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Garadacimab - CSL Behring

Drug Profile

Garadacimab - CSL Behring

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

Latest Information Update: 23 Feb 2024

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At a glance

  • Originator CSL Behring
  • Class Antibodies; Antifibrotics; Antithrombotics; 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; Hereditary angioedema
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Hereditary angioedema
  • Phase II COVID 2019 infections; Idiopathic pulmonary fibrosis; Interstitial lung diseases

Most Recent Events

  • 02 Jan 2024 CSL Behring completes a phase-II trial in Idiopathic pulmonary fibrosis in United Kingdom, Poland, Poland, Spain, Italy, Germany, Denmark, Belgium, Belgium, Canada, Austria, Australia and USA (IV, SC) (NCT05130970)
  • 14 Dec 2023 EMA accepts MAA for Garadacimab for Hereditary angioedema for review
  • 14 Dec 2023 US FDA accepts BLA for Garadacimab for Hereditary angioedema for review
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