Melanotan 1
Afamelanotide / Melanotan-1 family — Scenesse EPP label ≠ gray MT-I ≠ Melanotan II ≠ bremelanotide.
Editorial review:Evidence snapshot
This drawer marks papers. It is not a plan, a dose, or a source. A paper is a bounded report. It is not a protocol. Grades name the object. They are not a safety rating.
Identity lock (four-way). Melanotan 1 (MT-I; developmental synonym for [Nle⁴, D-Phe⁷]-α-MSH) is a linear synthetic α-MSH analogue. The same chemistry maps to afamelanotide. PubChem CID 16197727 (afamelanotide; Scenesse-titled CID 16154396 is the same formula/MW record); formula C78H111N21O19 / MW 1646.8; CAS 75921-69-6 (primary; also 1566590-77-9 on record). Four objects stay hard-separated: (1) afamelanotide implant (Scenesse) — FDA-approved in the United States for erythropoietic protoporphyria (EPP) phototoxicity in labeled populations; (2) gray-market “Melanotan 1 / MT-I” tanning preparations — not the Scenesse implant program, not interchangeable in identity, purity, or status; (3) Melanotan II — separate drawer (CID 92432); (4) bremelanotide (Vyleesi / PT-141) — separate drawer. EPP implant efficacy does not travel to cosmetic vials. This drawer marks what papers report. It is not use advice.
Bottom line
Two research tracks must stay apart: (1) early developmental Melanotan-I / NDP-MSH human pigmentation studies and population-risk commentary on unregulated α-MSH analogues; (2) afamelanotide (Scenesse-class) clinical work in EPP (including a pivotal randomized NEJM trial) plus smaller programs in vitiligo and Hailey–Hailey disease. Related chemistry does not erase the product–label gap. Cosmetic tanning from unregulated MT-I is not the EPP labeled object.
Papers
Labeled / regulated afamelanotide object (EPP and related dermatology)
PMID 26132941 — Langendonk 2015
Tested: multicenter randomized, double-blind, placebo-controlled trial of afamelanotide for phototoxicity in erythropoietic protoporphyria (pain and quality-of-life endpoints).
Does not show: that gray-market Melanotan 1 vials equal the trial/approved implant object, or a cosmetic-tanning approval.
PMID 32186677 — Wensink 2020
Tested: association of afamelanotide with outcomes in EPP in clinical practice (observational practice-context report).
Does not show: a new pivotal randomized efficacy package by itself, or Melanotan II equivalence.
PMID 28063031 — Minder 2017
Tested: review of afamelanotide pharmacokinetics/pharmacodynamics and clinical use in dermatologic phototoxicity disorders.
Does not show: unregulated tanning safety, or Melanotan II approval.
PMID 26979527 — Kim 2016
Tested: clinical review of afamelanotide in erythropoietic protoporphyria.
Does not show: a cosmetic Melanotan-1 indication, or interchangeability with Melanotan II.
PMID 38784937 — Polańska 2024
Tested: review of afamelanotide in protoporphyria and other skin diseases.
Does not show: that every cited dermatology use is an approved indication in every jurisdiction.
PMID 25230094 — Lim 2015
Tested: randomized multicenter trial of afamelanotide plus narrowband UV-B for vitiligo.
Does not show: an EPP-label substitute, or a stand-alone cosmetic tanning claim.
PMID 24256215 — Biolcati 2014
Tested: clinical report of Nle⁴-D-Phe⁷-α-MSH (afamelanotide chemistry) in Hailey–Hailey disease.
Does not show: a broad dermatology approval package or Melanotan II identity.
Early developmental Melanotan-I / NDP-MSH pigmentation studies
PMID 11045725 — Dorr 2000
Tested: short developmental human study of Melanotan-I ([Nle⁴-D-Phe⁷]-α-MSH) on eumelanin expression and tanning measures in volunteers.
Does not show: a modern cosmetic approval, long-term skin-cancer safety, or identity with the Scenesse EPP implant program as used today.
PMID 15262693 — Dorr 2004
Tested: Phase 1–style Melanotan-1 studies combined with UV-B or sunlight on tanning in volunteers.
Does not show: regulatory approval for cosmetic tanning, or equivalence to labeled afamelanotide EPP use.
PMID 9760697 — Hadley 1998
Tested: discovery/development narrative for Melanotan-I and Melanotan-II as melanogenic drug candidates.
Does not show: completed modern cosmetic-tanning approval for Melanotan I, or that Melanotan I and II are the same molecule.
Unregulated-use risk / population context (α-MSH analogues)
PMID 28266027 — Habbema 2017
Tested: review of risks of unregulated α-MSH analogue use (melanotan I/II), contrasting with separately regulated afamelanotide context.
Does not show: that unregulated Melanotan 1 is safe for cosmetic self-administration.
PMID 19224885 — Evans-Brown 2009
Tested: commentary/report on use of melanotan I and II in the general population.
Does not show: efficacy or safety establishing medical cosmetic use.
What is not established
That gray-market Melanotan 1 equals afamelanotide (Scenesse) as a labeled EPP product. Safe cosmetic tanning from unregulated MT-I. Equivalence to Melanotan II or to FDA-approved bremelanotide (different objects). That EPP implant trial results travel to unlabeled injectable “tanning peptide” preparations. Product identity and purity for unregulated melanotan preparations. This drawer does not provide use advice, schedules, or sourcing.
Selected sources
26132941 32186677 28063031 26979527 38784937 25230094 24256215 11045725 15262693 9760697 28266027 19224885
Reported experiences
Reported topics are not established benefits.Risks and unknowns
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