Regulator: U.S. Food and Drug Administration (FDA)
GLP-1 drugs and peptides in United States
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.
Last verified 2026-09-29 · how we verify
Official regulator siteGLP-1 medicines
Approved GLP-1 medicines: semaglutide (Ozempic and Rybelsus/Ozempic tablets for type 2 diabetes; Wegovy for weight management, cardiovascular risk reduction and MASH, as injection and, since 22 December 2025, tablet); tirzepatide (Mounjaro for type 2 diabetes; Zepbound for weight management and obstructive sleep apnea); liraglutide (Victoza, Saxenda and generics; Saxenda to be discontinued in January 2027); dulaglutide (Trulicity); exenatide (generic only); and orforglipron (Foundayo, obesity, approved 1 April 2026). Compounded copies: the shortage that allowed them ended (tirzepatide December 2024, semaglutide February 2025). FDA reports 990 adverse event reports for compounded semaglutide and more than 730 for compounded tirzepatide as of 31 May 2026, and warns of dosing errors, salt forms and fraudulent labels. 503A pharmacies may still compound for an individual patient only where a prescriber documents a clinically significant difference from the approved product; FDA has said it does not intend to act if four or fewer prescriptions of an essentially-copy product are filled in a calendar month. Coverage: the Medicare GLP-1 Bridge (1 July 2026 to 31 December 2027, $50 copay, no Part D deductible, no low-income subsidy) covers Foundayo, Wegovy and the Zepbound KwikPen for people who meet BMI and condition criteria and get prior authorization. Price context: TrumpRx.gov, launched 5 February 2026 as a federal price directory for manufacturer direct-to-consumer offers, showed on 29 September 2026 monthly prices of $149 for the Wegovy tablet, $199 for Wegovy and Ozempic pens and $299 for Zepbound against listed prices of about $1,028 to $1,349. Pipeline: CagriSema is under FDA review (decision expected in 2026 per Novo Nordisk); retatrutide, survodutide, eloralintide, maridebart cafraglutide and mazdutide are investigational, and FDA treats sales of retatrutide as illegal. FDA says it has warned companies selling semaglutide, tirzepatide, retatrutide, survodutide or mazdutide falsely labelled 'for research purposes' or 'not for human consumption'.
Peptides
No peptide in the trending group is FDA-approved. Approved peptide medicines that share names with 'research' products are narrow: tesamorelin (Egrifta, HIV lipodystrophy), bremelanotide (Vyleesi, premenopausal HSDD), setmelanotide (Imcivree, rare genetic and hypothalamic obesity) and elamipretide (Forzinity, Barth syndrome). Compounding: a 503A pharmacy may use a bulk peptide only if it has a USP/NF monograph, is a component of an approved drug, or is on the 503A bulks list. FDA's interim policy sorts nominated substances into Category 1 (under evaluation; FDA does not intend to act if conditions are met), Category 2 (significant safety risk) and Category 3 (insufficient support). As of the 14 May 2026 list, NAD and GHK-Cu (except injectable routes) are in Category 1; kisspeptin-10 is in 503A Category 2; ipamorelin acetate is in 503B Category 2. FDA's Category 2 page (updated 22 April 2026) shows that the nominations for BPC-157, TB-500, MOTS-c, KPV, Semax, Selank, Epitalon, DSIP (emideltide), LL-37, CJC-1295, AOD-9604, Melanotan II and other peptides were withdrawn, which removed them from Category 2 but did not authorise compounding. Sermorelin