Which peptides are FDA-approved?
A status board for every compound on Residue, built from Drugs@FDA and FDA’s compounding lists — each cell cites the record it came from.
In brief
Of the 25 peptides Residue covers, 6 have an FDA-approved application that Drugs@FDA lists as marketed (Afamelanotide, Bremelanotide, Elamipretide, Semaglutide, Tesamorelin, Tirzepatide)1FDADrugs@FDA: SCENESSE (NDA210797). CLIVUNEL INC; original approval 2019-10-08; Prescription.2FDADrugs@FDA: VYLEESI (AUTOINJECTOR) (NDA210557). COSETTE; original approval 2019-06-21; Prescription.3FDADrugs@FDA: FORZINITY (NDA215244). STEALTH BIOTHERAPS; original approval 2025-09-19; Prescription.4FDADrugs@FDA: WEGOVY, WEGOVY HD, WEGOVY FLEXTOUCH (NDA215256). NOVO; original approval 2021-06-04; Prescription.5FDADrugs@FDA: EGRIFTA (BLA022505). THERATECHNOLOGIES; original approval 2010-11-10; Prescription.6FDADrugs@FDA: ZEPBOUND, ZEPBOUND KWIKPEN, ZEPBOUND (AUTOINJECTOR) (NDA217806). ELI LILLY AND CO; original approval 2023-11-08; Prescription., 1 was approved but is now discontinued (Sermorelin)7FDADrugs@FDA: GEREF (NDA019863). EMD SERONO; original approval 1990-12-28; Discontinued., and 18 returned no approved application when we searched Drugs@FDA. 16 of them appear on FDA's lists of bulk substances flagged for compounding safety concerns8FDACertain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. U.S. FDA, content current as of 04/22/2026..
- 6 FDA-approved, marketed
- 1 approved, discontinued
- 18 no approved application
- 16 on FDA compounding-risk lists
| Compound | Grade | FDA approval | Approved products | Compounding |
|---|---|---|---|---|
| Afamelanotide Melanotan & PT-141 | A | Approved | SCENESSE NDA210797 · first approved 2019-10-081 | Not on FDA list |
| Bremelanotide Melanotan & PT-141 | A | Approved | VYLEESI (AUTOINJECTOR) NDA210557 · first approved 2019-06-212 | Not on FDA list |
| Elamipretide Mitochondrial | A | Approved | FORZINITY NDA215244 · first approved 2025-09-193 | Not on FDA list |
| Semaglutide GLP-1 class | A | Approved | WEGOVY, WEGOVY HD, WEGOVY FLEXTOUCH NDA215256 · first approved 2021-06-04WEGOVY NDA218316 · first approved 2025-12-22OZEMPIC, RYBELSUS NDA213051 · first approved 2019-09-20OZEMPIC NDA209637 · first approved 2017-12-05RYBELSUS NDA213182 · first approved 2020-01-16SEMAGLUTIDE ANDA220314 · first approved 2026-04-074910111213 | Not on FDA list |
| Tesamorelin GHRH & GHRP | A | Approved | EGRIFTA BLA022505 · first approved 2010-11-105 | Not on FDA list |
| Tirzepatide GLP-1 class | A | Approved | ZEPBOUND, ZEPBOUND KWIKPEN, ZEPBOUND (AUTOINJECTOR) NDA217806 · first approved 2023-11-08MOUNJARO, MOUNJARO KWIKPEN, MOUNJARO (AUTOINJECTOR) NDA215866 · first approved 2022-05-13614 | Not on FDA list |
| Sermorelin GHRH & GHRP | A | Discontinued | GEREF NDA019863 · first approved 1990-12-28GEREF NDA020443 · first approved 1997-09-26715 | Not on FDA list |
| AOD-9604 GHRH & GHRP | D | Not approved | None in Drugs@FDA | Nomination withdrawn; risks listed8 |
| BPC-157 Repair | C | Not approved | None in Drugs@FDA | Nomination withdrawn; risks listed8 |
| Cagrilintide GLP-1 class | B | Not approved | None in Drugs@FDA | Not on FDA list |
| CJC-1295 GHRH & GHRP | C | Not approved | None in Drugs@FDA | Nomination withdrawn; risks listed8 |
| DSIP Neuro & bioregulators | C | Not approved | None in Drugs@FDA | Nomination withdrawn; risks listed8 |
| Epitalon Neuro & bioregulators | C | Not approved | None in Drugs@FDA | Nomination withdrawn; risks listed8 |
| GHK-Cu Repair | C | Not approved | None in Drugs@FDA | Nomination withdrawn; risks listed8 |
| Ipamorelin GHRH & GHRP | C | Not approved | None in Drugs@FDA | Category 2 (503B)8 |
| Kisspeptin-10 Neuro & bioregulators | B | Not approved | None in Drugs@FDA | Category 2 (503A)8 |
| KPV Repair | D | Not approved | None in Drugs@FDA | Nomination withdrawn; risks listed8 |
| LL-37 Immune | B | Not approved | None in Drugs@FDA | Nomination withdrawn; risks listed8 |
| Melanotan II Melanotan & PT-141 | C | Not approved | None in Drugs@FDA | Nomination withdrawn; risks listed8 |
| MOTS-c Mitochondrial | D | Not approved | None in Drugs@FDA | Nomination withdrawn; risks listed8 |
| Retatrutide GLP-1 class | B | Not approved | None in Drugs@FDA | Not on FDA list |
| Selank Neuro & bioregulators | C | Not approved | None in Drugs@FDA | Nomination withdrawn; risks listed8 |
| Semax Neuro & bioregulators | C | Not approved | None in Drugs@FDA | Nomination withdrawn; risks listed8 |
| TB-500 Repair | D | Not approved | None in Drugs@FDA | Nomination withdrawn; risks listed8 |
| Thymosin alpha-1 Immune | B | Not approved | None in Drugs@FDA | Nomination withdrawn; risks listed8 |
Download: CSV · JSON · licensed for reuse with attribution.
