Educational reference only. Not medical advice. Consult a healthcare provider before starting any protocol.
Melanotan I (Afamelanotide)
Afamelanotide ([Nle4, D-Phe7]-alpha-MSH)
What it is
A synthetic 13 amino acid linear analog of alpha-melanocyte-stimulating hormone (alpha-MSH), approved in the US, EU, and Australia as Scenesse for the prevention of phototoxicity in adults with erythropoietic protoporphyria (EPP). Afamelanotide is a selective MC1R agonist that stimulates eumelanin production independent of UV exposure, providing systemic photoprotection. Substitutions at positions 4 (norleucine) and 7 (D-phenylalanine) confer approximately 4-fold greater MC1R potency and significantly improved enzymatic stability compared to native alpha-MSH. It is administered as a bioresorbable subcutaneous implant by a healthcare professional.
Community-reported ranges
Dosing and side effects sourced from FDA prescribing information (NDA 210797) and EMA SmPC. Clinical data from published phase III trials. Not dosing guidance.
Reported dose range
16000–16000 mcg
Estimated half-life
~30 min (intrinsic peptide); ~15 hours (apparent, from sustained-release implant)
Source: FDA prescribing information (NDA 210797) and EMA SmPC
Reported cycle length
8–52 weeks on
Per label: implant every 60 days; year-round use approved in EU (2025) and US weeks off
Route
subcutaneous_implant
Common vial sizes
16mg implant
Reported timing
Implant administered every 60 days; no specific daily timing
Reported frequency
One 16mg subcutaneous implant every 60 days, administered by a healthcare professional
Frequently discussed alongside
Based on community forum discussions. Not a recommendation to combine compounds.
Published research
Afamelanotide was evaluated in multiple phase II and III clinical trials for EPP. The pivotal phase III trial (Langendonk et al., NEJM 2015) demonstrated a significant increase in pain-free time in direct sunlight (median 69.4 hours vs. 40.8 hours placebo over 6 months, p=0.005). The drug has 4-fold greater MC1R potency than native alpha-MSH with an extended duration of action via bioresorbable implant. Peak plasma levels (~3.7 ng/mL) occur at ~36 hours post-implant; >90% of drug is released by day 5. The EMA initially restricted use to seasonal months but approved year-round treatment in September 2025. Investigational applications include vitiligo, polymorphic light eruption, and xeroderma pigmentosum.
Reported side effects
From community self-reports. Not from controlled studies.
Per FDA/EMA prescribing information: implant site reactions (21%, including bruising, erythema, pain, swelling), nausea (~19%), headache (~20%), fatigue, dizziness, somnolence, abdominal pain, diarrhea, vomiting, flushing, generalized skin darkening, darkening or appearance of new nevi, oropharyngeal pain, cough, and musculoskeletal pain. Postmarketing: rare anaphylaxis. Skin examinations every 6 months are recommended due to changes in moles and pigmentation. Contraindicated in severe hepatic impairment or hepatic porphyria.
Regulatory status
FDA (United States)
FDA-approved (October 8, 2019). NDA 210797. Marketed as Scenesse for EPP in adults. Orphan Drug and Priority Review designations. Approved only for EPP — not for tanning, photoprotection in healthy individuals, or any other indication.
Health Canada
Not yet authorized. CLINUVEL filed a New Drug Submission (NDS) on October 1, 2024; review is ongoing as of March 2026.
WADA (Competitive Athletes)
Not explicitly named on the WADA Prohibited List, but as a synthetic alpha-MSH analog it is likely captured under S2 (Peptide Hormones) catch-all provisions. Athletes with EPP would require a Therapeutic Use Exemption (TUE).
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