acetate is a component of a previously approved drug (Geref, discontinued), so 503A pharmacies may use it as a bulk substance if the other 503A conditions are met. Advisory process: the Pharmacy Compounding Advisory Committee met on 23 and 24 July 2026 on BPC-157 (ulcerative colitis), KPV, TB-500, MOTS-c, DSIP, Semax and Epitalon. A law-firm report says it voted in favour of recommending all but DSIP (for example BPC-157, KPV and TB-500 8 to 6, Semax 8 to 5, MOTS-c 7 to 5, Epitalon 7 to 4; DSIP 6 to 7). The votes are non-binding; adding a substance to the 503A list requires FDA acceptance and notice-and-comment rulemaking, and nothing has changed legally. FDA says it will consult the committee again before the end of February 2027 on GHK-Cu, and a law-firm report adds dihexa, LL-37, PEG-MGF and Melanotan II. Retatrutide and cagrilintide cannot be compounded under federal law. Sale and 'research use only': FDA treats products sold with 'research use only' or 'not for human consumption' labels as unapproved new drugs when the website or other context shows intended human use, and it treats bacteriostatic water sold alongside as evidence of injectable use (warning letters of 31 March and 24 August 2026). Introducing an unapproved new drug into interstate commerce violates FD&C Act sections 301(d) and 505(a). Import: personal importation of unapproved drugs is generally illegal, and US Customs and Border Protection seized about 5,000 mis-declared shipments of peptides including MOTS-c, Semax and cagrilintide in Cincinnati between December 2025 and 25 March 2026. Sport: the US Anti-Doping Agency states BPC-157 is prohibited under WADA category S0 (non-approved substances) and that a therapeutic use exemption is unlikely; athletes should check every substance on the current WADA list or Global DRO. Evidence: most human evidence for the trending peptides is limited, and FDA describes little or no human safety data for several of them.
Advertising rules
Prescription drug ads (brand-name products) must be truthful and not misleading and must present fair balance of risks and benefits under FD&C Act section 502(n) and 21 CFR 202.1, including a 'major statement' of risks and, for broadcast, a brief summary or 'adequate provision' to reach the full label. The FDA Office of Prescription Drug Promotion reviews promotion. On 9 September 2025 FDA and HHS announced thousands of letters to drug makers, about 100 cease-and-desist letters and plans for rulemaking to close the 'adequate provision' pathway; a proposed rule titled 'Transparency in Direct-to-Consumer Advertising' is listed with a December 2026 target date and would, according to legal commentary citing the Unified Agenda, make TV ads much harder. It is a plan, not a rule. For compounded drugs FDA warns telehealth firms against claiming a compounded drug is 'generic', the same as or equivalent to an approved drug, FDA-approved or evaluated, clinically proven to match the approved drug, made by an 'FDA-approved' pharmacy, or branded so it looks as if the telehealth firm is the compounder (30 warning letters on 3 March 2026; guidance page updated 15 June 2026). Selling or promoting unapproved drugs, including products labelled 'research use only', is treated as marketing an unapproved new drug. The Federal Trade Commission separately requires competent and reliable scientific evidence for health and weight-loss claims in non-prescription advertising and in general marketing.
