Encyclopedia

Melanotan-1

Melanotan-1 is a synthetic tridecapeptide analog of alpha-MSH that acts as an MC1R agonist, raising skin eumelanin without UV exposure. The FDA approved it as the Scenesse implant in 2019 for erythropoietic protoporphyria, distinct from the unapproved Melanotan-2. Educational only, not medical advice.

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Category	Cosmetic / Skin
Regulatory status	FDA-approved as Scenesse (afamelanotide) implant (approved October 2019) to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).

Mechanism

A synthetic tridecapeptide analog of alpha-melanocyte-stimulating hormone (alpha-MSH) that is a melanocortin-1 receptor (MC1R) agonist, increasing eumelanin production in the skin independent of UV exposure and providing photoprotection.

Half-life

Short for the peptide itself, but the approved product is a sustained-release subcutaneous implant delivering drug over roughly 2 months; free-peptide plasma half-life is on the order of hours.

Regulatory status

FDA-approved as Scenesse (afamelanotide) implant (approved October 2019) to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria (EPP). Note: this is distinct from Melanotan-2 (an unapproved research chemical sold for tanning/libido).

Safety

Reported adverse effects include implant-site reactions, headache, nausea, fatigue, and skin hyperpigmentation/darkening of nevi (warranting dermatologic monitoring). Unapproved 'Melanotan' products sold for tanning carry significant safety and purity risks.

Evidence

Human trials supporting approval in EPP; approved drug with established (if specialized) evidence base.

Sources

Barnetson RS, et al. Effects of a superpotent melanotropic peptide with solar UV radiation on tanning in human volunteers. Arch Dermatol. 2004;140(7):827-835. https://pubmed.ncbi.nlm.nih.gov/15262693/
Langendonk JG, et al. Afamelanotide for erythropoietic protoporphyria. N Engl J Med. 2015;373(1):48-59. https://pubmed.ncbi.nlm.nih.gov/26132941/
Biolcati G, et al. Long-term observational study of afamelanotide in 115 patients with EPP. Br J Dermatol. 2015;172(6):1601-1612. https://pubmed.ncbi.nlm.nih.gov/25494545/
Grimes PE, et al. Efficacy of afamelanotide and narrowband UV-B for repigmentation of vitiligo. JAMA Dermatol. 2013;149(1):68-73. https://pubmed.ncbi.nlm.nih.gov/23407924/
Haylett AK, et al. Efficacy of afamelanotide for long-term treatment of EPP. JAMA Dermatol. 2020;156(12):1366-1370. https://pubmed.ncbi.nlm.nih.gov/32186677/

PepWise is an informational and educational tracking tool, not medical advice and not a medical device. Melanotan-1 may be experimental, restricted, or prescription-only; many research peptides are not FDA-approved. Consult a licensed healthcare provider before starting, changing, or stopping any protocol. Operated by STC Consulting, Inc.