Supplement Monograph

Melanotan I (Afamelanotide)

Melanotan I (afamelanotide, brand Scenesse) is an alpha-MSH analogue melanocortin agonist, FDA- and EMA-approved as an implant to reduce phototoxicity in erythropoietic protoporphyria.

What Is Melanotan I?

Melanotan I (afamelanotide, brand name Scenesse) is a synthetic analogue of alpha-melanocyte-stimulating hormone (α-MSH) that activates the melanocortin-1 receptor to increase eumelanin production, approved as a subcutaneous implant. It is a genuine, regulator-reviewed drug — approved by the EMA (2014) and FDA (2019) — but for a narrow indication: reducing phototoxic reactions and increasing pain-free light exposure in adults with erythropoietic protoporphyria (EPP), a rare, painful light-sensitivity disorder. It is distinct from the unapproved grey-market tanning peptide melanotan II. It is not an approved dietary supplement or an over-the-counter tanning product.

Evidence

Approval was supported by two multicentre, randomised, double-blind, placebo-controlled trials of a 16 mg subcutaneous afamelanotide implant given every 60 days in EPP patients, published in the New England Journal of Medicine; afamelanotide increased the duration of sun/light exposure without pain and improved quality of life versus placebo, with an acceptable adverse-event profile 1Reference 1Langendonk JG et al et al. · 2015RCTAfamelanotide for Erythropoietic Protoporphyria — randomised/RCTView study →. It has also been studied in vitiligo and other conditions, but EPP is the indication with the strongest randomised evidence and the basis for approval. Its popular association with “tanning” reflects its melanogenic mechanism rather than an approved cosmetic use.

Dosage & Safety

The approved regimen is a 16 mg controlled-release implant inserted subcutaneously by a healthcare professional roughly every two months during high-light seasons — this is the drug’s prescribing information, not a personal recommendation. In trials it was generally well tolerated, with implant-site effects, headache and nausea among reported events 1Reference 1Langendonk JG et al et al. · 2015RCTAfamelanotide for Erythropoietic Protoporphyria — randomised/RCTView study →; because it darkens skin, monitoring of pigmented lesions is prudent, and it should be used under specialist supervision. It is an approved prescription implant for a specific rare disease, not a dietary supplement and not an OTC tanning agent. Informational only — this is not medical advice.

References

  1. Langendonk JG et al. (2015). Afamelanotide for Erythropoietic Protoporphyria — randomised/RCT. N Engl J Med. https://pubmed.ncbi.nlm.nih.gov/26132941/