Oleogel S10

Drug Profile

Oleogel S10

Alternative Names: AP 101; Betulin-based oleogel; Birch-triterpene; Episalvan; Oleogel-S10; Sericare

Latest Information Update: 12 Sep 2018

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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

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

Most Recent Events

  • 10 Sep 2018 US FDA approves IND application for oleogel S10 in Epidermolysis Bullosa
  • 02 Aug 2018 Oleogel S10 receives Rare Pediatric Disease Designation for Epidermolysis bullosa in USA
  • 29 Mar 2017 Phase-III clinical trials in Epidermolysis bullosa (In adolescents, In children, In the elderly, In adults) in Spain (Topical) (EudraCT2016-002066-32)
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