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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: 10 Apr 2025

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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; Urticaria; Pemphigus
  • 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

  • 26 Mar 2025 Efficacy and adverse events data from a phase II trial in Ischaemic stroke released by Clinuvel Pharmaceuticals
  • 26 Mar 2025 Clinuvel Pharmaceuticals completes a phase II CUV803 trial in Ischaemic stroke (In adults, In the elderly) in Spain (SC) (EudraCT2021-006126-52)
  • 28 Feb 2025 No recent reports of development identified for phase-I development in Xeroderma-pigmentosum(In volunteers, In adults) in United Kingdom (SC, Implant)

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