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Garadacimab - CSL Behring

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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: 02 Apr 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

  • 23 Feb 2024 Pharmacokinetics and adverse events data from a phase I pharmacokinetics trial presented at 2024 Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2024)
  • 23 Feb 2024 Pooled efficacy and adverse events data from phase III VANGUARD study and open label phase III study in Hereditary Angioedema presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2024)
  • 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)
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