Melanotan I (Afamelanotide)
Afamelanotide is an approved melanocortin receptor agonist. It treats erythropoietic protoporphyria.
Checked by the PU Research editorial team — evidence-graded against primary sources. Last check: 23 July 2026. Sources: 2. Who checks this
Safety notice. Melanotan II is not approved in any country. Indexed case reports link it to rhabdomyolysis, priapism, renal infarction, posterior reversible encephalopathy, and melanoma. Several national health agencies published warnings. Read the safety section of its profile in full.
01Identity & Classification
The approved name is afamelanotide. The brand name is Scenesse.
It is a synthetic linear α-MSH analog with 13 amino acids. The chemical description is [Nle⁴,D-Phe⁷]-α-MSH.
It is a melanocortin receptor agonist, mostly at MC1R.
02Mechanism: How It Works
Afamelanotide activates MC1R on melanocytes. This increases eumelanin production, and the increase does not need UV exposure.
Eumelanin gives photoprotection in two ways: it absorbs UV, and it scavenges reactive oxygen species.
03Research Findings
Evidence tier: clinical. This is the highest tier in this library.
Two multicenter randomized double-blind placebo-controlled trials studied erythropoietic protoporphyria. The European trial enrolled 74 participants. The United States trial enrolled 94 participants. Both used a 16 mg subcutaneous implant every 60 days (Langendonk, Balwani et al., NEJM 2015).
In the United States study, median pain-free time was 69.4 hours with afamelanotide and 40.8 hours with placebo (P = 0.04).
04Reported Dosing & Delivery
Source: the FDA and EMA label.
A 16 mg subcutaneous implant, every 60 days. The implant gives sustained release. A prescriber places it.
05Pharmacokinetics & Timing
The implant is bioresorbable. It gives sustained exposure across the 60-day interval.
06Interactions & Combinations
Sources do not document interactions extensively.
Compare with Melanotan II, which has no approval and a different safety record.
07Safety & Contraindications
Documented adverse events in NEJM 2015 are headache, nausea, nasopharyngitis, and back pain.
About one-third of participants had mild hyperpigmentation at the implant site. Some had darkening of moles.
The trials showed no difference between groups in serious adverse events.
The trial report notes one point directly. Some people believe that an α-MSH analog stimulates melanoma. These data do not support that belief.
08Monitoring & Biomarkers
Skin checks and nevus (mole) checks.
09Regulatory Status
The EMA approved it in December 2014, under exceptional circumstances. The FDA approved it on 8 October 2019, under NDA 210797.
An EMA label amendment in September 2025 permits year-round dosing.
It is not a standard WADA performance-enhancing class. See the FDA-approved peptides list.
10Works Cited
- 01Langendonk JG, et al. New England Journal of Medicine, 2015;373:48–59. DOI 10.1056/NEJMoa1411481. PMID 26132941. View source →
- 02FDA NDA 210797. View source →
More in Melanocortin & Skin
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