A peptide class of 3 compounds
Melanocortin peptides
Which melanocortin peptides are approved, and which are not?
All three are synthetic analogs of α-melanocyte-stimulating hormone. Afamelanotide, first synthesized in 1980, acts on the melanocortin-1 receptor that drives skin pigmentation1PubMedPharmacokinetics and Pharmacodynamics of Afamelanotide and its Clinical Use in Treating Dermatologic Disorders. Minder EI et al. Clin Pharmacokinet. 2017.. Melanotan II is a shorter cyclic analog that darkened skin and caused erections in its first human study2PubMedEvaluation of melanotan-II, a superpotent cyclic melanotropic peptide in a pilot phase-I clinical study. Dorr RT et al. Life Sci. 1996.. Bremelanotide (PT-141) has high affinity for the melanocortin-4 receptor, linked to sexual function3PubMedBremelanotide: First Approval. Dhillon S & Keam SJ Drugs. 2019..
Two are approved drugs: afamelanotide as the Scenesse implant for erythropoietic protoporphyria, and bremelanotide as Vyleesi for low sexual desire in premenopausal women4FDADrugs@FDA: SCENESSE (NDA210797). CLIVUNEL INC; original approval 2019-10-08; Prescription.,5FDADrugs@FDA: VYLEESI (AUTOINJECTOR) (NDA210557). COSETTE; original approval 2019-06-21; Prescription.. Melanotan II never was; FDA lists it among withdrawn compounding nominations and records case reports of melanoma and priapism6FDACertain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. U.S. FDA, content current as of 04/22/2026..
| Grade | Compound | Literature | Registered studies |
|---|---|---|---|
| A | AfamelanotideFDA-approved (Scenesse implant) · Prescription | 121 | 23 · 1 active |
| A | BremelanotideFDA-approved (Vyleesi) · Prescription | 113 | 10 · 1 active |
| C | Melanotan IINot FDA-approved · FDA compounding nomination withdrawn | 625 | 1 · 1 active |
Monographs in this class
- A Afamelanotide
The first α-MSH analog given to people, and the one that became a medicine: a 16 mg implant approved for a rare light-sensitivity disorder.
- A Bremelanotide
A melanocortin-receptor agonist approved in 2019 as an on-demand injection for low sexual desire in premenopausal women. The benefit in trials was statistically significant but modest.
- C Melanotan II
A cyclic analog of α-MSH that darkens skin and triggers erections. The controlled human data are three small studies from the 1990s; most later papers are case reports of harm.
Comparisons
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 PubMed Minder EI, Barman-Aksoezen J, Schneider-Yin X. Pharmacokinetics and Pharmacodynamics of Afamelanotide and its Clinical Use in Treating Dermatologic Disorders. Clin Pharmacokinet 2017. PMID 28063031; doi:10.1007/s40262-016-0501-5.
- 2 PubMed Dorr RT, Lines R, Levine N, et al. Evaluation of melanotan-II, a superpotent cyclic melanotropic peptide in a pilot phase-I clinical study. Life Sci 1996. PMID 8637402; doi:10.1016/0024-3205(96)00160-9.
- 3 PubMed Dhillon S, Keam SJ. Bremelanotide: First Approval. Drugs 2019. PMID 31429064; doi:10.1007/s40265-019-01187-w.
- 4 FDA Drugs@FDA: SCENESSE (NDA210797). CLIVUNEL INC; original approval 2019-10-08; Prescription.
- 5 FDA Drugs@FDA: VYLEESI (AUTOINJECTOR) (NDA210557). COSETTE; original approval 2019-06-21; Prescription.
- 6 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.