Every molecule in United States
| Molecule | Status | What it means | Verified |
|---|---|---|---|
| Amycretin | Not approved | No FDA approval or filing; Novo Nordisk now calls it zenagamtide and has started Phase 3 trialsDetails →source | 2026-09-29 |
| AOD-9604 | Not approved | No FDA approval; FDA lists AOD-9604 among withdrawn nominations after noting possible serious adverse eventsDetails →source | 2026-09-29 |
| BPC-157 | 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 bindingDetails →source | 2026-09-29 |
| Bremelanotide (PT-141) | Approved, restricted | FDA-approved as Vyleesi (2019) only for low sexual desire in premenopausal women with a specific diagnosisDetails →source | 2026-09-29 |
| Cagrilintide (and CagriSema) | Under review | Not approved alone; Novo Nordisk's CagriSema (cagrilintide plus semaglutide) is under FDA review for obesity, and cagrilintide cannot be compoundedDetails →source | 2026-09-29 |
| CJC-1295 | Not approved | No FDA approval; FDA lists CJC-1295 among withdrawn nominations and cites serious adverse events, so it is not on the 503A listDetails →source | 2026-09-29 |
| DSIP (delta sleep-inducing peptide) | Not approved | No FDA approval; advisers reviewed emideltide (DSIP) in July 2026 and, per a law-firm report, did not recommend itDetails →source | 2026-09-29 |
| Dulaglutide | Approved | FDA-approved as Trulicity for type 2 diabetes since 2014; as a biologic it cannot be compoundedDetails →source | 2026-09-29 |
| Ecnoglutide | Not approved | Not approved in the US; only early-stage US studies of an oral form have been registeredDetails →source | 2026-09-29 |
| Elamipretide (SS-31) | Approved, restricted | FDA-approved under accelerated approval on 19 September 2025 as Forzinity for Barth syndrome onlyDetails →source | 2026-09-29 |
| Eloralintide | Not approved | Investigational; Eli Lilly is running Phase 3 obesity trials and nothing is approved or filedDetails →source | 2026-09-29 |
| Epitalon | Not approved | No FDA approval; an advisory panel voted in July 2026 to recommend considering it, but the vote is not bindingDetails →source | 2026-09-29 |
| Exenatide | Generics available | Byetta and Bydureon BCISE are listed as discontinued; an FDA-approved generic exenatide (Amneal) is on the marketDetails →source | 2026-09-29 |
| GHK-Cu (copper peptide) | Compounding restricted | Not approved as a drug; FDA treats non-injectable GHK-Cu as under evaluation (Category 1) but the injectable route is not coveredDetails →source | 2026-09-29 |
| Ipamorelin | Not approved | No FDA approval; FDA keeps ipamorelin in Category 2 for 503B outsourcing facilities because of immunogenicity and safety concernsDetails →source | 2026-09-29 |
| Kisspeptin | Not approved | No FDA approval; kisspeptin-10 is in FDA's 503A Category 2 because of immunogenicity and missing safety dataDetails →source | 2026-09-29 |
| KPV | 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)Details →source | 2026-09-29 |
| Liraglutide | Generics available | Brand Victoza and Saxenda plus several FDA-approved generics; liraglutide is still on FDA's shortage list and Saxenda is being discontinuedDetails →source | 2026-09-29 |
| LL-37 | 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 2027Details →source | 2026-09-29 |
| Maridebart cafraglutide (MariTide) | Not approved | Investigational; Amgen is running Phase 3 trials (MARITIME programme) and no FDA approval or filing has been reportedDetails →source | 2026-09-29 |
| Mazdutide | Not approved | Not approved by FDA; Eli Lilly has run US Phase 2 studies of the medicine (LY3305677) but no application has been reportedDetails →source | 2026-09-29 |
| Melanotan II | 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 2027Details →source | 2026-09-29 |
| MOTS-c | Not approved | No FDA approval; FDA found no human exposure data, and a July 2026 advisory vote to consider it is non-bindingDetails →source | 2026-09-29 |
| NAD+ | 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 policyDetails →source | 2026-09-29 |
| Orforglipron | Approved | FDA-approved on 1 April 2026 as Foundayo, a tablet for obesity, or overweight with a weight-related conditionDetails →source | 2026-09-29 |
