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Garadacimab - CSL Behring

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Drug Profile

Garadacimab - CSL Behring

Alternative Names: ANDEMBRY; Andembry; Anti-FXIIa mAb - CSL Behring; Anti-FXIIa monoclonal antibody - CSL Behring; CSL 312; Factor XIIa antagonist monoclonal antibody - CSL Behring

Latest Information Update: 20 Jun 2025

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At a glance

  • Originator CSL Behring
  • Class Antibodies; Antifibrotics; Antithrombotics; Antivirals; Monoclonal antibodies; Skin disorder therapies; Vascular disorder therapies
  • Mechanism of Action Factor XIIa inhibitors
  • Orphan Drug Status

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

    Yes - Angioedema
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Hereditary angioedema
  • Discontinued COVID 2019 infections; Idiopathic pulmonary fibrosis; Interstitial lung diseases

Most Recent Events

  • 16 Jun 2025 Registered for Hereditary angioedema (Prevention) in United Arab Emirates (unspecified route)
  • 16 Jun 2025 Registered for Hereditary angioedema (Prevention, In the elderly, In adolescents, In adults) in USA (SC)
  • 18 Apr 2025 Launched for Hereditary angioedema (Prevention) in Japan (SC) - First global launch

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