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Afamelanotide - Clinuvel Pharmaceuticals

Drug Profile

Afamelanotide - Clinuvel Pharmaceuticals

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

Latest Information Update: 16 Jan 2019

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At a glance

  • Originator University of Arizona
  • Developer Clinuvel Pharmaceuticals
  • Class Antineoplastics; Antipyretics; Melanocyte-stimulating hormones; Peptides; Skin disorder therapies
  • Mechanism of Action Melanin stimulants; Melanocortin type 1 receptor agonists; Melanocyte modulators
  • 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 II Pemphigus; Vitiligo
  • Suspended Photodamage; Polymorphus light eruptions; Urticaria
  • Discontinued Acne vulgaris; Actinic keratosis; Squamous cell cancer

Most Recent Events

  • 10 Jan 2019 Afamelanotide receives priority review status for Erythropoietic protoporphyria (EPP) (Prevention) in USA
  • 10 Jan 2019 FDA assigns PDUFA action date of (08/07/2019) for afamelanotide for Erythropoietic protoporphyria (EPP) (Prevention)
  • 19 Dec 2018 Pooled efficacy and adverse events data from the phase II CUV103 trial in Vitiligo released by Clinuvel Pharmaceuticals
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