Garadacimab FDA Approval Status
Last updated by Melisa Puckey, BPharm on May 30, 2025.
FDA Approved: No
Generic name: garadacimab
Dosage form: Injection
Company: CSL Behring
Treatment for: Hereditary Angioedema
Garadacimab is an investigational first-in-class, Factor XIIa Inhibitor for the prophylactic treatment of hereditary angioedema (HAE)
- Hereditary angioedema (HAE) is a rare, genetic and potentially life-threatening condition that causes painful, debilitating and unpredictable episodes of swelling of the abdomen, larynx, face and extremities, among other areas of the body.
- Garadacimab is a novel Factor XIIa-inhibitory monoclonal antibody (anti-FXIIa mAb) that has completed Phase 3 clinical development as a potential new type of once-monthly subcutaneous prophylactic treatment for attacks related to HAE, a form of bradykinin-mediated angioedema. Garadacimab uniquely inhibits the plasma protein, FXIIa. When FXII is activated, it initiates the cascade of events leading to edema formation. By targeting activated FXII (FXIIa), garadacimab inhibits this cascade at the top as compared to HAE therapies that target downstream mediators.
- If approved, patients will have the benefit of an auto injector (pre-filled pen) for convenient administration.
- CSL is also investigating garadacimab for other indications beyond HAE, including idiopathic pulmonary fibrosis, where FXIIa inhibition may play an important role in improving clinical outcomes.
Development timeline for garadacimab
Further information
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