Peptide regulatory tracker
Where each compound stands with the FDA, compounding rules and anti-doping lists, with dated changes and sources. Updated monthly.
This page summarises public regulatory actions for reference. It is not legal advice, and statuses can change between updates. Check the primary source before relying on any entry.
Recent changes
| Date | Change |
|---|---|
| July 23–24, 2026 | FDA's Pharmacy Compounding Advisory Committee voted to recommend adding BPC-157, KPV and TB-500 (each 8–6, one abstention), MOTS-c (7–5, two abstentions), epitalon and semax to the 503A bulk drug substances list. It did not support emideltide (DSIP). FDA's own reviewers had recommended against the additions. The votes are advisory; any change must come through FDA notice-and-comment rulemaking. |
| July 23, 2026 | Eli Lilly reported positive TRIUMPH phase 3 results for retatrutide and said it plans to submit a Biologics License Application in the first quarter of 2027. Retatrutide remains investigational. |
| September 19, 2025 | FDA granted accelerated approval to elamipretide (SS-31) as Forzinity, the first treatment for Barth syndrome, for patients weighing at least 30 kg. |
Status by compound
| Compound | US status | WADA |
|---|---|---|
| 5-Amino-1MQ | Not an FDA-approved drug | Check current list |
| Abaloparatide | FDA-approved (Tymlos) | Check current list |
| Afamelanotide | FDA-approved (Scenesse, 2019) | Check current list |
| AOD-9604 | Not FDA-approved for any use | Check current list |
| ARA-290 (cibinetide) | Not FDA-approved for any use | Check current list |
| Argireline (acetyl hexapeptide-8) | Cosmetic ingredient; not a drug | Check current list |
| BPC-157 | Not FDA-approved; PCAC recommended 503A listing (July 2026), FDA action pending | Prohibited (S0) |
| Cagrilintide | Investigational | Check current list |
| Calcitonin (salmon) | FDA-approved (Miacalcin) | Check current list |
| Cerebrolysin | Not FDA-approved; approved in some other countries | Check current list |
| CJC-1295 | Not FDA-approved for any use | Prohibited (S2) |
| Dihexa | Not FDA-approved for any use | Check current list |
| DSIP | Not FDA-approved; PCAC did not support 503A listing (July 2026) | Check current list |
| Epitalon | Not FDA-approved; PCAC recommended 503A listing (July 2026), FDA action pending | Check current list |
| Exenatide | FDA-approved (Byetta, Bydureon) | Check current list |
| Follistatin-344 | Not FDA-approved for any use | Prohibited (S4) |
| FOXO4-DRI | Not FDA-approved for any use | Check current list |
| GHK-Cu | Not FDA-approved for any use | Check current list |
| GHRP-2 | Not FDA-approved for any use | Prohibited (S2) |
| GHRP-6 | Not FDA-approved for any use | Prohibited (S2) |
| Glutathione | Not an FDA-approved drug | Check current list |
| Gonadorelin | Previously FDA-approved (Factrel); not marketed in the US | Prohibited in males (S2) |
| Hexarelin | Not FDA-approved for any use | Prohibited (S2) |
| Humanin | Not FDA-approved for any use | Check current list |
| IGF-1 LR3 | Not FDA-approved for any use | Prohibited (S2) |
| Ipamorelin | Not FDA-approved for any use | Prohibited (S2) |
| Kisspeptin-10 | Not FDA-approved for any use | Check current list |
| KPV | Not FDA-approved; PCAC recommended 503A listing (July 2026), FDA action pending | Check current list |
| Larazotide | Not FDA-approved for any use | Check current list |
| Liraglutide | FDA-approved (Victoza, Saxenda) | Check current list |
| LL-37 | Not FDA-approved for any use | Check current list |
| Matrixyl (palmitoyl pentapeptide-4) | Cosmetic ingredient; not a drug | Check current list |
| Mazdutide | Investigational; not approved in the US | Check current list |
| Melanotan II | Not FDA-approved for any use | Check current list |
| MK-677 (ibutamoren) | Not FDA-approved | Prohibited (S2) |
| MOTS-c | Not FDA-approved; PCAC recommended 503A listing (July 2026), FDA action pending | Check current list |
| NAD+ | Not an FDA-approved drug | Check current list |
| Noopept | Not FDA-approved | Check current list |
| Oxytocin | FDA-approved (Pitocin) | Check current list |
| PEG-MGF | Not FDA-approved for any use | Prohibited (S2) |
| Pinealon | Not FDA-approved for any use | Check current list |
| Pramlintide | FDA-approved (Symlin) | Check current list |
| PT-141 (bremelanotide) | FDA-approved as bremelanotide (Vyleesi, 2019) | Check current list |
| Retatrutide | Investigational; BLA submission planned for Q1 2027 | Check current list |
| Selank | Not FDA-approved for any use | Check current list |
| Semaglutide | FDA-approved (Ozempic, Wegovy, Rybelsus) | Check current list |
| Semax | Not FDA-approved; PCAC recommended 503A listing (July 2026), FDA action pending | Check current list |
| Sermorelin | Previously FDA-approved (Geref); discontinued in the US | Prohibited (S2) |
| Setmelanotide | FDA-approved (Imcivree, 2020) | Check current list |
| Snap-8 | Not FDA-approved for any use | Check current list |
| SS-31 (elamipretide) | FDA accelerated approval as elamipretide (Forzinity, Sept 2025) | Check current list |
| Survodutide | Investigational; not approved in the US | Check current list |
| TB-500 | Not FDA-approved; PCAC recommended 503A listing (July 2026), FDA action pending | Prohibited (S2) |
| Teriparatide | FDA-approved (Forteo) | Check current list |
| Tesamorelin | FDA-approved (Egrifta) | Prohibited (S2) |
| Thymalin | Not FDA-approved for any use | Check current list |
| Thymosin α1 | Not FDA-approved; approved in several other countries (Zadaxin) | Check current list |
| Thymosin β4 | Not FDA-approved for any use | Prohibited (S2) |
| Tirzepatide | FDA-approved (Mounjaro, Zepbound) | Check current list |
| Triptorelin | FDA-approved (Trelstar and others) | Prohibited in males (S2) |
| VIP (vasoactive intestinal peptide) | Not FDA-approved for any use | Check current list |
What the terms mean
503A bulks list. The list of bulk drug substances that state-licensed pharmacies may use to compound for individual prescriptions under Section 503A of the Food, Drug, and Cosmetic Act when no applicable USP monograph or approved-drug component exists. An advisory committee vote is a recommendation; FDA decides.
PCAC. The Pharmacy Compounding Advisory Committee, which advises FDA on which substances belong on the compounding lists.
WADA S0 and S2. Sections of the World Anti-Doping Agency Prohibited List. S0 covers non-approved substances; S2 covers peptide hormones, growth factors and related substances. Both are prohibited at all times, in and out of competition.
Sources
- U.S. Food and Drug Administration. FDA grants accelerated approval to first treatment for Barth syndrome. September 19, 2025.
- Hyman, Phelps & McNamara, FDA Law Blog. PCAC approves four bulk drug substances for the 503A list. July 2026.
- Mintz. FDA's advisory committee votes on peptides: what it does and doesn't do. July 29, 2026.
- Healio. FDA committee recommends looser restrictions for several peptides. July 24, 2026.
- HCPLive. Retatrutide meets phase 3 weight-loss endpoints in 2 obesity trials. July 23, 2026.
- World Anti-Doping Agency. The Prohibited List.
Cite this page
PeptideWiki. (2026). Peptide regulatory tracker. Retrieved from https://peptidewiki.net/regulatory/