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Clascoterone - Cosmo Pharmaceuticals

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Drug Profile

Clascoterone - Cosmo Pharmaceuticals

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

Latest Information Update: 13 Mar 2026

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At a glance

  • Originator Cosmo Pharmaceuticals
  • Developer 3SBio; Cassiopea; Cosmo Pharmaceuticals; Glenmark Pharmaceuticals Ltd; Sun Pharmaceutical Industries
  • 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.

    No
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Acne vulgaris
  • Phase III Alopecia

Most Recent Events

  • 09 Mar 2026 Zhejiang Sunshine Mandi Pharmaceutical plans a phase III trial for Acne vulgaris (In adolescents, In adults, In the elderly) in May 2025 (Topical) (NCT07457294)
  • 18 Nov 2025 Registered for Acne vulgaris (In adolescents, In children, In adults) in European Union (Topical)
  • 18 Nov 2025 Registered for Acne vulgaris (In children, In adults, In adolescents) in Iceland, Liechtenstein, Norway (Topical)

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