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Afamelanotide - Clinuvel Pharmaceuticals

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Drug Profile

Afamelanotide - Clinuvel Pharmaceuticals

Alternative Names: [Nle4,DPhe7]-alpha-MSH; Afamelanotide acetate; CUV-1647; EPT-1647; Melanotan I; Melanotan™; MT I; PRENUMBRA; Scenesse; Scenesse® Enfance

Latest Information Update: 07 Aug 2026

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At a glance

  • Originator University of Arizona
  • Developer Clinuvel Pharmaceuticals; Winhealth Pharma
  • Class Antiacnes; Antineoplastics; Antipyretics; Melanocyte-stimulating hormones; Peptides; Skin disorder therapies; Vascular disorder therapies
  • Mechanism of Action Melanocortin type 1 receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Erythropoietic protoporphyria; Pemphigus; Urticaria
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Erythropoietic protoporphyria
  • Phase III Polymorphus light eruptions; Vitiligo
  • Phase II Hepatic-porphyria; Ischaemic stroke; Pemphigus; Xeroderma pigmentosum
  • Preclinical Parkinson's disease
  • Suspended Urticaria
  • Discontinued Acne vulgaris; Actinic keratosis; Photodamage; Squamous cell cancer

Most Recent Events

  • 28 Jul 2026 Clinuvel Pharmaceuticals plans a phase III trial for Vitiligo in November 2026
  • 13 Jul 2026 Registered for Erythropoietic protoporphyria (Prevention) in Canada (SC)
  • 24 Apr 2026 CLINUVEL Pharmaceuticals receives scientific advice from EMA for design of phase III CUV-107 trial in Vitiligo

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