Melanotan I
Also known as Afamelanotide · NDP-MSH · developed by Clinuvel
Licensed by at least one major regulator for a specific indication, on the strength of completed phase 3 trials. Approval is for that indication in that population — it is not a general endorsement of the compound.
What it is
A linear, MC1R-selective analogue of alpha-MSH. Unlike Melanotan II it completed clinical development and is a licensed medicine — though for a rare condition, not for cosmetic tanning.
How it is thought to work
Selective MC1R agonist, stimulating eumelanin production. Selectivity is the key difference from Melanotan II: it largely avoids the MC3R and MC4R effects.
What the studies found
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Approved for erythropoietic protoporphyria
Randomised trials showed increased pain-free sunlight exposure in people with EPP, a rare inherited disorder causing severe phototoxic pain. Approved in the EU in 2014 and by the FDA in 2019, administered as a subcutaneous implant under specialist supervision.
What the evidence does not show
- The evidence base is for EPP specifically. It says little about use by people without the condition.
- It is supplied as a controlled-release implant placed by a clinician, not as an injectable.
- Long-term pigmentary and melanoma surveillance data remains limited.
Reported risks and adverse effects
- Reported effects include nausea, headache and localised skin reactions.
- Regular skin monitoring is part of the licensed protocol, because increased pigmentation can obscure skin lesions.
- The safety profile that supported approval reflects specialist administration and monitoring.
This is a summary of what has been reported in the literature, not a complete safety profile. For anything concerning your own health, speak to a doctor.
Regulatory status
A licensed prescription medicine for EPP in the EU and US, supplied as an implant through specialist centres. It is not licensed for cosmetic use anywhere.