Afamelanotide

Afamelanotide (Scenesse) — MC1R Agonist

Evidence & Status

  • FDA Approved
  • Strong Human Evidence
  • Strong

At a Glance

A 16 mg controlled-release SCENESSE implant for adults with EPP and phototoxic reactions. It is inserted above the anterior supra-iliac crest every 2 months to increase pain-free light exposure; it is not a tanning treatment.

Plain English

Afamelanotide is the active molecule in SCENESSE, a controlled-release implant used for adults with erythropoietic protoporphyria. The labeled goal is more pain-free light exposure, not cosmetic tanning or general anti-aging photoprotection. Skin monitoring and light-protection measures remain important.

Overview

Afamelanotide is a synthetic alpha-MSH analogue and MC1R agonist. SCENESSE is a 16 mg controlled-release subcutaneous implant for adults with a history of phototoxic reactions from erythropoietic protoporphyria (EPP), intended to increase pain-free light exposure. The implant is inserted above the anterior supra-iliac crest. This record does not equate SCENESSE with native alpha-MSH, Melanotan II, setmelanotide, or unapproved tanning peptides.

Research Summary

Human randomized evidence supports SCENESSE for adult EPP, where the treatment increased pain-free light exposure in the studied population. The current product is a controlled-release 16 mg implant placed above the anterior supra-iliac crest every 2 months, with an apparent half-life of approximately 15 hours for the implant formulation. EPP evidence must not be transferred to cosmetic tanning, generalized UV protection, anti-aging, or non-EPP photoprotection.

Research Areas

  • Erythropoietic protoporphyria
  • Photoprotection
  • Melanocyte biology
  • MC1R pharmacology
  • Skin pigmentation
  • Phototoxicity

Safety & Risks

Serious Risks

  • Serious hypersensitivity reactions, including anaphylaxis, have been reported with SCENESSE
  • SCENESSE is contraindicated in patients with a history of severe hypersensitivity to afamelanotide or its excipients
  • Darkening of existing nevi and ephelides can occur; twice-yearly full-body skin examinations are recommended to monitor existing and new pigmented lesions

Reported Side Effects

  • Implant site reactions
  • Nausea
  • Oropharyngeal pain
  • Cough
  • Fatigue
  • Dizziness
  • Skin hyperpigmentation
  • Somnolence
  • Melanocytic nevus changes
  • Skin irritation
United States
FDA-approved as SCENESSE, a 16 mg controlled-release subcutaneous implant, to increase pain-free light exposure in adults with erythropoietic protoporphyria (EPP).
United Kingdom
International regulatory status is not represented by the selected sources in this record.
Australia
International regulatory status is not represented by the selected sources in this record.
Canada
International regulatory status is not represented by the selected sources in this record.

Citations & Sources