How should this table be read?
“Approved” means Drugs@FDA lists at least one application for the molecule with a marketed (prescription) status. It says nothing about any product sold outside that application, and approval covers only the uses on the label. “Not approved” means Drugs@FDA returned no application for the name we searched. The compounding column reports only whether FDA names the substance on its bulk-substance lists; absence from those lists is not permission.
Are peptides legal?
“Peptide” covers both prescription medicines and unapproved substances, so the answer depends on the molecule and the product. The 6 approved molecules in this table (Afamelanotide, Bremelanotide, Elamipretide, Semaglutide, Tesamorelin, Tirzepatide) are legal prescription drugs when supplied under their FDA-approved applications. The 18 with no application in Drugs@FDA have no FDA approval for any human use, whatever a seller's label says. 16 appear on FDA's bulk-substance lists for compounding safety concerns, which tell pharmacies and outsourcing facilities that FDA has identified significant safety risks 8. Possession and sale rules vary by jurisdiction and are outside the scope of this tracker; nothing here is legal advice.
Grades come from our methodology: an A follows from an approval for at least one use and does not carry over to other uses.
Questions readers ask
Which peptides on Residue are FDA-approved?
Afamelanotide, Bremelanotide, Elamipretide, Semaglutide, Tesamorelin, Tirzepatide each have at least one FDA-approved application listed as marketed in Drugs@FDA at our last fetch. Approval covers only the uses on each product's label.
What does "Category 2" mean?
Category 2 is FDA's list of bulk drug substances nominated for compounding that raise significant safety risks; FDA also lists substances whose nominations were withdrawn while recording its safety concerns. Neither is an approval.
Are peptides legal?
It depends on the product, not the word "peptide". Afamelanotide, Bremelanotide, Elamipretide, Semaglutide, Tesamorelin, Tirzepatide are approved prescription drugs when dispensed under their FDA applications. The others have no marketed FDA approval for any human use, and 16 appear on FDA's compounding safety lists. Possession and sale rules vary by jurisdiction and are outside this tracker.
How current is this table?
It is rebuilt from a snapshot of openFDA and FDA's compounding page. The snapshot date is October 19, 2026; FDA's compounding page states it was current as of 04/22/2026.
References
Every source below was retrieved from its official API or page and cached on the data-edition date. Numbers match the margin notes.
- 1 FDA Drugs@FDA: SCENESSE (NDA210797). CLIVUNEL INC; original approval 2019-10-08; Prescription.
- 2 FDA Drugs@FDA: VYLEESI (AUTOINJECTOR) (NDA210557). COSETTE; original approval 2019-06-21; Prescription.
- 3 FDA Drugs@FDA: FORZINITY (NDA215244). STEALTH BIOTHERAPS; original approval 2025-09-19; Prescription.
- 4 FDA Drugs@FDA: WEGOVY, WEGOVY HD, WEGOVY FLEXTOUCH (NDA215256). NOVO; original approval 2021-06-04; Prescription.
- 5 FDA Drugs@FDA: EGRIFTA (BLA022505). THERATECHNOLOGIES; original approval 2010-11-10; Prescription.
- 6 FDA Drugs@FDA: ZEPBOUND, ZEPBOUND KWIKPEN, ZEPBOUND (AUTOINJECTOR) (NDA217806). ELI LILLY AND CO; original approval 2023-11-08; Prescription.
- 7 FDA Drugs@FDA: GEREF (NDA019863). EMD SERONO; original approval 1990-12-28; Discontinued.
- 8 FDA Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. U.S. FDA, content current as of 04/22/2026.
- 9 FDA Drugs@FDA: WEGOVY (NDA218316). NOVO; original approval 2025-12-22; Prescription.
- 10 FDA Drugs@FDA: OZEMPIC, RYBELSUS (NDA213051). NOVO; original approval 2019-09-20; Prescription.
- 11 FDA Drugs@FDA: OZEMPIC (NDA209637). NOVO; original approval 2017-12-05; Prescription, Discontinued.
- 12 FDA Drugs@FDA: RYBELSUS (NDA213182). NOVO NORDISK INC; original approval 2020-01-16; Prescription.
- 13 FDA Drugs@FDA: SEMAGLUTIDE (ANDA220314). APOTEX INC; original approval 2026-04-07; None (Tentative Approval).
- 14 FDA Drugs@FDA: MOUNJARO, MOUNJARO KWIKPEN, MOUNJARO (AUTOINJECTOR) (NDA215866). ELI LILLY AND CO; original approval 2022-05-13; Prescription.
- 15 FDA Drugs@FDA: GEREF (NDA020443). EMD SERONO INC; original approval 1997-09-26; Discontinued.