Melanocortin
Afamelanotide
An approved melanocortin implant for a rare light-sensitivity disease — not a tanning drug, whatever the internet says.
- How settled this rating is:
- high confidence in the current evidence rating
- Routes studied:
- Implant
- Also known as:
- Scenesse, Nle4-D-Phe7-alpha-MSH
- Last reviewed:
- 2026-08-23
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Evidence passport
Afamelanotide
A one-screen evidence identity for this compound. These fields describe research maturity, confidence and legal status. They are not a safety guarantee, efficacy percentage or recommendation.
- Evidence level
- L5Repeated human trials
- Confidence
- High confidence in rating
- Regulatory status
- Approved for a specific indication · See jurisdiction details
- Development status
- Approved
Evidence strength
Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.
Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number.
The 0-100 values rate the strength and maturity of evidence, not how effective or safe the compound is.
- Evidence base
- Includes human studies
- Furthest established stage
- Approved
- Human research maturity
- Approved orphan medicine with completed pivotal trials
- Source curation
- Sources fully curated
Routes recorded
Overview
Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.
Higher = more animal, tissue or cell research. Preclinical results are a starting point, not proof of a human benefit.
Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number.
How to read these scores
Every number here rates the evidence, not the compound. They are editorial 0-100 strength ratings, not percentages, and not a rating out of five stars.
- Human efficacy evidence strength — Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.
- Preclinical evidence strength — Higher = more animal, tissue or cell research. Preclinical results are a starting point, not proof of a human benefit.
- Human safety evidence strength — Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number. A score of 80 does not mean “80% safe”.
- Evidence level (L0-L5) — the strongest type of study behind the compound, from anecdote (L0) to large replicated human trials (L5). It is a description of the study evidence, not a quality, safety or recommendation rating.
- Confidence — how likely we think it is that this rating changes as new research lands. Low confidence means the picture is unsettled, not that the compound is bad.
None of these ratings is medical advice, a safety guarantee, or a recommendation to use anything. How we grade evidence.
How far human research has progressed: Approved orphan medicine with completed pivotal trials
Routes & formulations
Studied / approved routes
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
Discovery
Preclinical
Phase I
Phase II
Phase III
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.
Related evidence
Useful next reads based on this compound — not recommendations.
- Related compound
Melanotan II evidence profile
A synthetic melanocortin peptide sold for tanning — unapproved everywhere, and routinely confused with genuinely approved melanocortin medicines.
- Compare
Compare Afamelanotide vs Melanotan II evidence
Same questions, same fields, side by side — including how much human evidence exists.
- Checked claim
Claim review: “Melanotan II is basically the same approved medicine as afamelanotide.”
A closely related claim we have graded, from Melanocortin.
- Context
Safety Centre
What approved, investigational and unapproved actually mean for documented human safety.
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
This section covers questions raised by how the compound works in the body, plus anything regulators and trial teams keep an eye on. It is not a statement that this compound causes cancer — for most compounds here, no human data exist in either direction.
Monitored in trials; not demonstrated in humans
Regulatory status
Regulatory decisions apply to specific jurisdictions, products, formulations and indications. An approval elsewhere is not automatically an approval in your country.
Named regulators: FDA (US)
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
Substantial, consistent controlled human evidence supporting a specified outcome, preferably independently replicated. Approval is reported separately.
What would change our rating?
- Long-term registry data from the approved EPP population.
References and sources
Source transparency
A provenance snapshot of this profile. Counts show what kinds of sources are cited, not how much scientific weight each source deserves.
- Last editorial review
- 2026-08-23
- Recently reviewed · 54 days ago
- Linked curated sources
- 2
- Sources still pending
- 0
- External specialist reviews
- 0
- None recorded for this profile
Review provenance
Registry editorial review: Colin Jackson-White, creator and editor, who is not a doctor or clinician. External specialist review is credited only when a named reviewer has completed a review of this exact profile.
Literature-discovery and AI tools may help locate or challenge candidate evidence, but they are not counted as evidence sources here. Registry judgements are tied to the underlying papers, trial records, regulator documents and official study records.
- Regulatory / labelFDA orphan drug designation record — afamelanotide
- Regulatory / labelFDA NDA review — Scenesse (afamelanotide), 2019
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
These entries record changes to our assessment of the published evidence — not changes to the compound itself.
No recorded changes yet. Baseline position set on 2026-08-23.