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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

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 effect10 studies

Studies that measured pain-free sun exposure time

Quality of Life (EPP)

Improved outdoor activity participation

Improves (the measure goes up)Moderate effect10 studies

Studies that measured quality of life (epp)

Phototoxic Reactions

77 vs 146 reactions over 9 months treatment

Improves (the measure goes down)Large effect3 studies

Studies that measured phototoxic reactions

Skin Health

Skin Health: outcomes studied for Afamelanotide
GradeOutcomeEffectSizeStudiesPeopleStudies list
Eumelanin Production

Consistent melanogenic activity in all subjects

Improves (the measure goes up)Large effect3 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 effect11 studies

Studies that measured skin repigmentation (vitiligo)

and 1 more in the citations list

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

Studies that measured safety/tolerability

Liver Protection

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

Improves (the measure goes up)Small effect5 studies

Studies that measured liver protection

Immune Function

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

Improves (the measure goes up)Small effect4 studies

Studies that measured immune function

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

28 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. Afamelanotide in protoporphyria and other skin diseases: a reviewExpert Opin Orphan Drugs, 2024 · PMID 38715490
  5. Bridging Molecular Mechanism and Clinical Practice in Vitiligo Treatment: An Updated Review.Dermatology (Basel, Switzerland), 2024 · PMID 38417409
  6. 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
  7. Afamelanotide in protoporphyria and other skin diseases: a review.Postepy dermatologii i alergologii, 2024 · PMID 38784937
  8. 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
  9. Afamelanotide Is Associated with Dose-Dependent Protective Effect from Liver Damage Related to Erythropoietic Protoporphyria.Life (Basel, Switzerland), 2023 · PMID 37109595
  10. Afamelanotide for prevention of phototoxicity in erythropoietic protoporphyriaExpert Rev Clin Pharmacol, 2021 · PMID 33486349
  11. Afamelanotide for prevention of phototoxicity in erythropoietic protoporphyria.Expert review of clinical pharmacology, 2021 · PMID 33507118
  12. Immunopathogenesis and management of polymorphic light eruption.Dermatologic therapy, 2021 · PMID 34676645
  13. 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
  14. Afamelanotide in combination with NB-UVB for treatment of vitiligo in an Asian populationJ Dermatol Treat, 2020 · PMID 32498495
  15. Current and innovative emerging therapies for porphyrias with hepatic involvement.Journal of hepatology, 2019 · PMID 31102718
  16. Risks of unregulated use of alpha-melanocyte-stimulating hormone analogues: a review.International journal of dermatology, 2017 · PMID 28266027
  17. Afamelanotide: A Review in Erythropoietic ProtoporphyriaAm J Clin Dermatol, 2016 · PMID 26979527
  18. Afamelanotide for Erythropoietic ProtoporphyriaN Engl J Med, 2015 · PMID 26132941
  19. Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trialJAMA Dermatol, 2015 · PMID 25230094
  20. Afamelanotide (CUV1647) in dermal phototoxicity of erythropoietic protoporphyria.Expert review of clinical pharmacology, 2015 · PMID 25470471
  21. 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
  22. Afamelanotide: first-in-class melanocortin 1 receptor agonistExp Dermatol, 2014 · PMID 24854299
  23. 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
  24. A review and update on melanocyte stimulating hormone therapy: afamelanotide.Journal of drugs in dermatology : JDD, 2013 · PMID 23884489
  25. A one-year open-label safety study of afamelanotide in erythropoietic protoporphyriaBr J Dermatol, 2012 · PMID 22762766
  26. Afamelanotide, an agonistic analog of α-melanocyte-stimulating hormone, in dermal phototoxicity of erythropoietic protoporphyria.Expert opinion on investigational drugs, 2010 · PMID 21073357
  27. A randomized double-blind vehicle-controlled study to assess the safety and efficacy of afamelanotide in the treatment of vitiligoArch Dermatol, 2009 · PMID 19220089
  28. An open-label, dose-escalation study of afamelanotide in erythropoietic protoporphyriaBr J Dermatol, 2009 · PMID 20337532