| Pramlintide | Approved, restricted | Approved as Symlin in 2005 for mealtime insulin users with diabetes, but the maker has notified FDA it is discontinuing the productDetails →source | 2026-09-29 |
| Retatrutide | Prohibited | Not approved; FDA says retatrutide cannot be compounded and has warned sellers, so lawful access is limited to trials and expanded accessDetails →source | 2026-09-29 |
| Selank | Not approved | No FDA approval; FDA lists Selank among withdrawn nominations and it was not on the July 2026 advisory agendaDetails →source | 2026-09-29 |
| Semaglutide | Approved | FDA-approved as Ozempic, Rybelsus and Wegovy; compounded copies lost their shortage cover in 2025 and 503B is proposing a formal exclusionDetails →source | 2026-09-29 |
| Semax | Not approved | No FDA approval; an advisory panel voted in July 2026 to recommend considering it for the 503A list, but FDA has not actedDetails →source | 2026-09-29 |
| Sermorelin | Compounding restricted | Previously FDA-approved as Geref (now discontinued, not for safety reasons); sermorelin acetate can be compounded only under 503A/503B conditionsDetails →source | 2026-09-29 |
| Setmelanotide | Approved, restricted | FDA-approved as Imcivree (2020) for specific rare genetic or hypothalamic forms of obesity, not for general obesityDetails →source | 2026-09-29 |
| Survodutide | Not approved | Investigational; Boehringer Ingelheim has US Phase 3 trials running and no FDA approval existsDetails →source | 2026-09-29 |
| TB-500 (thymosin beta-4 fragment) | 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-bindingDetails →source | 2026-09-29 |
| Tesamorelin | Approved, restricted | FDA-approved since 2010 as Egrifta only for extra belly fat in adults with HIV and lipodystrophy; not for weight lossDetails →source | 2026-09-29 |
| Tirzepatide | Approved | FDA-approved as Mounjaro (type 2 diabetes) and Zepbound (weight management, sleep apnea); shortage over since December 2024Details →source | 2026-09-29 |
For experts
The regulatory detail
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.
Official sources we monitor
- Federal Register API: FDA documents on compounding · JSON API
- Federal Register API: FDA documents mentioning peptides · JSON API
- openFDA Drugs@FDA API (approvals, labels, marketing status) · JSON API
- openFDA Drug Shortages API · JSON API
- openFDA Drug Labeling API · JSON API
- FDA Drug Shortages database · HTML
- FDA Warning Letters (searchable table) · HTML
- FDA Warning Letters export · XLSX
- FDA Press Releases RSS · RSS
- FDA Health Fraud RSS · RSS
- FDA Drugs RSS · RSS
- FDA MedWatch safety alerts RSS · RSS
- FDA Drug Alerts and Statements (includes the GLP-1 concerns page) · HTML
- FDA 503A categories list (Category 1, 2, 3) · PDF
- FDA Category 2 safety risks and withdrawn nominations · HTML
- FDA 503B bulk drug substances list · HTML
- FDA Pharmacy Compounding Advisory Committee · HTML
- CMS Medicare GLP-1 Bridge · HTML
- ClinicalTrials.gov API v2 (trial status for pipeline drugs) · JSON API
- SEC EDGAR submissions: Eli Lilly · JSON API
- SEC EDGAR submissions: Novo Nordisk · JSON API
Recent changes in United States
2026-08-28
FDA approves Mounjaro to lower cardiovascular risk in adults with type 2 diabetes
Eli Lilly announced on 28 August 2026 that the FDA approved Mounjaro to lower the risk of major cardiovascular events in adults with type 2 diabetes at high risk. The approval was based on SURPASS-CVOT, which compared tirzepatide with dulaglutide and showed non-inferiority.
2026-08-27
Fifth Circuit upholds the FDA's tirzepatide shortage decision
On 27 August 2026 the US Court of Appeals for the Fifth Circuit affirmed the lower court's ruling in Outsourcing Facilities Association v. FDA (No. 25-10600). It held that the FDA's decision to remove tirzepatide from its shortage list did not violate the Administrative Procedure Act, either for lack of notice-and-comment rulemaking or as arbitrary and capricious. The opinion is not designated for publication.
2026-08-24
FDA sends more warning letters to online peptide sellers
The FDA issued further warning letters to online peptide sellers dated 24 August 2026. One letter said 'research use only' and 'not for human consumption' labels did not change that website evidence showed the products were intended to be drugs for human use. These are the FDA's stated positions, not court findings.
