- Mechanism of action
- Agonist at the melanocortin-1 receptor (MC1R); activates a cAMP cascade in melanocytes and drives eumelanin synthesis while reducing free-radical formation.
- Benefits & use
- Photoprotection in EPP - increased pain-free light exposure; in research also studied for pigmentation (no approved cosmetic indication).
- Study status
- EMA approval 2014, FDA approval 2019 (Scenesse, NDA 210797); two pivotal Phase 3 trials in EPP. Critical literature on unregulated "Melanotan-1" products: Langan 2010, PMID 19747333.
- Dosing note
- No dosage advice here. Approved Scenesse dose: one 16 mg subcutaneous implant every 2 months, by trained professionals only; no approved dose for Melanotan-1 in any other dosage form.
Use in the injection calculator
Melanotan-1 is a synthetic peptide hormone and analogue of endogenous alpha-melanocyte-stimulating hormone (alpha-MSH). It acts as an agonist at the melanocortin-1 receptor (MC1R) on melanocytes and drives eumelanin synthesis. As afamelanotide it is approved under the brand name Scenesse by the EMA (since 2014) and the FDA (since 2019) - but only as a subcutaneous implant for adults with erythropoietic protoporphyria (EPP). A cosmetic tanning indication is not approved.
What is Melanotan-1 and how does it work?
Melanotan-1 (also known as [Nle4-D-Phe7]-alpha-MSH) is a linear peptide with markedly greater stability than endogenous alpha-MSH. MC1R binding triggers a cAMP cascade in melanocytes, leading to:
- increased eumelanin (dark pigment) production,
- decreased phaeomelanin (light pigment) production,
- antioxidant effects in the skin via reduced free-radical formation.
The net effect is a built-in photoprotective layer - a slow, biological "sunscreen" that reduces UV-induced damage.
What is Melanotan-1 approved for?
The only regulatorily approved form is Scenesse (afamelanotide 16 mg), a subcutaneous implant. Indication: adults with erythropoietic protoporphyria (EPP), a rare porphyria in which even brief light exposure triggers painful phototoxic reactions. In the pivotal Phase 3 trials, Scenesse significantly increased pain-free sunlight exposure versus placebo. The EMA EPAR and the FDA multi-disciplinary review for NDA 210797 document the underlying evidence in detail.
What is the evidence base?
EPP approval rests on two pivotal Phase 3 trials supporting both EMA and FDA decisions. For cosmetic tanning there is no approved indication and only very limited controlled data. The critical dermatological literature on unregulated internet "Melanotan-1" is summarised by Langan et al., 2010 (PMID 19747333). Importantly, unregulated "Melanotan-1" from uncontrolled sources has not been verified for identity, purity or potency.
How is Scenesse administered?
The approved dose is a single 16 mg implant inserted subcutaneously above the anterior supra-iliac crest every two months - only by trained healthcare professionals. Self-reconstitution and self-injection are not part of the Scenesse label. The FDA label explicitly recommends biannual full-body skin examinations, because afamelanotide can darken pre-existing nevi and ephelides.
How should Melanotan-1 be stored?
Lyophilised powder should be kept cool, dry and dark - see the guide on storing peptides: powder and mixed solution. For a broader look at reconstitution, dosing helpers and other tools, see the Peptipedia tools overview.