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Research summary

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Melanotan I (MT-1 / Afamelanotide)

Clinical — 10 studies

Melanotan I, known in clinical papers as afamelanotide, is a modified form of alpha-MSH, the hormone that prompts pigment cells to make melanin. All of the studies cited here involve people, and most concern erythropoietic protoporphyria, a rare condition in which sunlight causes pain.

Updated

Being studied for

  • Erythropoietic protoporphyria studies
  • Melanocortin analogue pharmacology
  • Skin pigmentation and UV exposure
  • Inflammatory skin disease trials
  • Peptide immunogenicity testing

What the research shows

Ten publications are cited, spanning 2006 to 2026. Seven concern erythropoietic protoporphyria (EPP): randomised controlled trials published in 2015, a phase 3 study of immunogenicity, and five observational cohorts, among them Austrian, German and US patient groups and a long-term series of 115 patients. The other three are a 2006 study in fair-skinned volunteers and two phase 2 trials from 2014, one in acne vulgaris and one in Hailey-Hailey disease.

In the EPP trials, afamelanotide was associated with longer sun exposure without pain and higher quality-of-life scores, with an adverse-event profile the investigators judged acceptable. The immunogenicity study detected no anti-drug antibodies during long-term administration. Four of the cohorts reported gains in quality of life under routine conditions, two of them also in light tolerance, with high adherence and few discontinuations in the 115-patient series. The US cohort found no change in protoporphyrin levels or liver function measures, and a multicentre cohort found vitamin D levels unaffected. Outside EPP, the volunteer study reported increased pigmentation and less UV damage in fair-skinned people who normally burn, the acne trial described apparent anti-inflammatory effects, and the Hailey-Hailey investigators concluded that skin lesions responded.

The evidence is narrow. Seven of the ten studies concern one rare disorder, and the 2015 trials used a controlled-release pharmaceutical implant; they say nothing about cosmetic tanning, and that formulation cannot be assumed equivalent to other material. The cohort data are observational, without the randomised comparison of the 2015 trials. Outside EPP, the evidence is one volunteer study and two phase 2 trials, and the acne investigators called for further trials to confirm what they saw.

Published Research

Evidence profile

Human Phase 3 evidence

10 cited publications · 5 primary trials

Findings below belong to the studies that reported them. They describe the material and conditions those authors used, not this product, and not an outcome to expect.

Core evidence

The publications most central to understanding this compound.

ClinicalRandomised controlled trials

Afamelanotide for Erythropoietic Protoporphyria

Langendonk JG et al. · The New England journal of medicine · 2015

Population: Adults with erythropoietic protoporphyria

The controlled trials of afamelanotide in erythropoietic protoporphyria, measuring pain-free time tolerated in sunlight.

As reported by the study

Route reported
Subcutaneous implant
Duration
Multiple treatment periods across two trials

Context: Studied a controlled-release pharmaceutical implant in a rare photodermatosis. It does not describe cosmetic tanning use, and the material is not comparable.

PMID 26132941DOI 10.1056/NEJMoa1411481NCT00979745View on PubMed

Supporting evidence

ClinicalPrimary trial · Phase 3

Evaluation of the immunogenicity of the synthetic α-melanocyte-stimulating hormone (α-MSH) analogue afamelanotide ([Nle4-D-Phe7]-α-MSH, Scenesse®) in erythropoietic protoporphyria patients by ELISA detecting both anti-afamelanotide and anti-α-MSH antibodies

Lengweiler S et al. · Skin pharmacology and physiology · 2015

The study reportedThe new ELISA is suitable to determine ADA against afamelanotide and α-MSH. Afamelanotide did not elicit ADA during long-term administration in patients with EPP.

PMID 25402764DOI 10.1159/000362174View on PubMed
ClinicalPrimary trial · Phase 2

Beneficial effects of the melanocortin analogue Nle4-D-Phe7-α-MSH in acne vulgaris

Böhm M et al. · Journal of the European Academy of Dermatology and Venereology : JEADV · 2014

The study reportedAfamelanotide appears to have anti-inflammatory effects in patients with mild-to-moderate acne vulgaris. Future trials are needed to confirm the anti-inflammatory action of this melanocortin analogue in patients with acne vulgaris.

PMID 22845050DOI 10.1111/j.1468-3083.2012.04658.xView on PubMed
ClinicalPrimary trial · Phase 2

Efficacy of the melanocortin analogue Nle4-D-Phe7-α-melanocyte-stimulating hormone in the treatment of patients with Hailey-Hailey disease

Biolcati G et al. · Clinical and experimental dermatology · 2014

The study reportedAfamelanotide is effective for the treatment of skin lesions in HHD.

PMID 24256215DOI 10.1111/ced.12203View on PubMed
ClinicalPrimary trial

[Nle4-D-Phe7]-alpha-melanocyte-stimulating hormone significantly increased pigmentation and decreased UV damage in fair-skinned Caucasian volunteers

Barnetson RS et al. · The Journal of investigative dermatology · 2006

The study reportedThymine dimer formation was also shown to be reduced by 59% (P = 0.002) in the epidermal basal layer. This study has shown for the first time the potential ability of a synthetic hormone that augments melanin production to provide photoprotection to people who normally burn in direct sunlight.

PMID 16763547DOI 10.1038/sj.jid.5700317View on PubMed
Additional indexed literature (5)

Published studies summarised here concern the specific investigational or pharmaceutical materials and study conditions described by their authors. Their findings are not performance claims for Cobalt Peptides material. Citations verified against PubMed on 2026-09-29.

Afamelanotide, or Melanotan I, has no approval as a cosmetic for general use, and this page reports it only as a subject of published research.

Notice

All information on this page is provided strictly for laboratory research and educational purposes only.