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Peptide

Afamelanotide

Afamelanotide (Scenesse) is an FDA-approved (2019) prescription drug for erythropoietic protoporphyria (EPP), a rare genetic photosensitivity disorder. It's a synthetic α-MSH analog that stimulates eumelanin production WITHOUT UV exposure. A-GRADE evidence for increasing pain-free sun exposure and reducing phototoxic reactions. B-GRADE for vitiligo repigmentation (with NB-UVB). This is a PRESCRIPTION IMPLANT, not a tanning supplement. Related to but distinct from illegal 'Melanotan II'.

Research notice. This page is for education and research. Peptides may not be FDA-approved for human use and may only be legally available for research. Talk to a qualified clinician before considering any peptide.

Best evidence
Grade A
Conditions studied
3
Outcomes
8
Graded outcomes
4211

Evidence by condition

  • Strong
  • Moderate
  • Limited
  • Very limited

3 conditions, plus general outcomes

Photodermatoses: outcomes studied for Afamelanotide
GradeOutcomeEffectSizeStudiesPeopleStudies list
Pain-Free Sun Exposure Time

69.4 vs 40.8 hours median (US trial); 6.0 vs 0.8 hours (EU trial)

Changes; see studiesLarge effect6 studies
Quality of Life (EPP)

Improved outdoor activity participation

Improves (the measure goes up)Moderate effect6 studies
Phototoxic Reactions

77 vs 146 reactions over 9 months treatment

Improves (the measure goes down)Large effect2 studies

Studies that measured phototoxic reactions

Skin Health: outcomes studied for Afamelanotide
GradeOutcomeEffectSizeStudiesPeopleStudies list
Eumelanin Production

Consistent melanogenic activity in all subjects

Improves (the measure goes up)Large effect2 studies

Studies that measured eumelanin production

Vitiligo

  • Skin Repigmentation (Vitiligo): improves
Vitiligo: outcomes studied for Afamelanotide
GradeOutcomeEffectSizeStudiesPeopleStudies list
Skin Repigmentation (Vitiligo)

48.64% vs 33.26% repigmentation with NB-UVB combination

Improves (the measure goes up)Moderate effect7 studies

Studies that measured skin repigmentation (vitiligo)

General

  • Safety/Tolerability: improves
  • Liver Protection: improves
  • Immune Function: improves
General: outcomes studied for Afamelanotide
GradeOutcomeEffectSizeStudiesPeopleStudies list
Safety/Tolerability

5 human trials support this finding. Human clinical trial data available.

Improves (the measure goes up)Small effect7 studies
Liver Protection

3 human trials support this finding. Human clinical trial data available.

Improves (the measure goes up)Small effect5 studies
Immune Function

2 human trials support this finding. Human clinical trial data available.

Improves (the measure goes up)Small effect4 studies

Key findings

  • Pain-Free Sun Exposure TimePhotodermatosesChanges; see studies
  • Quality of Life (EPP)PhotodermatosesImproves (the measure goes up)
  • Phototoxic ReactionsPhotodermatosesImproves (the measure goes down)

Studies cited

21 studies from PubMed

  1. German Cohort Observational Study to Investigate the Short- and Long-Term Safety and Clinical Effectiveness of Afamelanotide 16 mg (SCENESSE) in Patients With Erythropoietic Protoporphyria (EPP)Br J Dermatol, 2025 · PMID 40082741
  2. Afamelanotide in managing cutaneous phototoxicity in erythropoietic protoporphyria: a Scottish perspective.Clinical and experimental dermatology, 2025 · PMID 40692281
  3. Treatment Advances in Vitiligo: An Updated Review.Dermatology practical & conceptual, 2025 · PMID 40117616
  4. Bridging Molecular Mechanism and Clinical Practice in Vitiligo Treatment: An Updated Review.Dermatology (Basel, Switzerland), 2024 · PMID 38417409
  5. A systematic review of case series and clinical trials investigating systemic oral or injectable therapies for the treatment of vitiligo.Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI), 2024 · PMID 38454597
  6. Afamelanotide in protoporphyria and other skin diseases: a review.Postepy dermatologii i alergologii, 2024 · PMID 38784937
  7. A feasibility and safety study of afamelanotide in acute stroke patients - an open label, proof of concept, phase iia clinical trial.BMC neurology, 2023 · PMID 37496004
  8. Afamelanotide Is Associated with Dose-Dependent Protective Effect from Liver Damage Related to Erythropoietic Protoporphyria.Life (Basel, Switzerland), 2023 · PMID 37109595
  9. Afamelanotide for prevention of phototoxicity in erythropoietic protoporphyria.Expert review of clinical pharmacology, 2021 · PMID 33507118
  10. Immunopathogenesis and management of polymorphic light eruption.Dermatologic therapy, 2021 · PMID 34676645
  11. Beyond pigmentation: signs of liver protection during afamelanotide treatment in Swiss patients with erythropoietic protoporphyria, an observational study.Therapeutic advances in rare disease, 2021 · PMID 37181106
  12. Current and innovative emerging therapies for porphyrias with hepatic involvement.Journal of hepatology, 2019 · PMID 31102718
  13. Risks of unregulated use of alpha-melanocyte-stimulating hormone analogues: a review.International journal of dermatology, 2017 · PMID 28266027
  14. Afamelanotide: A Review in Erythropoietic ProtoporphyriaAm J Clin Dermatol, 2016 · PMID 26979527
  15. Afamelanotide for Erythropoietic ProtoporphyriaN Engl J Med, 2015 · PMID 26132941
  16. Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trialJAMA Dermatol, 2015 · PMID 25230094
  17. Afamelanotide (CUV1647) in dermal phototoxicity of erythropoietic protoporphyria.Expert review of clinical pharmacology, 2015 · PMID 25470471
  18. 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.Skin pharmacology and physiology, 2015 · PMID 25402764
  19. A bioassay for the detection of neutralizing antibodies against the α-melanocyte stimulating hormone analog afamelanotide in patients with erythropoietic protoporphyriaJ Pharm Biomed Anal, 2013 · PMID 23277150
  20. A review and update on melanocyte stimulating hormone therapy: afamelanotide.Journal of drugs in dermatology : JDD, 2013 · PMID 23884489
  21. Afamelanotide, an agonistic analog of α-melanocyte-stimulating hormone, in dermal phototoxicity of erythropoietic protoporphyria.Expert opinion on investigational drugs, 2010 · PMID 21073357