 as Foundayz (Eli Lilly); the register does not state the indication (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Not approved. No Medsafe data sheet listed for orforglipron; not approved for use in New Zealand (verified 2026-09-29; source: https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm) - United Arab Emirates: Approved. Approved by the EDE in April 2026 as Foundayo, a daily pill for chronic weight management; UAE was the second country to approve it (verified 2026-09-29; source: https://www.tradearabia.com/News/413619/Emirates-Drug-Establishment-approves-oral-obesity-treatment) - United Kingdom: Approved. Licensed by the MHRA on 10 August 2026 as Foundayo, a once-daily tablet for weight management and type 2 diabetes (verified 2026-09-29; source: https://www.gov.uk/government/news/uk-first-in-europe-to-authorise-orforglipron-for-weight-management-and-type-2-diabetes) - United States: Approved. FDA-approved on 1 April 2026 as Foundayo, a tablet for obesity, or overweight with a weight-related condition (verified 2026-09-29; source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf) ### Pramlintide - Page: https://glp1base.com/molecules/pramlintide - Also known as: Pramlintide acetate, Amylin analogue (human amylin analog), AC137 - Brand names (nominative use only): Symlin (SymlinPen) - Class: Amylin analogue - Targets: Amylin receptors (calcitonin receptor paired with RAMP1, RAMP2 or RAMP3) - Route: Subcutaneous injection at major meals, given as an add-on to mealtime insulin (US label: pen injector). Not taken by mouth. - Last verified: 2026-09-29 Simple: Pramlintide is a lab-made, slightly changed version of amylin, a hormone your pancreas releases along with insulin when you eat. It slows how fast food leaves the stomach, lowers a hormone that raises blood sugar, and helps you feel full. In the US it was approved as an add-on to mealtime insulin. The FDA now lists all Symlin products as discontinued. Expert: Pramlintide is a 37-residue synthetic analogue of human amylin (IAPP). It differs from the human peptide by proline substitutions at positions 25, 28 and 29, which limit the self-aggregation seen with native amylin; it keeps the Cys2-Cys7 disulfide and C-terminal amide (molecular weight about 3949 Da). It acts as an agonist at amylin receptors, heterodimers of the calcitonin receptor and a RAMP. In humans it slows gastric emptying, blunts the meal-related rise in glucagon and reduces energy intake. After subcutaneous injection, absolute bioavailability is about 30-40% and the half-life in healthy people is about 48 minutes; the main metabolite, des-Lys1 pramlintide, is active in vitro. The FDA approved it in March 2005 (Symlin, NDA 021332) as an adjunct for people with type 1 or type 2 diabetes who use mealtime insulin and have not reached glycaemic goals. The label carries a boxed warning for severe hypoglycaemia. In 52-week randomised trials it lowered HbA1c from baseline by roughly 0.3-0.6 percentage points at week 52, significantly more than placebo, with modest weight loss instead of weight gain, and nausea was the commonest adverse effect. Phase 2 studies in obesity (published 2007-2008) showed weight loss, but pramlintide is not approved for weight management and that use is unapproved. Drugs@FDA lists all Symlin products as discontinued. Approval status at other regulators was not verified for this record. Evidence level: Approved. Approved by the US FDA in 2005 on the strength of randomised, double-blind, placebo-controlled 26- to 52-week trials in type 1 and type 2 diabetes (mealtime add-on to insulin). Weight-management studies were phase 2 only (a 16-week study and a 4-month study with an 8-month extension) and did not lead to an obesity approval; that use is unapproved. - Evidence source: Diabetes Care, "A randomized study and open-label extension evaluating the long-term efficacy of pramlintide as an adjunct to insulin therapy in type 1 diabetes" (2002-04) https://doi.org/10.2337/diacare.25.4.724 - Evidence source: Diabetic Medicine, "Amylin replacement with pramlintide as an adjunct to insulin therapy improves long-term glycaemic and weight control in Type 1 diabetes mellitus: a 1-year, randomized controlled trial" (2004-11) https://doi.org/10.1111/j.1464-5491.2004.01319.x - Evidence source: Diabetes Care, "Pramlintide as an adjunct to insulin therapy improves long-term glycemic and weight control in patients with type 2 diabetes: a 1-year randomized controlled trial" (2003-03) https://doi.org/10.2337/diacare.26.3.784 - Evidence source: U.S. National Library of Medicine, DailyMed (label: AstraZeneca), "SYMLIN (pramlintide acetate) injection, prescribing information (DailyMed label)" (2019-12-18) https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4aea30ff-eb0d-45c1-b114-3127966328ff - Evidence source: Diabetes Care, "Sustained weight loss following 12-month pramlintide treatment as an adjunct to lifestyle intervention in obesity" (2008-09) https://doi.org/10.2337/dc08-0029 - Evidence source: Journal of Clinical Endocrinology & Metabolism, "Progressive reduction in body weight after treatment with the amylin analog pramlintide in obese subjects: a phase 2, randomized, placebo-controlled, dose-escalation study" (2007-08) https://doi.org/10.1210/jc.2006-2003 - Evidence source: BioDrugs (Adis R&D profile), "Pramlintide: (AC 137, AC 0137, Symlin, Tripro-Amylin)" (2003) https://doi.org/10.2165/00063030-200317010-00008 - Evidence source: U.S. Food and Drug Administration, "Drugs@FDA: SYMLIN (pramlintide acetate), NDA 021332" (2026-09-29) https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021332 Half-life: About 48 minutes in healthy people (peak blood level after about 20 minutes) (source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4aea30ff-eb0d-45c1-b114-3127966328ff) Status by country: - Australia: Not approved. Not on the ARTG and no application on the TGA's evaluation list. It could only be reached through unapproved-medicine pathways. (verified 2026-09-29; source: https://www.tga.gov.au/resources/artg?keywords=pramlintide) - Brazil: Not approved. No Brazilian registration for pramlintide (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Not approved. No pramlintide product is authorised in Canada (verified 2026-09-29; source: https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=pramlintide) - China: Not approved. Not approved in China; only old clinical-stage filings by domestic developers appear in the public register. (verified 2026-09-29; source: https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d) - European Union: Not approved. No EU marketing authorisation; not listed in EMA or Union Register data (verified 2026-09-29; source: https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json) - India: Not approved. Not approved in India: no CDSCO marketing permission found for pramlintide (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf) - Japan: Not approved. No marketing approval in Japan; pramlintide (an amylin analogue) is not in PMDA's approved-drug lists or package-insert database (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. No registration for pramlintide found in COFEPRIS lists (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Not approved. No pramlintide product is approved, listed by Medsafe or funded in New Zealand (verified 2026-09-29; source: https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm) - United Arab Emirates: Unverified. Could not confirm whether pramlintide (Symlin) is registered by the EDE; no UAE-specific record was found (verified 2026-09-29; source: https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae) - United Kingdom: Not approved. Not licensed in the UK (verified 2026-09-29; source: https://www.gov.uk/guidance/find-product-information-about-medicines) - United States: Approved, restricted. Approved as Symlin in 2005 for mealtime insulin users with diabetes, but the maker has notified FDA it is discontinuing the product (verified 2026-09-29; source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021332s028lbl.pdf) ### Retatrutide - Page: https://glp1base.com/molecules/retatrutide - Also known as: LY3437943, LY-3437943 - Class: In clinical trials - Targets: GIP receptor, GLP-1 receptor, Glucagon receptor - Route: Investigational. In clinical trials it is given by subcutaneous injection once a week. It has no approved route because it is not approved anywhere. Lilly's May 2026 release described it as legally available only to participants in Lilly's clinical trials. Since June 2026 Lilly has also listed a pre-approval, single-patient expanded-access programme, requested by a treating physician, for a narrow group of adults with severe obesity who cannot join a trial. - Last verified: 2026-09-29 Simple: Retatrutide is an experimental once-a-week injection from Eli Lilly. It copies three natural gut and body hormones at once (GIP, GLP-1 and glucagon). In large trials, people lost a lot of weight, but it is not approved anywhere yet. Lilly says it plans to ask the US FDA for approval in early 2027. Expert: Retatrutide (LY3437943) is an investigational, once-weekly, subcutaneously administered single-peptide agonist of the GIP, GLP-1 and glucagon receptors (GIPR, GLP-1R, GCGR). It is a 39-residue synthetic peptide (about 4.73 kDa) with three non-proteinogenic residues (Aib at positions 2 and 20, alpha-methyl-leucine at position 13), a C-terminal amide, and a C20 fatty diacid attached to Lys17 through a linker. In vitro it shows balanced GCGR and GLP-1R activity with relatively more GIPR activity (Coskun 2022). In a phase 1b multiple-ascending-dose study in type 2 diabetes, exposure was dose-proportional and the half-life was about 6 days, supporting weekly dosing. Phase 2 trials in obesity (NEJM 2023, NCT04881760) and type 2 diabetes (Lancet 2023, NCT04867785) showed dose-dependent weight and HbA1c reductions; the obesity trial reported a 24.2% mean weight reduction at 48 weeks in the highest-dose group versus 2.1% with placebo. The phase 3 TRIUMPH programme reported topline results in TRIUMPH-4 (knee osteoarthritis, December 2025), TRIUMPH-1 (obesity, May 2026, 2,339 participants, up to 28.3% mean weight loss at 80 weeks on the efficacy estimand versus 2.2% with placebo) and TRIUMPH-2 and TRIUMPH-3 (July 2026). TRANSCEND-T2D-1, a 40-week phase 3 monotherapy trial in type 2 diabetes, has been peer-reviewed (Lancet 2026). Common adverse events are gastrointestinal (nausea, diarrhoea, constipation, vomiting); dysesthesia has emerged as a notable dose-related signal in phase 3. Retatrutide is not approved by any regulator. Lilly says it plans a US Biologics License Application in Q1 2027; whether FDA treats it as a biologic (BLA) or a drug (NDA) has been disputed in court because of how amino acids in the molecule are counted. Outside clinical trials and a limited expanded-access programme it has no lawful supply, and products sold online as retatrutide are unapproved. Evidence level: Phase 3 trials. Not approved by any regulator. Evidence comes from Lilly-sponsored trials: phase 1 (single and multiple ascending dose), two published phase 2 trials (obesity, n=338; type 2 diabetes, n=281), a phase 2a liver-fat sub-study, one peer-reviewed phase 3 trial (TRANSCEND-T2D-1, n=537, 40 weeks) and industry topline press releases from the phase 3 TRIUMPH programme (TRIUMPH-4, -1, -2, -3). The TRIUMPH-1, -2, -3 and -4 figures are company-reported topline results that had not been peer-reviewed as of 2026-09-29. No dedicated cardiovascular outcomes result has been reported (in TRIUMPH-3, Lilly reported that major adverse cardiovascular events occurred less often than anticipated in both the retatrutide and placebo arms; the pre-specified hazard ratio for a five-component composite was 0.82, 95% CI 0.55 to 1.22, a range that does not exclude no effect). Lilly plans a US filing in Q1 2027. Preclinical work (mice, rats, hamsters) is used only for mechanism and is labelled animal-only below. - Evidence source: New England Journal of Medicine (PubMed), "Triple-Hormone-Receptor Agonist Retatrutide for Obesity - A Phase 2 Trial" (2023-08-10) https://pubmed.ncbi.nlm.nih.gov/37366315/ - Evidence source: The Lancet (PubMed), "Retatrutide, a GIP, GLP-1 and glucagon receptor agonist, for people with type 2 diabetes: a randomised, double-blind, placebo and active-controlled, parallel-group, phase 2 trial conducted in the USA" (2023-08-12) https://pubmed.ncbi.nlm.nih.gov/37385280/ - Evidence source: The Lancet (PubMed), "Efficacy and safety of retatrutide, a GIP, GLP-1, and glucagon receptor agonist, in people with type 2 diabetes and inadequate glycaemic control with diet and exercise (TRANSCEND-T2D-1): a double-blind, randomised, phase 3 trial" (2026-06-13) https://pubmed.ncbi.nlm.nih.gov/42250575/ - Evidence source: Eli Lilly and Company (PR Newswire), "Lilly's triple agonist, retatrutide, delivered powerful weight loss in pivotal Phase 3 obesity trial (TRIUMPH-1 topline)" (2026-05-21) https://www.prnewswire.com/news-releases/lillys-triple-agonist-retatrutide-delivered-powerful-weight-loss-in-pivotal-phase-3-obesity-trial-302778859.html - Evidence source: Eli Lilly and Company (PR Newswire), "Lilly's triple agonist, retatrutide, successful in two additional Phase 3 obesity trials (TRIUMPH-2 and TRIUMPH-3 topline)" (2026-07-23) https://www.prnewswire.com/news-releases/lillys-triple-agonist-retatrutide-successful-in-two-additional-phase-3-obesity-trials-delivering-significant-improvements-in-weight-and-a1c-302832674.html - Evidence source: Eli Lilly and Company (PR Newswire), "Lilly's triple agonist, retatrutide, delivered weight loss of up to an average of 71.2 lbs along with substantial relief from osteoarthritis pain in first successful Phase 3 trial (TRIUMPH-4 topline)" (2025-12-11) https://www.prnewswire.com/news-releases/lillys-triple-agonist-retatrutide-delivered-weight-loss-of-up-to-an-average-of-71-2-lbs-along-with-substantial-relief-from-osteoarthritis-pain-in-first-successful-phase-3-trial-302638804.html - Evidence source: BioSpace, "Lilly, FDA retatrutide biologic dispute comes to a head as submission nears" (2026-08-05) https://www.biospace.com/fda/lilly-fda-retatrutide-biologic-dispute-comes-to-a-head-as-submission-nears - Evidence source: ClinicalTrials.gov, U.S. National Library of Medicine, "A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight" (2023-07) https://clinicaltrials.gov/study/NCT05929066 - Evidence source: ClinicalTrials.gov, U.S. National Library of Medicine, "Pre-approval Expanded Access of Retatrutide (LY3437943)" (2026-06) https://clinicaltrials.gov/study/NCT07629401 Half-life: About 6 days (phase 1b study in type 2 diabetes) (source: https://pubmed.ncbi.nlm.nih.gov/36354040/) Status by country: - Australia: Prohibited. 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. (verified 2026-09-29; source: https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/tga-tests-counterfeit-retatrutide-product-following-serious-adverse-event-report) - Brazil: Prohibited. Not approved anywhere; Anvisa says products sold as retatrutide are illegal and has seized them (verified 2026-09-29; source: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/retatrutida-ainda-nao-esta-aprovada-para-uso-em-nenhum-lugar-do-mundo) - Canada: Prohibited. Not authorised; Health Canada named retatrutide among unauthorised injectable drugs it has seized (April 2026) (verified 2026-09-29; source: https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm) - China: Not approved. Not approved in China or anywhere else; only trial-stage filings exist. (verified 2026-09-29; source: https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d) - European Union: Not approved. Investigational; no EU marketing authorisation and no application under evaluation (verified 2026-09-29; source: https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm) - India: Not approved. Not approved in India; retatrutide is only in CDSCO-permitted Phase III trials run by Eli Lilly (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Endocrinology%20%26%20Metabolism%20dated%20on%2009.05.2024.pdf) - Japan: Not approved. No marketing approval in Japan; the investigational triple agonist retatrutide does not appear in PMDA's approved-drug lists to September 2026 (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. Not registered in Mexico; retatrutide is unapproved everywhere (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Prohibited. Not approved; Medsafe says retatrutide sold to the public is black-market and is being seized (verified 2026-09-29; source: https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp) - United Arab Emirates: Prohibited. Not approved; the EDE named retatrutide in July 2026 when it acted against 71 sources marketing or selling unapproved peptide products (verified 2026-09-29; source: https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities) - United Kingdom: Prohibited. Not authorised in the UK; the MHRA says selling it is illegal and has raided sites making and supplying it (verified 2026-09-29; source: https://www.gov.uk/government/news/no-summer-shortcut-for-safe-weight-loss) - United States: Prohibited. Not approved; FDA says retatrutide cannot be compounded and has warned sellers, so lawful access is limited to trials and expanded access (verified 2026-09-29; source: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss) ### Selank - Page: https://glp1base.com/molecules/selank - Also known as: TP-7, Selanc, Thr-Lys-Pro-Arg-Pro-Gly-Pro, Threonyl-lysyl-prolyl-arginyl-prolyl-glycyl-proline, Tuftsin analogue heptapeptide - Class: Trending peptide - Targets: GABA-A receptor (positive allosteric modulation reported in rat brain membranes; not confirmed in humans), Enkephalin-degrading enzymes in blood plasma (inhibition shown in vitro), Exact receptor unknown; a receptor for Selank has not been identified - Route: In its Russian registration Selank is given as nasal drops (intranasal); the Vidal drug reference lists it as a non-prescription medicine. Laboratory studies in rodents have used intranasal and intraperitoneal administration. The only registered form found is the nasal drop; no oral or injectable form was found in any registration checked, and this page gives no usage instructions. - Last verified: 2026-09-29 Simple: Selank is a short chain of seven amino acids, built from a natural immune-system fragment called tuftsin. In Russia it is a registered nasal drop for anxiety. The FDA has not approved it, and no approval by other major regulators was found. Human studies are few, small and mostly in Russian, and most of how it might work comes from animal and lab tests. Expert: Selank (TP-7) is a synthetic linear heptapeptide, Thr-Lys-Pro-Arg-Pro-Gly-Pro (C33H57N11O9, 751.9 Da), made by adding a Pro-Gly-Pro tail to the C-terminus of tuftsin (Thr-Lys-Pro-Arg, a fragment of the IgG heavy chain) to improve metabolic stability and prolong action; it was developed at the Institute of Molecular Genetics of the Russian Academy of Sciences. It is registered in the Russian Federation as Selank nasal drops (diacetate salt; ATC N05BX, held by Peptogen) for anxiety-spectrum conditions, and is used intranasally. The Russian label reports 92.8% nasal bioavailability, plasma detection within 30 seconds, plasma concentration falling over roughly 5 to 5.5 minutes, and no parent drug or metabolites in 24-hour urine because of rapid tissue peptidase degradation. No independent pharmacokinetic paper was found, so no formal half-life is given here. The mechanism is not established in humans. Preclinical and in vitro work reports inhibition of enkephalin-degrading enzymes in human plasma (IC50 15 microM), positive allosteric modulation of GABA-A binding in rat brain membranes, altered expression of GABAergic and inflammatory genes and of BDNF content in rodents, and cytokine changes in patient blood samples; a receptor has not been identified. Human efficacy evidence is limited to small, mostly open or comparator-controlled Russian studies (for example 62 patients with generalized anxiety disorder or neurasthenia compared with medazepam, and 60 patients compared with phenazepam). No placebo-controlled trial published in a major international journal was found, and no approval outside Russia was found in the sources checked. The FDA lists selank acetate among compounding nominations that were withdrawn and states it lacks important safety information for administration to humans. Use in any indication or country outside the Russian registration is unapproved. Evidence level: Small human studies. Human data are small, mostly Russian-language clinical studies: a 62-patient comparison with medazepam in generalized anxiety disorder and neurasthenia, a 60-patient comparison with phenazepam, and a 70-patient study comparing Selank plus phenazepam with phenazepam alone. These used psychometric scales but were not, as far as the abstracts state, placebo-controlled, and no independent replication outside Russia was found. Mechanism evidence is mostly animal (rats and mice) and in vitro (rat brain membranes, cell lines, human blood samples). Selank is registered in Russia. It is not FDA-approved, and no approval by other major regulators was found in the sources checked. Any use outside the Russian label is unapproved. - Evidence source: Zh Nevrol Psikhiatr Im S S Korsakova (via PubMed), "Efficacy and possible mechanisms of action of a new peptide anxiolytic selank in the therapy of generalized anxiety disorders and neurasthenia (Zozulia et al.)" (2008) https://pubmed.ncbi.nlm.nih.gov/18454096/ - Evidence source: Zh Nevrol Psikhiatr Im S S Korsakova (via PubMed), "A comparison of the anxiolytic effect and tolerability of selank and phenazepam in the treatment of anxiety disorders (Medvedev et al.)" (2014) https://pubmed.ncbi.nlm.nih.gov/25176261/ - Evidence source: Zh Nevrol Psikhiatr Im S S Korsakova (via PubMed), "Optimization of the treatment of anxiety disorders with selank (Medvedev et al.)" (2015) https://pubmed.ncbi.nlm.nih.gov/26356395/ - Evidence source: J Clin Pharmacol (via PubMed), "Sedative-Hypnotic Agents That Impact Gamma-Aminobutyric Acid Receptors: Focus on Flunitrazepam, Gamma-Hydroxybutyric Acid, Phenibut, and Selank (Doyno et al.)" (2021-08) https://pubmed.ncbi.nlm.nih.gov/34396551/ Status by country: - Australia: Not approved. No selank product is on the ARTG. It counts as an unapproved peptide, and advertising or supplying it is likely unlawful. (verified 2026-09-29; source: https://www.tga.gov.au/resources/artg?keywords=selank) - Brazil: Not approved. No Anvisa registration for Selank; a medical council warns against injectable use (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Prohibited. Not authorised; named in Health Canada's 2025 seizure notices (Optimum Wellness Centre, Canada Peptide) (verified 2026-09-29; source: https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=selank) - China: Not approved. No NMPA approval found for Selank; it cannot lawfully be sold as a medicine in China. (verified 2026-09-29; source: https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html) - European Union: Not approved. No EU marketing authorisation; not listed in EMA or Union Register data (verified 2026-09-29; source: https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json) - India: Not approved. Not approved in India: no CDSCO marketing permission found for Selank; making or selling it as a medicine would be unapproved (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf) - Japan: Not approved. Not an approved medicine in Japan; Selank is absent from PMDA's approved-drug lists and package-insert database (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. No registration for selank found in COFEPRIS lists (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Not approved. No Medsafe-approved medicine contains Selank; Medsafe's advisory lists a misspelt 'sealank' (verified 2026-09-29; source: https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp) - United Arab Emirates: Not approved. Not approved in the UAE: no marketing authorisation found for Selank; unapproved peptide products are under EDE enforcement (verified 2026-09-29; source: https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities) - United Kingdom: Not approved. Selank is not licensed in the UK (verified 2026-09-29; source: https://www.gov.uk/guidance/find-product-information-about-medicines) - United States: Not approved. No FDA approval; FDA lists Selank among withdrawn nominations and it was not on the July 2026 advisory agenda (verified 2026-09-29; source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) ### Semaglutide - Page: https://glp1base.com/molecules/semaglutide - Also known as: NN9535, NNC 0113-0217 - Brand names (nominative use only): Ozempic, Wegovy, Rybelsus - Class: Approved GLP-1 medicine - Targets: GLP-1 receptor - Route: Approved as a once-weekly subcutaneous injection (Ozempic, Wegovy) or as a once-daily oral tablet co-formulated with SNAC (Rybelsus, Ozempic tablets, Wegovy tablets), prescribed and supervised by a clinician. - Last verified: 2026-09-29 Simple: Semaglutide copies a gut hormone called GLP-1. It helps the pancreas release insulin when blood sugar is high, slows the stomach a little, and quiets hunger signals in the brain. A fatty side chain lets it stick to a blood protein, so it lasts about a week in the body. It is approved medicine. Expert: Semaglutide is a GLP-1 receptor agonist: a 31-residue peptide analogue with 94% sequence homology to human GLP-1, with its peptide backbone made by yeast fermentation (C187H291N45O59, 4113.58 g/mol). Three changes drive its profile: Aib at position 8 (stabilises it against DPP-4), Arg at position 34 (so only one lipid attaches), and a C18 fatty diacid on Lys26 via a hydrophilic spacer, which binds albumin (>99% bound) and lowers renal clearance. Subcutaneous bioavailability is 89%, peak levels come 1 to 3 days after a dose, and the elimination half-life is about 1 week, with steady state after 4 to 5 weeks. Tablets are co-formulated with the absorption enhancer SNAC; the label estimates absolute bioavailability at about 0.4% to 1% for Rybelsus and 1% to 2% for Ozempic tablets. It is approved by the FDA and EMA (Ozempic and Rybelsus for type 2 diabetes; Wegovy for weight management, with FDA-approved cardiovascular risk reduction and, under accelerated approval, MASH). Key trials: SUSTAIN-6 (cardiovascular outcomes in type 2 diabetes), STEP 1 (weight), SELECT (cardiovascular outcomes without diabetes), FLOW (kidney outcomes) and ESSENCE (MASH). Evidence level: Approved. Approved by the FDA (Ozempic 2017, Rybelsus 2019, Wegovy 2021; MASH indication 2025; Wegovy tablet December 2025) and by the EMA (Ozempic 2018, Rybelsus 2020, Wegovy 2022). Evidence comes from large randomised, placebo-controlled phase 3 trials: SUSTAIN-6 (3,297 people with type 2 diabetes), STEP 1 (1,961 adults with overweight or obesity), SELECT (17,604 adults with heart disease and overweight or obesity, no diabetes), FLOW (3,533 people with type 2 diabetes and chronic kidney disease) and ESSENCE part 1 (800 people in the interim analysis). All were funded by Novo Nordisk. - Evidence source: New England Journal of Medicine (via PubMed), "Once-Weekly Semaglutide in Adults with Overweight or Obesity (STEP 1)" (2021-03-18) https://pubmed.ncbi.nlm.nih.gov/33567185/ - Evidence source: New England Journal of Medicine (via PubMed), "Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes (SUSTAIN-6)" (2016-11-10) https://pubmed.ncbi.nlm.nih.gov/27633186/ - Evidence source: New England Journal of Medicine (via PubMed), "Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes (SELECT)" (2023-12-14) https://pubmed.ncbi.nlm.nih.gov/37952131/ - Evidence source: New England Journal of Medicine (via PubMed), "Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes (FLOW)" (2024-07-11) https://pubmed.ncbi.nlm.nih.gov/38785209/ - Evidence source: New England Journal of Medicine (via PubMed), "Phase 3 Trial of Semaglutide in Metabolic Dysfunction-Associated Steatohepatitis (ESSENCE)" (2025-06-05) https://pubmed.ncbi.nlm.nih.gov/40305708/ - Evidence source: U.S. Food and Drug Administration (openFDA Drugs@FDA), "Drugs@FDA record, NDA 209637 (Ozempic): original approval 2017-12-05" (2017-12-05) https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA209637 - Evidence source: U.S. Food and Drug Administration (openFDA Drugs@FDA), "Drugs@FDA record, NDA 213051 (Rybelsus): original approval 2019-09-20" (2019-09-20) https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA213051 - Evidence source: U.S. Food and Drug Administration (openFDA Drugs@FDA), "Drugs@FDA record, NDA 215256 (Wegovy): original approval 2021-06-04" (2021-06-04) https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA215256 - Evidence source: U.S. Food and Drug Administration (openFDA Drugs@FDA), "Drugs@FDA record, NDA 218316 (Wegovy tablets): original approval 2025-12-22" (2025-12-22) https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA218316 - Evidence source: Novo Nordisk (PR Newswire), "Wegovy approved by FDA for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis" (2025-08-15) https://www.prnewswire.com/news-releases/wegovy-approved-by-fda-for-the-treatment-of-adults-with-noncirrhotic-mash-with-moderate-to-advanced-liver-fibrosis-302531394.html - Evidence source: European Medicines Agency, "Ozempic: EPAR (European public assessment report)" (2026-08) https://www.ema.europa.eu/en/medicines/human/EPAR/ozempic - Evidence source: European Medicines Agency, "Rybelsus: EPAR (European public assessment report)" (2026-04) https://www.ema.europa.eu/en/medicines/human/EPAR/rybelsus - Evidence source: European Medicines Agency, "Wegovy: EPAR (European public assessment report)" (2026-09) https://www.ema.europa.eu/en/medicines/human/EPAR/wegovy - Evidence source: DailyMed (U.S. National Library of Medicine) / Novo Nordisk, "RYBELSUS and OZEMPIC (semaglutide) tablets: prescribing information" (2026-01) https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98 Half-life: About 1 week (elimination half-life); the drug stays in the blood for about 5 weeks after the last injection (source: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79) Status by country: - Australia: Approved. 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. (verified 2026-09-29; source: https://www.tga.gov.au/resources/artg/308324) - Brazil: Approved. Approved as Ozempic, Rybelsus and Wegovy, with Brazilian-made versions approved from May 2026 (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Generics available. Approved as Ozempic, Rybelsus and Wegovy; generic semaglutide approved from April 2026 and on sale since May 2026 (verified 2026-09-29; source: https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=semaglutide) - China: Approved. Approved in China as an imported brand; domestic generics are still waiting for approval. (verified 2026-09-29; source: https://www.nhsa.gov.cn/module/download/downfile.jsp?classid=0&filename=a32f9f2f3fc046afaf08471f87456ce3.pdf) - European Union: Approved. Authorised EU-wide for type 2 diabetes, weight management and MASH (Ozempic, Rybelsus, Wegovy, Kayshild) (verified 2026-09-29; source: https://www.ema.europa.eu/en/medicines/human/EPAR/wegovy) - India: Generics available. Approved in India (Novo Nordisk's Wegovy and type 2 diabetes products); Indian generics on sale since March 2026, prescription-only (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Endocrinology%20Metabolism%2023.04.2026%20%281%29.pdf) - Japan: Approved. Approved for type 2 diabetes (Ozempic, Rybelsus) and obesity (Wegovy); Wegovy use is limited by an MHLW guideline (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Approved. Approved in Mexico as Ozempic, Rybelsus and Wegovy; generic applications are pending but none is registered (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/526719/Alop_ticos_2019.pdf) - New Zealand: Approved. Approved as Wegovy for weight management and heart-risk reduction; not publicly funded (verified 2026-09-29; source: https://www.medsafe.govt.nz/profs/datasheet/w/wegovyinjection.pdf) - United Arab Emirates: Approved. Approved: Wegovy (injection and, since June 2026, a daily pill) for weight management, Ozempic for type 2 diabetes; prescription-only (verified 2026-09-29; source: https://www.ede.gov.ae/en/w/emirates-drug-establishment-approves-oral-wegovy%C2%AE-semaglutide-for-weight-management-and-cardiovascular-risk-reduction) - United Kingdom: Approved. Licensed in the UK: Ozempic and Rybelsus for type 2 diabetes, Wegovy for weight management (now also as a tablet) (verified 2026-09-29; source: https://www.gov.uk/government/publications/glp-1-medicines-for-weight-loss-and-diabetes-what-you-need-to-know) - United States: Approved. FDA-approved as Ozempic, Rybelsus and Wegovy; compounded copies lost their shortage cover in 2025 and 503B is proposing a formal exclusion (verified 2026-09-29; source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209637Orig1s039lbl.pdf) ### Semax - Page: https://glp1base.com/molecules/semax - Also known as: ACTH(4-7)PGP, ACTH(4-7)-Pro-Gly-Pro, MEHFPGP, Met-Glu-His-Phe-Pro-Gly-Pro, Semax acetate (salt form) - Class: Trending peptide - Targets: Not fully defined. Specific, saturable membrane binding sites have been described in rat basal forebrain tissue (dissociation constant about 2.4 nM), but the binding molecule has not been identified, BDNF/TrkB and NGF neurotrophin signalling (increased expression in rat brain; animal data), Enkephalin-degrading peptidases (inhibited in vitro, in human serum; IC50 about 10 micromolar) - Route: In Russian clinical practice it is given as an intranasal solution (nasal drops), in two strengths. Published human studies have used the intranasal route almost exclusively; FDA reviewers found no human data for subcutaneous injection. This record describes how semax has been studied and registered in Russia, not how anyone should use it. - Last verified: 2026-09-29 Simple: Semax is a short chain of seven amino acids, built from a piece of a natural stress hormone called ACTH. It is a registered nasal-drop medicine in Russia, where it is used mainly to treat stroke. It is not approved by the US FDA, and no approval by other major regulators was found. Human studies are few, small and mostly in Russian, and most of the lab evidence is from rats. Expert: Semax is a synthetic linear heptapeptide, H-Met-Glu-His-Phe-Pro-Gly-Pro-OH (C37H51N9O10S, 813.93 g/mol; CAS 80714-61-0; PubChem CID 9811102). It consists of the ACTH(4-7) fragment (Met-Glu-His-Phe) joined to a C-terminal Pro-Gly-Pro tripeptide that is thought to slow peptidase hydrolysis; it is often loosely described as an ACTH(4-10) analogue. It lacks the corticotropic (adrenal) and melanotropic activity of full-length ACTH but keeps neurobehavioural effects in rodents. Developed at the Institute of Molecular Genetics, Russian Academy of Sciences, it is registered in Russia as a nootropic/neuroprotective nasal-drop medicine in two strengths; it is not a component of any FDA-approved drug, no approval by the EMA, MHRA, PMDA, NMPA, TGA or Health Canada was identified in the sources checked, and it has no USP/NF, European, Japanese or International Pharmacopoeia monograph. Its mechanism is not established. In rodents it rapidly raises Bdnf, Ngf and TrkB expression, binds specific membrane sites in the basal forebrain, and alters serotonergic and dopaminergic signalling; it also shows anticoagulant/antithrombotic and analgesic effects in rodents, and inhibits enkephalin-degrading peptidases in vitro. After intranasal delivery to rats it reaches the brain within minutes but is degraded quickly, with Pro-Gly-Pro the main metabolite. FDA reviewers found no human pharmacokinetic data by any route. Clinical evidence consists of small, mostly Russian-language, open-label or non-blinded studies (for example ischemic stroke rehabilitation, cerebrovascular insufficiency, optic neuropathy, motor neuron disease, and one small fMRI study in healthy volunteers); no large randomised placebo-controlled trials were identified. In the US, semax was no longer in the FDA compounding 'Category 2' list by April 2026 (FDA lists its nomination as withdrawn), and on 24 July 2026, the second day of a two-day meeting, the FDA Pharmacy Compounding Advisory Committee voted 8-5 (1 abstention) to recommend adding it to the 503A bulks list, against the recommendation of FDA staff, who judged the evidence of effectiveness insufficient and the substance not well characterised. That vote is advisory only, and rulemaking has not been completed. Evidence level: Small human studies. No approval from a major regulator. In Russia semax is a registered drug, and human data come from small, mostly Russian-language studies that are open-label, non-blinded or reported only as abstracts. Examples: 110 post-stroke patients followed for 5 months in subgroups with and without semax (plasma BDNF and Barthel index; the English abstract does not describe blinding or randomisation); 187 patients with cerebrovascular insufficiency; 27 patients with motor neuron disease in an open-label trial (no effect on disease course, some improvement in a quality-of-life score); and a resting-state fMRI study of 14 healthy adults on semax versus 10 on placebo. For the uses nominated in the US (cerebral ischemia, migraine and trigeminal neuralgia), FDA reviewers in 2026 found only two usable clinical references: a meeting abstract without clinical endpoints and one small, uncontrolled, open-label study. They did not assess the Russian-language stroke studies because no English translations were available, and they concluded there was insufficient evidence of effectiveness. Most mechanistic work is in rats and cell cultures (animal-only and cell-only). - Evidence source: U.S. Food and Drug Administration, "FDA Briefing Document for Semax-Related Bulk Drug Substances (Semax (free base) and Semax acetate), Pharmacy Compounding Advisory Committee meeting, July 23-24, 2026" (2026-05) https://www.fda.gov/media/193348/download - Evidence source: Zhurnal Nevrologii i Psikhiatrii im. S.S. Korsakova (PubMed), "The efficacy of semax in the treatment of patients at different stages of ischemic stroke" (2018) https://pubmed.ncbi.nlm.nih.gov/29798983/ - Evidence source: Zhurnal Nevrologii i Psikhiatrii im. S.S. Korsakova (PubMed), "Semax in prevention of disease progress and development of exacerbations in patients with cerebrovascular insufficiency" (2005) https://pubmed.ncbi.nlm.nih.gov/15792140/ - Evidence source: Zhurnal Nevrologii i Psikhiatrii im. S.S. Korsakova (PubMed), "The study of chronic partial denervation and quality of life in patients with motor neuron disease treated with semax" (2007) https://pubmed.ncbi.nlm.nih.gov/18379501/ - Evidence source: Bulletin of Experimental Biology and Medicine (PubMed), "Effects of Semax on the Default Mode Network of the Brain" (2018-09) https://pubmed.ncbi.nlm.nih.gov/30225715/ - Evidence source: Vestnik Oftalmologii (PubMed), "Evaluation of therapeutic effect of new Russian drug semax in optic nerve disease" (2000) https://pubmed.ncbi.nlm.nih.gov/10741256/ - Evidence source: Pharmaceutics (PubMed Central), "Development of Peptide Biopharmaceuticals in Russia" (2022-03-27) https://pmc.ncbi.nlm.nih.gov/articles/PMC9030433/ Status by country: - Australia: Not approved. No semax product is on the ARTG. It counts as an unapproved peptide, and advertising or supplying it is likely unlawful. (verified 2026-09-29; source: https://www.tga.gov.au/resources/artg?keywords=semax) - Brazil: Not approved. No Anvisa registration for Semax; a medical council warns against injectable use (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Prohibited. Not authorised; named in Health Canada's 2025 Canada Peptide seizure notice (verified 2026-09-29; source: https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=semax) - China: Not approved. No NMPA approval found for Semax; it cannot lawfully be sold as a medicine in China. (verified 2026-09-29; source: https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html) - European Union: Not approved. No EU marketing authorisation; not listed in EMA or Union Register data (verified 2026-09-29; source: https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json) - India: Not approved. Not approved in India: no CDSCO marketing permission found for Semax; making or selling it as a medicine would be unapproved (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf) - Japan: Not approved. Not an approved medicine in Japan; Semax is absent from PMDA's approved-drug lists and package-insert database (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. No registration for semax found in COFEPRIS lists; approved only in Russia (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Not approved. No Medsafe-approved medicine contains Semax; Medsafe's advisory lists a misspelt 'seamax' (verified 2026-09-29; source: https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp) - United Arab Emirates: Not approved. Not approved in the UAE: no marketing authorisation found for Semax; unapproved peptide products are under EDE enforcement (verified 2026-09-29; source: https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities) - United Kingdom: Not approved. Semax is not licensed in the UK (verified 2026-09-29; source: https://www.gov.uk/guidance/find-product-information-about-medicines) - United States: Not approved. No FDA approval; an advisory panel voted in July 2026 to recommend considering it for the 503A list, but FDA has not acted (verified 2026-09-29; source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) ### Sermorelin - Page: https://glp1base.com/molecules/sermorelin - Also known as: Sermorelin acetate, GHRH(1-29)-NH2, GRF(1-29)-NH2, hGRF(1-29)-NH2, Geref (former US brand, withdrawn) - Class: Trending peptide - Targets: Growth hormone-releasing hormone (GHRH) receptor on pituitary somatotroph cells - Route: When it was FDA-approved (Geref), it was given by injection: as a single intravenous test to check pituitary growth hormone reserve, and as a daily subcutaneous injection for children with idiopathic growth hormone deficiency under specialist care. It has also been studied in small trials by subcutaneous and intravenous routes and by continuous subcutaneous infusion; a nasal route was tested in healthy men and absorbed poorly (about 3 to 5% bioavailability). It is not approved for any other use. - Last verified: 2026-09-29 Simple: Sermorelin is a lab-made copy of the first 29 building blocks of a natural brain hormone that tells the pituitary gland to release growth hormone. The US once approved it as a test and for children with low growth hormone. The maker stopped selling it, and both US approvals were withdrawn in 2009. FDA said this was not for safety reasons. Expert: Sermorelin is GHRH(1-29)-NH2, a 29-residue C-terminally amidated peptide (C149H246N44O42S, about 3358 Da) whose sequence is identical to the N-terminal 29 residues of human growth hormone-releasing hormone (GHRH 1-44); it is the shortest fragment that keeps the full biological activity of the parent hormone. It activates the GHRH receptor (a class B G protein-coupled receptor coupled to Gs) on pituitary somatotrophs, stimulating pulsatile GH release and, downstream, IGF-I, with the physiological feedback system (somatostatin) remaining in place. It has no engineered half-life extension: a Serono review attributes its short half-life mostly to renal ultrafiltration and N-terminal enzymatic degradation (plasma dipeptidyl-peptidase removal of Tyr-Ala was shown for GHRH 1-44), and its plasma half-life in humans is short, reported as about 10 to 20 minutes in a review, with a disappearance half-time of 4.3 min in an infusion study in ten men, yet GH stays raised for about 3 hours after an intravenous dose. Subcutaneous exposure was about 4% of intravenous in an anaesthetised-rat study (animal-only). Regulatory history (FDA): NDA 19-863 (diagnostic ampules, evaluation of pituitary GH secretory ability) was approved 1990-12-28 and NDA 20-443 (idiopathic GH deficiency in children with growth failure) on 1997-09-26, both held by EMD Serono. The company reported discontinuation in 2008 and requested withdrawal; approval of both NDAs was withdrawn effective 2009-06-18, and in 2013 FDA determined the products were not withdrawn for reasons of safety or effectiveness. Key evidence is an open-label, 110-child, one-year study (Geref International Study Group, 1996) and a 1999 review; mean height velocity rose from 4.1 to 8.0 cm/yr at 6 months and 7.2 cm/yr at 12 months in GH-deficient children. A 1999 review notes there was no direct comparison with somatropin, and that height-velocity gains with sermorelin given by continuous infusion or in three divided doses were smaller than with daily somatropin in other children; effect on final adult height was not established. Use in healthy adults, or for anti-ageing or body-composition aims, is unapproved and rests on small, short human studies. Compounding and country-by-country legal status are covered in the status records, not here. Evidence level: Small human studies. Sermorelin has real human clinical data, but no current marketing authorisation. The best data are one open-label, uncontrolled 12-month study of 110 previously untreated children with growth hormone deficiency (Geref International Study Group, 1996), earlier small paediatric studies (for example, eight children in a 1990 continuous-infusion study), and a 1999 review that supported the former US approvals. In adults there are only small, short studies, such as a two-week crossover in old men that raised GH and IGF-I. No large randomised trial shows benefit for healthy adults, and none of the studies we reviewed reports final adult height; the 1999 review notes only a few children followed for up to 36 months. Its FDA approvals (1990 and 1997) were withdrawn in 2009 after the company stopped selling it. - Evidence source: PubMed / Journal of Clinical Endocrinology & Metabolism, "Once daily subcutaneous growth hormone-releasing hormone therapy accelerates growth in growth hormone-deficient children during the first year of therapy (Geref International Study Group; J Clin Endocrinol Metab)" (1996-03) https://pubmed.ncbi.nlm.nih.gov/8772599/ - Evidence source: PubMed / BioDrugs, "Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency (Prakash A, Goa KL; BioDrugs 12(2):139-157)" (1999-08) https://pubmed.ncbi.nlm.nih.gov/18031173/ - Evidence source: PubMed / Journal of Clinical Endocrinology & Metabolism, "Growth hormone (GH)-releasing hormone-(1-29) twice daily reverses the decreased GH and insulin-like growth factor-I levels in old men (Corpas E et al.; J Clin Endocrinol Metab)" (1992-08) https://pubmed.ncbi.nlm.nih.gov/1379256/ - Evidence source: PubMed / Clinical Endocrinology, "Continuous subcutaneous GHRH(1-29)NH2 promotes growth over 1 year in short, slowly growing children (Clinical Endocrinology)" (1990-02) https://pubmed.ncbi.nlm.nih.gov/2140733/ - Evidence source: U.S. Food and Drug Administration, Federal Register (78 FR 14095), "Determination That GEREF (Sermorelin Acetate) Injection, 0.5 mg Base/Vial and 1.0 mg Base/Vial, and GEREF (Sermorelin Acetate) Injection, 0.05 mg Base/Amp, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness" (2013-03-04) https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-05-milligrams-basevial-and-10-milligrams Half-life: Short: about 10 to 20 minutes in humans, according to a 2003 review by Serono scientists, mostly because the kidneys filter it out and enzymes cut its front end. (source: https://pubmed.ncbi.nlm.nih.gov/14499707/) Status by country: - Australia: Not approved. 