Afamelanotide

Melanocortin Receptor Agonist (alpha MSH Analogue)Rx: PrescriptionCompound: Approved

Also known as: [Nle4,D-Phe7]-α-MSH, CUV1647, MT-II precursor analog, NDP-MSH, Scenesse

Educational Only — Not medical advice. Consult a qualified clinician before using any peptide.

Summary

Afamelanotide is a potent, prolonged-acting MC1R agonist delivered as a subcutaneous implant. It is approved in the EU and USA for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). It increases skin melanin content to reduce pain and discomfort from sun exposure.

Mechanism of Action

Synthetic analogue of alpha-melanocyte-stimulating hormone (α-MSH) that binds and activates melanocortin-1 receptor (MC1R) on melanocytes, stimulating melanin synthesis (eumelanin production) and increasing skin pigmentation, thereby providing photoprotection.

Routes of Administration

Subcutaneous

Goals & Uses

  • Vitiligo repigmentationInvestigational UseLow
  • Reduction of phototoxic pain episodesSymptom ManagementHigh
  • Prevention of phototoxic reactions in erythropoietic protoporphyriaDisease ManagementHigh
  • Solar urticaria managementInvestigational UseLow
  • Variegate porphyria photoprotectionInvestigational UseLow
  • Increased skin melanin/pigmentationPhotoprotectionHigh

Contraindications

  • Other active malignant melanocytic lesionsOncologicHigh
  • Melanoma or history of melanomaOncologicHigh
  • PregnancyPopulationHighPotential fetal risk or insufficient safety data
  • Hypersensitivity to afamelanotide or excipientsAllergy/immunologicHigh
  • Renal or hepatic impairment (severe)Organ ImpairmentModerate

Adverse Effects

  • HeadacheNeurologicCommonPain in the head or upper neck
  • Hyperpigmentation of skin and mucous membranesDermatologicCommon
  • NauseaGastrointestinalCommonFeeling of sickness or urge to vomit
  • Implant site reactions (bruising, pain, scarring)Local/dermatologicCommon
  • FatigueGeneralUncommonLow energy or tiredness
  • New or changed melanocytic neviDermatologicUncommon

Drug Interactions

  • Photosensitizing agentsModerate
  • ImmunosuppressantsLowPotential interaction with immune pathways or infection risk

Population Constraints

  • Pediatric patients (<18 years)AgeRelative
  • Breastfeeding womenReproductiveRelative
  • Patients with numerous atypical neviDermatologic RiskRelative
  • Pregnant womenReproductiveRelative
  • Patients with personal or family history of melanomaOncologic HistoryAbsolute

Regulatory Status

  • European UnionApprovedApproved: Prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP)Approved by EMA in December 2014 under brand name Scenesse. Orphan designation. Marketed by Clinuvel Pharmaceuticals.
  • United StatesApprovedApproved: Prevention of phototoxicity in adults with erythropoietic protoporphyria (EPP)FDA approved October 2019 (NDA 210797). Orphan drug designation. Breakthrough therapy designation received during review.
  • United KingdomApprovedApproved: Prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP)Retained EU approval status post-Brexit; regulated by MHRA.

Approved by EMA in 2014 (Scenesse) for EPP in adults. FDA approved in 2019 for the same indication. Orphan drug designation in both EU and USA.

Evidence & Sources

No sources recorded yet.

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