Melanotan I is the research name of afamelanotide, approved as an implant for erythropoietic protoporphyria, a rare disease with intense pain on exposure to light. The 'Melanotan' products sold online for tanning are not authorized.
Regulatory status
Approved (FDA / EMA)
Family
Alpha-melanocyte-stimulating hormone (α-MSH) analog
Scientific evidence
Moderate
Number of findings
1
Where it acts
Skin and aging
Also known as
Melanotan I, MT-I, afamelanotide, Scenesse, CUV1647, [Nle4,D-Phe7]-α-MSH
Regulatory status
FDA (US): Approved (2019, Scenesse) to increase pain-free light exposure in adults with erythropoietic protoporphyria
EMA (EU): Approved (2014, Scenesse, under exceptional circumstances) to prevent phototoxicity in adults with erythropoietic protoporphyria
Dose
One 16 mg subcutaneous implant every 2 months, placed by a trained professional (FDA prescribing information 2019; EMA 2014).
Safety
Reactions at the implant site, nausea, fatigue, and darkening of the skin and moles; a skin check twice a year is recommended. In the EU it is contraindicated in severe liver disease and in hepatic or renal impairment. Melanotan I bought online has no quality control: not recommended.
Interactions
With anticoagulants, aspirin, or anti-inflammatories there may be more bruising or bleeding at the implant site (EU prescribing information).
Differences between women and men
In the EU, women of childbearing age must use effective contraception during treatment and for up to 3 months afterward; it must not be used in pregnancy or breastfeeding (EMA prescribing information).
Effect by goal · level of evidence
Pain-free time in the sun in erythropoietic protoporphyria
increasesModerateRCT (AA)in people
More pain-free hours in the sun
Two double-blind trials (US and Europe) in adults with protoporphyria: with the implant, hours of pain-free sunlight exposure increased and quality of life improved vs placebo, with a good safety profile.
Activates the MC1R receptor on melanocytes and increases production of eumelanin, the dark pigment of the skin. That extra melanin filters light and protects against the phototoxic reaction, without the need to be exposed to the sun.
What the evidence says
In people
Pain-free time in the sun in erythropoietic protoporphyria. Two double-blind trials (US and Europe) in adults with protoporphyria: with the implant, hours of pain-free sunlight exposure increased and quality of life improved compared with placebo, with a good safety profile. PubMed 26132941