FDA Status of Common Research Peptides: A Reference Table

Research-use-only context. This article summarizes published third-party scientific literature and laboratory practice. It is not medical advice, not a therapeutic or performance claim, and not a usage guide. US Prime Peptides products are supplied strictly for in vitro laboratory research and are not for human or veterinary use.

Buyers ask whether a given compound "has FDA approval" about almost every item in a research catalog, and the answer is usually "no, and the question needs reframing." This reference lists the US status of more than 40 compounds carried by US Prime Peptides, names the approved product where one exists, flags investigational and withdrawn cases, and explains why a research vial differs from an approved product even when the molecule is the same.

How to read the status column

Every entry falls into one of five states. Approved means the FDA has approved a specific finished product under a New Drug Application or Biologics License Application, and we name it. Investigational means registered trials or FDA review with no approved product. Formerly approved means an application once existed and the product was discontinued. Veterinary means approval exists only under an animal-drug application. Not an approved drug means no US application has been approved, which covers most of the catalog.

Approval attaches to a product, not to a molecule. When the table says LY3298176 is approved as Mounjaro, it means Eli Lilly's finished product under its label. A lyophilized research vial of LY3298176 is documented by a certificate of analysis, carries no label for human use, and is not Mounjaro. That is why "approved" should never be a bare adjective for a research compound; say "approved by the FDA as X" and name the product, or say "not an approved drug." See 503A, 503B and research use only for the categories most often confused with approval.

The reference table

Status is as of October 2026, checked against Drugs@FDA, FDA labels, FDA's compounding and advisory-committee materials, the Federal Register, FDA's animal-drug database and ClinicalTrials.gov. Recheck the AM833, LY3437943 and compounding-list rows before relying on them.

Approved products: the eight molecules with a name attached

Eight molecules in the catalog exist as approved US products: LY3298176 (Mounjaro, Zepbound), NN9535 (Ozempic, Rybelsus, Wegovy), TH9507 (Egrifta and successors), bremelanotide (Vyleesi), afamelanotide (Scenesse), oxytocin (Pitocin and generics), elamipretide (Forzinity) and, in veterinary form only, gonadorelin (Factrel, Cystorelin, Fertagyl). The newest is Forzinity, approved by the FDA on September 19, 2025 under accelerated approval.

Each approval covers a sponsor's finished product. Research-grade material under the same name shares a sequence and, if the certificate is sound, a mass spectrum, but no formulation, device, label or application; FDA's 2024 to 2026 warning letters make the same point, as discussed in are research peptides legal in the United States.

Investigational, withdrawn and veterinary cases

LY3437943 and AM833 are the two investigational molecules. LY3437943 is in Phase 3 trials sponsored by Eli Lilly with no application on file that we could find. AM833 reached the FDA in December 2025 as half of CagriSema, Novo Nordisk's fixed combination with NN9535, and was under review as this was written; any approval would cover that combination product only.

Sermorelin is the clearest "formerly approved" case. EMD Serono's Geref (NDA 020443) was discontinued by the sponsor in 2008; a March 2013 Federal Register notice records FDA's determination that the withdrawal was not for safety or effectiveness reasons. No generic has produced a marketed product. Gonadorelin is the veterinary case: the human diagnostic Factrel is discontinued, while the cattle products Factrel, Cystorelin and Fertagyl remain approved by FDA's Center for Veterinary Medicine.

Compounding lists are not approvals

Many rows mention FDA's 503A and 503B bulk-substance lists. Under FDA's interim policy, Category 1 substances may be used by compounders while evaluation continues, Category 2 means the agency identified significant safety risks, and Category 3 means the nomination lacked enough information. In September 2023 FDA placed a group of peptides in Category 2; in April 2026 it removed a dozen; and on July 23 and 24, 2026 its Pharmacy Compounding Advisory Committee reviewed seven (BPC-157, KPV, TB-500, MOTS-c, emideltide, Semax and Epitalon). Trade press reported narrow advisory votes in favor of six, over FDA reviewers' objections, with no final rule as of writing.

None of this changes a row's status column. A substance on the 503A bulks list may be compounded by a licensed pharmacy for an identified individual; it is still not an approved drug, and FDA's compounding page states that compounded drugs are not approved. For a research buyer the lists matter chiefly as the best public summary of what FDA knows about each compound's human exposure data, which for most of the table is "none." For the certificate that documents a research lot, see how to read a peptide certificate of analysis.

