Afamelanotide (Melanotan I) | Peptide Research Hub

At a Glance

Afamelanotide (often referred to in non-clinical contexts as Melanotan I) is an α-melanocyte-stimulating hormone (α-MSH) analog. It has randomized clinical trial evidence in erythropoietic protoporphyria (EPP), a rare photosensitivity disorder. [PMID: 26132941]

⚠️ Prescription Medication: Afamelanotide is approved for EPP in some jurisdictions. This page is educational and intentionally does not include protocols/dosing.

Mechanism of Action (TBD)

Afamelanotide is an α-MSH analog and is generally framed as acting via melanocortin receptor signaling (notably MC1R in pigmentation biology). Mechanistic details and downstream effects are indication-dependent.

Evidence Summary

Erythropoietic Protoporphyria (Randomized Trial)

High Confidence RCT 3-10 Years

Randomized trial evidence in EPP reported improved tolerance of light exposure and reduced phototoxicity-related outcomes versus placebo in the studied setting. [PMID: 26132941]

U.S. treatment context (post-approval report)

Moderate Confidence Observational ≤3 Years

A U.S. report notes afamelanotide approval in 2019 for EPP and describes patient-reported improvements in daily life after treatment in a cohort. [PMID: 37683058]

Safety & Unknowns

Indication-specific safety should be reviewed from primary sources and prescribing information.
Extrapolating to unrelated contexts (e.g., cosmetic tanning use) is not supported by the EPP evidence base.

Regulatory Status

Region	Status
United States (FDA)	Approved for EPP (see literature discussion)
European Union (EMA)	Approved for EPP in some jurisdictions
WADA	Check current list (status may change)

Melanotan II: Related melanocortin peptide
Bremelanotide (PT-141): Melanocortin peptide with different clinical context

Changelog

Date	Change
2026-01-23	Added dossier and linked primary literature