Melanotan I / Afamelanotide

Afamelanotide is a synthetic alpha-melanocyte stimulating hormone (alpha-MSH) analog approved by the FDA for erythropoietic protoporphyria (EPP). It stimulates melanin production, providing photoprotection for patients with EPP. It is administered as a controlled-release subcutaneous implant.

PubMed results: 3 · Human studies: 3 · Animal studies: 3

Ranges reflect protocols studied in published research and animal-model extrapolation. Presented for research purposes only, not a recommendation or instruction for human use.

• Subcutaneous Implant — standard range 16 mg, Every 60 days. Ongoing treatment

2-3 days (release from implant) (high confidence)

• Photoprotection in erythropoietic protoporphyria (EPP) (Strong clinical): Clinical trials and FDA approval support afamelanotide as a controlled-release alpha-MSH analog that increases melanin and improves light tolerance measures in EPP.
• Melanocortin-1 receptor–mediated melanogenesis (Strong clinical): Research demonstrates afamelanotide stimulates melanin production via melanocortin pathways, providing a mechanistic basis for photoprotective effects studied in porphyria populations.
• Reduced sunlight-related phototoxicity burden (Moderate clinical): Controlled studies in EPP reported improvements in pain-free time in sunlight and related phototoxicity endpoints relative to placebo.

• Implant-site reactions — Mild, Common. Clinical use of the subcutaneous implant formulation is associated with local reactions at the implant site, including erythema, bruising, or discomfort.
• Nausea — Mild, Common. Nausea has been reported among patients receiving afamelanotide in clinical and post-approval experience.
• Skin darkening / pigmentary change — Mild, Common. Increased pigmentation is an expected pharmacodynamic effect of melanocortin agonism rather than an off-target toxicity in many research and clinical descriptions.

• History of melanoma or suspicious pigmented lesions under evaluation (Clinical): Melanogenesis stimulation raises theoretical and clinical caution around undiagnosed or active melanoma; product labeling and clinical practice emphasize skin surveillance.
• Known hypersensitivity to afamelanotide (Established): Standard peptide-drug contraindication where prior hypersensitivity to the active substance or implant components is documented.

Lyophilized (powder): Refrigerated (2-8°C), Per manufacturer shelf life for implant product. Light sensitive: yes, store dark

Reconstituted (solution): Refrigerated (2-8°C), Not applicable for controlled-release implant; research peptide stock 4-6 weeks if reconstituted. Solvent: Bacteriostatic water