Afamelanotide

Peptide

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'.

Quick Answer

What it is

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.

Key findings

  • Grade A: Pain-Free Sun Exposure Time (Photodermatoses)
  • Grade A: Phototoxic Reactions (Photodermatoses)
  • Grade A: Quality of Life (EPP) (Photodermatoses)

Safety

No specific caution or interaction language was detected in the current summary/outcome notes.

⚠️ Research Notice

This peptide information is for educational and research purposes only. Peptides may not be FDA-approved for human use and may only be legally available for research purposes. Consult qualified healthcare professionals before considering any peptide compounds.

ℹ️ Quick Facts: Afamelanotide

Quick Facts: Afamelanotide

  • Best Evidence:Grade A
  • Conditions Studied:3
  • Research Outcomes:8
  • Grade A Findings:4
  • Grade B Findings:2
  • Key Effect:Photodermatoses
A4
B2
C1
D1
3 conditions · 8 outcomes

Detailed Outcomes

|
A
Pain-Free Sun Exposure Time
69.4 vs 40.8 hours median (US trial); 6.0 vs 0.8 hours (EU trial)
largeWorsens
A
Phototoxic Reactions
77 vs 146 reactions over 9 months treatment
largeImproves
A
Quality of Life (EPP)
Improved outdoor activity participation
moderateImproves
A
Eumelanin Production
Consistent melanogenic activity in all subjects
largeImproves
B
Safety/Tolerability
5 human trials support this finding. Human clinical trial data available.
smallImproves
C
Liver Protection
3 human trials support this finding. Human clinical trial data available.
smallImproves
D
Immune Function
2 human trials support this finding. Human clinical trial data available.
smallImproves
B
Skin Repigmentation (Vitiligo)
48.64% vs 33.26% repigmentation with NB-UVB combination
moderateImproves

Research Citations (28)

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)
(2025)
PMID: 40082741
Afamelanotide in managing cutaneous phototoxicity in erythropoietic protoporphyria: a Scottish perspective.
(2025)
PMID: 40692281
Treatment Advances in Vitiligo: An Updated Review.
(2025)
PMID: 40117616
Afamelanotide in protoporphyria and other skin diseases: a review
(2024)
PMID: 38715490
Bridging Molecular Mechanism and Clinical Practice in Vitiligo Treatment: An Updated Review.
(2024)
PMID: 38417409
A systematic review of case series and clinical trials investigating systemic oral or injectable therapies for the treatment of vitiligo.
(2024)
PMID: 38454597
Afamelanotide in protoporphyria and other skin diseases: a review.
(2024)
PMID: 38784937
A feasibility and safety study of afamelanotide in acute stroke patients - an open label, proof of concept, phase iia clinical trial.
(2023)
PMID: 37496004
Afamelanotide Is Associated with Dose-Dependent Protective Effect from Liver Damage Related to Erythropoietic Protoporphyria.
(2023)
PMID: 37109595
Afamelanotide for prevention of phototoxicity in erythropoietic protoporphyria
(2021)
PMID: 33486349