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APZ 2

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Drug Profile

APZ 2

Alternative Names: ABCB5+-cells; ABCB5-positive mesenchymal stem cells - RHEACELL; allo-APZ2-ACLF; allo-APZ2-CVU; allo-APZ2-DFU; allo-APZ2-EB; ALLO-APZ2-PAOD; AMESANAR; APZ-1; APZ2; EBESANAR

Latest Information Update: 09 Jun 2025

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At a glance

  • Originator RHEACELL
  • Class Mesenchymal stem cell therapies; Stem cell therapies
  • Mechanism of Action Cell replacements
  • 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 Varicose ulcer
  • Phase III Epidermolysis bullosa
  • Phase II Diabetic foot ulcer
  • Phase I/II Liver failure
  • Preclinical Graft-versus-host disease; Polycystic kidney disease; Transplant rejection
  • No development reported Peripheral arterial occlusive disorders

Most Recent Events

  • 27 May 2025 RHEACELL and AOP Health enters into an agreement to commercialize RHEACELL's cell therapies for Epidermolysis bullosa and chronic venous wounds
  • 27 May 2025 RHEACELL announces intention to submit the regulatory application to the EMA in 2026
  • 05 Jul 2024 RHEACELL plans a phase III trial for Varicose ulcer (Topical) (NCT06489028)

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