Afamelanotide
MC1R agonist
Also Scenesse, Melanotan I, Melanotan 1, MT-1, MT-I, CUV1647
- Evidence
- AStrong human evidence
- FDA status
- FDA approvedas of 2026-10-26
- Route
- Implant
- Studies cited
- 3 human0 animal or cell
An implant that lets people with a rare sun-pain disease stay in daylight longer. Trials in 168 adults show it works for that, but none show it works for tanning.
Sold for
Afamelanotide is best known as the first drug for EPP, a rare disease in which sunlight causes burning pain, and in its earlier life as a candidate 'sunless tan' because it darkens skin.
Studies say
Randomized trials show it lengthens the time EPP patients can spend in sunlight without pain, which earns grade A for that indication; there are no trials supporting cosmetic tanning.
Why grade A. Two randomized, double-blind, placebo-controlled trials in 168 adults with EPP (94 in the United States, 74 in the European Union) showed more pain-free hours in sunlight, and a 117-patient post-authorisation cohort followed for about two years confirmed the effect in routine practice. Consensus guidelines recommend it for preventing phototoxic symptoms. The evidence is strong for EPP and nonexistent for the tanning use the compound is also known for. 567
FDA. Afamelanotide is FDA-approved and sold as Scenesse, a subcutaneous implant, approved in October 2019 to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria (EPP). The European Medicines Agency authorised it for the same disease in 2014. 134
Written from 9 cited sources. Last refreshed 2026-10-27. Not physician reviewed.
What this means for you
- What people take it for
- Staying in sunlight without pain, in the rare disease EPP.
- Can a US doctor prescribe it?
- Yes, FDA approved for adults with EPP, a rare disease where sunlight causes pain.
- Properly tested in people?
- Yes, in large controlled trials: two trials in 168 adults.
Evidence checklist
- Randomised controlled trial Two placebo-controlled trials in EPPyes
- Human study over 100 people 168 trial patients; 117-patient cohortyes
- More than one research group US and EU trials plus Dutch academic cohortyes
- Clinical outcomes, not surrogate markers Pain-free sun time, phototoxic reactionsyes
- Human safety data beyond case reports Trials, two-year cohort and label datayes
Drawn from the cited studies below. A dash means the sources give no information.
What it is
Afamelanotide is a lab-made version of alpha-melanocyte-stimulating hormone (alpha-MSH). This natural peptide tells pigment cells to make melanin. The drug has 13 amino acids. Two swaps make it more stable and more potent than the natural hormone. It was developed in the 1980s at the University of Arizona. Clinuvel Pharmaceuticals later ran the clinical trials. 12
The approved product is Scenesse. It is a small rod. A healthcare professional puts it under the skin. The rod dissolves over about two months. It is a prescription drug. In the United States it is sold through a restricted programme. 18
How it works
Afamelanotide switches on the melanocortin-1 receptor (MC1R). This receptor sits on melanocytes, the pigment cells of the skin. Switching it on makes more eumelanin, the brown-black form of melanin. No ultraviolet light is needed. 1
In EPP, a genetic enzyme defect causes a build-up of protoporphyrin IX. It collects in red blood cells and skin. Visible light excites this molecule, including light outside the ultraviolet range. The result is a burning reaction within minutes. Extra eumelanin soaks up some of that light. It absorbs the light before it reaches the protoporphyrin. Eumelanin also acts as an antioxidant, which may dull the reaction. 15
What human research shows
Two multicentre randomized trials were published together in 2015. They enrolled 168 adults with EPP. The US study had 94 patients and ran 270 days. Median pain-free time in direct sunlight was 69.4 hours with afamelanotide. With placebo it was 40.8 hours. The European Union study had 74 patients and ran 180 days. There the figures were 6.0 hours versus 0.8 hours. Phototoxic reactions were also fewer (77 versus 146). Quality of life got better in both trials. 5
A cohort study was run at Erasmus MC after approval. It followed 117 EPP patients on afamelanotide for a median of two years. Time outdoors rose by 6.1 hours per week. Quality of life scores for the disease got about 14% better. Reactions were less painful, though not fewer. 98% of patients stayed on treatment. 6
Consensus guidelines for EPP and X-linked protoporphyria came out in 2023. They are based on the evidence. They recommend afamelanotide to prevent phototoxic symptoms. They also advise avoiding the sun. Patients should be checked for liver disease and vitamin D deficiency. 7
| Study | Model | Finding |
|---|---|---|
| Langendonk 2015, NEJM (US trial) | Humans, n=94 adults with EPP, randomized double-blind placebo-controlled, 270 days | Median pain-free sunlight exposure 69.4 hours with afamelanotide versus 40.8 hours with placebo. 5 |
| Langendonk 2015, NEJM (EU trial) | Humans, n=74 adults with EPP, randomized double-blind placebo-controlled, 180 days | Median pain-free time 6.0 versus 0.8 hours; phototoxic reactions 77 versus 146. 5 |
| Wensink 2020, JAMA Dermatology | Humans, n=117, prospective post-authorisation cohort, median 2 years | Time outdoors increased by 6.1 hours per week, quality of life improved, reactions were less painful, 98% continued treatment. 6 |
| EPP consensus guidelines 2023 | Systematic review and expert consensus | Afamelanotide is recommended for preventing phototoxic symptoms in EPP and X-linked protoporphyria. 7 |
Safety
In the phase 3 trials, most adverse events were mild. Serious events were judged unrelated to the drug. The most common effects are implant-site reactions, nausea, headache, fatigue and skin darkening. The darkening is the intended effect. In the two-year Dutch cohort, side effects were minor and went away on their own. 56
The US label warns of serious hypersensitivity reactions, including anaphylaxis. It advises full-body skin exams. The drug darkens moles and freckles. That could make melanoma harder to spot. No one knows if MC1R stimulation changes melanoma risk over decades. The trials were too short and too small to tell. Unregulated 'melanotan' products sold online for tanning are different compounds. Nobody oversees how they are made. 28
Questions for your clinician
- Is there any controlled human trial for the use I have in mind, such as tanning?
- How often would my skin need checking while I have an implant?
- What are the signs of a hypersensitivity reaction to the implant?
Questions people ask
Is afamelanotide FDA-approved?
Yes. Scenesse was approved in October 2019. It is for adults with a history of phototoxic reactions from erythropoietic protoporphyria. It has been authorised in the European Union since 2014. 134
Is afamelanotide the 'Barbie drug'?
That nickname stuck to the drug in the 2000s. It darkens skin without sun. The approved drug is used only for EPP. Illicit 'melanotan' tanning injections sold online are not afamelanotide. They have no quality control. 2
Citations
- FDA: Scenesse (afamelanotide) prescribing information, 2019 accessdata.fda.gov
- McGill Office for Science and Society: the 'Barbie drug' mcgill.ca
- EMA: Scenesse European public assessment report ema.europa.eu
- BioSpace 2019: FDA approves first treatment to increase pain-free light exposure in EPP biospace.com
- Langendonk 2015, NEJM: afamelanotide for erythropoietic protoporphyria pubmed.ncbi.nlm.nih.gov
- Wensink 2020, JAMA Dermatology: afamelanotide outcomes in clinical practice pubmed.ncbi.nlm.nih.gov
- J Am Acad Dermatol 2023: consensus guidelines for EPP and X-linked protoporphyria pubmed.ncbi.nlm.nih.gov
- DailyMed: Scenesse label, warnings and precautions dailymed.nlm.nih.gov
- Langendonk 2015, NEJM (DOI) doi.org