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. (verified 2026-09-29; source: https://www.legislation.gov.au/F2026L00633/latest/text) - Brazil: Not approved. No Brazilian registration for sermorelin; the unregistered-peptide rules apply (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Prohibited. Not authorised; named in Health Canada's 2025 Canada Peptide seizure notice and banned in sport (verified 2026-09-29; source: https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=sermorelin) - China: Not approved. No NMPA approval found for sermorelin; it cannot lawfully be sold as a medicine in China and is banned in sport. (verified 2026-09-29; source: https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html) - European Union: Not approved. No EU marketing authorisation; banned in sport (WADA S2.2.4) (verified 2026-09-29; source: https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json) - India: Not approved. Not approved in India: no CDSCO marketing permission found for Sermorelin; making or selling it as a medicine would be unapproved (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf) - Japan: Not approved. Not an approved medicine in Japan; sermorelin is absent from PMDA's lists, and WADA bans it in sport (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. No current registration for sermorelin found in COFEPRIS lists (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Not approved. No Medsafe-approved medicine contains sermorelin; it is classed as a prescription medicine (verified 2026-09-29; source: https://www.medsafe.govt.nz/profs/class/classintro.asp) - United Arab Emirates: Unverified. Could not determine sermorelin's UAE status; no registration or enforcement record was found (verified 2026-09-29; source: https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae) - United Kingdom: Not approved. Sermorelin is not licensed in the UK (verified 2026-09-29; source: https://www.gov.uk/guidance/find-product-information-about-medicines) - United States: Compounding restricted. Previously FDA-approved as Geref (now discontinued, not for safety reasons); sermorelin acetate can be compounded only under 503A/503B conditions (verified 2026-09-29; source: https://api.fda.gov/drug/drugsfda.json?search=products.brand_name:GEREF&limit=30) ### Setmelanotide - Page: https://glp1base.com/molecules/setmelanotide - Also known as: RM-493, BIM-22493, Acetyl-Arg-Cys-D-Ala-His-D-Phe-Arg-Trp-Cys-NH2 (cyclic disulfide) - Brand names (nominative use only): Imcivree - Class: Approved peptide medicine - Targets: Melanocortin-4 receptor (MC4R) agonist; about 20-fold less active at MC3R and MC1R - Route: Subcutaneous injection, given once daily in approved use (US and EU labels). Not given by mouth, intravenously or into muscle. - Last verified: 2026-09-29 Simple: Setmelanotide is a small protein-like medicine for rare kinds of obesity where the brain's hunger-control system is broken, by a gene fault or by damage to the hypothalamus. It switches on the melanocortin-4 receptor, which tells the brain you are full. It is given as a daily injection and is not for common obesity. Expert: Setmelanotide is a synthetic cyclic octapeptide, acetyl-Arg-Cys-D-Ala-His-D-Phe-Arg-Trp-Cys-NH2 with a Cys2-Cys8 disulfide (C49H68N18O9S2, 1117.3 Da), built around the core melanocortin pharmacophore His-D-Phe-Arg-Trp. The D-amino acids, N-terminal acetylation and C-terminal amide are stabilising modifications. It is an agonist of the melanocortin-4 receptor (MC4R) with about 20-fold less activity at MC3R and MC1R (US label); MC4R signalling in the hypothalamus regulates hunger, satiety and energy expenditure, and setmelanotide acts downstream of the leptin-POMC step that is defective in POMC, PCSK1 and LEPR deficiency. After subcutaneous injection the median Tmax is about 8 hours, apparent volume of distribution 75.2 L, plasma protein binding 79.1%, about 39% is excreted unchanged in urine over a dosing interval, and the half-life is about 11 hours, consistent with once-daily use. The FDA approved it on 27 November 2020 for POMC, PCSK1 or LEPR deficiency (single-arm phase 3 trials in 10 and 11 people), later added Bardet-Biedl syndrome, and on 19 March 2026 added acquired hypothalamic obesity (age 4+) on the basis of the randomised phase 3 TRANSCEND trial (NEJM 2026). The EU authorised it in July 2021 and now lists the same three indication groups. The US label has no boxed warning; warnings cover depression and suicidal ideation, hypersensitivity including anaphylaxis, skin hyperpigmentation and nevi, sexual arousal disturbances, and (in acquired hypothalamic obesity) adrenal insufficiency and sodium imbalance. It is not approved for common polygenic obesity. Evidence level: Approved. Approved by the US FDA (2020, expanded since) and the European Commission (2021, expanded since) for narrowly defined rare conditions. Evidence is one randomised placebo-controlled phase 3 trial in acquired hypothalamic obesity (TRANSCEND; the NEJM paper reports 120 randomised participants, while the current US label and the company's press release report 142 randomised patients with a placebo-adjusted BMI difference of -18.4%; the sources checked do not explain the difference, so the trial figures in this record are the NEJM ones), a randomised phase 3 trial in Bardet-Biedl and Alstrom syndromes (38 patients), and two very small single-arm phase 3 trials in POMC/PCSK1 and LEPR deficiency (10 and 11 people). Use in other types of obesity is unapproved. - Evidence source: New England Journal of Medicine, "Setmelanotide for the Treatment of Acquired Hypothalamic Obesity" (2026-07-09) https://doi.org/10.1056/NEJMoa2512275 - Evidence source: The Lancet Diabetes & Endocrinology, "Efficacy and safety of setmelanotide, a melanocortin-4 receptor agonist, in patients with Bardet-Biedl syndrome and Alstrom syndrome: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial with an open-label period" (2022-12) https://doi.org/10.1016/S2213-8587(22)00277-7 - Evidence source: The Lancet Diabetes & Endocrinology, "Efficacy and safety of setmelanotide, an MC4R agonist, in individuals with severe obesity due to LEPR or POMC deficiency: single-arm, open-label, multicentre, phase 3 trials" (2020-12) https://doi.org/10.1016/S2213-8587(20)30364-8 - Evidence source: New England Journal of Medicine, "Proopiomelanocortin Deficiency Treated with a Melanocortin-4 Receptor Agonist" (2016-07-21) https://doi.org/10.1056/NEJMoa1512693 - Evidence source: U.S. National Library of Medicine, DailyMed (label: Rhythm Pharmaceuticals), "IMCIVREE (setmelanotide) injection, prescribing information (DailyMed label)" (2026-04-01) https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=70c3ccf7-4df0-4c75-ba07-fede9970c8d9 Half-life: About 11 hours (median time to peak about 8 hours after subcutaneous injection) (source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=70c3ccf7-4df0-4c75-ba07-fede9970c8d9) Status by country: - Australia: Not approved. No setmelanotide product is on the ARTG and none appears on the TGA's evaluation list. Access would need an unapproved-medicine pathway. (verified 2026-09-29; source: https://www.tga.gov.au/resources/artg?keywords=setmelanotide) - Brazil: Not approved. No Anvisa registration found for setmelanotide (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Approved, restricted. Approved as Imcivree for weight management in acquired hypothalamic obesity, BBS and specific genetic deficiencies (verified 2026-09-29; source: https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102647) - China: Not approved. Not approved in China; the only CDE record we found is a 2022 import clinical-trial application. (verified 2026-09-29; source: https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d) - European Union: Approved, restricted. Authorised EU-wide as Imcivree, only for rare genetic or hypothalamic obesity (verified 2026-09-29; source: https://www.ema.europa.eu/en/medicines/human/EPAR/imcivree) - India: Not approved. Not approved in India: no CDSCO marketing permission found for setmelanotide (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf) - Japan: Approved, restricted. Approved on 24 August 2026 as Imcivree, only for acquired hypothalamic obesity; not yet on the NHI price list (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. No registration for setmelanotide found in COFEPRIS lists (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Not approved. No setmelanotide product is approved by Medsafe or listed with a data sheet (verified 2026-09-29; source: https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm) - United Arab Emirates: Unverified. Could not confirm whether setmelanotide (Imcivree) is registered by the EDE; no UAE-specific record was found (verified 2026-09-29; source: https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae) - United Kingdom: Approved, restricted. Licensed in the UK as Imcivree for rare genetic and hypothalamic obesity; NICE funds it for POMC or LEPR deficiency (verified 2026-09-29; source: https://assets.publishing.service.gov.uk/media/6ab5418d997a4b2950cceed1/Orphan_Register_Ver1_Sep_2026.csv) - United States: Approved, restricted. FDA-approved as Imcivree (2020) for specific rare genetic or hypothalamic forms of obesity, not for general obesity (verified 2026-09-29; source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213793s009lbl.pdf) ### Survodutide - Page: https://glp1base.com/molecules/survodutide - Also known as: BI 456906, BI-456906 - Class: In clinical trials - Targets: Glucagon receptor, GLP-1 receptor - Route: In clinical trials, survodutide has been given as a once-weekly injection under the skin (subcutaneous), with the amount increased gradually at the start of treatment. Pre-filled syringe and pen-type injector formulations have been compared in phase 1 bioequivalence studies. It has no approved route because it is not approved. - Last verified: 2026-09-29 Simple: Survodutide is an experimental weekly injection that copies two natural hormones: GLP-1, made in the gut, and glucagon, made in the pancreas. It is being tested for obesity and for fatty liver disease. Large trials show weight loss and less liver fat, but it is not approved by any regulator we checked, and stomach side effects were common. Expert: Survodutide (BI 456906) is a synthetic, once-weekly, subcutaneous dual agonist of the glucagon receptor (GCGR) and the GLP-1 receptor (GLP-1R). It is a 29-residue glucagon-based peptide amidated at the C-terminus, with a non-natural 1-aminocyclobutanecarboxylic acid residue at position 2 and a C18 fatty diacid attached, through a gamma-glutamate and a short glycine/serine linker, to the side chain of the lysine at position 24 (molecular formula C192H289N47O61, about 4,232 Da; PubChem). Acylation of this kind is the usual strategy for prolonging action in blood; a survodutide-specific terminal half-life was not verified from a primary source for this page. GLP-1R agonism reduces appetite and slows gastric emptying, while glucagon receptor agonism is thought to act directly on the liver and to add to energy balance effects; in humans, plasma glucagon and amino acids fall after dosing, consistent with engagement of both receptors. Survodutide is developed by Boehringer Ingelheim; Zealand Pharma is eligible for royalties and milestone payments under a licence agreement. It is investigational and is not approved by the FDA, EMA, MHRA, PMDA, NMPA, TGA or Health Canada; no marketing application was found in public sources as of 2026-09-29. The phase 3 SYNCHRONIZE programme in obesity has reported: SYNCHRONIZE-1 (NCT06066515, n=725, 76 weeks) showed mean body-weight change with the treatment-regimen estimand of -12.2% and -13.0% in the two survodutide groups versus -5.4% with placebo (published in NEJM), and -16.6% versus -3.2% with the efficacy estimand (company release). SYNCHRONIZE-MASLD (n=216, 48 weeks) met its liver-fat and weight co-primary endpoints. SYNCHRONIZE-2 (type 2 diabetes) is complete, and Zealand Pharma said in August 2026 that its results would be presented at the EASD annual meeting (28 September to 2 October 2026); the cardiovascular outcomes trial is listed as completed, with results expected later in 2026; and the LIVERAGE phase 3 trials in MASH are still recruiting. Gastrointestinal adverse events were the main safety finding. Evidence level: Phase 3 trials. Investigational, not approved anywhere that we could verify. Phase 3 obesity data are published: SYNCHRONIZE-1 (adults without diabetes, n=725, 76 weeks; NEJM 2026) and SYNCHRONIZE-MASLD (n=216, 48 weeks; Nature Medicine 2026). Earlier phase 2 trials in obesity (n=387, Lancet Diabetes & Endocrinology 2024) and in MASH with fibrosis (n=293, NEJM 2024) support the programme. Full results of SYNCHRONIZE-2 (type 2 diabetes; due at EASD 2026) and of the completed cardiovascular outcomes trial had not been published in the sources we reviewed, and phase 3 trials in MASH (LIVERAGE) are recruiting. The headline 16.6% weight loss comes from the trial's efficacy estimand (participants who stayed on treatment as planned); the primary published analysis, the treatment-regimen estimand, gave 12.2% and 13.0%. - Evidence source: New England Journal of Medicine (PubMed), "Survodutide Once Weekly for the Treatment of Adults with Obesity (SYNCHRONIZE-1)" (2026-06-07) https://pubmed.ncbi.nlm.nih.gov/42253238/ - Evidence source: Zealand Pharma (GlobeNewswire), "Zealand Pharma announces Boehringer Ingelheim's novel glucagon/GLP-1 dual agonist survodutide achieved significant weight loss of 16.6% delivering meaningful metabolic improvement in people with obesity or overweight in Phase 3 trial" (2026-04-28) https://www.globenewswire.com/news-release/2026/04/28/3282220/0/en/zealand-pharma-announces-boehringer-ingelheim-s-novel-glucagon-glp-1-dual-agonist-survodutide-achieved-significant-weight-loss-of-16-6-delivering-meaningful-metabolic-improvement-i.html - Evidence source: Nature Medicine (PubMed), "Survodutide in adults with obesity and metabolic dysfunction-associated steatotic liver disease: SYNCHRONIZE-MASLD" (2026-06-07) https://pubmed.ncbi.nlm.nih.gov/42252333/ - Evidence source: The Lancet Diabetes & Endocrinology (PubMed), "Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial" (2024-02-05) https://pubmed.ncbi.nlm.nih.gov/38330987/ - Evidence source: New England Journal of Medicine (PubMed), "A Phase 2 Randomized Trial of Survodutide in MASH and Fibrosis" (2024-06-07) https://pubmed.ncbi.nlm.nih.gov/38847460/ Status by country: - Australia: Not approved. Investigational only. No survodutide product is on the ARTG and no application appears on the TGA's evaluation list. (verified 2026-09-29; source: https://www.tga.gov.au/resources/artg?keywords=survodutide) - Brazil: Not approved. Survodutide has no Brazilian registration and is not on the market (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Not approved. Survodutide is an investigational drug with no Health Canada authorisation (verified 2026-09-29; source: https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=survodutide) - China: Not approved. Not approved in China; Boehringer Ingelheim has trial-stage filings and a Chinese study only. (verified 2026-09-29; source: https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d) - European Union: Not approved. Investigational; no EU marketing authorisation and no application under evaluation (verified 2026-09-29; source: https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm) - India: Not approved. Not approved in India; survodutide (BI 456906) appears only in a CDSCO-permitted clinical trial (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Cardiovascular%2011.09.2024.pdf) - Japan: Not approved. 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 (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. Not registered in Mexico; survodutide is an investigational Boehringer Ingelheim medicine (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Not approved. Survodutide is an investigational medicine with no Medsafe consent in New Zealand (verified 2026-09-29; source: https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm) - United Arab Emirates: Not approved. No EDE approval found for survodutide; an investigational medicine, not marketed in the UAE (verified 2026-09-29; source: https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae) - United Kingdom: Not approved. Survodutide has no UK licence (verified 2026-09-29; source: https://www.gov.uk/guidance/find-product-information-about-medicines) - United States: Not approved. Investigational; Boehringer Ingelheim has US Phase 3 trials running and no FDA approval exists (verified 2026-09-29; source: https://clinicaltrials.gov/study/NCT06632444) ### TB-500 (thymosin beta-4 fragment) - Page: https://glp1base.com/molecules/tb-500 - Also known as: TB-500, TB500, Ac-LKKTETQ, N-acetyl-LKKTETQ, Ac-Leu-Lys-Lys-Thr-Glu-Thr-Gln-OH, Thymosin beta-4 fragment 17-23 (N-acetylated) - Class: Trending peptide - Targets: G-actin (actin monomers): proposed through the LKKTET actin-binding motif of thymosin beta-4; not demonstrated for the N-acetylated peptide itself, No confirmed receptor or molecular target for TB-500 itself - Route: No approved route: TB-500 has no approved medical use. In the studies that exist, it was given by subcutaneous injection to horses (a doping-control study) and by intraperitoneal injection to rats (a metabolism study). Most wound-healing research used the full-length thymosin beta-4 protein, or the non-acetylated LKKTETQ peptide, mostly applied to skin wounds in mice and rats (one rat study also gave the full protein by intraperitoneal injection). FDA notes it was nominated for compounding as an injectable, but no human use has been studied. - Last verified: 2026-09-29 Simple: TB-500 is a tiny lab-made piece of a body protein called thymosin beta-4. It is not an approved medicine anywhere, and no studies in people have been found. A few animal and cell-dish studies looked at wound healing, mostly with the full protein or a slightly different piece. It is banned in sport. Expert: TB-500 is a synthetic, N-terminally acetylated heptapeptide, Ac-Leu-Lys-Lys-Thr-Glu-Thr-Gln-OH (Ac-LKKTETQ), corresponding to residues 17-23 of the 43-residue human protein thymosin beta-4 (C38H68N10O14, 889.01 g/mol; the acetate salt is a separate bulk substance at 949.1 g/mol). Residues LKKTET form the central actin-binding motif of thymosin beta-4, which sequesters globular actin; whether the short acetylated fragment reproduces that buffering activity, or any other activity of the parent protein, has not been shown. FDA reviewers stress that TB-500 and thymosin beta-4 are not the same substance and that acetylation alters charge, hydrophobicity and binding, so results from the full protein or from the non-acetylated LKKTETQ peptide cannot be transferred directly. Evidence is preclinical. The non-acetylated LKKTETQ peptide promoted dermal repair in aged mice comparably to full-length thymosin beta-4 (Philp 2003, Wound Repair Regen), but in a 2024 cell-scratch assay TB-500 itself did not close fibroblast wounds, whereas its truncated metabolite Ac-LKKTE gave a small significant effect, raising the possibility that any activity depends on metabolic conversion (Rahaman 2024, J Chromatogr B). The only pharmacokinetic data are from horses given a single subcutaneous injection: plasma levels were sub-ng/mL, peaked 1-2 hours after injection and were unquantifiable after 6-10 hours; C-terminally truncated N-acetylated metabolites (Ac-LKKTET, Ac-LKKTE, Ac-LKKT, Ac-LKK, Ac-LK) form by sequential loss of residues; they were identified with equine liver in vitro, several were found in horse plasma and urine and in rat urine, and similar truncation occurred in human serum in vitro (Ho 2012; Rahaman 2024). Regulatory status: FDA's review states TB-500 is not a component of any FDA-approved drug, is not in the European or Japanese pharmacopoeias, and has no authorised products in the EU or in Canada, Australia, the UK and several other countries; FDA found no human studies of any kind. In its briefing for the July 2026 Pharmacy Compounding Advisory Committee, FDA staff concluded that the evaluation criteria weighed against adding TB-500 to the 503A Bulks List (wound-healing use: no human efficacy data and no in-vivo nonclinical wound-healing studies of TB-500; no toxicology data; injectable-peptide immunogenicity and aggregation concerns; poor characterisation). The committee nonetheless voted 8-6 with 1 abstention on 23 July 2026 to recommend it; the vote is non-binding, and FDA had not adopted it in any source verified as of 29 September 2026. The WADA Prohibited List names thymosin-beta-4 and its derivatives, e.g. TB-500, under S2.3 (banned at all times). Human clinical work exists only for full-length thymosin beta-4, for example a phase 2 topical trial in 73 patients with venous stasis ulcers and a small phase 2 trial of an eye-drop form in severe dry eye; none of it is evidence for TB-500. Evidence level: Animal studies only. There are no published studies of TB-500 in people; FDA searched PubMed, Embase, ClinicalTrials.gov and adverse-event databases and found none. The best available evidence is animal and cell work: the non-acetylated LKKTETQ peptide (not TB-500) improved wound repair in aged mice, and full-length thymosin beta-4 (not TB-500) improved wound repair in rats. A 2024 cell study found that TB-500 itself did not close scratch wounds in fibroblasts while a metabolite did, and the only pharmacokinetic data are from horses (doping-control work). Human trials of the full-length protein exist but are not evidence for TB-500. Evidence level is therefore labelled animal, and it is indirect. - Evidence source: U.S. Food and Drug Administration, "FDA Evaluation of TB-500-Related Bulk Drug Substances (TB-500 (Free Base) and TB-500 acetate), briefing document for the Pharmacy Compounding Advisory Committee, July 23-24, 2026" (2026-05-15) https://www.fda.gov/media/193349/download - Evidence source: Wound Repair and Regeneration (PubMed), "Thymosin beta 4 and a synthetic peptide containing its actin-binding domain promote dermal wound repair in db/db diabetic mice and in aged mice" (2003) https://pubmed.ncbi.nlm.nih.gov/12581423/ - Evidence source: Journal of Chromatography B (PubMed), "Simultaneous quantification of TB-500 and its metabolites in in-vitro experiments and rats by UHPLC-Q-Exactive orbitrap MS/MS and their screening by wound healing activities in-vitro" (2024-03-01) https://pubmed.ncbi.nlm.nih.gov/38382158/ - Evidence source: Journal of Investigative Dermatology (PubMed), "Thymosin beta4 accelerates wound healing" (1999-09) https://pubmed.ncbi.nlm.nih.gov/10469335/ - Evidence source: Journal of Chromatography A (PubMed), "Doping control analysis of TB-500, a synthetic version of an active region of thymosin beta4, in equine urine and plasma by liquid chromatography-mass spectrometry" (2012-11-23) https://pubmed.ncbi.nlm.nih.gov/23084823/ Status by country: - Australia: Prohibited. Unapproved and controlled: TB-500 and thymosin beta 4 are prescription-only, possession without authority is illegal, and the TGA has seized it. (verified 2026-09-29; source: https://www.legislation.gov.au/F2026L00633/latest/text) - Brazil: Not approved. Not registered in Brazil; Anvisa says it has no authorisation as a supplement and injectables are irregular (verified 2026-09-29; source: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa) - Canada: Prohibited. Not authorised; named in Health Canada's 2026 seizure advisory and banned in sport (verified 2026-09-29; source: https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm) - China: Not approved. Not an approved medicine in China; it is unlawful to make, import or sell it as a drug, and it is banned in sport. (verified 2026-09-29; source: https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html) - European Union: Not approved. Not authorised as a medicine in the EU; banned in sport (WADA S2.3) (verified 2026-09-29; source: https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json) - India: Not approved. Not approved in India: no CDSCO marketing permission found for TB-500; making or selling it as a medicine would be unapproved (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf) - Japan: Not approved. Not an approved medicine in Japan; sale and advertising as a drug are illegal, and WADA bans TB-500 in sport (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Not approved. Not approved in Mexico; unregistered peptide named in a July 2026 bill (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/1096704/Alop_ticos_2026.pdf) - New Zealand: Prohibited. Not approved; Medsafe names TB-500 and thymosin peptides as illegal unapproved products (verified 2026-09-29; source: https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp) - United Arab Emirates: Not approved. Not approved in the UAE: no marketing authorisation for TB-500; unapproved peptide products are under EDE enforcement (verified 2026-09-29; source: https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities) - United Kingdom: Not approved. TB-500 is not licensed in the UK (verified 2026-09-29; source: https://www.gov.uk/guidance/find-product-information-about-medicines) - United States: Not approved. 