Dossier overview
4
research areas
3
references
3
handling notes
01
Mechanism of action
Afamelanotide activates the melanocortin-1 (MC1R) on melanocytes, increasing eumelanin production. In EPP, the elevated cutaneous eumelanin is associated with reduced light-induced phototoxicity caused by protoporphyrin IX accumulation.
02
Research applications
- Erythropoietic protoporphyria (approved indication)
- Photodermatosis and pigmentary disorder research
- Vitiligo research (investigational)
- Melanocortin pharmacology
Evidence at a glance
What's behind this profile
3 citations · 2015–2019
- Human
- 1
- Review
- 2
Studies in human volunteers or patients (incl. early-phase trials).
Narrative or systematic reviews; no primary data.
Publication years
- 15
- 16
- 17
- 18
- 19
Counts are derived from the cited studies below. A study covering both in vivo and in vitro work is counted by its primary model. Sample size is reported in 1 of 3 citations. Findings remain model-specific and are not extrapolated to therapeutic use.
03
Study references
Each profile cites a minimum of two peer-reviewed sources, with model type and reported sample size where the source provides it. Findings are model-specific and must not be extrapolated to therapeutic use.
Afamelanotide for Erythropoietic Protoporphyria
2015
Langendonk JG et al. · New England Journal of Medicine
- Model
- Two multicentre randomised double-blind placebo-controlled trials in adults with EPP
- Sample
- n=168 (74 EU, 94 US)
Subcutaneous afamelanotide implants were associated with increased pain-free sun exposure duration and improved quality of life in adults with erythropoietic protoporphyria.
Pharmacokinetics and Pharmacodynamics of Afamelanotide and its Clinical Use in Treating Dermatologic Disorders
2017
Minder EI et al. · Clinical Pharmacokinetics
- Model
- Narrative review of pharmacokinetic and clinical-trial data
- Sample
- N/A (review)
Reviewed afamelanotide PK/PD and clinical evidence across erythropoietic protoporphyria and other photodermatoses, summarising the safety profile from approved-product use.
X-Linked Protoporphyria
2019
Balwani M et al. · GeneReviews
- Model
- Clinical genetic review
- Sample
- N/A (review)
Discussed X-linked protoporphyria management including afamelanotide administration to reduce phototoxicity and pain through MC1R-mediated melanogenesis.
Evidence caveats
- FDA approval is specific to erythropoietic protoporphyria. Off-label use (including for cosmetic tanning) is not endorsed and is associated with adverse events documented in the dermatology literature.
- Synthetic 'Melanotan-1' sold through unregulated channels is not equivalent to the approved Scenesse implant and may have purity, dose, and contamination risks.
04
Storage and handling
Approved product is supplied as a controlled-release implant via authorised channels. Research-grade material must be stored under controlled laboratory conditions per protocol.
- Approved product (Scenesse) is supplied as a controlled-release subcutaneous implant; administered only by Clinuvel-authorised healthcare professionals.
- Research-grade material requires controlled storage and full batch documentation.
- Synthetic Melanotan-1 sold outside the approved Scenesse channel is not equivalent to the regulated product.