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Melanotan I

low risk

Also: MT-1 · Afamelanotide · Scenesse

Strong Evidence FDA Approved

Melanotan I (Afamelanotide/Scenesse) is FDA-approved for erythropoietic protoporphyria (EPP), a rare disease causing extreme sun sensitivity. It stimulates melanogenesis (tanning) without UV exposure, providing photoprotection. Clean safety profile as an approved drug.

Molecular Weight
1647.9 Da
Formula
C78H111N21O19
Common Dosing
0.16 mg subdermal implant every 2 months (approved EPP dose)
Category
therapeutic
Last Reviewed
2025-01-15

Reported Benefits

Photoprotection in EPP

Strong Evidence 34 studies

FDA approved; Phase III RCT: significantly increased pain-free sun exposure in EPP patients.

Mechanism of Action

Non-selective melanocortin receptor agonist (MC1R primary target); stimulates melanocyte dendricity and melanin synthesis; photoprotective pigmentation.

Key Clinical Studies

Langendonk et al. (2015)

Phase III RCT · n=74

PubMed →

Significantly increased pain-free light exposure time in EPP vs. placebo

EPP: A Rare Approved Indication

EPP (erythropoietic protoporphyria) is a painful genetic disease where sunlight exposure causes severe burning and blistering. Melanotan I’s FDA approval here establishes the melanocortin pharmacology is safe and effective — a foundation for understanding its broader applications.

Differs from Melanotan II

Melanotan I (MC1R selective) is safer and approved. Melanotan II (less selective, includes MC4R) is unapproved and has more side effects including sexual stimulation.

Regulatory Status

FDA Approved

FDA approved as Scenesse (afamelanotide) for EPP

Safety Profile

Side Effects

  • Nausea (transient)
  • Flushing
  • Hyperpigmentation (nevi darkening — requires monitoring)
  • Fatigue

Contraindications

  • History of melanoma
  • Active malignancy

Primary Uses

PhotoprotectionTanningErythropoietic protoporphyria (EPP)

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Disclaimer: This information is for educational and research purposes only. Not medical advice. Consult a qualified healthcare provider before using any compound.