Afamelanotide: Benefits, Dosage & FDA Status
Afamelanotide (Scenesse)
An FDA-approved selective MC1R agonist used to increase eumelanin density in erythropoietic protoporphyria patients. Off-label cosmetic tanning use is widespread internationally.
FDA Status
FDA-approved (2019) for erythropoietic protoporphyria (EPP)
Typical Dose
16 mg subcutaneous implant every 2 months (clinical use)
Evidence Grade
AStrong RCT or FDA-approved evidence
Half-Life
Implant releases over weeks
Routes of Administration
subcutaneous implant
First Synthesized
1980s
Clinics Indexed
14 providers have offered Afamelanotide in our tracked directory.
Mechanism of Action
Synthetic α-MSH analog with high MC1R selectivity; increases eumelanin synthesis in melanocytes.
Key Reported Benefits
- ✓MC1R-selective tanning
- ✓FDA-approved for EPP
Benefits listed reflect commonly reported effects from clinical trials and practitioner use. Individual response varies. Evidence-grade A indicates strong rct or fda-approved evidence.
Reported Side Effects
- •Implant-site reactions
- •Nausea
- •Freckling
Contraindications
- ⚠Personal/family history of melanoma
- ⚠Pregnancy
Afamelanotide vs Other Peptides
Regulatory & Safety Context
FDA status: FDA-approved (2019) for erythropoietic protoporphyria (EPP)
This page is for educational purposes only and does not constitute medical advice. Peptide use outside of an FDA-approved indication should be discussed with a licensed medical professional. Source quality, cold-chain storage, and injection hygiene all materially affect safety outcomes.
See state-by-state legality: US peptide legality by state →
References
Selected primary literature on Afamelanotide. Full PubMed records linked. Additional citations are available on request.
Last reviewed: 2026-04-30
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