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Clascoterone - Cassiopea

Drug Profile

Clascoterone - Cassiopea

Alternative Names: Breezula; CB-03-01; Cortexolone 17alpha-propionate; Winlevi

Latest Information Update: 14 Mar 2021

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At a glance

  • Originator Cosmo Pharmaceuticals
  • Developer Cassiopea; Intrepid Therapeutics
  • Class Antiacnes; Esters; Pregnenediones; Propionates; Skin disorder therapies; Small molecules
  • Mechanism of Action Androgen receptor antagonists
  • Orphan Drug Status

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

  • New Molecular Entity Yes

Highest Development Phases

  • Registered Acne vulgaris
  • Phase II Alopecia

Most Recent Events

  • 30 Oct 2020 Cassiopea announces intention to launch clascoterone for Acne vulgaris in USA (Topical, Cream) in the first quarter of 2021
  • 27 Aug 2020 Registered for Acne vulgaris (In adolescents, In children, In adults) in USA (Topical, Cream) - First global approval
  • 30 Jun 2020 Cassiopea submits special protocol assessment to the US FDA for a phase III trial in Alopecia (In men) (Topical, Solution) before June 2020
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