Peptide Legal Status Tracker
Every FDA, advisory committee and enforcement change in 2026, per peptide, with the source for each entry. Latest entry: 29 Sep 2026.
Not legal advice
Showing 42 of 42 peptides
| Peptide | FDA status | PCAC, Jul 2026 | Latest logged event |
|---|---|---|---|
| Tirzepatide | FDA approved (Mounjaro, Zepbound) | Not reviewed | |
| Retatrutide | Investigational · phase 3 | Not reviewed | |
| Semaglutide | FDA approved (Ozempic, Wegovy, Rybelsus) | Not reviewed | |
| BPC-157 | PCAC voted 8–6 for 503A (Jul 2026) | 8–6 for | |
| GHK-Cu | Injectable off Category 2 (Apr 2026) | Not reviewed | |
| Oxytocin | FDA approved (prescription only) | Not reviewed | No event loggedchecked |
| Sermorelin | Compounded by prescription | Not reviewed | No event loggedchecked |
| Tesamorelin | FDA approved (Egrifta) | Not reviewed | |
| Enclomiphene | Not FDA approved · compounded | Not reviewed | No event loggedchecked |
| HGH | FDA approved (prescription only) | Not reviewed | No event loggedchecked |
| hCG | FDA approved (prescription only) | Not reviewed | No event loggedchecked |
| PT-141 | FDA approved for HSDD (Vyleesi) | Not reviewed | |
| MOTS-c | PCAC voted 7–5 for 503A (Jul 2026) | 7–5 for | |
| CJC-1295 | Not FDA approved · research chemical | Not reviewed | No event loggedchecked |
| KLOW | Not FDA approved · unstudied blend | Not reviewed | No event loggedchecked |
| GLOW | Not FDA approved · unstudied blend | Not reviewed | No event loggedchecked |
| Melanotan II | Off FDA Category 2 (Apr 2026) | Not reviewed | |
| TB-500 | PCAC voted 8–6 for 503A (Jul 2026) | 8–6 for | |
| CJC-1295 + Ipamorelin | Not FDA approved · research blend | Not reviewed | No event loggedchecked |
| Ipamorelin | Not FDA approved · research chemical | Not reviewed | |
| Cagrilintide | Investigational (CagriSema component) | Not reviewed | |
| Wolverine | Not FDA approved · unstudied blend | Not reviewed | No event loggedchecked |
| 5-Amino-1MQ | Not FDA approved · research chemical | Not reviewed | No event loggedchecked |
| SLU-PP-332 | Not FDA approved · research chemical | Not reviewed | No event loggedchecked |
| Orforglipron | FDA approved (Foundayo, Apr 2026) | Not reviewed | |
| IGF-1 LR3 | Not FDA approved · research chemical | Not reviewed | No event loggedchecked |
| Selank | Not FDA approved · research chemical | Not reviewed | No event loggedchecked |
| Kisspeptin-10 | Not FDA approved · research chemical | Not reviewed | No event loggedchecked |
| SS-31 | FDA accelerated approval for Barth syndrome (Sep 2025) | Not reviewed | |
| AOD-9604 | Not FDA approved · research chemical | Not reviewed | No event loggedchecked |
| Thymosin Alpha-1 | Not FDA approved · approved abroad | Not reviewed | No event loggedchecked |
| DSIP | PCAC did not recommend (Jul 2026) | Not recommended | |
| KPV | PCAC voted 8–6 for 503A (Jul 2026) | 8–6 for | |
| Dihexa | Off FDA Category 2 (Apr 2026) | Not reviewed | |
| Epitalon | PCAC voted 7–5 for 503A (Jul 2026) | 7–5 for | |
| VIP | Not FDA approved · compounded or research | Not reviewed | No event loggedchecked |
| Survodutide | Investigational · phase 3 | Not reviewed | |
| CagriSema | Investigational · filed with FDA | Not reviewed | No event loggedchecked |
| Mazdutide | Investigational in the US (approved in China) | Not reviewed | |
| ARA-290 | Not FDA approved · research chemical | Not reviewed | No event loggedchecked |
| LL-37 | Off FDA Category 2 (Apr 2026) | Not reviewed | |
| Semax | PCAC voted 8–5 for 503A (Jul 2026) | 8–5 for |
What a PCAC vote means
The committee only advises. A peptide becomes legal to compound under 503A after the FDA adds it to the bulk substances list through rulemaking. None of the July 2026 votes has been finalized yet.
Not legal adviceStatus reflects public FDA and WADA records on the date shown. Rules differ by country and state.
