PepsPeptide regulatory tracker
Where each peptide stands with U.S. regulators and anti-doping rules: FDA approval, FDA's compounding lists for pharmacies (503A), and the 2026 World Anti-Doping Agency (WADA) Prohibited List. Checked October 8, 2026.
35 of 113 profiles are in an FDA-approved medicine and 5 were approved but are now discontinued. 26 are named on the WADA list and 44 more are likely covered by one of its class rules. 16 research peptides, plus injectable GHK-Cu, left FDA's category 2 safety-risk list in April 2026 when their nominations were withdrawn; that did not make them approved or allowed for compounding.
How to read the columns
- FDA approval: whether any FDA-approved medicine contains the compound (Drugs@FDA). Approval covers a specific product and use, not research vials sold online.
- 503A category: FDA's interim lists of bulk substances nominated for use by compounding pharmacies. Category 1 can be used while FDA reviews it; category 2 raised significant safety risks; category 3 lacked enough support. "—" means not on these lists, which generally means pharmacies may not compound it.
- WADA 2026: "Named" means listed by name; "Class rule" means not named but likely covered by a class, often S0 (substances with no government approval for human use). Athletes should check with their anti-doping organization.
| Compound | FDA approval | 503A category | WADA 2026 | FDA actions |
|---|---|---|---|---|
| 5-Amino-1MQ | No | — | Class rule S0 | 1 |
| Abaloparatide | Approved | — | — | |
| Adipotide | No | — | Class rule S0 | |
| Afamelanotide | Approved | — | — | |
| AHK-Cu | No | — | Class rule S0 | |
| AOD-9604 | No | — (was Cat. 2) | Named S2.2.3 | 1 |
| ARA-290 | No | Cat. 3 | Class rule S2.1.5 | |
| Argireline | No | — | — | |
| B7-33 | No | — | Class rule S0 | |
| Bivalirudin | Approved | — | — | |
| BPC-157 | No | — (was Cat. 2) | Named S0 | 3 |
| Bremelanotide | Approved | — | — | 2 |
| Cagrilintide | No | — | Class rule S0 | 3 |
| Calcitonin salmon | Approved | — | — | |
| Cerebrolysin | No | — | — | 2 |
| CJC-1295 | No | — (was Cat. 2) | Named S2.2.4 | 1 |
| Cortistatin | No | — | Class rule S0 | |
| Cosyntropin | Approved | — | Named S2.2.2 | |
| Degarelix | Approved | — | — | |
| Desmopressin | Approved | — | Named S5 | |
| Dihexa | No | — (was Cat. 2) | Class rule S0 | |
| DSIP | No | — (was Cat. 2) | Class rule S0 | 2 |
| Dulaglutide | Approved | — | — | |
| Efpeglenatide | No | — | Class rule S0 | |
| Elamipretide | Approved | — | — | 2 |
| Enfuvirtide | Discontinued | — | — | |
| Enlicitide | Approved | — | — | |
| Epitalon | No | — (was Cat. 2) | Class rule S0 | 3 |
| Exenatide | Approved | — | — | |
| Follistatin 344 | No | — | Named S4.3 | 1 |
| FOXO4-DRI | No | — | Class rule S0 | |
| GHK | No | — | Class rule S0 | |
| GHK-Cu | No | Cat. 1 | Class rule S0 | 1 |
| Ghrelin | No | — | Named S2.2.4 | |
| GHRP-2 | No | Cat. 3 | Named S2.2.4 | 1 |
| GHRP-6 | No | Cat. 3 | Named S2.2.4 | 1 |
| Glucagon | Approved | — | — | |
| Glutathione | No | Cat. 1 | — | 1 |
| Gonadorelin | Discontinued | — | Named S2.2.1 | |
| HCG | Approved | — | Named S2.2.1 | 1 |
| Hexarelin | No | — | Named S2.2.4 | |
| HGH Fragment 176-191 | No | — | Named S2.2.3 | |
| Human insulin | Approved | — | Named S4.4.2 | |
| Humanin | No | — | Class rule S0 | |
| IGF-1 DES | No | — | Class rule S2.3 | |
| IGF-1 LR3 | No | — | Class rule S2.3 | 1 |
| Ipamorelin | No | — (was Cat. 2) | Named S2.2.4 | 3 |
| Kisspeptin-10 | No | Cat. 2 | Named S2.2.1 | |
| Kisspeptin-54 | No | — | Named S2.2.1 | |
| KPV | No | — (was Cat. 2) | Class rule S0 | 1 |
| L-Carnosine | No | Cat. 3 | — | |
| Lanreotide | Approved | — | — | |
| Larazotide | No | — | Class rule S0 | |
| Leuprolide | Approved | — | Named S2.2.1 | |
| Linaclotide | Approved | — | — | |
| Liraglutide | Approved | — | — | 1 |
| Lixisenatide | Approved | — | — | |
| LL-37 | No | — (was Cat. 2) | Class rule S0 | 2 |
| Matrixyl | No | — | — | |
| Mazdutide | No | — | — | 3 |
| Melanotan II | No | — (was Cat. 2) | Class rule S0 | 1 |
| MGF | No | Cat. 3 | Named S2.3 | |
