What the studies show
Nausea, headache and implant-site reactions; darkening of skin and moles, which requires skin monitoring on treatment. Serious events in the trials were not judged drug-related.
“Adverse events were mostly mild; serious adverse events were not thought to be related to the study drug.”
Several well-run randomised trials in people, pointing the same way. You can plan around this. It still says nothing about whether the effect is worth the side effects for you.
- 1Langendonk JG, Balwani M, Anderson KE, et al. Afamelanotide for erythropoietic protoporphyria.N Engl J Med, 2015Two phase 3 trials; EU n=74, US n=94.
In context
Afamelanotide is a linear analogue of the pigment hormone α-MSH, developed in the 1980s as the first 'Melanotan'. It is an approved medicine — as a subcutaneous implant replaced every two months — for erythropoietic protoporphyria, a genetic disorder in which sunlight causes severe pain within minutes. In two randomised trials it roughly doubled the hours patients could spend in direct sun without pain. The same molecule is sold illegally as a tanning injection; for that use there is no approval and no controlled evidence of safety.
Afamelanotide (Melanotan I) is approved (rx) — erythropoietic protoporphyria. Legal status differs by country — see the regulation section or the jurisdiction pages.
Questions
Is Afamelanotide (Melanotan I) proven to cause adverse effects?
What studies are behind the grade?
Is Afamelanotide (Melanotan I) approved for this?
Other outcomes for Afamelanotide (Melanotan I)
- APain-free sun exposure in erythropoietic protoporphyria2 phase 3 RCTs (EU n=74, US n=94)
- BSkin pigmentation (tanning)Early trials + the phase 3 programme
- CVitiligo repigmentationSmall RCTs with phototherapy
Written and maintained by LYO Research — how pages are written and checked. Reviewed 10 September 2026. Grades count human evidence only; see how LYO grades. Not medical advice. Correct this page →