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 (verified 2026-09-29; source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) ### Tesamorelin - Page: https://glp1base.com/molecules/tesamorelin - Also known as: TH9507, GHRH(1-44) with N-terminal hexenoyl group, N-trans-3-hexenoyl-GHRH(1-44) amide, Growth hormone-releasing factor analogue - Brand names (nominative use only): Egrifta (Egrifta SV, Egrifta WR) - Class: Approved peptide medicine - Targets: Growth hormone-releasing hormone (GHRH) receptor on pituitary somatotroph cells - Route: Subcutaneous injection once daily, into the abdomen, in the approved HIV-lipodystrophy use (US label). It is a prescription product for use under medical supervision; it is not taken by mouth. - Last verified: 2026-09-29 Simple: Tesamorelin is a lab-made copy of a natural brain hormone that tells the pituitary gland to release growth hormone. It is approved in the US for one narrow use: reducing extra belly fat in adults with HIV who have a fat-distribution problem called lipodystrophy. It is not approved for general weight loss. Expert: Tesamorelin is a 44-residue synthetic analogue of human growth hormone-releasing hormone, GHRH(1-44) amide, carrying a trans-3-hexenoyl group on the N-terminal tyrosine (C221H366N72O67S; 5135.9 Da as free base). The 44 residues match the endogenous sequence; the hexenoyl group is the engineered modification. It binds and activates the GHRH receptor (a class B G protein-coupled receptor) on pituitary somatotrophs with potency similar to endogenous GHRH, stimulating pulsatile growth hormone (GH) release and raising IGF-1 and IGFBP-3, with no clinically significant changes in TSH, LH, ACTH or prolactin in trials. After subcutaneous injection, absolute bioavailability is under 4%, median Tmax is 0.15 h and the elimination half-life is about 11 minutes for the current Egrifta WR formulation (26 to 38 minutes reported for the original formulation). The FDA approved Egrifta on 10 November 2010 for reducing excess abdominal fat in HIV-infected patients with lipodystrophy; Egrifta SV and, in March 2025, Egrifta WR are newer formulations. In two pooled phase 3 trials (806 patients, 26 weeks) visceral adipose tissue fell by a treatment effect of 15.4%, with triglyceride improvement and an IGF-1 rise. The label warns of neoplasm risk, IGF-1 elevation, fluid retention, glucose intolerance and hypersensitivity. The EU application was withdrawn in 2012; Health Canada approved it in 2014, but its Drug Product Database has listed the marketed Egrifta product as cancelled since September 2022. Approval status at PMDA, NMPA, TGA and MHRA was not verified. Other uses (for example fatty liver in HIV) are unapproved and investigational. Evidence level: Approved. Approved by the US FDA (2010) on the basis of two randomised, double-blind, placebo-controlled 26-week phase 3 trials in HIV-infected adults with excess abdominal fat, each followed by a 26-week safety extension (806 patients pooled). Evidence is specific to HIV-associated abdominal fat; long-term cardiovascular outcomes have not been shown. Small randomised trials in HIV-associated fatty liver disease exist but are exploratory, and that use is unapproved. - Evidence source: N Engl J Med (via PubMed), "Metabolic effects of a growth hormone-releasing factor in patients with HIV (Falutz et al.)" (2007-12-06) https://pubmed.ncbi.nlm.nih.gov/18057338/ - Evidence source: J Clin Endocrinol Metab (via PubMed), "Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data" (2010-09) https://pubmed.ncbi.nlm.nih.gov/20554713/ - Evidence source: U.S. National Library of Medicine, DailyMed (label: Theratechnologies), "EGRIFTA WR (tesamorelin) for injection, prescribing information (DailyMed label)" (2025-03) https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75 - Evidence source: JAMA (via PubMed), "Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial" (2014-07) https://pubmed.ncbi.nlm.nih.gov/25038357/ - Evidence source: Lancet HIV (via PubMed), "Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial" (2019-12) https://pubmed.ncbi.nlm.nih.gov/31611038/ Half-life: About 11 minutes for Egrifta WR in healthy subjects (26 minutes in healthy subjects and 38 minutes in HIV-infected patients for the original 2010 formulation) (source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75) Status by country: - Australia: Not approved. Not on the ARTG. The Poisons Standard lists growth hormone releasing hormones as a prescription-only class with a possession control. (verified 2026-09-29; source: https://www.tga.gov.au/resources/artg?keywords=tesamorelin) - Brazil: Not approved. No Anvisa registration for tesamorelin; a medical council lists it among unregistered injectable peptides (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Prohibited. Not authorised since Egrifta was cancelled in 2022; Health Canada has seized unauthorised tesamorelin (2025 notices) (verified 2026-09-29; source: https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=tesamorelin) - China: Not approved. No NMPA approval found for tesamorelin; it cannot lawfully be sold as a medicine in China. (verified 2026-09-29; source: https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d) - European Union: Not approved. Not authorised in the EU: the Egrifta application was withdrawn in 2012 (verified 2026-09-29; source: https://www.ema.europa.eu/en/medicines/human/EPAR/egrifta) - India: Not approved. Not approved in India: no CDSCO marketing permission found for tesamorelin (verified 2026-09-29; source: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf) - Japan: Not approved. No marketing approval in Japan; tesamorelin is not in PMDA's approved-drug lists, and WADA prohibits it in sport (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Unverified. COFEPRIS registered Egrifta (tesamorelin) in 2015; whether the registration is still valid could not be confirmed (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/303036/Alop_ticos_2015.pdf) - New Zealand: Not approved. No tesamorelin product is approved by Medsafe; it is classed as a prescription medicine (verified 2026-09-29; source: https://www.medsafe.govt.nz/profs/class/classintro.asp) - United Arab Emirates: Unverified. Could not confirm whether tesamorelin (Egrifta) is registered by the EDE; no UAE-specific record was found (verified 2026-09-29; source: https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae) - United Kingdom: Not approved. No UK licence for tesamorelin; the EU application was withdrawn in 2012 (verified 2026-09-29; source: https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/egrifta) - United States: Approved, restricted. FDA-approved since 2010 as Egrifta only for extra belly fat in adults with HIV and lipodystrophy; not for weight loss (verified 2026-09-29; source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022505s020lbl.pdf) ### Tirzepatide - Page: https://glp1base.com/molecules/tirzepatide - Also known as: LY3298176 - Brand names (nominative use only): Mounjaro, Zepbound - Class: Approved GLP-1 medicine - Targets: GIP receptor, GLP-1 receptor - Route: Subcutaneous injection, given once a week, supplied as prefilled pens or vials - Last verified: 2026-09-29 Simple: Tirzepatide is a small protein-like drug (a peptide, 39 building blocks long) that copies two gut hormones, GIP and GLP-1. Together they help the body control blood sugar and appetite. A fatty side chain lets it hitch a ride on a blood protein, so half of it is still there after about five days, and it is given once a week. It is approved for type 2 diabetes and weight management, and in the US for sleep apnea. Expert: Tirzepatide is a 39-residue synthetic peptide, based on the GIP sequence, that is an agonist at both the GIP receptor and the GLP-1 receptor. It carries aminoisobutyric acid (Aib) at positions 2 and 13 and a C-terminal amide, and Lys20 is acylated through a linker with a C20 fatty diacid (1,20-eicosanedioic acid) that enables albumin binding (about 99% bound). Molecular weight is 4813.53 Da (C225H348N48O68). After subcutaneous injection, absolute bioavailability is about 80% and time to maximum concentration is 8 to 72 hours. Elimination half-life is about 5 days in type 2 diabetes and 5 to 6 days in obesity, supporting once-weekly administration. Metabolism is by proteolytic cleavage of the backbone, beta-oxidation of the diacid and amide hydrolysis; intact drug is not found in urine or faeces. In vitro, tirzepatide behaves like native GIP at the GIP receptor and is biased at the GLP-1 receptor toward cAMP over beta-arrestin recruitment, and modelled receptor occupancy is higher at the GIP receptor than at the GLP-1 receptor. The FDA approved it (as Mounjaro) for type 2 diabetes on 13 May 2022 and (as Zepbound) for chronic weight management on 8 November 2023, and added obstructive sleep apnea on 20 December 2024. It is authorised in the EU for type 2 diabetes and weight management. Key trials: SURPASS-2 (greater HbA1c reduction than semaglutide at 40 weeks), SURMOUNT-1 (mean weight change of up to -20.9% at 72 weeks versus -3.1% with placebo), SURMOUNT-5 (-20.2% versus -13.7% with semaglutide), SURMOUNT-OSA, SUMMIT (HFpEF with obesity) and SURPASS-CVOT (non-inferior to dulaglutide for major cardiovascular events). Evidence level: Approved. Approved by the US FDA and the European Medicines Agency after large randomised phase 3 programmes: SURPASS (type 2 diabetes), SURMOUNT (obesity and sleep apnea), SUMMIT (heart failure with preserved ejection fraction and obesity) and SURPASS-CVOT (cardiovascular outcomes versus dulaglutide). The two head-to-head trials against semaglutide (SURPASS-2 and SURMOUNT-5) were open-label. The manufacturer funded the pivotal trials. - Evidence source: New England Journal of Medicine, "Tirzepatide Once Weekly for the Treatment of Obesity (SURMOUNT-1)" (2022-07-21) https://www.nejm.org/doi/full/10.1056/NEJMoa2206038 - Evidence source: New England Journal of Medicine, "Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes (SURPASS-2)" (2021-08-05) https://www.nejm.org/doi/full/10.1056/NEJMoa2107519 - Evidence source: New England Journal of Medicine, "Tirzepatide as Compared with Semaglutide for the Treatment of Obesity (SURMOUNT-5)" (2025-07-03) https://www.nejm.org/doi/full/10.1056/NEJMoa2416394 - Evidence source: New England Journal of Medicine, "Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity (SURMOUNT-OSA)" (2024-10-03) https://www.nejm.org/doi/full/10.1056/NEJMoa2404881 - Evidence source: New England Journal of Medicine, "Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity (SUMMIT)" (2025-01-30) https://www.nejm.org/doi/full/10.1056/NEJMoa2410027 - Evidence source: New England Journal of Medicine, "Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes (SURPASS-CVOT)" (2025-12-18) https://www.nejm.org/doi/full/10.1056/NEJMoa2505928 - Evidence source: U.S. National Library of Medicine (DailyMed), FDA-approved label, "MOUNJARO (tirzepatide) injection, prescribing information" (2026-09) https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0 - Evidence source: U.S. National Library of Medicine (DailyMed), FDA-approved label, "ZEPBOUND (tirzepatide) injection, prescribing information" (2026-09) https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=487cd7e7-434c-4925-99fa-aa80b1cc776b Half-life: About 5 days (5 to 6 days in adults with obesity) (source: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=487cd7e7-434c-4925-99fa-aa80b1cc776b) Status by country: - Australia: Approved. 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. (verified 2026-09-29; source: https://www.tga.gov.au/resources/artg/379330) - Brazil: Approved. Approved as Mounjaro for type 2 diabetes and, since June 2025, chronic weight management (verified 2026-09-29; source: https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv) - Canada: Approved. Approved as Mounjaro (type 2 diabetes) and Zepbound (weight management, sleep apnea); no generic submissions (verified 2026-09-29; source: https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106082) - China: Approved. Approved in China; Lilly's imported and locally made products are sold, and insurance covers it for type 2 diabetes only. (verified 2026-09-29; source: https://www.nhsa.gov.cn/module/download/downfile.jsp?classid=0&filename=a32f9f2f3fc046afaf08471f87456ce3.pdf) - European Union: Approved. Authorised EU-wide as Mounjaro for type 2 diabetes and for weight management in adults (verified 2026-09-29; source: https://www.ema.europa.eu/en/medicines/human/EPAR/mounjaro) - India: Approved, restricted. Approved in India (Mounjaro) for type 2 diabetes and weight management, prescription-only; no approved generic found (verified 2026-09-29; source: 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) - Japan: Approved. Approved for type 2 diabetes (Mounjaro) and obesity (Zepbound), plus sleep apnoea; Zepbound use is limited by an MHLW guideline (verified 2026-09-29; source: https://www.pmda.go.jp/files/000281577.pdf) - Mexico: Approved. Approved as Mounjaro (Eli Lilly), registered in 2024; COFEPRIS has warned about unregistered tirzepatide sold online (verified 2026-09-29; source: https://www.gob.mx/cms/uploads/attachment/file/969390/Alop_ticos_2024.pdf) - New Zealand: Approved. Approved as Mounjaro for type 2 diabetes, weight management and sleep apnoea; weight loss not funded (verified 2026-09-29; source: https://www.medsafe.govt.nz/profs/datasheet/m/MounjaroInj.pdf) - United Arab Emirates: Approved. On the market as Mounjaro by prescription; UAE doctors describe use for type 2 diabetes and weight management; EDE register entry not checked (verified 2026-09-29; source: https://www.khaleejtimes.com/lifestyle/health/mounjaro-safety-side-effects-3-things-to-know-about-this-new-weight-loss-drug) - United Kingdom: Approved. Licensed in the UK as Mounjaro for type 2 diabetes and for weight management; NHS access is being phased in (verified 2026-09-29; source: https://www.gov.uk/government/news/mhra-authorises-diabetes-drug-mounjaro-tirzepatide-for-weight-management-and-weight-loss) - United States: Approved. FDA-approved as Mounjaro (type 2 diabetes) and Zepbound (weight management, sleep apnea); shortage over since December 2024 (verified 2026-09-29; source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215866s044s045lbl.pdf) ## Countries and regions ### Australia - Page: https://glp1base.com/countries/australia - Regulator: Therapeutic Goods Administration (TGA), Australian Government Department of Health, Disability and Ageing (https://www.tga.gov.au) - Last verified: 2026-09-29 Simple: In Australia, the Therapeutic Goods Administration (TGA) decides which medicines can be sold. Ozempic, Wegovy and Mounjaro are approved. Pharmacists have not been allowed to make their own copies of GLP-1 drugs since 1 October 2024. Most "peptides" sold online, like BPC-157, are not approved, and the TGA is now acting against people who import, sell or advertise them. Ads for prescription medicines, including weight-loss injections, are banned. Expert: Therapeutic goods must be on the Australian Register of Therapeutic Goods (ARTG) before they are supplied, unless an exemption applies. Scheduling under the Poisons Standard (June 2026 edition) is given legal effect by state and territory law; semaglutide, tirzepatide, liraglutide, dulaglutide and exenatide are Schedule 4. Compounded medicines are unapproved goods that may be supplied for an individual patient on a prescription or request, but from 1 October 2024 pharmacists must not compound GLP-1 receptor agonist analogues. The Personal Importation Scheme allows import of unapproved goods for personal or immediate-family use, but prescription-only goods need a valid Australian prescription and unlabelled or unclear vials are not released. Public subsidy runs through PBAC and the PBS: the PBS records seen on 29 September 2026 show no listing of a GLP-1 for obesity; PBAC recommended Wegovy for people with established cardiovascular disease and obesity in November 2025 (a revised proposal is on the November 2026 PBAC agenda), and the Mounjaro type 2 diabetes listing has stalled because the sponsor is not proceeding. Since June 2026 unapproved peptides are a TGA compliance priority, with seizures, criminal import charges, infringement notices and Federal Court proceedings reported between April and September 2026, and Ahpra issued new prescriber guidance on 16 September 2026. - Source: Therapeutic Goods Administration (TGA), "Manufacturing, supplying and advertising compounded medicines lawfully" (2026-05-14) https://www.tga.gov.au/resources/guidance/manufacturing-supplying-and-advertising-compounded-medicines-lawfully - Source: Therapeutic Goods Administration (TGA), "Compounded medicines" (2026-05-14) https://www.tga.gov.au/products/unapproved-therapeutic-goods/compounded-medicines - Source: Federal Register of Legislation (Australian Government), "Therapeutic Goods (Poisons Standard - June 2026) Instrument 2026" (2026-05) https://www.legislation.gov.au/F2026L00633/latest/text - Source: Therapeutic Goods Administration (TGA), "The Poisons Standard (the SUSMP)" (2026-06-01) https://www.tga.gov.au/products/regulations-all-products/legislation-and-legislative-instruments/poisons-standard-susmp - Source: Therapeutic Goods Administration (TGA), "Notice of final decision to amend (or not amend) the current Poisons Standard - ACMS #43, ACCS #37, Joint ACMS-ACCS #35 (BPC-157)" (2024-05-22) 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 - Source: Therapeutic Goods Administration (TGA), "Personal Importation Scheme" (2026-09-08) https://www.tga.gov.au/products/unapproved-therapeutic-goods/access-pathways/personal-importation-scheme - Source: Therapeutic Goods Administration (TGA), "New packaging rules for personal imports" (2026-09-08) https://www.tga.gov.au/news/media-releases/new-packaging-rules-personal-imports - Source: Therapeutic Goods Administration (TGA), "Understanding your responsibilities when importing, compounding and supplying unapproved peptide products" (2026-04-13) https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/understanding-your-responsibilities-when-importing-compounding-and-supplying-unapproved-peptide-products - Source: Therapeutic Goods Administration (TGA), "TGA warning on the risks of importing unapproved peptide products" (2026-05-07) https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/tga-warning-risks-importing-unapproved-peptide-products - Source: Therapeutic Goods Administration (TGA), "Concerns regarding the public health risks associated with unapproved peptide products" (2026-06-19) https://www.tga.gov.au/news/media-releases/concerns-regarding-public-health-risks-associated-unapproved-peptide-products - Source: Therapeutic Goods Administration (TGA), "TGA strengthens compliance focus on unapproved peptide products as part of evolving risk response" (2026-06-10) https://www.tga.gov.au/news/media-releases/tga-strengthens-compliance-focus-unapproved-peptide-products-part-evolving-risk-response - Source: Therapeutic Goods Administration (TGA), "Unapproved peptide product promoters and suppliers are put on notice" (2026-07-20) https://www.tga.gov.au/news/media-releases/unapproved-peptide-product-promoters-and-suppliers-are-put-notice - Source: Therapeutic Goods Administration (TGA), "TGA flexes its muscle against illegal peptides and steroids" (2026-08-17) https://www.tga.gov.au/news/media-releases/tga-flexes-its-muscle-against-illegal-peptides-and-steroids - Source: Therapeutic Goods Administration (TGA), "Former company and directors behind BioV8 to face court for alleged unlawful advertising of peptides" (2026-09-28) https://www.tga.gov.au/news/media-releases/former-company-and-directors-behind-biov8-face-court-alleged-unlawful-advertising-peptides - Source: Therapeutic Goods Administration (TGA), "TGA tests counterfeit retatrutide product following serious adverse event report" (2026-09-14) https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/tga-tests-counterfeit-retatrutide-product-following-serious-adverse-event-report - Source: Therapeutic Goods Administration (TGA), "Individual issued 27 infringement notices for allegedly supplying Melanotan II" (2026-05-21) https://www.tga.gov.au/news/media-releases/individual-issued-27-infringement-notices-allegedly-supplying-melanotan-ii - Source: Therapeutic Goods Administration (TGA), "Complying with the restrictions on advertising prescription medicines to the public" (2026-06-18) https://www.tga.gov.au/resources/guidance/complying-restrictions-advertising-prescription-medicines-public - Source: Therapeutic Goods Administration (TGA), "TGA releases new guidance on advertising restrictions for prescription medicines" (2026-06-18) https://www.tga.gov.au/news/media-releases/tga-releases-new-guidance-advertising-restrictions-prescription-medicines - Source: Therapeutic Goods Administration (TGA), "Telehealth businesses fined over $300,000 for alleged unlawful advertising of weight loss medicines" (2024-07-12) https://www.tga.gov.au/news/media-releases/telehealth-businesses-fined-over-300000-alleged-unlawful-advertising-weight-loss-medicines - Source: Therapeutic Goods Administration (TGA), "Prime Medic Group issued infringement notices for alleged unlawful advertising of weight loss medicines" (2026-02-02) https://www.tga.gov.au/news/media-releases/prime-medic-group-issued-infringement-notices-alleged-unlawful-advertising-weight-loss-medicines - Source: Medical Board of Australia / Ahpra, "Crackdown on reckless prescribing as regulator ramps up peptides oversight" (2026-09-16) https://www.medicalboard.gov.au/News/2026-09-16-Peptide-prescribing-crackdown - Source: Sport Integrity Australia, "Prohibited List Explained" (2026) https://www.sportintegrity.gov.au/what-we-do/anti-doping/prohibited-list - Source: Therapeutic Goods Administration (TGA), "Prescription medicines under evaluation (last updated 21 