FDA Approved Sexual & Reproductive Health

Afamelanotide

also known as: Scenesse, Melanotan I, MT-I, NDP-α-MSH, Nle4-D-Phe7-α-MSH, CUV1647

An FDA-approved selective MC1R agonist marketed as Scenesse — the first-in-class treatment for erythropoietic protoporphyria (EPP), delivered as a subdermal implant.

A synthetic 13-amino-acid α-MSH analog (Nle4, D-Phe7) developed by Clinuvel Pharmaceuticals and FDA-approved in 2019 as Scenesse, delivered as a 16 mg slow-release subdermal implant for the rare disease erythropoietic protoporphyria.

Mechanism of action

Selective agonist at MC1R on melanocytes, upregulating tyrosinase activity and driving eumelanin synthesis. The increased eumelanin pigmentation absorbs and dissipates UV and visible-light photons, providing photoprotection in EPP patients whose porphyrin accumulation causes severe light-induced pain. Unlike melanotan II, afamelanotide is linear and MC1R-selective, avoiding MC3R/MC4R-mediated nausea and sexual side effects.

Primary uses

Erythropoietic protoporphyria (EPP) photoprotection
Vitiligo (investigational combination with narrowband UVB)

Typical dosing

16 mg every 2 months (subdermal implant)

Scenesse implant is 16 mg, placed by a trained healthcare provider. Not available as an injectable.

Regulatory status

FDA-approved October 2019 as Scenesse (Clinuvel Pharmaceuticals) for adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP). Approved earlier in the EU and Australia.

References

[fda-pi] Scenesse (afamelanotide) Prescribing Information. Clinuvel Pharmaceuticals.
[clinical-trial] Langendonk JG, et al. "Afamelanotide for Erythropoietic Protoporphyria." N Engl J Med, 2015;373:48-59.

Related peptides

Melanotan II

An unapproved cyclic heptapeptide melanocortin agonist marketed for tanning and sexual function — strongly associated with melanocytic changes and dysplastic nevi in case reports. Not recommended.

PT-141

An FDA-approved melanocortin agonist for acquired, generalized hypoactive sexual desire disorder in premenopausal women.

Disclaimer

This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.