Frequently Asked Questions

Which peptides are approved by the FDA?

Among compounds commonly sold for research: LY3298176 (Mounjaro, Zepbound), NN9535 (Ozempic, Rybelsus, Wegovy), TH9507 (Egrifta), bremelanotide (Vyleesi), afamelanotide (Scenesse), oxytocin (Pitocin) and elamipretide (Forzinity, 2025). Gonadorelin is approved only as a veterinary drug. Everything else in a typical catalog is not an approved drug.

Is BPC-157 approved by the FDA?

No. BPC-157 is not an approved drug in the US or anywhere else. FDA placed it in Category 2 of its 503A compounding list in September 2023, removed it in April 2026, and an advisory committee reviewed it on July 23, 2026; those steps concern pharmacy compounding, not drug approval.

Is a research peptide the same as the approved drug with the same name?

No. Approval attaches to a sponsor's finished product with its formulation, device and label. A research vial is lyophilized peptide documented by a certificate of analysis and supplied for in vitro work; it is not the approved product even when the sequence is identical.

What does "investigational" mean on the table?

It means the compound is in registered clinical trials or under FDA review but no product has been approved. LY3437943 (Phase 3) and AM833 (submitted within CagriSema in December 2025) are the two investigational compounds as of October 2026.

Citations

1. US FDA. Drugs@FDA: NDA 215866, Mounjaro (LY3298176), Eli Lilly and Co., approved May 13, 2022. accessdata.fda.gov
2. US FDA. Zepbound (LY3298176) prescribing information, NDA 217806, 2023. accessdata.fda.gov
3. US FDA. Ozempic (NN9535) prescribing information, NDA 209637, 2017. accessdata.fda.gov
4. US FDA. Wegovy (NN9535) prescribing information, NDA 215256, 2021. accessdata.fda.gov
5. US FDA. Egrifta WR (TH9507) prescribing information, NDA 022505, March 2025 revision. accessdata.fda.gov
6. US FDA. Vyleesi (bremelanotide) prescribing information, NDA 210557, 2019. accessdata.fda.gov
7. US FDA. Scenesse (afamelanotide) prescribing information, NDA 210797, 2019. accessdata.fda.gov
8. US FDA. Pitocin (oxytocin) prescribing information, NDA 018261. accessdata.fda.gov
9. US FDA. Forzinity (elamipretide) prescribing information, NDA 215244, September 2025. accessdata.fda.gov
10. Federal Register. Determination That GEREF (Sermorelin Acetate) ... Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness. 78 FR, March 4, 2013. federalregister.gov
11. US FDA Center for Veterinary Medicine. Freedom of Information Summary, Supplemental ANADA 200-134, Fertagyl (gonadorelin), Intervet Inc., approved June 1, 2020. animaldrugsatfda.fda.gov
12. Federal Register. Animal Drugs, Feeds, and Related Products; Gonadorelin (Fertagyl, ANADA 200-134, referencing Cystorelin NADA 098-379). July 19, 1996. govinfo.gov
13. Novo Nordisk. Novo Nordisk files for FDA approval of CagriSema (AM833 and NN9535). Press release, December 18, 2025. novonordisk.com
14. ClinicalTrials.gov. NCT06383390, Phase 3 study of LY3437943 (TRIUMPH program), Eli Lilly and Company. clinicaltrials.gov
15. King R, Tuthill C. Immune Modulation with Thymosin Alpha 1 Treatment. Vitam Horm. 2016;102:151-178. PMID 27450734
16. US FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (content current as of April 22, 2026). fda.gov
17. US FDA. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (content current as of May 14, 2026). fda.gov
18. US FDA. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee. fda.gov
19. US FDA. Compounding and the FDA: Questions and Answers. fda.gov
20. US FDA. Warning Letter to Wholesale Peptide, June 17, 2026 (gonadorelin, Prostamax). fda.gov

This article is for laboratory research reference only. US Prime Peptides products are supplied strictly for in vitro research. Not for human consumption.

Compliance Notice: US Prime Peptides products are supplied strictly for laboratory and academic research purposes only. They are not intended for human or veterinary consumption, diagnosis, treatment, or prevention of any disease. All content on this page is educational in nature and does not constitute medical advice or product claims. Researchers are responsible for handling these compounds in accordance with their institution’s safety protocols and applicable laws.