Sources
- 1Retatrutide phase 3 TRIUMPH-1 results publishedNEJM (PubMed 42814954) · 2026pubmed.ncbi.nlm.nih.govAccessed 2 Oct 2026
- 2FDA warning letters to five research-peptide sellersFDA warning letter (NuScience Peptides; 1 of 5) · 2026fda.govAccessed 2 Oct 2026
- 3Eli Lilly sues six retatrutide sellersEli Lilly (press release) · 2026investor.lilly.comAccessed 2 Oct 2026
- 4Health Canada wins a permanent injunction against an injectable-peptide sellerHealth Canada · 2026canada.ca
- 5Advisory committee backs 6 of 7 peptides for the 503A listNCPA · 2026ncpa.org
- 6Australia's TGA makes unapproved peptides a compliance priority (infringement notices, seizures, civil or criminal penalties)TGA · 2026tga.gov.auAccessed 2 Oct 2026
- 7FDA proposes excluding semaglutide, tirzepatide and liraglutide from the 503B bulks listFDA · 2026fda.govAccessed 2 Oct 2026
- 8FDA gives notice that 12 peptides will be removed from Category 2 (nominations withdrawn)FDA · 2026fda.govAccessed 2 Oct 2026
- 9Orforglipron approved as FoundayoFDA · 2026fda.govAccessed 2 Oct 2026
- 10Seven FDA warning letters to online sellers of GLP-1 productsFDA warning letter (Gram Peptides; 1 of 7) · 2026fda.govAccessed 2 Oct 2026
- 11HHS signals about 14 Category 2 peptides may move toward Category 1PBS NewsHour · 2026pbs.org
- 12United States: Approved by FDA: oxytocin injection NDAs/ANDAs (Pitocin, Par; generics from Fresenius Kabi, Hikma, Sagent) for initiation or improvement of uterine contractions in obstetric use (label quote).U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026
- 13United States: The only Drugs@FDA record for sermorelin is Geref (EMD Serono), with marketing status Discontinued; no currently marketed FDA-approved sermorelin product was found on 2 Oct 2026.U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026
- 14United States: No FDA-approved product found: Drugs@FDA (openFDA) search for active ingredient "enclomiphene" returned no matches on 2 Oct 2026.U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026
- 15US compounding: Enclomiphene citrate is listed in FDA's 503A category 1 (bulk drug substances under evaluation).U.S. Food and Drug Administration · 2026fda.govAccessed 2 Oct 2026
- 16United States: Approved by FDA as multiple somatropin (recombinant human growth hormone) products, e.g. Genotropin (Pfizer, 1995), Humatrope (Lilly, 1986) and Norditropin (Novo Nordisk), for growth failure and adult growth hormone deficiency (label quotes).U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026
- 17NOVAREL ® (chorionic gonadotropin) for injection, for intramuscular use Initial U.S. Approval: 1974FDA label, DailyMed · current labeldailymed.nlm.nih.govAccessed 2 Oct 2026
- 18United States: No FDA-approved product found: Drugs@FDA (openFDA) search for active ingredient "cjc-1295" returned no matches on 2 Oct 2026.U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026
- 19United States: Not an approved product anywhere; see components (GHK-Cu, BPC-157, TB-500, KPV). Drugs@FDA (openFDA) search for the component GHK-Cu returned no matches on 2 Oct 2026.U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026
- 20United States: Not an approved product anywhere; see components (BPC-157, TB-500). Drugs@FDA (openFDA) search for the component BPC-157 returned no matches on 2 Oct 2026.U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026
- 21United States: No FDA-approved product found: Drugs@FDA (openFDA) search for active ingredient "5-amino-1MQ" returned no matches on 2 Oct 2026.U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026
- 22United States: No FDA-approved product found: Drugs@FDA (openFDA) search for active ingredient "SLU-PP-332" returned no matches on 2 Oct 2026.U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026
- 23United States: No FDA-approved product found: Drugs@FDA (openFDA) search for active ingredient "IGF-1 LR3" returned no matches on 2 Oct 2026.U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026
- 24United States: No FDA-approved product found: Drugs@FDA (openFDA) search for active ingredient "selank" returned no matches on 2 Oct 2026.U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026
- 25United States: No FDA-approved product found: Drugs@FDA (openFDA) search for active ingredient "Kisspeptin-10" returned no matches on 2 Oct 2026.U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026
- 26United States: No FDA-approved product found: Drugs@FDA (openFDA) search for active ingredient "aod-9604" returned no matches on 2 Oct 2026.U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026
- 27United States: No FDA-approved product found: Drugs@FDA (openFDA) search for active ingredient "Thymosin Alpha-1" returned no matches on 2 Oct 2026.U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026
- 28United States: No FDA-approved product found: Drugs@FDA (openFDA) search for active ingredient "VIP" returned no matches on 2 Oct 2026.U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026
- 29United States: No FDA-approved product found: Drugs@FDA (openFDA) search for active ingredient "cagrisema" returned no matches on 2 Oct 2026.U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026
- 30United States: No FDA-approved product found: Drugs@FDA (openFDA) search for active ingredient "ARA-290" returned no matches on 2 Oct 2026.U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026
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