Afamelanotide

Drug Profile

Afamelanotide

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

Latest Information Update: 04 Aug 2016

Price : $50

At a glance

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

Most Recent Events

  • 03 Aug 2016 Clinuvel plans to request a Type C guidance meeting with the US FDA
  • 19 Jul 2016 Clinuvel announces intention to submit NDA to US FDA
  • 06 Jul 2016 Afamelanotide receives Fast Track designation for Erythropoietic protoporphyria [SC,Controlled release] (Prevention) in USA
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