Skin & Cosmetic FDA Approved

Melanotan I

A melanocortin peptide analogue tied to pigmentation and photoprotection research, and closely related to the approved drug afamelanotide.

PigmentationPhotoprotectionMelanocortin

Also referenced as: Afamelanotide, Scenesse

Also appears in: Hormone

Price compare
54 tracked offers across 54 vendors · 10 dosages
Best trust-adjusted value: Peptide Supply Co · Strong trust · $2.16/mg
From
$2.03/mg
Status
FDA Approved

This peptide maps to at least one regulated medical product or label context in the United States.

Category
Skin & Cosmetic

Primary lane: Skin & Cosmetic. Also surfaces under Hormone for browsing and discovery.

Aliases
2

Afamelanotide, Scenesse

Signal depth
High

FDA label signal · 23 trials · 119 PubMed results

Established
Research evidence

Melanotan I is an FDA-approved medicine with substantial published trial evidence. Note that research-market products sold under this name are not the approved medicine and are not held to the same manufacturing or labeling standards.

Melanotan I has 14 name-matched clinical trials (highest phase: Phase 3) and 119 PubMed-indexed publications and holds an FDA drug label. 7 trials have posted results.

Human data
Approved drug
Trial quality
Randomized
Outcomes
Surrogate / early
Replication
Multiple trials
Literature
Top-tier journals
PHASE3 · Randomized A Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet (NB-UVB) Light Versus NB-UVB Light Alone in Patients With Vitiligo PHASE3 · Randomized Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE) PHASE1/PHASE2 Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients New England Journal of Medicine · 280 citations Afamelanotide for Erythropoietic Protoporphyria JAMA Dermatology · 184 citations Afamelanotide and Narrowband UV-B Phototherapy for the Treatment of Vitiligo British Journal of Dermatology · 103 citations Long-term observational study of afamelanotide in 115 patients with erythropoietic protoporphyria
Evidence history

Re-checked nightly against the registries — tracked since 2026-07-09. No band changes yet.

Grades evidence strength, not efficacy or safety. Research-use context; not medical advice. Graded 2026-07-13 from PubMed, ClinicalTrials.gov, ISRCTN, openFDA, Health Canada, and OpenAlex — computed deterministically and refreshed nightly, with a retraction check. How we grade →

What melanotan I is

Melanotan I refers to a melanocortin peptide analogue better known clinically as afamelanotide. In regulated medicine, afamelanotide is the name that matters more than the older research-market shorthand.

Why it matters

It is one of the clearest examples of a peptide that sits across two different worlds: scientific and clinical development on one side, and aesthetic or tanning-oriented internet discussion on the other.

Regulatory context

Afamelanotide has FDA approval in the United States for a narrow labeled use. That does not mean all products sold under melanotan-style naming are equivalent to an approved medicine.

Practical reading note

This is a good reminder that a familiar peptide-market nickname can hide a very important distinction between approved pharmaceutical use and unregulated cosmetic-market interpretation.