September 2026)" (2026-09-21) https://www.tga.gov.au/resources/prescription-medicines-under-evaluation - Source: Therapeutic Goods Administration (TGA), "Prescription medicines under evaluation: orforglipron calcium (Eli Lilly Australia Pty Ltd, accepted January 2026)" (2026-01) https://www.tga.gov.au/resources/prescription-medicines-under-evaluation/tba-eli-lilly-australia-pty-ltd - Source: Australian Government Department of Health, Disability and Ageing (PBS), "PBS Medicines Status: semaglutide (Wegovy), established cardiovascular disease with obesity" (2026-07-23) https://www.pbs.gov.au/medicinestatus/document/1460 - Source: Australian Government Department of Health, Disability and Ageing (PBS), "PBS Medicines Status: tirzepatide (Mounjaro), type 2 diabetes mellitus" (2026-06-30) https://www.pbs.gov.au/medicinestatus/document/1609 - Source: Australian Government Department of Health, Disability and Ageing (PBS), "PBS Medicines Status: semaglutide (Ozempic), type 2 diabetes mellitus" (2026-03-31) https://www.pbs.gov.au/medicinestatus/document/1260 - Source: Australian Government Department of Health, Disability and Ageing (PBS), "PBAC advice on equitable access to GLP-1 obesity treatments" (2026-03-17) https://www.pbs.gov.au/reviews/PBAC-advice-equitable-access-to-GLP-1-obesity-treatments - Source: Therapeutic Goods Administration (TGA), "MOUNJARO tirzepatide solution for injection pre-filled pen (ARTG 379330)" (2022-12) https://www.tga.gov.au/resources/artg/379330 - Source: Therapeutic Goods Administration (TGA), "WEGOVY semaglutide solution for injection pre-filled pen (ARTG 356286)" (2022-09) https://www.tga.gov.au/resources/artg/356286 - Source: Therapeutic Goods Administration (TGA), "OZEMPIC semaglutide solution for injection pre-filled pen (ARTG 308324)" (2019-08) https://www.tga.gov.au/resources/artg/308324 - Source: Therapeutic Goods Administration (TGA), "RSS feeds" (2026-08-25) https://www.tga.gov.au/news/email-subscriptions/rss-feeds - Source: Australian Government Department of Health, Disability and Ageing (PBS), "PBS Medicines Status: semaglutide (Wegovy), established atherosclerotic cardiovascular disease with obesity (November 2026 PBAC meeting)" (2026-07-23) https://www.pbs.gov.au/medicinestatus/document/1650 - Source: Therapeutic Goods Administration (TGA), "Three Victorians arrested following seizure of over $2 million worth of steroids and peptides by the ABF and TGA" (2026-04-17) https://www.tga.gov.au/news/media-releases/three-victorians-arrested-following-seizure-over-2-million-worth-steroids-and-peptides-abf-and-tga - Source: Therapeutic Goods Administration (TGA), "Two Victorians charged with further offences related to alleged importation of illicit performance and image enhancing drugs" (2026-08-13) https://www.tga.gov.au/news/media-releases/two-victorians-charged-further-offences-related-alleged-importation-illicit-performance-and-image-enhancing-drugs - Source: BioDrugs (Adis), "Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency (BioDrugs 1999;12(2):139-57)" (1999-08) https://pubmed.ncbi.nlm.nih.gov/18031173/ ### Brazil - Page: https://glp1base.com/countries/brazil - Regulator: Agência Nacional de Vigilância Sanitária (Anvisa) (https://www.gov.br/anvisa/pt-br) - Last verified: 2026-09-29 Simple: In Brazil, the health agency Anvisa decides which medicines can be sold, and a medicine needs its registration first. Semaglutide, tirzepatide and liraglutide are approved, and after the semaglutide patent ended in March 2026 several Brazilian-made versions were approved. Prescription-only drugs cannot be advertised to the public. Anvisa calls unregistered peptides and unregistered weight-loss pens illegal, and it has seized them. Expert: Marketing authorisation. A medicine must hold an Anvisa registration before it is marketed; Anvisa publishes the register as open data and lists new medicines and new indications on its site. GLP-1 and related registrations found in the register on 2026-09-29: semaglutide (Ozempic 2018, Rybelsus 2020, Wegovy 2023, Extensior and Poviztra 2024, plus 2026 registrations for Ozivy and other Brazilian brands), tirzepatide (Mounjaro, registered September 2023; chronic weight management added June 2025; a multidose presentation registered March 2026), liraglutide (Victoza, Saxenda, Xultophy and Brazilian versions) and dulaglutide (Trulicity). Anvisa says the semaglutide patent expired on 2026-03-20 but registration is still mandatory. Ozivy (EMS, 2026-05-26) is classed as a new synthetic drug for type 2 diabetes, and the first semaglutide generics were registered in August 2026. Prescribing and dispensing. Prescription retention for GLP-1 agonists took effect on 2025-06-23 and is set out in RDC 973/2025 and IN 360/2025. It covers semaglutide, liraglutide, dulaglutide, tirzepatide and lixisenatide: prescriptions in two copies, valid 90 days, with sales logged in SNGPC. Compounding. Compounding is governed by RDC 67/2007 and needs an individual prescription. Despacho 97/2025 (published 2025-08-25) and Nota Técnica 200/2025 set criteria for importing and compounding GLP-1 ingredients. A biotechnology-derived ingredient such as semaglutide may be imported for compounding only if it comes from the same manufacturer as the medicine registered in Brazil. Anvisa said synthetic semaglutide could not be imported or compounded until a medicine with a synthetic ingredient was registered, and the first one (Ozivy) was registered on 2026-05-26. Anvisa did not ban tirzepatide compounding, but it is closely monitored. In June 2026 Anvisa suspended one compounder's tirzepatide production for selling standardised, non-individualised product. On 2026-04-06 Anvisa reported that more than 100 kg of ingredients were imported in the second half of 2025, 11 inspections and 8 interdictions in 2026, and said it is revising RDC 67/2007 and Nota Técnica 200/2025; on 2026-04-14 it said a draft revised technical note on GLP-1 ingredients would be presented that week. Import. Unregistered pens are the main enforcement target. Anvisa said it had published 10 prohibition actions against irregular GLP-1 products between January and early April 2026. Later examples include Resolution 2.238/2026 (June 2026), Resolution 3.480/2026 (September 2026, covering products sold by one website, including products claimed to contain retatrutide) and Resolution 3.626/2026 (September 2026, the T36 pen). These ban import, sale and advertising of the named products. In the first half of September 2026, Anvisa, the tax authority and the federal police seized 1,230 units of unregistered products at Rio's Galeão airport, as reported by Metrópoles. Personal import is also argued in court. On 2026-05-12 the TRF-5 federal appeals court ruled that customs acted unlawfully when it held Mounjaro that a person had brought in for her own and her mother's use, because a prescription, therapeutic use and no commercial purpose had been shown. Coverage and price. The price regulator CMED sets maximum prices; it placed Ozivy in its category for new presentations of drugs already sold in Brazil, so it was compared with Ozempic and Wegovy. The public health system (SUS) does not currently supply these drugs for obesity: Conitec rejected semaglutide and liraglutide in August 2025 on cost grounds, and on 2026-09-24 the Health Ministry asked Conitec to assess semaglutide and liraglutide for obesity. - Source: Agência Nacional de Vigilância Sanitária (Anvisa), "Dados abertos: registro de medicamentos (DADOS_ABERTOS_MEDICAMENTOS.csv)" (2026-09-29) https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv - Source: Agência Nacional de Vigilância Sanitária (Anvisa), "Anvisa anuncia novas medidas de combate a irregularidades na importação e manipulação de canetas emagrecedoras" (2026-04-06) 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 - Source: Agência Nacional de Vigilância Sanitária (Anvisa), "Anvisa prepara nova norma com regras para manipulação de canetas emagrecedoras" (2026-04-14) https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-prepara-nova-norma-com-regras-para-manipulacao-de-canetas-emagracedoras - Source: Agência Brasil (EBC), "Anvisa proíbe versões manipuladas da semaglutida, usada no Ozempic" (2025-08-26) https://agenciabrasil.ebc.com.br/saude/noticia/2025-08/anvisa-proibe-versoes-manipuladas-da-semaglutida-usada-no-ozempic - Source: Agência Nacional de Vigilância Sanitária (Anvisa), "Entra em vigor norma que prevê retenção de receita para medicamentos agonistas GLP-1" (2025-06-23) https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2025/entra-em-vigor-norma-que-preve-retencao-de-receita-para-medicamentos-agonistas-glp-1 - Source: Agência Nacional de Vigilância Sanitária (Anvisa), "Anvisa registra cinco novas canetas de semaglutida" (2026-07-29) https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-registra-cinco-novas-canetas-de-semaglutida - Source: Presidência da República (Planalto), "Lei nº 6.360, de 23 de setembro de 1976" (1976-09-23) https://www.planalto.gov.br/ccivil_03/leis/l6360.htm - Source: Conselho Federal de Farmácia (CFF), "Anvisa estabelece novas regras para prescrição e dispensação de medicamentos agonistas de GLP-1" (2026-01-16) 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 - Source: Agência Nacional de Vigilância Sanitária (Anvisa), "Anvisa aprova primeira caneta de semaglutida sintética análoga ao Ozempic para diabetes" (2026-05-26) https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-aprova-primeira-caneta-de-semaglutida-sintetica-analoga-ao-ozempic-para-diabetes - Source: Agência Nacional de Vigilância Sanitária (Anvisa), "Mounjaro (tirzepatida): nova indicação" (2025-06-09) https://www.gov.br/anvisa/pt-br/assuntos/medicamentos/novos-medicamentos-e-indicacoes/mounjaro-r-tirzepatida-nova-indicacao - Source: Agência Nacional de Vigilância Sanitária (Anvisa), "Checamos: peptídeos que prometem milagres NÃO estão registrados na Anvisa" (2026-07-02) https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa - Source: Agência Nacional de Vigilância Sanitária (Anvisa), "Anvisa proíbe caneta emagrecedora T36" (2026-09-16) https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-proibe-caneta-emagrecedora-t36 - Source: Agência Nacional de Vigilância Sanitária (Anvisa), "Anvisa proíbe venda de tirzepatida irregular" (2026-06-02) https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-proibe-venda-de-tirzepatida-irregular - Source: Ministério da Saúde, "Ministério da Saúde protocola na Conitec pedido de análise para incorporação de canetas emagrecedoras no SUS" (2026-09-24) https://www.gov.br/saude/pt-br/assuntos/noticias-ms/2026/setembro/ministerio-da-saude-protocola-na-conitec-pedido-de-analise-para-incorporacao-de-canetas-emagrecedoras-no-sus - Source: Conselho Federal de Farmácia (CFF), "Conitec rejeita inclusão de medicamentos contra diabetes e obesidade no SUS" (2025-08-21) https://site.cff.org.br/noticia/Noticias-gerais/21/08/2025/conitec-rejeita-inclusao-de-medicamentos-contra-diabetes-e-obesidade-no-sus - Source: Portal 6, "Anvisa aprova 14 novas canetas para diabetes e obesidade em 2026" (2026-09-14) https://portal6.com.br/2026/09/14/anvisa-aprova-14-novas-canetas-para-diabetes-e-obesidade-em-2026/ - Source: Conselho Federal de Farmácia (CFF), "Farmacêutica nacional promete semaglutida com preço 30% menor que concorrência estrangeira" (2026-06-01) https://site.cff.org.br/noticia/Noticias-gerais/01/06/2026/farmaceutica-nacional-promete-semaglutida-com-preco-30-menor-que-concorrencia-estrangeira - Source: Agência Nacional de Vigilância Sanitária (Anvisa), "Resolução RDC nº 96, de 17 de dezembro de 2008 (propaganda de medicamentos)" (2008-12-17) https://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2008/res0096_17_12_2008.html - Source: CNN Brasil, "Anvisa suspende publicidade de caneta emagrecedora Semavy" (2026-09-25) https://www.cnnbrasil.com.br/saude/anvisa-suspende-publicidade-do-remedio-semavy-para-diabetes-tipo-2/ - Source: Diário de Justiça (news report on a TRF-5 ruling), "É ilegal a retenção de Mounjaro importado por pessoa física para uso próprio e de familiar de primeiro grau" (2026-05-12) https://diariodejustica.com.br/e-ilegal-a-retencao-de-mounjaro-importado-por-pessoa-fisica-para-uso-proprio-e-de-familiar-de-primeiro-grau/ - Source: U.S. Anti-Doping Agency (USADA), "BPC-157: Experimental Peptide Creates Risk for Athletes" (2020-03-03) https://www.usada.org/spirit-of-sport/bpc-157-peptide-prohibited/ - Source: Autoridade Brasileira de Controle de Dopagem (ABCD), "A Lista de Substâncias e Métodos Proibidos de 2026 já está em vigor" (2026-01-01) https://www.gov.br/abcd/pt-br/noticias/noticias-de-2026/a-lista-de-substancias-e-metodos-proibidos-de-2026-ja-esta-em-vigor - Source: Metrópoles, "Anvisa apreende tirzepatida e anabolizantes irregulares no Galeão" (2026-09-23) https://www.metropoles.com/saude/anvisa-apreende-tirzepatida-e-anabolizantes-irregulares-no-galeao - Source: Conselho Regional de Medicina do Paraná (CRM-PR), "Câmara Técnica de Dermatologia elabora nota técnica de alerta sobre uso invasivo de peptídeos" (2026-04-07) https://www.crmpr.org.br/Camara-Tecnica-de-Dermatologia-elabora-nota-tecnica-de-alerta-sobre-uso-invasivo-de-peptid-11-61244.shtml ### Canada - Page: https://glp1base.com/countries/canada - Regulator: Health Canada (https://www.canada.ca/en/health-canada.html) - Last verified: 2026-09-29 Simple: In Canada, Health Canada decides which medicines can be sold. Semaglutide, tirzepatide and liraglutide are approved for diabetes or weight management, and cheaper generic semaglutide has been sold since May 2026. Health Canada says injectable peptides without approval, such as BPC-157, are illegal to sell and it has seized them. Expert: Approval. A drug is sold in Canada only after Health Canada authorises it and assigns an eight-digit Drug Identification Number (DIN). New products go through new drug submissions, and some indications are authorised conditionally under the NOC/c policy (for example Wegovy's MASH indication). The Drug Product Database (DPD) lists every authorised product and its market status, and the monthly Submissions Under Review lists show pending files: orforglipron (Eli Lilly, accepted 2026-01) and cagrilintide/semaglutide (Novo Nordisk, accepted 2026-03) were on the list current as of 2026-08-31. Marketed GLP-1 products in the DPD are semaglutide (Ozempic, Rybelsus, Wegovy and, since May 2026, generics from Dr. Reddy's and Apotex), tirzepatide (Mounjaro, Zepbound), liraglutide (Victoza, Saxenda) and dulaglutide (Trulicity). Health Canada approved the first generic semaglutide (Dr. Reddy's, type 2 diabetes) on 2026-04-28, making Canada the first G7 country to do so, followed by Apotex (2026-05-01), Sevmia (Apotex, the first generic for chronic weight management, 2026-06-29), Aspen and Sandoz (2026-09-16). As of 2026-08-31 the generic submissions list showed 9 semaglutide and 11 liraglutide submissions and none for tirzepatide, dulaglutide or exenatide. Compounding. Health Canada's compounding policy (POL-0051) leaves compounding to provincially regulated professionals, mainly pharmacists. It must be patient-specific, in limited quantities, based on a prescription and a patient-professional relationship, and use ingredients that are authorised or pharmacopoeial-grade. The policy says compounding should not copy a commercially available product except during a documented shortage and must not be used to bypass the federal review system. Copying a marketed product at scale is treated as manufacturing, which needs authorisation. Enforcement has centred on ingredient quality: in January 2025 a Calgary compounding pharmacy's semaglutide-plus-pyridoxine preparation was recalled because it was made with an unauthorised active pharmaceutical ingredient, and in May 2026 a Type I recall covered GHK-Cu and BPC-157 powders sold to compounding and community pharmacies as unauthorised ingredients. Importation. Section C.01.045 of the Food and Drug Regulations bars anyone other than a practitioner, drug manufacturer, wholesale druggist, pharmacist or foreign visitor from importing a prescription drug. Health Canada says it works with the Canada Border Services Agency to stop unauthorised shipments. We did not locate a current Health Canada page describing any personal-use importation exception, so none is described here. Coverage and price. Provincial and territorial plans decide public coverage, informed by CDA-AMC (formerly CADTH) recommendations and price negotiation through the pan-Canadian Pharmaceutical Alliance (pCPA). For Wegovy in adults with BMI 27 or more and established cardiovascular disease, the expert committee recommended reimbursement only with a price reduction; the pCPA closed negotiations without an agreement on 2025-12-01 (the manufacturer declined to negotiate) and BC PharmaCare listed it as a non-benefit on 2025-12-18. As reported by The Globe and Mail (2026-06-04), public plans already cover brand Ozempic for type 2 diabetes, the pCPA generic tiers price a generic at 50% of the brand with two manufacturers and 35% with three or more, and Apotex's generic had a wholesale price of CAD 78.14 per four weeks against CAD 240.48 for Ozempic before markups and insurance. Enforcement. Health Canada's advisories in this area are: a warning on fake or unauthorised GLP-1 products (2026-01-21); peptide seizures from Prime Research (2025-04-14), Optimum Wellness Centre in Calgary (2025-04-02), Canada Peptide (2025-08-01, a list of more than 40 products including unauthorised tirzepatide and retatrutide) and Rize Fitness in Vancouver (2025-12-24); and a public advisory on 2026-04-09 naming unauthorised injectable peptides it has seized. For authorised generics, Health Canada posted Type II recalls of specific Dr. Reddy's and Apotex semaglutide lots in August and September 2026 (a mislabelled pen, an out-of-specification impurity, and pens that may show and deliver the wrong dose). - Source: Health Canada, "Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874)" (2026-04-09) https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm - Source: Health Canada, "Thinking about buying GLP-1 drugs like Ozempic or Mounjaro? Beware of fake or unauthorized products" (2026-01-21) https://recalls-rappels.canada.ca/en/alert-recall/thinking-about-buying-glp-1-drugs-ozempic-or-mounjaro-beware-fake-or-unauthorized - Source: Health Canada, "Policy on Manufacturing and Compounding Drug Products in Canada (POL-0051)" (2009-01-26) https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/policy-manufacturing-compounding-drug-products.html - Source: Justice Laws Website, Government of Canada, "Food and Drug Regulations (C.R.C., c. 870), sections C.01.044 and C.01.045" (2026) https://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._870/page-51.html - Source: Health Canada, "Canada approves second generic semaglutide, the first G7 country to do so" (2026-05-01) https://www.canada.ca/en/health-canada/news/2026/05/canada-approves-second-generic-semaglutide-the-first-g7-country-to-do-so.html - Source: Health Canada, "Canada approves first generic semaglutide for weight loss" (2026-06-29) https://www.canada.ca/en/health-canada/news/2026/06/canada-approves-first-generic-semaglutide-for-weight-loss.html - Source: Health Canada, "Generic submissions under review (list current as of 2026-08-31)" (2026-08-31) https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/generic-submissions-under-review.html - Source: Health Canada, "Drug and Health Product Submissions Under Review: New drug submissions under review (list current as of 2026-08-31)" (2026-08-31) https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review/new-drug-submissions-under-review.html - Source: BC Ministry of Health (PharmaCare), "Drug Coverage Decision for BC PharmaCare: semaglutide (Wegovy)" (2025-12-18) https://www2.gov.bc.ca/assets/gov/health/health-drug-coverage/pharmacare/decisions/semaglutide_wegovy_4055_dds.pdf - Source: The Globe and Mail, "Generic semaglutide in Canada: availability, price and insurance" (2026-06-04) https://www.theglobeandmail.com/canada/article-generic-semaglutide-ozempic-canada-availability-price-insurance/ - Source: The Globe and Mail, "Dozens of online-pharmacy ads, including for weight-loss drugs, appear to violate federal rules" (2026-02-12) https://www.theglobeandmail.com/canada/article-skinny-inc-online-pharmacy-ads-weight-loss-drugs-federal-rules/ - Source: Health Canada, "Regulatory requirements for advertising health products" (2026-01-30) https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising.html - Source: Pharmaceutical Advertising Advisory Board (PAAB), "PAAB guidance on reminder advertisements and section C.01.044" (2025-10) https://www.paab.ca/question-174 - Source: Health Canada, "GHK-Cu & BPC-157 powder: Unauthorized active pharmaceutical ingredients (Type I recall)" (2026-05-07) https://recalls-rappels.canada.ca/en/alert-recall/ghk-cu-bpc-157-powder-unauthorized-active-pharmaceutical-ingredients - Source: Health Canada, "Semaglutide + Pyridoxine: produced with an unauthorized active pharmaceutical ingredient" (2025-01-21) https://recalls-rappels.canada.ca/en/alert-recall/semaglutide-pyridoxine-produced-unauthorized-active-pharmaceutical-ingredient - Source: Health Canada, "Unauthorized injectable peptide drugs seized and sold by Canada Peptide may pose serious health risks" (2025-08-01) https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious - Source: Health Canada, "Unauthorized injectable peptide drugs seized from Optimum Wellness Centre in Calgary, Alberta may pose serious health risks (RA-77218)" (2025-04-02) https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta - Source: Health Canada, "Unauthorized injectable peptide drugs sold by Prime Research may pose serious health risks" (2025-04-14) https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-sold-prime-research-may-pose-serious-health - Source: Health Canada, "Unauthorized health products sold online and seized at Rize Fitness may pose serious health risks" (2025-12-24) https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious - Source: World Anti-Doping Agency, "World Anti-Doping Code International Standard: Prohibited List 2026" (2025-09) https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf - Source: Sport Integrity Canada, "The Prohibited List" (2026) https://sportintegrity.ca/prohibited-list - Source: Health Canada (Drug Product Database), "Drug Product Database: ZEPBOUND product record" (2026-09) https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106082 - Source: Health Canada, "Canada becomes the first G7 country to approve a generic version of semaglutide" (2026-04-28) https://www.canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html - Source: Health Canada, "Semaglutide Injection: Incorrect Pen in Package (Type II recall, RA-82477)" (2026-08-11) https://recalls-rappels.canada.ca/en/alert-recall/semaglutide-injection-incorrect-pen-package - Source: Health Canada, "Semaglutide Injection: Out-of-Specification (Impurity) (Type II recall, RA-82537)" (2026-08-26) https://recalls-rappels.canada.ca/en/alert-recall/semaglutide-injection-out-specification-impurity - Source: Health Canada, "Apo-Semaglutide Injection: Incorrect dose display (Type II recall, RA-82536)" (2026-08-27) https://recalls-rappels.canada.ca/en/alert-recall/apo-semaglutide-injection-incorrect-dose-display - Source: Health Canada, "Apo-Semaglutide Injection: Incorrect dose display (Type II recall, RA-82679)" (2026-09-24) https://recalls-rappels.canada.ca/en/alert-recall/apo-semaglutide-injection-incorrect-dose-display-0 ### China - Page: https://glp1base.com/countries/china - Regulator: National Medical Products Administration (NMPA) (https://english.nmpa.gov.cn/) - Last verified: 