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Birch triterpenes - Amryt Pharma

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Drug Profile

Birch triterpenes - Amryt Pharma

Alternative Names: AP 101; Betulin-based oleogel; Episalvan; FILSUVEZ; Filsuvez; Oleogel-S10; Sericare

Latest Information Update: 07 Jul 2025

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At a glance

  • Originator Birken GmbH
  • Developer Amryt Pharma
  • Class Herbal medicines; Skin disorder therapies; Triterpenes
  • Mechanism of Action Keratinocyte modulators; Transient receptor potential channel stimulants
  • Orphan Drug Status

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

    Yes - Epidermolysis bullosa
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Epidermolysis bullosa
  • Registered Wounds
  • Phase III Burns
  • Phase II Actinic keratosis; Radiodermatitis

Most Recent Events

  • 18 Apr 2025 Phase-III clinical trials in Epidermolysis bullosa (In infants, In children, In adolescents, In adults, In the elderly) in Japan (Topical) (NCT06917690)
  • 08 Apr 2025 Chiesi Farmaceutici plans a phase III REVIVE trial in Epidermolysis Bullosa (In infants, In adults, In elderly, In children) in Japan (Topical) in April 2025 (NCT06917690)
  • 19 Dec 2023 Registered for Epidermolysis bullosa (In adolescents, In adults, In children, In the elderly) in USA (Topical)

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