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Melanocortin

Afamelanotide

An approved melanocortin implant for a rare light-sensitivity disease — not a tanning drug, whatever the internet says.

L5Practice-changingApproved — narrow indicationApprovedHigh confidenceLast reviewed 2026-08-23
Implant

Also known as: Scenesse, Nle4-D-Phe7-alpha-MSH

Evidence passport

Last reviewed 2026-08-23

Evidence level
L5Practice-changing
Confidence
High confidence
Human efficacy
78/100
Human safety
75/100
Regulatory status
Approved — narrow indication
Development
Approved
Routes
Implant
Evidence base
Includes human data
Furthest stage
Approved
Source curation
Sources fully curated
Clinical maturity
Approved orphan medicine with completed pivotal trials

Overview

Human evidence78/100
Preclinical evidence70/100
Human safety evidence75/100

Clinical maturity: Approved orphan medicine with completed pivotal trials

Routes & formulations

Studied / approved routes

Implant

The approved product is a subcutaneous implant administered by healthcare professionals in a certified setting. It is categorically not the same product or evidence base as research-market 'melanotan' injections.

Route availability is not evidence of efficacy, and evidence from one route does not transfer to another. The Registry never provides dosing or sourcing information.

Peptide lifecycle

  1. Discovery

  2. Preclinical

  3. Phase I

  4. Phase II

  5. Phase III

  6. Approved

Approved

What it is

A synthetic alpha-MSH analogue that stimulates melanin production, developed to give people with EPP more tolerance to light.

What people claim

  • Increases pain-free light exposure in EPP
  • Confused online with unapproved 'melanotan' tanning products

What the evidence actually says

Randomised controlled trials supported its approval for EPP — a genuine rare-disease success. The approval does not extend to cosmetic tanning, and the registry treats conflation with unapproved Melanotan products as a misinformation pattern, not a grey area.

Human evidence

  • Randomised controlled trials in adults with erythropoietic protoporphyria measuring pain-free light exposure.

Preclinical evidence

  • MC1R pharmacology and pigmentation biology.

Animal and cell findings are Level 1–2 evidence.

Mechanism and pathways

  • MC1R agonism on melanocytes increases eumelanin production, raising light tolerance.

Safety and unknowns

  • Labelled effects include implant-site reactions, nausea and headache.
  • Administration is restricted to clinical settings under the approved programme.

Cancer relevance

Monitored in trials; not demonstrated in humans

Because it stimulates melanocytes, melanoma surveillance is part of its clinical monitoring. That is a monitored precaution, not a demonstrated cancer risk.

Regulatory status

FDA-approved (Scenesse) for increasing pain-free light exposure in adults with erythropoietic protoporphyria (EPP), a rare genetic disorder of severe light sensitivity. Approval is specific to that orphan indication.

Evidence grade

L5Practice-changingHigh confidence

Replicated large randomised trials, pivotal Phase 3 programmes, or a major regulatory decision.

What would change our rating?

  • Long-term registry data from the approved EPP population.

References and sources

Sources fully curated

Source hierarchy: regulatory documents and trial registries first, peer-reviewed work next, sponsor material flagged as non-independent. We never use supplier or clinic marketing as evidence, and where a verified source has not yet been curated we say so rather than inventing one.

Evidence change history

No recorded changes yet. Baseline position set on 2026-08-23.