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 BehringLatest Information Update: 23 Feb 2024
Price :
$50
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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
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- 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