2026-08-12
Lilly files six lawsuits over unapproved retatrutide products
On 12 August 2026 Eli Lilly said it had filed six new lawsuits against US entities including compounding pharmacies, medical spas and online sellers over products marketed as retatrutide, which is not approved anywhere. Lilly said it had reported more than 14,000 websites, advertisements, social media posts and product listings and referred more than 200 parties to authorities. The allegations are Lilly's and had not been decided by a court at the time of the announcement.
2026-07-30
Owner of Paradigm Peptides sentenced to 70 months in prison
On 30 July 2026 the US Attorney's Office for the Northern District of Indiana announced that the owner of Paradigm Peptides had been sentenced to 70 months in prison and his sister to 16 months, after each pleaded guilty to introducing unapproved new drugs into interstate commerce with intent to defraud and mislead. The office said the business sold peptides and other drugs for human consumption without FDA approval; the owner also pleaded guilty to illegally importing merchandise.
2026-07-23
FDA advisory committee votes on seven peptides for the 503A compounding list, against FDA staff advice
At a two-day Pharmacy Compounding Advisory Committee meeting on 23 and 24 July 2026, the panel voted to recommend BPC-157, KPV and TB-500 (each 8-6), MOTS-c, epitalon and semax for the 503A bulks list, but not emideltide (DSIP), according to a law-firm summary. It reports that FDA scientists recommended against inclusion in each case. The votes are advice only: adding a peptide requires FDA notice-and-comment rulemaking, and the votes do not make any of these peptides an approved medicine.
2026-07-21
Novo Nordisk sues Eli Lilly over GLP-1 advertising
On 21 July 2026 Novo Nordisk filed a lawsuit against Eli Lilly in federal court in New Jersey, according to CNBC. Novo alleges false advertising and unfair competition, including under the Lanham Act, in Lilly's advertising for its obesity and diabetes medicines such as Zepbound. Lilly said it stands firmly behind its advertising. These are allegations that no court had ruled on at the time of the report.
2026-07-01
Medicare GLP-1 Bridge set to start, with a $50 co-pay for eligible weight-management prescriptions
CMS's Medicare GLP-1 Bridge, a short-term demonstration, was set to give eligible Part D beneficiaries access to certain GLP-1 drugs for weight management at a $50 co-pay from 1 July 2026, outside the normal Part D benefit. CMS lists Wegovy (injection and tablets), Foundayo and Zepbound (KwikPen) as eligible. In April 2026 CMS extended the Bridge to run through 31 December 2027.
2026-04-30
FDA proposes to bar bulk compounding of semaglutide, tirzepatide and liraglutide by outsourcing facilities
On 30 April 2026 the FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, saying it found no clinical need for outsourcing facilities to compound them from bulk substances. The FDA invited comments until 29 June 2026 and said it would consider them before making a final determination.
2026-04-21
CMS delays the Medicare part of the BALANCE model and extends the GLP-1 Bridge through 2027
On 21 April 2026 CMS announced it would not implement the BALANCE model in Medicare Part D in 2027 and would instead extend the temporary Medicare GLP-1 Bridge to the end of 2027. The Medicaid part of BALANCE, which state Medicaid programmes can join, continues.
Sources (64)
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- 02FDA clarifies policies for compounders as national GLP-1 supply begins to stabilizeU.S. Food and Drug Administration · 2026-04-01 · accessed 2026-09-29
- 03List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B (proposal not to include semaglutide, tirzepatide, liraglutide)Federal Register (FDA) · 2026-05-01 · accessed 2026-09-29
- 04List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B; Extension of Comment PeriodFederal Register (FDA) · 2026-06-26 · accessed 2026-09-29
- 05Bulk Drug Substances Used in CompoundingU.S. Food and Drug Administration · 2026-03-26 · accessed 2026-09-29
- 06Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C ActU.S. Food and Drug Administration · 2026-05-14 · accessed 2026-09-29
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- 15Cincinnati CBP foils scheme to smuggle over 5,000 unapproved peptides into the U.S.U.S. Customs and Border Protection · 2026-03-31 · accessed 2026-09-29
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