Subcutaneous implant that darkens the skin by increasing melanin. It is approved for erythropoietic protoporphyria, a rare disease in which sunlight causes intense skin pain.
Regulatory status
Approved (FDA / EMA)
Family
Melanocortin receptor agonist (alpha-MSH analog)
Scientific evidence
Moderate
Number of findings
1
Where it acts
Skin and aging
Also known as
afamelanotide, Scenesse, CUV1647, [Nle4, D-Phe7]-α-MSH, melanotan I
Regulatory status
FDA (U.S.): Approved (2019, Scenesse) to increase pain-free light exposure in adults with erythropoietic protoporphyria with a history of phototoxic reactions.
EMA (EU): Approved (2014, Scenesse) to prevent phototoxicity in adults with erythropoietic protoporphyria.
Dose
One 16 mg implant under the skin every 2 months, placed by a health professional (FDA label 2019 / EMA 2014).
Safety
Nausea, headache, reactions at the implant site, tiredness, and darkening of the skin and moles; periodic skin checks are recommended. Not recommended in pregnancy. Do not confuse with the 'melanotan' products sold without oversight for tanning: they are not approved and their use is dangerous.
Effect by goal · level of evidence
Sun tolerance in erythropoietic protoporphyria
improvesModerateRCT (AA)in people
Multicenter double-blind trials in adults with erythropoietic protoporphyria. Afamelanotide increased the time of pain-free exposure to direct sunlight and improved quality of life compared with placebo, with an acceptable adverse-effect profile.
It mimics the hormone alpha-MSH and activates the melanocortin 1 receptor (MC1R) on melanocytes. These produce more eumelanin, the dark pigment that filters light and protects the skin. It does not replace sun protection.
What the evidence says
In people
Sun tolerance in erythropoietic protoporphyria. Multicenter double-blind trials in adults with erythropoietic protoporphyria. Afamelanotide increased the time of pain-free direct sun exposure and improved quality of life compared with placebo, with an acceptable adverse-effect profile. PubMed 26132941