| MK-677 | No | Cat. 2 | Named S2.2.4 | 3 |
| Modified GRF 1-29 | No | — | Class rule S2.2.4 | |
| MOTS-c | No | — (was Cat. 2) | Named S4.4.1 | 1 |
| N-Acetyl Selank | No | — | Class rule S0 | |
| NA-Semax Amidate | No | — | Class rule S0 | |
| NAD+ | No | Cat. 1 | — | 1 |
| Nesfatin-1 | No | — | Class rule S0 | |
| Neuropeptide Y | No | — | Class rule S0 | |
| Nisotirostide | No | — | Class rule S0 | |
| Octreotide | Approved | — | — | |
| Orexin-A | No | — | Class rule S0 | |
| Oxytocin | Approved | — | — | |
| P21 | No | — | Class rule S0 | |
| PACAP-38 | No | — | Class rule S0 | |
| Pasireotide | Approved | — | — | |
| PE-22-28 | No | — | Class rule S0 | |
| PEG-MGF | No | — (was Cat. 2) | Class rule S2.3 | 1 |
| Pemvidutide | No | — | Class rule S0 | |
| Peptide bioregulators (Khavinson peptides) | No | — | Class rule S0 | |
| Peptide YY | No | — | Class rule S0 | |
| Pinealon | No | — | Class rule S0 | |
| Plecanatide | Approved | — | — | |
| PNC-27 | No | — | Class rule S0 | |
| Pramlintide | Discontinued | — | — | |
| PTD-DBM | No | — | Class rule S0 | |
| Retatrutide | No | — | Class rule S0 | 3 |
| Selank | No | — (was Cat. 2) | — | 2 |
| Semaglutide | Approved | — | — | 3 |
| Semax | No | — (was Cat. 2) | — | 3 |
| Sermorelin | Discontinued | — | Named S2.2.4 | 1 |
| Setmelanotide | Approved | — | — | |
| SLU-PP-332 | No | — | Class rule S0 | |
| SNAP-8 | No | — | — | |
| Survodutide | No | — | Class rule S0 | 3 |
| TB-500 | No | — (was Cat. 2) | Named S2.3 | 2 |
| Teduglutide | Approved | — | — | |
| Teriparatide | Approved | — | — | |
| Terlipressin | Approved | — | Class rule S5 | |
| Tesamorelin | Approved | — | Named S2.2.4 | 3 |
| Thymalin | No | — | — | |
| Thymopentin | No | — | — | |
| Thymosin alpha-1 | No | — (was Cat. 2) | — | 1 |
| Thymosin beta-4 | No | — | Named S2.3 | 2 |
| Thymulin | No | Cat. 3 | Class rule S0 | |
| Tirzepatide | Approved | — | — | 3 |
| TRH (thyrotropin-releasing hormone) | Discontinued | — | — | |
| Triptorelin | Approved | — | Named S2.2.1 | |
| Vasopressin | Approved | — | Class rule S5 | |
| VIP | No | Cat. 1 | — | |
| Vosoritide | Approved | — | — | |
| Ziconotide | Approved | — | — |
Recent FDA actions
- 2026-10-01 · Cagrilintide: FDA states that cagrilintide cannot be used in compounding under federal law and is not a component of any FDA-approved drug (page updated October 1, 2026). source
- 2026-08-24 · Bremelanotide: FDA warning letter to a "research peptide" seller (Peptide Partners) naming "PT-141" (bremelanotide), SS-31 and tesamorelin as unapproved new drugs despite research-use-only labeling. source
- 2026-08-24 · Bremelanotide: FDA warning letter to a "research peptide" seller (NuScience Peptides) naming "PT-141 Peptide (Bremelanotide)" among other peptides as unapproved new drugs. source
- 2026-08-24 · Elamipretide: FDA warning letter to a "research peptide" seller (Peak Performance Peptides) naming "SS-31" (elamipretide), "PT-141", tesamorelin and GLP-1 products as unapproved new drugs. source
- 2026-08-24 · Elamipretide: FDA warning letter to a "research peptide" seller (Royal Peptides) naming "SS-31 (Elamipretide)", tesamorelin, PT-141 and GLP-1 products as unapproved new drugs. source
- 2026-07 · BPC-157: FDA presented BPC-157 (free base and acetate) to its Pharmacy Compounding Advisory Committee (July 23, 2026) for possible addition to the 503A bulks list; FDA's briefing document proposed NOT adding it. The committee's vote is advisory; no final FDA decision found. source
- 2026-07 · DSIP: FDA presented emideltide (DSIP) to its Pharmacy Compounding Advisory Committee (July 24, 2026) for possible addition to the 503A bulks list; FDA's briefing document proposed NOT adding it. The committee's vote is advisory; no final FDA decision found. source
- 2026-07 · Epitalon: FDA presented epitalon (free base and acetate) to its Pharmacy Compounding Advisory Committee (July 24, 2026) for possible addition to the 503A bulks list; FDA's briefing document proposed NOT adding it. The committee's vote is advisory; no final FDA decision found. source
