Peptide Graded

Afamelanotide

Is Afamelanotide legal in the US?

Yes, FDA approved for adults with EPP, a rare disease where sunlight causes pain.

AStrong human evidenceFDA approvedas of 2026-10-26

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

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

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More on Afamelanotide

Citations

  1. FDA: Scenesse (afamelanotide) prescribing information, 2019 accessdata.fda.gov
  2. McGill Office for Science and Society: the 'Barbie drug' mcgill.ca
  3. EMA: Scenesse European public assessment report ema.europa.eu
  4. BioSpace 2019: FDA approves first treatment to increase pain-free light exposure in EPP biospace.com
  5. Langendonk 2015, NEJM: afamelanotide for erythropoietic protoporphyria pubmed.ncbi.nlm.nih.gov
  6. Wensink 2020, JAMA Dermatology: afamelanotide outcomes in clinical practice pubmed.ncbi.nlm.nih.gov
  7. J Am Acad Dermatol 2023: consensus guidelines for EPP and X-linked protoporphyria pubmed.ncbi.nlm.nih.gov
  8. DailyMed: Scenesse label, warnings and precautions dailymed.nlm.nih.gov
  9. Langendonk 2015, NEJM (DOI) doi.org

Reference information only, not medical advice. Drawn from the Afamelanotide article, fact-checked against the cited sources. No dosing anywhere on this site.