Human RCT-level evidence

Melanotan 1

What the research and the regulators actually say, sourced to primary documents.

Studies indexed
0
Clinical trials
0
Last updated
July 23, 2026

Updated · sourced to primary documents

Research information only, not medical advice. Melanotan-1 (afamelanotide; marketed as Scenesse, formerly CUV1647; also [Nle4,D-Phe7]-alpha-MSH / NDP-MSH) is a synthetic alpha-melanocyte-stimulating hormone analog acting as a melanocortin-1 receptor (MC1R) agonist. The FDA approved it in 2019 as a 16 mg subcutaneous controlled-release implant to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria (EPP). It acts via MC1R-mediated stimulation of eumelanin synthesis, which darkens skin and absorbs/scatters the visible light that activates accumulated protoporphyrin. It must not be confused with melanotan-2, an unapproved drug sold illegally online as an injectable tanning agent and subject to FDA warning action.

Melanotan 1 at a glance

The evidence base consists of two multicenter randomized, double-blind, placebo-controlled phase 3 trials (n=168) that supported the 2019 FDA approval (Langendonk et al., NEJM 2015, PMID 26132941). Afamelanotide increased median pain-free direct sunlight exposure versus placebo (US: 69.4 vs 40.8 hours, P=0.04; EU: 6.0 vs 0.8 hours, P=0.005). The most common adverse events were headache, nausea, and nasopharyngitis, similar across groups, with implant-site discoloration specific to afamelanotide recipients; no drug-related serious adverse events were reported.

See how we grade evidence for the methodology behind this page.

Evidence profile

57 studies
  • Human RCT 1 · 2%
  • Human trial 12 · 21%
  • Review 23 · 40%
  • Animal 1 · 2%
  • In-vitro 8 · 14%
  • Unknown 12 · 21%

The longer the green, the stronger the human evidence. For most research peptides the bar is dominated by animal and in-vitro work, which is a signal to read every claim carefully.

Regulatory status

Indexed research

Sorted by evidence level, strongest first.

+ 47 more studies indexed for Melanotan 1.

Frequently asked questions

Is Melanotan 1 approved for human use?
Melanotan-1 (afamelanotide; marketed as Scenesse, formerly CUV1647; also [Nle4,D-Phe7]-alpha-MSH / NDP-MSH) is a synthetic alpha-melanocyte-stimulating hormone analog acting as a melanocortin-1 receptor (MC1R) agonist. The FDA approved it in 2019 as a 16 mg subcutaneous controlled-release implant to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria (EPP). It acts via MC1R-mediated stimulation of eumelanin synthesis, which darkens skin and absorbs/scatters the visible light that activates accumulated protoporphyrin. It must not be confused with melanotan-2, an unapproved drug sold illegally online as an injectable tanning agent and subject to FDA warning action.
What does the research on Melanotan 1 show?
The evidence base consists of two multicenter randomized, double-blind, placebo-controlled phase 3 trials (n=168) that supported the 2019 FDA approval (Langendonk et al., NEJM 2015, PMID 26132941). Afamelanotide increased median pain-free direct sunlight exposure versus placebo (US: 69.4 vs 40.8 hours, P=0.04; EU: 6.0 vs 0.8 hours, P=0.005). The most common adverse events were headache, nausea, and nasopharyngitis, similar across groups, with implant-site discoloration specific to afamelanotide recipients; no drug-related serious adverse events were reported.