2026-09-29 Simple: In China a medicine can only be sold if the national drug regulator, the NMPA, has approved it. Several GLP-1 weight-loss and diabetes drugs are approved, including some developed by Chinese companies, and cheaper local copies of semaglutide are still waiting for approval. The national health insurance pays for these drugs only for type 2 diabetes, not for weight loss. Peptides such as BPC-157 have no approval, and the law does not allow them to be made, imported or sold as medicines. Expert: Medicines are regulated under the Drug Administration Law (in force 2019-12-01) and its Implementing Regulations (State Council Order No. 828, promulgated 2026-01-16, effective 2026-05-15). The NMPA, with its Center for Drug Evaluation (CDE), grants marketing authorisation under the Provisions for Drug Registration (SAMR Order 27, 2020). Article 98 of the Law prohibits producing or importing a drug without an approval document, and Article 124 sets confiscation and fines of 15 to 30 times the goods value, with a mitigation clause for small quantities of a drug that is lawfully marketed abroad. There is no compounding-pharmacy channel comparable to US 503A/503B: medical-institution preparations (Article 76) must meet a clinical need not supplied by the market, need provincial approval, may be used only on prescription inside the preparing institution (or, with drug-regulator approval, transferred between designated institutions), and may not be sold on the market (Law, Article 76; Implementing Regulations, Articles 54-59). Personal importation is limited to a reasonable personal-use quantity carried or posted in under the customs rules (Law, Article 65; Implementing Regulations, Article 48); the Law does not turn an unapproved drug into a lawful one. Reimbursement is through the National Reimbursement Drug List (NRDL). In the 2025 edition, effective 2026-01-01, every GLP-1 entry (semaglutide, tirzepatide, dulaglutide, liraglutide, exenatide, lixisenatide, PEG-loxenatide, efsubaglutide alfa and two insulin combinations) is limited to type 2 diabetes, with no obesity indication, and the 2026 adjustment cycle is under way (818 applications received, 557 passing initial review for the basic list). Prices of imported brands fell sharply in late 2025 ahead of the semaglutide compound patent expiry on 2026-03-20. As of 2026-09-08 a listed developer stated that no domestically made semaglutide was approved and only the originator's imported product was on the market, while many domestic biosimilar and generic applications were accepted by CDE. Enforcement in the distribution chain is run through NMPA campaigns such as the 2026 Qingyuan action; we did not find a GLP-1-specific NMPA enforcement notice, and the NMPA's own database could not be queried automatically, so approvals were cross-checked against NMPA announcements, the NRDL, CDE's public application register and company filings. - Source: National Medical Products Administration (NMPA), "Drug Administration Law of the PRC (中华人民共和国药品管理法)" (2019-08-26) https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html - Source: National Medical Products Administration (NMPA), "Regulations for the Implementation of the Drug Administration Law (State Council Order No. 828; 中华人民共和国药品管理法实施条例)" (2026-01-16) https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20260127172639127.html - Source: State Administration for Market Regulation (SAMR), "Provisions for Drug Registration (SAMR Order No. 27; 药品注册管理办法)" (2020-01-22) https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_3275cb2a929d4c34ac8c0421b2a9c257.html - Source: National Medical Products Administration (NMPA), "Advertising Law of the PRC, 2021 amendment (中华人民共和国广告法)" (2021-04-29) https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20230328161808137.html - Source: State Administration for Market Regulation (SAMR), "Measures for the Supervision of Online Drug Sales (SAMR Order No. 58; 药品网络销售监督管理办法)" (2022-08) https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_27f2fba302ab48239dfde1a5b5095156.html - Source: National Healthcare Security Administration (NHSA), "Notice issuing the 2025 National Reimbursement Drug List and Commercial Health Insurance Innovative Drug List (医保发〔2025〕33号)" (2025-12-07) https://www.nhsa.gov.cn/art/2025/12/7/art_104_18970.html - Source: National Healthcare Security Administration (NHSA), "National Basic Medical Insurance, Maternity Insurance and Work-Related Injury Insurance Drug List (2025 edition), effective 2026-01-01" (2025-12) https://www.nhsa.gov.cn/module/download/downfile.jsp?classid=0&filename=a32f9f2f3fc046afaf08471f87456ce3.pdf - Source: National Healthcare Security Administration (NHSA), "Interpretation of the public notice on drugs passing the preliminary formal review for the 2026 NRDL and commercial insurance list adjustment" (2026-06-29) https://www.nhsa.gov.cn/art/2026/6/29/art_105_21130.html - Source: National Medical Products Administration (NMPA), "NMPA innovative drug approvals list (创新药品名录)" (2026-09) https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/index.html - Source: National Medical Products Administration (NMPA), "NMPA publishes 4 typical cases of illegal drug distribution under the Qingyuan action (国家药监局公布4起药品经营环节“清源”行动违法违规典型案例)" (2026-06-16) https://www.nmpa.gov.cn/yaowen/ypjgyw/ypyw/20260616164441171.html - Source: National Medical Products Administration (NMPA), "NMPA approves visepegenatide injection for marketing (国家药监局批准维培那肽注射液上市)" (2025-11-20) https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20251120141806140.html - Source: National Medical Products Administration (NMPA), "NMPA approves mazdutide injection for marketing (国家药监局批准玛仕度肽注射液上市)" (2025-06-27) https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20250627145044169.html - Source: National Medical Products Administration (NMPA), "NMPA approves ecnoglutide injection for marketing (国家药监局批准埃诺格鲁肽注射液上市)" (2026-01-30) https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20260130142923121.html - Source: Sciwind Biosciences, "Sciwind Biosciences announces ecnoglutide injection approved by China's NMPA for chronic weight management" (2026-03-06) https://www.sciwindbio.com/portal/index/newsdetail/id/125.html - Source: Center for Drug Evaluation (CDE), NMPA, "CDE public register of accepted drug applications (受理品种目录浏览)" (2026-09-29) https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d - Source: Yicai Global, "Prices of imported GLP-1 weight-loss drugs halve as patent protection in China to expire" (2025-12-29) https://www.yicaiglobal.com/news/prices-of-imported-glp-1-weight-loss-drugs-halve-as-patent-protection-in-china-to-expire - Source: Chongqing Zhifei Biological Products (Shenzhen Stock Exchange filing), "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)" (2026-09-08) http://static.cninfo.com.cn/finalpage/2026-09-08/1225553187.PDF - Source: World Anti-Doping Agency (WADA), "The Prohibited List (2026)" (2026) https://www.wada-ama.org/en/prohibited-list - Source: China Anti-Doping Agency (CHINADA), "China Anti-Doping Agency (CHINADA) official website" (2026) https://www.chinada.cn/ ### European Union - Page: https://glp1base.com/countries/european-union - Regulator: European Medicines Agency (EMA) with the European Commission; national competent authorities in each member state (https://www.ema.europa.eu) - Last verified: 2026-09-29 Simple: In the EU, medicines are approved in one of two ways. Most new and important medicines get one EU-wide approval from the European Commission after the European Medicines Agency reviews them. Other medicines are approved country by country. GLP-1 drugs such as Ozempic, Wegovy and Mounjaro are approved EU-wide, but you need a prescription. Peptides such as BPC-157 have no approval, so they cannot legally be sold as medicines. Who pays for weight-loss drugs is decided by each country, and it differs a lot. Expert: Medicines need a marketing authorisation before they are placed on the market (Directive 2001/83/EC, Art. 6). The centralised procedure is compulsory for medicines made by biotechnology (such as recombinant DNA technology), for new active substances for diabetes and certain other listed diseases, and for orphan medicines; other new active substances may opt in (Regulation (EC) No 726/2004, Art. 3 and Annex). In that procedure EMA's CHMP gives an opinion and the European Commission issues a decision that applies in all member states (register: Union Register). Directive 2001/83/EC excludes magistral and officinal pharmacy preparations (Art. 3(1)-(2)) and lets member states allow supply of unauthorised medicines to fill special needs on a named-patient basis (Art. 5(1)). These exceptions are implemented nationally, and there is no EU-level equivalent of the US shortage-based compounding regime. A product presented as treating disease, or able to change physiological functions pharmacologically, is a medicinal product (Art. 1(2)). Prescription medicines may be sold online to the public only where national law allows it and only by authorised sellers (Art. 85c), and EU-registered online pharmacies show the common EU logo. Member states set pricing and reimbursement. Examples: Germany excludes weight-loss medicines from statutory health insurance (§ 34(1) SGB V); the G-BA added Wegovy to Annex II (lifestyle medicines) of its Pharmaceutical Directive on 21 March 2024, and the current Annex II (in force 20 August 2025) lists Saxenda, Wegovy and Mounjaro when used for weight reduction. Italy classes Wegovy, Saxenda and Mounjaro for obesity as class C, paid by the patient. France has reimbursed Wegovy and Mounjaro at 65% since 15 June 2026 for BMI of 40 and above, or 35 and above with a listed comorbidity, with initial prescription restricted to specialist obesity settings (arrêtés of 23 May 2026, amended 10 June 2026). Recent enforcement and warnings: EMA and the Heads of Medicines Agencies warned on 3 September 2025 of a sharp rise in illegal medicines, including falsified semaglutide, liraglutide and tirzepatide, sold via fraudulent websites and social media, and EMA warned on 18 October 2023 about falsified Ozempic pens. Enforcement against individual sellers is national and was not surveyed one country at a time. The EU pharmaceutical legislation reform (political agreement reported by the Commission in December 2025) is intended to replace Directive 2001/83/EC; its adoption status, advertising and other provisions were not assessed here. - Source: European Union (EUR-Lex), "Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)" (2025-01-01) https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0083-20250101 - Source: European Union (EUR-Lex), "Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products (Art. 3 and Annex)" (2004-03-31) https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32004R0726 - Source: European Commission, "Union Register of medicinal products for human use" (2026-09-29) https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm - Source: European Medicines Agency, "EMA medicines data (JSON report): human and veterinary medicines, with authorisation status" (2026-09-29) https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json - Source: European Medicines Agency, "Applications for new human medicines under evaluation by the CHMP (September 2026)" (2026-09-04) https://www.ema.europa.eu/en/documents/report/applications-new-human-medicines-under-evaluation-september-2026_en.xlsx - Source: European Medicines Agency and Heads of Medicines Agencies, "Warning about sharp rise in illegal medicines sold in the EU" (2025-09-03) https://www.ema.europa.eu/en/news/warning-about-sharp-rise-illegal-medicines-sold-eu - Source: Austrian Federal Office for Safety in Health Care (BASG), "Sharp rise in illegal medicines in the EU: warning about falsified GLP-1 receptor agonists" (2025-09-04) https://www.basg.gv.at/en/market-surveillance/official-announcements/detail/starker-anstieg-illegaler-arzneimittel-in-der-eu-warnung-vor-gefaelschten-glp-1-rezeptoragonisten - Source: European Medicines Agency, "EMA alerts EU patients and healthcare professionals to reports of falsified Ozempic pens" (2023-10-18) https://www.ema.europa.eu/en/news/ema-alerts-eu-patients-healthcare-professionals-reports-falsified-ozempic-pens - Source: European Medicines Agency, "EU actions to tackle shortages of GLP-1 receptor agonists" (2024-06-26) https://www.ema.europa.eu/en/news/eu-actions-tackle-shortages-glp-1-receptor-agonists - Source: European Medicines Agency, "EMA partners with content creators to promote safe and responsible use of GLP-1 medicines" (2025-10-21) https://www.ema.europa.eu/en/news/ema-partners-content-creators-promote-safe-responsible-use-glp-1-medicines - Source: European Medicines Agency, "European Commission launches logo for online pharmacies to protect patients from falsified medicines" (2014-06-24) https://www.ema.europa.eu/en/news/european-commission-launches-logo-online-pharmacies-protect-patients-falsified-medicines - Source: Vidal, "Obesite: prise en charge de Wegovy et Mounjaro a partir du 15 juin 2026, sous conditions" (2026-05-28) https://www.vidal.fr/actualites/37850-obesite-prise-en-charge-de-wegovy-et-mounjaro-a-partir-du-15-juin-2026-sous-conditions.html - Source: Gemeinsamer Bundesausschuss (G-BA), "G-BA press release on Wegovy and the statutory exclusion of weight-loss medicines (Annex II)" (2024-03-21) https://www.g-ba.de/presse/pressemitteilungen-meldungen/1170/ - Source: Italian Medicines Agency (AIFA), "New diabetes and obesity medicines: an AIFA guide" (2026-05-18) https://www.aifa.gov.it/en/-/nuovi-farmaci-diabete-obesita-guida-aifa - Source: European Commission, "Reform of EU pharmaceutical legislation" (2025-12) https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe/reform-eu-pharmaceutical-legislation_en - Source: World Anti-Doping Agency, "The 2026 Prohibited List" (2025-09) https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf - Source: European Medicines Agency, "First oral GLP-1 treatment for weight management" (2026-05-22) https://www.ema.europa.eu/en/news/first-oral-glp-1-treatment-weight-management - Source: European Medicines Agency, "Meeting highlights from the CHMP 18-21 May 2026" (2026-05-22) https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-18-21-may-2026 - Source: Légifrance, Journal officiel de la République française, "Arrêté du 23 mai 2026 modifiant la liste des spécialités pharmaceutiques remboursables aux assurés sociaux (WEGOVY)" (2026-05-28) https://www.legifrance.gouv.fr/jorf/id/JORFTEXT000054144081 - Source: Gemeinsamer Bundesausschuss (G-BA), "Arzneimittel-Richtlinie Anlage II: Lifestyle-Arzneimittel (Stand 20. August 2025)" (2025-08-20) https://www.g-ba.de/downloads/83-691-1029/AM-RL-II-Lifestyle-2025-08-20.pdf - Source: European Medicines Agency, "Kyinsu: EPAR (European public assessment report)" (2026-02-12) https://www.ema.europa.eu/en/medicines/human/EPAR/kyinsu ### India - Page: https://glp1base.com/countries/india - Regulator: Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services (https://cdsco.gov.in) - Last verified: 2026-09-29 Simple: In India, the national medicines regulator, CDSCO, decides which new medicines can be sold. Semaglutide and tirzepatide are approved and sold on prescription, and cheaper Indian copies of semaglutide arrived in March 2026. Peptides such as BPC-157 have no approval, and in 2026 the regulator began cracking down on illegal sales and sneaky advertising of weight-loss injections. Expert: Approval: CDSCO, under the Drugs Controller General (India), is the Central Licensing Authority. Under the New Drugs and Clinical Trials Rules, 2019, a drug not approved by the CLA is a 'new drug' (rule 2(1)(w)) and cannot be imported or made for sale or distribution without permission (rules 74, 75 to 76 and 80). Applications go to Subject Expert Committees, whose published recommendations often attach conditions such as prescriber restrictions, Phase IV studies and post-marketing surveillance; the committee has also cleared synthetic-origin generic semaglutide company by company. Compounding: the Act excludes 'compounding or dispensing' in the ordinary course of retail business from the definition of manufacture, and licence conditions require a registered pharmacist to supervise compounding at licensed premises. There is no US-style regime for producing copies of drugs, and the documents reviewed do not address bespoke compounding of an unapproved peptide, so that point is left open. Personal import: rule 36 of the Drugs Rules, 1945 lets a passenger bring in small quantities for exclusive personal use as bona fide baggage (not more than 100 average doses of a single drug, declared to Customs if asked); other personal imports need a permit backed by a doctor's prescription. Coverage and price: the sources reviewed describe private cash-pay sale, with reported March 2026 launch prices for Indian generic semaglutide varying widely by company and strength; I found no verified description of public reimbursement. Enforcement: after a 10 March 2026 advisory against surrogate promotion, CDSCO ran an audit drive covering online pharmacy warehouses, wholesalers, retail outlets and wellness and slimming clinics, and on 27 March 2026 (posted publicly 18 May 2026) asked State Drug Controllers to monitor the supply chain and advertising under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and the Drugs and Cosmetics Act, 1940. A CDSCO public notice dated 18 May 2026 states that injectables are not cosmetics, and a counterfeit-semaglutide alert was reported in July 2026. - Source: Central Drugs Standard Control Organisation (CDSCO), "Strengthening Enforcement against Unauthorized Promotion and Distribution of GLP-1 Based Drugs (letter to State/UT Drug Controllers, 27 March 2026)" (2026-03-27) https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/34801%20%282%29.pdf - Source: Central Drugs Standard Control Organisation (CDSCO), "Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)" (2026-08-10) https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/MANUFACTURING%20AND%20MARKETING.pdf - Source: Central Drugs Standard Control Organisation (CDSCO), "Public Notice dated 18 May 2026: injectable preparations do not fall under the definition of cosmetics" (2026-05-18) https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Public%20Notice%20dated%2018.05.2026.pdf - Source: News On AIR (All India Radio), "India Tightens Surveillance on GLP-1 Weight Loss Drug Sales" (2026-03-24) https://www.newsonair.gov.in/india-tightens-surveillance-on-glp-1-weight-loss-drug-sales - Source: ETV Bharat, "Drug regulator warns pharma firms against surrogate ads, off-label promotion of weight loss drugs" (2026-03-25) https://www.etvbharat.com/en/health/drug-regulator-warns-pharma-firms-against-surrogate-ads-off-label-promotion-of-weight-loss-drugs-enn26032504110 - Source: Pearce IP, "Generic semaglutide launches in India, including by Dr Reddy's, Zydus, Alkem, Sun Pharma, Glenmark" (2026-03-21) https://www.pearceip.law/2026/03/21/generic-semaglutide-launches-in-india-including-by-dr-reddys-zydus-alkem-sun-pharma-glenmark/ - Source: Whalesbook, "CDSCO tightens semaglutide oversight after counterfeit alert" (2026-07-28) https://www.whalesbook.com/news/English/healthcarebiotech/CDSCO-Tightens-Semaglutide-Oversight-After-Counterfeit-Alert/6a680060d1570ec59e568da2 - Source: Central Drugs Standard Control Organisation (CDSCO), "The Drugs and Cosmetics Act, 1940 (CDSCO consolidated text)" (2022-11) https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/acts_and_rules/Drugs%20and%20Cosmetics%20Act%2C%201940.pdf - Source: Central Drugs Standard Control Organisation (CDSCO), "The New Drugs and Clinical Trials Rules, 2019 (CDSCO consolidated text)" (2023-02) https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/new_DC_rules/23NEW%20DRUGS%20AND%20CLINICAL%20TRIALS%20RULES%2C%202019.pdf - Source: Central Drugs Standard Control Organisation (CDSCO), "The Drugs and Cosmetics Act, 1940 and Rules, 1945 (rule 36 personal import; rule 65 licence conditions; rule 106 and Schedule J)" (2016) https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf - Source: World Anti-Doping Agency, "World Anti-Doping Code International Standard: Prohibited List 2026" (2025-09) https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf - Source: Central Drugs Standard Control Organisation (CDSCO), "CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)" (2026-09-23) https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/ - Source: Central Drugs Standard Control Organisation (CDSCO), "CDSCO Public Notices index" (2026-09-14) https://cdsco.gov.in/opencms/opencms/en/Notifications/Public-Notices/ - Source: Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee, "Recommendations of the SEC (Endocrinology & Metabolism) made in its 09 th/26 meeting held on 23.04.2026 at CDSCO HQ" (2026-04-23) https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Endocrinology%20Metabolism%2023.04.2026%20%281%29.pdf - Source: Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee, "Recommendations of the SEC (Endocrinology & Metabolism) made in its 13th/26 meeting held on 20.05.2026 at CDSCO HQ" (2026-05-20) https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations-%20Endocrinology%20Metabolism%2020.05.2026%20%281%29.pdf - Source: Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee, "Recommendations of the SEC Endocrinology & Metabolism made in its 12th/24 meeting held on 19.06.2024 at CDSCO HQ" (2024-06-19) https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Endocrinology%20%26%20Metabolism%2019.06.2024.pdf - Source: Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee, "Recommendations of the SEC (Endocrinology & Metabolism) made in its 06th/26 meeting held on 23.03.2026 at CDSCO HQ" (2026-03-23) https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Endocrinology%20Metabolism%2023.03.2026%20%281%29%20%282%29.pdf ### Japan - Page: https://glp1base.com/countries/japan - Regulator: Ministry of Health, Labour and Welfare (MHLW), with the Pharmaceuticals and Medical Devices Agency (PMDA) doing the scientific review and safety monitoring (https://www.mhlw.go.jp/) - Last verified: 2026-09-29 Simple: In Japan, the health ministry (MHLW) decides which medicines can be sold, and an agency called PMDA reviews them first. Semaglutide (Wegovy) and tirzepatide (Zepbound) are approved for obesity, but only for people who also have a related health problem, and doctors are asked to follow a strict national guideline. Peptides sold online, such as BPC-157, are not approved medicines in Japan, and it is illegal to sell or advertise them as medicines. Expert: Under the PMD Act (Act No. 145 of 1960), Article 14 requires ministerial approval, item by item, before a drug is marketed; PMDA reviews the application and MHLW approves. Art. 55(2) bars selling drugs marketed in breach of Art. 14, Art. 84 sets penalties of up to three years' imprisonment or a fine of up to JPY 3 million, and Art. 49 restricts designated prescription drugs to people holding a prescription. Under the Pharmacists Act, only a pharmacist may dispense (Art. 19, with narrow exceptions for doctors dispensing on their own prescriptions) and only on a prescription (Art. 23); we found no separate statutory route in Japan for bulk or outsourced compounding of unapproved peptides. Individuals may import a prescription drug for personal use up to one month's supply under a customs check, larger quantities need an import confirmation certificate from a regional bureau of health and welfare, and passing the drug to anyone else is not allowed; physicians may import unapproved drugs under their own responsibility. GLP-1 medicines appear on the NHI (national