Last updated October 21, 2026. Approval line checked October 21, 2026. No compounding source date is assigned.
FDA status
Approved
Approved. Afamelanotide is the active ingredient in Scenesse, FDA-approved to increase pain-free light exposure in adults with erythropoietic protoporphyria. Approval is specific to that product and indication.
Drugs@FDA: Scenesse (NDA 210797)By signing up you agree to get PeptideX update emails. Unsubscribe anytime. Educational only, not medical advice.
Evidence tier
Human RCT. The tier is the highest indexed study type. It is not a safety rating and it is not an FDA approval. Confidence score 5/5. 116 PubMed citations indexed.
Afamelanotide is a synthetic tridecapeptide analog of alpha-melanocyte stimulating hormone (α-MSH) with a substituted methionine7→norvaline modification that increases stability and receptor binding d
What the literature studies
Immune Research
Evidence tier
Human RCT
Compounding record
Status not verified
Status not verified. No product-specific FDA primary source is recorded for this entry. FDA approval and compounding eligibility are not verified. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route.
Regulatory source not verified; no checked date is assigned.
Afamelanotide causes darkening of all existing nevi and ephelides, requiring twice-yearly full-body skin examinations; long-term melanoma risk remains a subject of post-marketing s
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Educational only. Not medical advice. This page does not give doses or sourcing. See the medical and editorial disclaimer.