- 2026-07 · KPV: FDA presented KPV (free base and acetate) to its Pharmacy Compounding Advisory Committee (July 23, 2026) for possible addition to the 503A bulks list; FDA's briefing document proposed NOT adding it. The committee's vote is advisory; no final FDA decision found. source
- 2026-07 · MOTS-c: FDA presented MOTS-c (free base and acetate) to its Pharmacy Compounding Advisory Committee (July 23, 2026) for possible addition to the 503A bulks list; FDA's briefing document proposed NOT adding it. The committee's vote is advisory; no final FDA decision found. source
- 2026-07 · Semax: FDA presented semax (free base and acetate) to its Pharmacy Compounding Advisory Committee (July 24, 2026) for possible addition to the 503A bulks list; FDA's briefing document proposed NOT adding it. The committee's vote is advisory; no final FDA decision found. source
- 2026-07 · TB-500: FDA presented TB-500 (free base and acetate) to its Pharmacy Compounding Advisory Committee (July 23, 2026) for possible addition to the 503A bulks list; FDA's briefing document proposed NOT adding it. The committee's vote is advisory; no final FDA decision found. source
- 2026-04-30 · Liraglutide: FDA proposed excluding liraglutide (with semaglutide and tirzepatide) from the 503B bulks list, finding no clinical need for outsourcing facilities to compound it from bulk. source
- 2026-03-31 · Cagrilintide: FDA warning letter to a "research peptide" seller (Prime Sciences) naming cagrilintide, mazdutide and GLP-1 products as unapproved new drugs. source
- 2026-02-06 · Semaglutide: FDA statement announcing intent to restrict GLP-1 APIs used in mass-marketed non-approved compounded drugs and to act on misleading marketing. source
- 2026-01-20 · 5-Amino-1MQ: FDA warning letter to an outsourcing facility (GenoGenix) naming 5-Amino-1MQ (5-amino-1-methylquinolinium iodide) as a bulk substance not eligible for 503B compounding. source
- 2025-12-12 · MK-677: FDA warning letter (SARMS America) citing MK-677 sold as an unapproved new drug. source
- 2025-12-12 · MK-677: FDA warning letter (Monster King / GE Labs): ibutamoren is excluded from the dietary supplement definition. source
- 2025-09-23 · MK-677: FDA health-fraud notice: lab testing found undeclared ibutamoren in a children's "growth" supplement (Agebox iKids). source
- 2025-09-09 · Retatrutide: FDA warning letter (GLP-1 Solution) stating compounded retatrutide does not qualify for 503A exemptions: no USP/NF monograph, not a component of an approved drug, not on the 503A bulks list. source
- 2024-12-10 · Cagrilintide: FDA warning letter to a "research peptide" seller (Xcel Research) naming cagrilintide, "CagriLean" (cagrilintide plus semaglutide), retatrutide and others as unapproved new drugs despite research-use-only labeling. source
- 2023-06-12 · BPC-157: FDA warning letter (Warrior Labz) citing BPC-157 and TB-500 injectable and nasal products sold online as unapproved new drugs. source
- 2021-11-10 · Cerebrolysin: FDA warning letter to a clinic-based compounder (Guyer Institute) stating Cerebrolysin had not been nominated for the 503A bulks list and could not be used under the 503A exemptions. source
- 2020-07-13 · HCG: FDA consumer warning that over-the-counter HCG weight-loss products are illegal and unproven; HCG is approved only as a prescription drug for other uses. source
- 2020-04-01 · AOD-9604: FDA warning letter to a compounding pharmacy (Tailor Made Compounding) listing AOD 9604 among bulk substances that are not eligible for 503A compounding exemptions. source
Sources
- FDA 503A bulk drug substance categories (updated 2026-05-14)
- FDA: bulk substances that may present significant safety risks (updated 2026-04-22)
- WADA 2026 Prohibited List (PDF)
- WADA 2026 Monitoring Program (PDF)
- FDA Pharmacy Compounding Advisory Committee, July 23–24, 2026
- Drugs@FDA · Approval data cross-checked via openFDA drugsfda endpoint (data updated 2026-10-07).
Compiled with AI assistance from the official documents above and checked against openFDA. Not legal or medical advice; rules change, so confirm with the source before relying on a status.