health insurance) price list applicable from 13 August 2026: Ozempic, Rybelsus, Wegovy, Mounjaro, Zepbound, Trulicity and the liraglutide combination Xultophy, with Victoza carrying a transitional-use deadline of 31 March 2027 and Mounjaro marked for new prices from 1 August 2026. Wegovy and Zepbound are subject to MHLW Optimal Use Promotion Guidelines that limit them to qualified facilities and to patients with obesity plus hypertension, dyslipidaemia or type 2 diabetes. On 16 June 2026 MHLW's Pharmaceutical Safety Division and two divisions of its Health Policy Bureau told prefectures, cities with public health centres and special wards that some clinics and pharmacies use GLP-1 and GIP/GLP-1 medicines for cosmetic or slimming purposes outside approved indications, asked them to alert providers, and said supply is normal. The notice also restates advertising limits and asks that off-label cosmetic use be flagged in adverse-reaction reports. - Source: Digital Agency (e-Gov Law Search), "Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated text" (2026-05-21) https://laws.e-gov.go.jp/law/335AC0000000145 - Source: Digital Agency (e-Gov Law Search), "Pharmacists Act (薬剤師法), consolidated text" (2026-05-21) https://laws.e-gov.go.jp/law/335AC0000000146 - Source: Pharmaceuticals and Medical Devices Agency (PMDA), "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）)" (2026-09) https://www.pmda.go.jp/files/000281577.pdf - Source: Pharmaceuticals and Medical Devices Agency (PMDA), "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）)" (2026-03) https://www.pmda.go.jp/files/000277965.pdf - Source: Pharmaceuticals and Medical Devices Agency (PMDA), "List of Approved Drugs, April 2004 to February 2026 (new drugs)" (2026) https://www.pmda.go.jp/files/000281190.pdf - Source: Pharmaceuticals and Medical Devices Agency (PMDA), "Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)" (2026-09-29) https://www.pmda.go.jp/PmdaSearch/iyakuSearch/ - Source: Ministry of Health, Labour and Welfare (MHLW), "NHI drug price list and generic drug information, applicable from 13 August 2026 (薬価基準収載品目リスト)" (2026-08-13) https://www.mhlw.go.jp/topics/2026/04/tp20260401-01.html - Source: Ministry of Health, Labour and Welfare (MHLW), "Optimal Use Promotion Guideline: semaglutide (Wegovy), obesity (revised June 2026)" (2026-06) https://www.pmda.go.jp/files/000281140.pdf - Source: Ministry of Health, Labour and Welfare (MHLW), "Optimal Use Promotion Guideline: tirzepatide (Zepbound), obesity (revised May 2026)" (2026-05) https://www.pmda.go.jp/files/000280607.pdf - Source: Ministry of Health, Labour and Welfare (MHLW), "Notice on proper use of GLP-1 receptor agonists and GIP/GLP-1 receptor agonists (医薬安発0616第16号)" (2026-06-16) https://www.mhlw.go.jp/content/001720946.pdf - Source: Ministry of Health, Labour and Welfare (MHLW), "Personal import of pharmaceuticals and related products (医薬品等の個人輸入について)" (2025) https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/kojinyunyu/topics/tp010401-1.html - Source: Ministry of Health, Labour and Welfare (MHLW), "Guidance for people buying medicines and related products from overseas (医薬品等を海外から購入しようとされる方へ)" (2025) https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/kojinyunyu/index.html - Source: Ministry of Health, Labour and Welfare (MHLW), "Notes on personal import of medicines by physicians and dentists (医師・歯科医師の方へ)" (2012-03) https://www.mhlw.go.jp/topics/0104/dl/tp0401-1c.pdf - Source: Ministry of Health, Labour and Welfare (MHLW), "Revision of the Standards for Fair Advertising Practices concerning Medicinal Products (医薬品等適正広告基準, notice 薬生発0929第4号)" (2017-09-29) https://www.mhlw.go.jp/file/06-Seisakujouhou-11120000-Iyakushokuhinkyoku/0000179264.pdf - Source: Ministry of Health, Labour and Welfare (MHLW), "Guidelines on advertising by medical institutions (医療広告等ガイドライン), last revised 30 March 2026" (2026-03-30) https://www.mhlw.go.jp/content/001683594.pdf - Source: World Anti-Doping Agency (WADA), "World Anti-Doping Code International Standard: Prohibited List 2026" (2025-09) https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf - Source: Japan Anti-Doping Agency (JADA), "Japan Anti-Doping Agency (JADA) website" (2026) https://www.playtruejapan.org/ ### Mexico - Page: https://glp1base.com/countries/mexico - Regulator: COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios, Secretaría de Salud) (https://www.gob.mx/cofepris) - Last verified: 2026-09-29 Simple: In Mexico, a federal health agency called COFEPRIS decides which medicines can be sold. Semaglutide (Ozempic, Wegovy, Rybelsus), tirzepatide (Mounjaro), liraglutide and dulaglutide are registered and need a doctor's prescription. Some companies have applied to sell generic semaglutide, but none was on COFEPRIS's list of new registrations as of August 2026. Peptides sold online as 'research' products have no registration in Mexico, and a member of Congress has proposed a ban on selling them. Expert: Medicines need a sanitary registration (registro sanitario) from COFEPRIS before sale, and COFEPRIS's lists show most GLP-1 products in class IV of Article 226 of the Ley General de Salud, a class of medicines that need a prescription. COFEPRIS publishes yearly lists of registrations issued, cancelled and extended, and lists of applications received, including generic and biocomparable filings that open a ten-working-day window for patent opposition. New active ingredients already approved in the EU, Switzerland, the US, Canada or Australia can be filed under equivalence agreements; Lilly's tirzepatide was filed that way in April 2024. COFEPRIS and Brazil's ANVISA announced on 24 September 2026 that they are moving toward mutual recognition of regulatory opinions, after Mexico published guidelines on 2 September 2026 recognising ANVISA's requirements. As of 31 August 2026 the applications list has six generic semaglutide and seven generic or biocomparable liraglutide entries for 2026, and none appears in COFEPRIS's list of registrations issued in 2026 (updated 4 August 2026). Press reports say a court gave semaglutide ten years of clinical-data protection, which the generics association ANAFAM disputes. On compounding, we could not retrieve the current text of the rules on magistral formulas and found no COFEPRIS guidance on compounded GLP-1s, so we make no claim. On personal importation, COFEPRIS lists permit procedures for personal-use imports of medicines, but we could not read the eligibility rules. On coverage, we found no official statement on public reimbursement of GLP-1s for obesity; a COFEPRIS alert says liraglutide lots were destined for the public health sector, and one press report puts an Ozempic pen at about 4,500 to 6,500 pesos. On enforcement, COFEPRIS issued alerts on illegal tirzepatide (9 February 2026), counterfeit Victoza (19 February 2026), counterfeit Ozempic (17 June 2025, 26 March 2026 and 25 May 2026) and counterfeit Rybelsus (13 April 2026). - Source: COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), "COFEPRIS: portal oficial (registros, alertas, publicidad, importación)" (2026-09-29) https://www.gob.mx/cofepris - Source: COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), "Alertas sanitarias de medicamentos (índice)" (2026-09-28) https://www.gob.mx/cofepris/documentos/alertas-sanitarias-de-medicamentos - Source: COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), "Listados de registros sanitarios de medicamentos (visor y listas anuales)" (2025-08-21) https://www.gob.mx/cofepris/documentos/registros-sanitarios-medicamentos - Source: COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), "Consulta de solicitudes ingresadas de registros sanitarios para medicamentos alopáticos" (2025-09-22) https://www.gob.mx/cofepris/acciones-y-programas/solicitudes-de-registros-sanitarios - Source: COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), "Solicitudes de medicamentos genérico o biocomparable ingresadas en 2026" (2026-08-31) https://www.gob.mx/cms/uploads/attachment/file/1102316/Solicitudes_Reg_Gen_ricos_y_Biocomparables_2026_aviso.pdf - Source: COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), "Solicitudes de medicamentos (excepto genérico y biocomparable) ingresadas en 2026" (2026-08-31) https://www.gob.mx/cms/uploads/attachment/file/1102317/Solicitudes_Reg_Excepto_Gen_ricos_y_Biocomp_2026.pdf - Source: COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), "Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitario" (2026-02-09) https://www.gob.mx/cms/uploads/attachment/file/1055652/Alerta_Sanitaria_Tirzepatida_09022026.pdf - Source: COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), "Alerta sanitaria: falsificación de Victoza (liraglutida) solución inyectable" (2026-02-19) https://www.gob.mx/cms/uploads/attachment/file/1058153/Alerta_Sanitaria_Victoza_19022026.pdf - Source: COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), "Alerta sanitaria: falsificación y comercialización de Rybelsus (semaglutida) tabletas" (2026-04-13) https://www.gob.mx/cms/uploads/attachment/file/1070696/Alerta_Sanitaria_Rybelsus_13042026.pdf - Source: Cámara de Diputados, Sistema de Información Legislativa (dip. Ivonne Ortega Pacheco, MC), "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" (2026-07) http://sil.gobernacion.gob.mx/Archivos/Documentos/2026/07/asun_5112302_20260729_1784761524.pdf - Source: Verificado, "Qué son los péptidos que usan influencers y por qué las autoridades no los aprueban" (2026-04-01) https://verificado.com.mx/peptidos-influencers-autoridades-no-los-aprueban/ - Source: Su Médico, "Ozempic y los medicamentos revividos por jueces: protección de datos para semaglutida" (2026-07-31) https://www.sumedico.com/especialidades/otras-enfermedades/2026/7/31/ozempic-los-tres-medicamentos-revividos-por-jueces-53074.html - Source: COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), "Importación de consumo personal (trámites y permisos)" (2026-04-29) https://www.gob.mx/cofepris/acciones-y-programas/importacion-de-consumo-personal - Source: COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), "Permisos sanitarios: trámites (incluye permiso de publicidad COFEPRIS-02-001)" (2026-04-30) https://www.gob.mx/cofepris/acciones-y-programas/permiso-sanitario-tramites - Source: COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), "Plataforma de proveedores irregulares de medicamentos" (2026-09-25) https://www.gob.mx/cofepris/acciones-y-programas/plataforma-de-proveedores-irreulares-de-medicamentos?state=published - Source: COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), "COFEPRIS y ANVISA avanzan hacia el reconocimiento regulatorio mutuo" (2026-09-24) https://www.gob.mx/cofepris/articulos/cofepris-y-anvisa-avanzan-hacia-el-reconocimiento-regulatorio-mutuo-para-ampliar-el-acceso-a-medicamentos-en-mexico-y-brasil - Source: Novo Nordisk México, "Novo Nordisk anuncia el lanzamiento de semaglutida en México a partir de abril de 2025 (comunicado de prensa)" (2025-02-26) 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 - Source: COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), "Medicamentos biotecnológicos de referencia (versión 10)" (2024-05) https://www.gob.mx/cms/uploads/attachment/file/1030531/Listado_de_Medicamentos_Biotecnol_gicos_de_Referencia__versi_n_10__05-2024.pdf - Source: COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), "Alerta sanitaria: falsificación y comercialización irregular de Ozempic, Wegovy y Saxenda" (2025-06-17) https://www.gob.mx/cms/uploads/attachment/file/1002514/Alerta_Sanitaria_Ozempic_17062025.pdf - Source: COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), "Alerta sanitaria: falsificación de OZEMPiC (semaglutida) solución inyectable en pluma precargada" (2026-03-26) https://www.gob.mx/cms/uploads/attachment/file/1067535/Alerta_Sanitaria_OZEMPiC_26032026.pdf - Source: COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), "Alerta sanitaria: falsificación de OZEMPiC 0.25 mg-0.5 mg/dosis (semaglutida) en pluma precargada" (2026-05-25) https://www.gob.mx/cms/uploads/attachment/file/1080351/Alerta_Sanitaria_OZEMPiC_25052026.pdf - Source: Secretaría de Gobernación, Sistema de Información Legislativa, "SIL: contenido del asunto 'Que adiciona un artículo 215 Bis a la Ley General de Salud' (Gaceta Parlamentaria 22/07/2026)" (2026-07-22) http://sil.gobernacion.gob.mx/Librerias/pp_ContenidoAsuntos.php?SID=&Clave=5112302 ### New Zealand - Page: https://glp1base.com/countries/new-zealand - Regulator: Medsafe (New Zealand Medicines and Medical Devices Safety Authority, Ministry of Health) (https://www.medsafe.govt.nz/) - Last verified: 2026-09-29 Simple: In New Zealand, a government agency called Medsafe decides which medicines can be sold. Wegovy and Mounjaro are approved for weight loss, but the government does not pay for them, so patients pay the full price. Peptides sold online as 'research chemicals' are illegal to import or sell, and Medsafe says it seizes them. Expert: The Medicines Act 1981 requires ministerial consent, delegated to Medsafe, before a new medicine is sold, supplied or advertised (s 20). The Medicines Amendment Act 2025, in force from 19 November 2025, added consent by verification for a new medicine that already has full marketing authorisation from two or more recognised overseas regulators (s 22D); Medsafe published the guideline and application form for this route in June 2026. Exemptions allow an authorised prescriber to obtain an unapproved medicine for a known patient under their care (s 25, including direct importation or asking a pharmacy to compound it), and allow a pharmacist to compound a medicine to suit a particular person (s 26(4)); a prescription medicine may only be supplied on prescription (s 26(3)(b)). Personal importation of prescription medicines needs a reasonable excuse, meaning a letter or prescription from a New Zealand authorised prescriber, and is limited to three months' supply. Medsafe's classification database lists semaglutide, tirzepatide, liraglutide, dulaglutide, exenatide and a range of peptide classes as prescription medicines. Funding is decided separately by Pharmac. The October 2026 Pharmaceutical Schedule funds dulaglutide and liraglutide (Victoza) for type 2 diabetes under Special Authority. Wegovy for weight loss is on Pharmac's Options for Investment list and is unfunded, and Mounjaro has no weight-loss funding application; Pharmac does not control the private price. On enforcement, Medsafe's 21 May 2026 advisory says it is seizing unapproved peptides and SARMs and that 'for research purposes only' labels have no legal effect. - Source: Medsafe (New Zealand Medicines and Medical Devices Safety Authority), "Consumer advisory: Unapproved peptide products health warning" (2026-05-21) https://www.medsafe.govt.nz/safety/Alerts/Consumer-advisory-Unapproved-peptide-products-health-warning.asp - Source: New Zealand Parliamentary Counsel Office, "Medicines Act 1981 (version as at 10 July 2026)" (2026-07-10) https://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html - Source: Medsafe (New Zealand Medicines and Medical Devices Safety Authority), "Use of Unapproved Medicines and Use of approved Medicines for an unapproved purpose" (2025-12-12) https://www.medsafe.govt.nz/profs/RIss/unapp.asp - Source: Medsafe (New Zealand Medicines and Medical Devices Safety Authority), "Personal Importation of Medicines" (2021-11-12) https://www.medsafe.govt.nz/Consumers/MIET/ImportMedicines.asp - Source: Medsafe (New Zealand Medicines and Medical Devices Safety Authority), "Medicines Classification Database (Schedule 1, Medicines Regulations 1984)" (2026-09-25) https://www.medsafe.govt.nz/profs/class/classintro.asp - Source: Medsafe (New Zealand Medicines and Medical Devices Safety Authority), "Data sheets index (medicines with consent to be distributed in New Zealand)" (2026-09-29) https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm - Source: Medsafe (New Zealand Medicines and Medical Devices Safety Authority), "Product/Application Search (product and application records searched by ingredient on 29 September 2026)" (2026-07-07) https://www.medsafe.govt.nz/DbSearch/ - Source: Medsafe (New Zealand Medicines and Medical Devices Safety Authority), "Medicines Amendment Act 2025 (Prescriber Update, March 2026)" (2026-03) https://www.medsafe.govt.nz/profs/PUArticles/March2026/Medicines-Amendment-Act-2025.html - Source: Medsafe (New Zealand Medicines and Medical Devices Safety Authority), "What's New (29 June 2026: Verification Pathway for New Medicine Applications guideline and consent-by-verification application form)" (2026-08-24) https://www.medsafe.govt.nz/other/new.asp - Source: Pharmac (Pharmaceutical Management Agency), "Wegovy and Mounjaro for weight loss not funded" (2026-05-14) https://www.pharmac.govt.nz/news-and-resources/news/semaglutide-wegovy-ozempic - Source: Pharmac (Pharmaceutical Management Agency), "Record of the Obesity Treatments Advisory Group meeting, December 2025" (2025-12) https://www.pharmac.govt.nz/assets/2025-12-11-Obesity-Treatments-Advisory-Group-record.pdf - Source: Pharmac (Pharmaceutical Management Agency), "Pharmaceutical Schedule, October 2026 (Volume 33)" (2026-10) https://schedule.pharmac.govt.nz/2026/10/01/Schedule.pdf - Source: Medsafe (New Zealand Medicines and Medical Devices Safety Authority), "Guidelines on the Regulation of Therapeutic Products in New Zealand, Part 7: Advertising of therapeutic products" (2023-10) https://www.medsafe.govt.nz/regulatory/Guideline/GRTPNZ/Part7_Advertising_of_therapeutic_products.pdf - Source: Medsafe (New Zealand Medicines and Medical Devices Safety Authority), "Weight Management / Weight Loss Products" (2019-12-19) https://www.medsafe.govt.nz/regulatory/weight/weightloss.asp - Source: Advertising Standards Authority (New Zealand), "Therapeutic and Health Advertising resources" (2026) https://asa.co.nz/industry-guidance/therapeutic-and-health-advertising-resources/ - Source: Advertising Standards Authority (New Zealand), "Latest decisions, 20 August 2026 (complaint 26/128, Novo Nordisk, Wegovy billboard)" (2026-08-20) https://asa.co.nz/2026/08/20/latest-decisions-20-august-2026/ - Source: Bell Gully, "Reducing the prescription: updates on pharmacy regulation, medicines advertising and the proposed Medical Products Bill" (2025-10-24) https://www.bellgully.com/insights/reducing-the-prescription-updates-on-pharmacy-regulation-medicines-advertising-and-the-proposed-medical-products-bill/ - Source: Science Media Centre New Zealand, "Why does NZ allow weight-loss drug billboards? Expert reaction" (2026-08-07) https://www.sciencemediacentre.co.nz/2026/08/07/why-does-nz-allow-weight-loss-drug-billboards-expert-reaction/ - Source: Sport Integrity Commission (New Zealand), "Prohibited substances (WADA Prohibited List and 2026 changes)" (2026) https://sportintegrity.nz/integrity/anti-doping/substances/prohibited-substances ### United Arab Emirates - Page: https://glp1base.com/countries/united-arab-emirates - Regulator: Emirates Drug Establishment (EDE), the federal medicines regulator (https://www.ede.gov.ae/) - Last verified: 2026-09-29 Simple: In the UAE, a federal agency called the Emirates Drug Establishment (EDE) decides which medicines can be sold. Semaglutide (Wegovy, Ozempic), tirzepatide (Mounjaro) and the weight-loss pill Foundayo are on the market, and all need a prescription. Insurance often pays only for diabetes use, although Abu Dhabi covers Foundayo for eligible adults in its weight programme. Peptides sold online that the EDE has not approved are being cracked down on: in July 2026 the EDE took action against 71 sellers and promoters. Expert: Federal Decree-Law 38/2024 makes the Emirates Drug Establishment the federal regulator for medical products. The decree-law took effect on 2 January 2025, and the EDE took over 44 core services from the Ministry of Health and Prevention (MOHAP) with effect from 29 December 2025, including marketing authorisations, import and export permits and GMP certification, while MOHAP kept community and compounding pharmacies and five narcotics-control services (Kayrouz and Associates, March 2026). Under Article 5, no medical product may be imported, distributed, sold or used without EDE marketing approval, although products made in licensed compounding pharmacies are exempt; a foreign manufacturer must appoint a UAE licensed agent, and products need an EDE pricing certificate and advertising approval. Administrative fines on pharmaceutical establishments range from AED 1,000 to AED 1 million (Article 160). In February 2026 the EDE approved a mechanism requiring companies to appoint more than one importer for each medical product marketed in the UAE, to reduce single-distributor control. Recent approvals show the EDE moving quickly on obesity medicines: Foundayo (orforglipron) was announced on 3 April 2026, and oral Wegovy was approved on 1 June 2026, described as the second country in each case. On funding, prices are set through EDE pricing certificates. Press reports say insurers often cover Ozempic and Mounjaro for type 2 diabetes but rarely for weight management, and Abu Dhabi's Department of Health said in April 2026 that Foundayo will be covered for adults eligible for its Personalised Weight Management Programme. On personal importation, a July 2026 travel guide reports a limit of three months' supply, an original prescription (stated to need embassy attestation), original packaging, and prior MOHAP approval for psychotropic medicines; I could not confirm this on an official page. On enforcement, the EDE announced in July 2026 action against 71 sources marketing unapproved peptide products (14 registered facilities cited, 14 influencers referred to the National Media Office) and said it is inspecting compounding pharmacies; a Sharjah court fined defendants in July 2026 for selling Mounjaro without a licence. The EDE reported 2,030 inspection visits and 828 non-compliant advertisements in the first half of 2026 (WAM, 22 September 2026). - Source: Emirates Drug Establishment (EDE), "Legislations (Federal Decree-Law 38/2024 and other instruments)" (2026-09-29) https://www.ede.gov.ae/en/legislations - Source: Emirates Drug Establishment (EDE), "Federal Decree-Law No. (38) of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments (Arabic text)" (2024-10-01) https://www.ede.gov.ae/documents/d/ede/-38-2024-pdf - Source: Kayrouz and Associates, "Pharmaceutical licensing and drug registration in the UAE (Federal Decree-Law 38 of 2024)" (2026-03-18) https://www.kayrouzandassociates.com/insights/pharmaceutical-licensing-drug-registration-uae - Source: CMS, "CMS Expert Guide to advertising of medicines and medical devices: United Arab Emirates" (2024-05-08) https://cms.law/en/int/expert-guides/cms-expert-guide-to-advertising-of-medicines-and-medical-devices/united-arab-emirates - Source: Emirates Drug Establishment (EDE), "Emirates Drug Establishment approves oral Wegovy (semaglutide) for weight management and cardiovascular risk reduction" (2026-06-01) https://www.ede.gov.ae/en/w/emirates-drug-establishment-approves-oral-wegovy%C2%AE-semaglutide-for-weight-management-and-cardiovascular-risk-reduction - Source: Khaleej Times, "UAE authority approves new oral obesity treatment to be available from May" (2026-04-03) https://www.khaleejtimes.com/uae/new-oral-obesity-treatment-approval - Source: Department of Health Abu Dhabi, "Abu Dhabi Expands Access to Innovative Daily Oral Obesity Treatment, Enhancing Outcomes and Quality of Life" (2026-04-24) https://www.doh.gov.ae/en/news/ad-expands-access-to-innovative-daily-oral-obesity-treatment - Source: Khaleej Times, "UAE cracks down on illegal weight-loss products, targets 71 violators" (2026-07-25) https://www.khaleejtimes.com/uae/crack-down-illegal-weightloss-products-71-entities - Source: Gulf News, "UAE weight-loss drug crackdown: 71 sources, 14 influencers face action" (2026-07-25) https://gulfnews.com/uae/health/uae-weight-loss-drug-crackdown-71-sources-14-influencers-face-action-1.500619741 - Source: Emirates 24|7, "Abu Dhabi health authority launches online form for reporting side effects from peptide products" (2026-09-25) https://www.emirates247.com/uae/abu-dhabi-health-authority-launches-online-form-for-reporting-side-effects-from-peptide-products/6023 - Source: Khaleej Times, "UAE summer travel: What you can and cannot bring into Dubai" (2026-07-12) https://www.khaleejtimes.com/business/uae-summer-travel-what-you-can-and-cannot-bring-into-dubai - Source: Gulf News, "New UAE law: Advertiser permit now mandatory for influencers and creators for social media" (2026-02-01) https://gulfnews.com/uae/new-uae-law-advertiser-permit-now-mandatory-for-influencers-and-creators-for-social-media-1.500427938 - Source: Gulf News, "Dubai issues social media rules for doctors, health facilities and influencers; bans misleading claims" (2026-09-01) https://gulfnews.com/uae/health/dubai-issues-social-media-rules-for-doctors-health-facilities-and-influencers-bans-misleading-claims-1.500659503 - Source: The National, "UAE's drug monopoly rules bring promise of cheaper health care" (2026-02-26) https://www.thenationalnews.com/news/uae/2026/02/26/uaes-drug-monopoly-rules-bring-promise-of-cheaper-health-care/ - Source: Khaleej Times, "Are Ozempic, Mounjaro, other weight-loss drugs covered by insurance in the UAE?" (2026-02-27) https://www.khaleejtimes.com/lifestyle/health/uae-is-ozempic-mounjaro-wegovy-covered-by-insurance - Source: Gulf News, "Dh10,000 fine for selling Mounjaro injections without a licence in Sharjah" (2026-07-31) https://gulfnews.com/uae/crime/dh10000-fine-for-selling-mounjaro-injections-without-a-licence-in-sharjah-1.500626515 - Source: U.S. Anti-Doping Agency, "BPC-157: Experimental Peptide Creates Risk for Athletes (updated August 2026)" (2020-03-03) https://www.usada.org/spirit-of-sport/bpc-157-peptide-prohibited/ - Source: Emirates News Agency (WAM), "Emirates Drug Establishment boosts pharmaceutical readiness in H1 2026" (2026-09-22) https://wam.ae/article/17ft72p-emirates-drug-establishment-boosts-pharmaceutical ### United Kingdom - Page: https://glp1base.com/countries/united-kingdom - Regulator: Medicines and Healthcare products Regulatory Agency (MHRA) (https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency) - Last verified: 2026-09-29 Simple: In the UK, a regulator called the MHRA decides which medicines can be sold. Several GLP-1 drugs are approved, and you need a prescription for all of them. Weight-loss versions are also sold privately through online pharmacies. Medicines that are not approved, including retatrutide, cannot legally be sold, and the MHRA has raided sites making them. Many 'peptides' sold online count as medicines under UK law and would need a licence too. It is also illegal to advertise prescription-only medicines to the public. Expert: Medicines in the UK are authorised by the MHRA under the Human Medicines Regulations 2012 (HMR). A product needs a marketing authorisation before it can be sold or supplied (reg 46), and a substance is a medicinal product if it is presented as treating disease or is used to modify physiological function through a pharmacological, immunological or metabolic action. Licensed GLP-1 receptor agonists include semaglutide (Ozempic, Rybelsus, Wegovy, with an oral Wegovy approved on 11 June 2026 and a conditional MASH indication on 3 July 2026), tirzepatide (Mounjaro), liraglutide (Saxenda and generics authorised from 2024), dulaglutide, and orforglipron (Foundayo, authorised on 10 August 2026). All are prescription-only. There is no US-style compounding route for mass supply. Unlicensed 'specials' under HMR reg 167 may be supplied only in response to an unsolicited order from a prescriber for an individual patient's special clinical need that a licensed product cannot meet, and MHRA Guidance Note 14 says cost or convenience does not qualify; the manufacturer or importer must hold an MHRA specials licence. Separately, a pharmacy may prepare a medicine for an individual prescription under section 10 of the Medicines Act 1968 and HMR reg 4. The MHRA says GLP-1 products supplied as powder in vials for mixing are not authorised. Personal import: HMR reg 17(6) exempts an individual importing a medicinal product to administer to themselves or a member of their household from the manufacturer's licence requirement, but selling or supplying an unauthorised product remains an offence and the MHRA says sellers outside the UK that ship directly to UK consumers may fall outside its legal jurisdiction. Coverage and price: NICE recommends tirzepatide (TA1026, December 2024) with a phased NHS England roll-out, semaglutide (TA875, 2023) for up to two years within specialist weight management services, and liraglutide (TA664) in specialist tier 3 services; NHS reimbursement prices for Mounjaro were raised from September 2025. Neither oral Wegovy nor Foundayo was available on the NHS at approval. Enforcement: the MHRA Criminal Enforcement Unit dismantled an illicit production facility in Northampton in October 2025, raided two premises in Lincolnshire and Nottinghamshire in February 2026, and made two arrests in a raid near Northampton in May 2026 (about 12,000 doses of unlicensed weight-loss medicines recovered); the MHRA says the 2026 sites are believed to have been used to make retatrutide, tirzepatide and peptide products. The GPhC's April 2026 review of inspections and concerns found weight management medicines mentioned in one in twenty pharmacy inspection reports and 1,307 concerns received between January 2024 and December 2025. - Source: Medicines and Healthcare products Regulatory Agency (MHRA), "GLP-1 medicines for weight loss and diabetes: what you need to know" (2026-02-05) https://www.gov.uk/government/publications/glp-1-medicines-for-weight-loss-and-diabetes-what-you-need-to-know - Source: Medicines and Healthcare products Regulatory Agency (MHRA), "First GLP-1 tablet for weight loss approved in the UK" (2026-06-11) https://www.gov.uk/government/news/first-glp-1-tablet-for-weight-loss-approved-in-the-uk - Source: Medicines and Healthcare products Regulatory Agency (MHRA), "UK first in Europe to authorise orforglipron for weight management and type 2 diabetes" (2026-08-10) https://www.gov.uk/government/news/uk-first-in-europe-to-authorise-orforglipron-for-weight-management-and-type-2-diabetes - Source: Medicines and Healthcare products Regulatory Agency (MHRA), "Semaglutide (Wegovy) approved to treat form of liver disease" (2026-07-03) https://www.gov.uk/government/news/semaglutide-wegovy-approved-to-treat-form-of-liver-disease - Source: Medicines and Healthcare products Regulatory Agency (MHRA), "MHRA authorises diabetes drug Mounjaro (tirzepatide) for weight management and weight loss" (2023-11-08) https://www.gov.uk/government/news/mhra-authorises-diabetes-drug-mounjaro-tirzepatide-for-weight-management-and-weight-loss - Source: UK Government (legislation.gov.uk), "The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)" (2012) https://www.legislation.gov.uk/uksi/2012/1916/regulation/46 - Source: UK Government (legislation.gov.uk), "The Human Medicines Regulations 2012, regulation 17 (manufacture, assembly and import; personal import exemption)" (2012) https://www.legislation.gov.uk/uksi/2012/1916/regulation/17 - Source: UK Government (legislation.gov.uk), "The Human Medicines Regulations 2012, regulation 167 (supply of unlicensed 'specials')" (2012) https://www.legislation.gov.uk/uksi/2012/1916/regulation/167 - Source: UK Government (legislation.gov.uk), "The Human Medicines Regulations 2012, regulation 284 (prohibition of advertising prescription-only medicines to the public)" (2012) https://www.legislation.gov.uk/uksi/2012/1916/regulation/284 - Source: Medicines and Healthcare products Regulatory Agency (MHRA), "Supply unlicensed medicinal products (specials)" (2025-01-29) https://www.gov.uk/government/publications/supply-unlicensed-medicinal-products-specials - Source: Medicines and Healthcare products Regulatory Agency (MHRA), "The supply of unlicensed medicinal products ('specials'), MHRA Guidance Note 14" (2023-05) https://assets.publishing.service.gov.uk/media/645e19f5ad8a03000c38b3bc/The_supply_of_unlicensed_medicinal_products__special_GN14.pdf - Source: Medicines and Healthcare products Regulatory Agency (MHRA), "Borderline products: how to tell if your product is a medicine" (2026-07-02) https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine - Source: Medicines and Healthcare products Regulatory Agency (MHRA), "Import a human medicine" (2025-01-29) https://www.gov.uk/guidance/import-a-human-medicine - Source: Medicines and Healthcare products Regulatory Agency (MHRA), "Find product information about medicines (MHRA Products register)" (2026-09-25) https://www.gov.uk/guidance/find-product-information-about-medicines - Source: Medicines and Healthcare products Regulatory Agency (MHRA), "Blue Guide: advertising and promoting medicines" (2025-03-28) https://www.gov.uk/government/publications/blue-guide-advertising-and-promoting-medicines - Source: Medicines and Healthcare products Regulatory Agency (MHRA), "MHRA and partners unite to reaffirm prescription weight-loss medicine advertising rules" (2025-09-26) https://www.gov.uk/government/news/mhra-and-partners-unite-to-reaffirm-prescription-weight-loss-medicine-advertising-rules - Source: Medicines and Healthcare products Regulatory Agency (MHRA), "Advertising investigations: Medicinal treatment services for weight loss - August 2026" (2026-09-09) https://www.gov.uk/government/publications/advertising-investigations-august-2026/medicinal-treatment-services-for-weight-loss-august-2026 - Source: National Institute for Health and Care Excellence (NICE), "Tirzepatide for managing overweight and obesity (TA1026)" (2024-12-23) https://www.nice.org.uk/guidance/ta1026 - Source: National Institute for Health and Care Excellence (NICE), "Semaglutide for managing overweight and obesity (TA875)" (2023-03-08) https://www.nice.org.uk/guidance/ta875 - Source: National Institute for Health and Care Excellence (NICE), "Liraglutide for managing overweight and obesity (TA664)" (2020-12-09) https://www.nice.org.uk/guidance/ta664 - Source: NHS Business Services Authority (NHSBSA), "Mounjaro (tirzepatide) price increase: Drug Tariff redetermination" (2025-09) https://www.nhsbsa.nhs.uk/mounjaro-tirzepatide-price-increase-drug-tariff-redetermination - Source: General Pharmaceutical Council (GPhC), "Weight management medicines and services: a review of GPhC inspections and concerns" (2026-04) https://assets.pharmacyregulation.org/files/2026-04/Weight-management-medicines-and-services-a-review-of-GPhC-inspections-and-concerns-April-2026.pdf - Source: Advertising Standards Authority (ASA) / CAP, "Enforcement report: weight loss prescription-only medicines" (2026-04-02) https://www.asa.org.uk/resource/enforcement-report-weight-loss-prescription-only-medicines.html - Source: Advertising Standards Authority (ASA) / CAP, "Advertising guidance: Weight control - prescription-only medicines" (2026-05-29) https://www.asa.org.uk/advice-online/weight-control-prescription-only-medicines.html - Source: UK Anti-Doping (UKAD), "What's banned in sport - the Prohibited List" (2026) https://www.ukad.org.uk/athletes/whats-banned-sport-prohibited-list - Source: Medicines and Healthcare products Regulatory Agency (MHRA), "MHRA smashes major illicit weight loss medicine production facility in record seizure" (2025-10-24) https://www.gov.uk/government/news/mhra-smashes-majorillicitweight-loss-medicine-production-facility-in-record-seizure - Source: Medicines and Healthcare products Regulatory Agency (MHRA), "MHRA disrupts second manufacturing facility suspected to be involved in the manufacture of illegal weight loss medicines" (2026-02-25) 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 - Source: Medicines and Healthcare products Regulatory Agency (MHRA), "Two arrested during the MHRA's largest ever seizure of unlicensed weight loss medicines" (2026-05-29) https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines - Source: Medicines and Healthcare products Regulatory Agency (MHRA), "No summer shortcut for safe weight loss" (2026-07-24) https://www.gov.uk/government/news/no-summer-shortcut-for-safe-weight-loss - Source: Medicines and Healthcare products Regulatory Agency (MHRA), "Warning on promoting newly licensed prescription-only medicines and unlicensed medicines for weight management" (2026-06-18) https://www.gov.uk/government/news/warning-on-promoting-newly-licensed-prescription-only-medicines-and-unlicensed-medicines-for-weight-management - Source: UK Government (legislation.gov.uk), "The Human Medicines Regulations 2012, regulation 279 (advertising of products without a marketing authorisation)" (2012) https://www.legislation.gov.uk/uksi/2012/1916/regulation/279 - Source: UK Government (legislation.gov.uk), "The Human Medicines Regulations 2012, regulation 4 (pharmacy exemption under section 10 of the Medicines Act 1968)" (2012) https://www.legislation.gov.uk/uksi/2012/1916/regulation/4 - Source: Medicines and Healthcare products Regulatory Agency (MHRA), "GLP-1 receptor agonists and dual GLP-1/GIP receptor agonists: strengthened warnings on acute pancreatitis, including necrotising and fatal cases" (2026-01-29) https://www.gov.uk/drug-safety-update/glp-1-receptor-agonists-and-dual-glp-1-slash-gip-receptor-agonists-strengthened-warnings-on-acute-pancreatitis-including-necrotising-and-fatal-cases - Source: Medicines and Healthcare products Regulatory Agency (MHRA), "Semaglutide (Wegovy, Ozempic and Rybelsus): risk of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)" (2026-02-05) https://www.gov.uk/drug-safety-update/semaglutide-wegovy-ozempic-and-rybelsus-risk-of-non-arteritic-anterior-ischemic-optic-neuropathy-naion - Source: Medicines and Healthcare products Regulatory Agency (MHRA), "Fake Mounjaro (tirzepatide) KwikPen 15mg pre-filled pens" (2026-02-24) https://www.gov.uk/government/news/fake-mounjaro-tirzepatide-kwikpen-15mg-pre-filled-pens ### United States - Page: https://glp1base.com/countries/united-states - Regulator: U.S. Food and Drug Administration (FDA) (https://www.fda.gov) - Last verified: 2026-09-29 Simple: In the US, the FDA decides which medicines can be sold. Semaglutide, tirzepatide, liraglutide and the new tablet orforglipron are approved for specific uses. Pharmacies can only make custom copies in narrow cases, and FDA has ended the shortage rules that used to allow copies of semaglutide and tirzepatide. Most trending peptides, like BPC-157, are not approved for anything. Bringing in unapproved drugs is usually illegal, and FDA has sent many warning letters about misleading ads and sellers. Expert: Approval. Drugs need FDA approval before marketing (NDA under FD&C Act 505; biologics under a BLA). The approved incretin and related products in this atlas are semaglutide (Ozempic, Rybelsus, Wegovy injection and tablet), tirzepatide (Mounjaro, Zepbound), liraglutide (Victoza, Saxenda and several ANDA generics), dulaglutide (Trulicity), orforglipron (Foundayo, approved 1 April 2026 for obesity), exenatide (brands discontinued; generic marketed) and pramlintide (Symlin, being discontinued). CagriSema (cagrilintide plus semaglutide) has an NDA under review; retatrutide and the other pipeline agents are unapproved. Compounding. Section 503A covers state-licensed pharmacies and physicians compounding for an identified patient; section 503B covers registered outsourcing facilities (CGMP, adverse-event reporting, office-stock allowed). 503A may use bulk drug substances only if they meet a USP/NF monograph, are components of an FDA-approved drug, or appear on the 503A bulks list; 503B may use them only if on the 503B clinical-need list or if the drug is on FDA's shortage list. Both bar routine compounding of drugs that are essentially copies of commercially available products (FDA treats a product with the same active ingredient in the same, similar or easily substitutable strength by the same route as essentially a copy, and says semaglutide plus vitamin B12 may count as one). FDA declared the tirzepatide shortage resolved on 19 December 2024 and the semaglutide shortage resolved on 21 February 2025; enforcement discretion ended in 2025 after courts denied injunctions. On 1 May 2026 FDA proposed not to include semaglutide, tirzepatide or liraglutide on the 503B bulks list (comment period extended to 30 July 2026); that proposal is not final. Liraglutide presentations are still on FDA's shortage list, and biologics such as dulaglutide cannot be compounded at all. FDA says retatrutide and cagrilintide cannot be compounded and has said it knows of no lawful basis for semaglutide salt forms. Personal importation. FDA says it is illegal in most circumstances to import drugs for personal use; case-by-case discretion is narrow (serious condition, no domestic alternative, three-month supply, written personal-use affirmation). FDA also runs a green-list import alert (66-80) for GLP-1 active ingredients of concern. Coverage and pricing. CMS runs a temporary Medicare GLP-1 Bridge demonstration from 1 July 2026 to 31 December 2027, outside the normal Part D benefit and payment flow, with a $50 copay for eligible people using Foundayo, Wegovy or the Zepbound KwikPen. The federal TrumpRx.gov site lists reduced cash prices for several GLP-1 brands. Recent enforcement. FDA sent 30 warning letters to telehealth firms on 3 March 2026 over sameness and sourcing claims for compounded GLP-1s (thousands of advertising letters since September 2025), and CDER issued warning letters in 2026 to online sellers of unapproved retatrutide, semaglutide and peptides with 'research use only' labels. US customs seized about 5,000 shipments of mis-declared peptides in Cincinnati between December 2025 and March 2026. - Source: U.S. Food and Drug Administration, "FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss" (2026-09-01) https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss - Source: U.S. Food and Drug Administration, "FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize" (2026-04-01) https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize - Source: Federal Register (FDA), "List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B (proposal not to include semaglutide, tirzepatide, liraglutide)" (2026-05-01) 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 - Source: Federal Register (FDA), "List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B; Extension of Comment Period" (2026-06-26) https://www.federalregister.gov/documents/2026/06/26/2026-12937/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal - Source: U.S. Food and Drug Administration, "Bulk Drug Substances Used in Compounding" (2026-03-26) https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding - Source: U.S. Food and Drug Administration, "Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act" (2026-05-14) https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act - Source: U.S. Food and Drug Administration, "Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (Categories 1, 2 and 3)" (2026-05-14) https://www.fda.gov/media/94155/download?attachment - Source: U.S. Food and Drug Administration, "Bulk Drug Substances Nominated for Use in Compounding Under Section 503B (Categories 1, 2 and 3)" (2025-03-21) https://www.fda.gov/media/94164/download?attachment - Source: U.S. Food and Drug Administration, "Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 and withdrawn nominations)" (2026-04-22) https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks - Source: U.S. Food and Drug Administration, "July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee" (2026-08-06) https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026 - Source: McDermott Will & Schulte, "Bulk list bound? PCAC backs majority of peptides in two-day public meeting" (2026-07-27) https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/ - Source: Mintz, "FDA's Advisory Committee Votes on Peptides: What It Does and Does Not Mean" (2026-07-29) https://www.mintz.com/insights-center/viewpoints/2146/2026-07-29-fdas-advisory-committee-votes-peptides-what-it-does-and - Source: U.S. Food and Drug Administration, "Compounding and the FDA: Questions and Answers" (2025-09-16) https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers - Source: U.S. Food and Drug Administration, "Personal Importation" (2025-08-18) https://www.fda.gov/industry/import-basics/personal-importation - Source: U.S. Customs and Border Protection, "Cincinnati CBP foils scheme to smuggle over 5,000 unapproved peptides into the U.S." (2026-03-31) https://www.cbp.gov/newsroom/local-media-release/cincinnati-cbp-foils-scheme-smuggle-over-5000-unapproved-peptides-us - Source: U.S. Food and Drug Administration, "FDA warning letter 721806 to an online seller of retatrutide, tirzepatide and bacteriostatic water labelled 'research use only'" (2026-03-31) https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gram-peptides-721806-03312026 - Source: U.S. Food and Drug Administration, "FDA warning letter 735127 to an online seller of retatrutide, semaglutide, SS-31, PT-141 and tesamorelin labelled 'research use only'" (2026-08-24) https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026 - Source: U.S. Food and Drug Administration, "FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s" (2026-03-03) https://www.fda.gov/news-events/press-announcements/fda-warns-30-telehealth-companies-against-illegal-marketing-compounded-glp-1s - Source: U.S. Food and Drug Administration, "FDA to Telehealth Companies: What to Know When Promoting Compounded Drugs" (2026-06-15) https://www.fda.gov/drugs/human-drug-compounding/fda-telehealth-companies-what-know-when-promoting-compounded-drugs - Source: U.S. Food and Drug Administration, "FDA Launches Crackdown on Deceptive Drug Advertising" (2025-09-09) https://www.fda.gov/news-events/press-announcements/fda-launches-crackdown-deceptive-drug-advertising - Source: Legal Information Institute, Cornell Law School (Code of Federal Regulations), "21 CFR 202.1 Prescription-drug advertisements" (2026) https://www.law.cornell.edu/cfr/text/21/202.1 - Source: FDA Law Blog (Hyman, Phelps & McNamara), "Coming soon: proposed rule to remove 'adequate provision' and ban DTC TV ads" (2026-07-07) https://www.thefdalawblog.com/2026/07/coming-soon-proposed-rule-to-remove-adequate-provision-and-ban-dtc-tv-ads/ - Source: Federal Trade Commission, "Health Products Compliance Guidance" (2022-12) https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance - Source: Centers for Medicare & Medicaid Services, "Medicare GLP-1 Bridge" (2026-07-13) https://www.cms.gov/medicare/coverage/prescription-drug-coverage/medicare-glp-1-bridge - Source: Medicare.gov (CMS), "Medicare GLP-1 Bridge: who is eligible and which drugs are covered" (2026) https://www.medicare.gov/glp1bridge - Source: The White House, "Fact Sheet: President Donald J. Trump Launches TrumpRx.gov to Bring Lower Drug Prices to American Patients" (2026-02-05) https://www.whitehouse.gov/fact-sheets/2026/02/fact-sheet-president-donald-j-trump-launches-trumprx-gov-to-bring-lower-drug-prices-to-american-patients/ - Source: TrumpRx.gov (U.S. federal government), "TrumpRx.gov home page (price cards observed 2026-09-29)" (2026-09-29) https://trumprx.gov/ - Source: U.S. Anti-Doping Agency, "BPC-157: What Athletes Should Know About the Prohibited Experimental Peptide" (2026-08-10) https://www.usada.org/spirit-of-sport/education/bpc-157/