garadacimab

Garadacimab is a fully human recombinant **monoclonal antibody** developed by CSL as a long-acting prophylactic therapy for **hereditary angioedema**. It selectively inhibits **activated coagulation factor XII** at the **Factor XIIa** stage, thereby blocking initiation of the plasma contact system and downstream kallikrein-bradykinin signaling that drives edema formation in bradykinin-mediated angioedema. Clinical data from phase 2 and phase 3 studies, including the VANGUARD trial, support once-monthly **subcutaneous** administration for prevention of HAE attacks, with a loading-dose regimen used in phase 3 and a favorable safety profile without an observed bleeding signal despite pharmacodynamic prolongation of aPTT. CSL has also explored garadacimab in other FXIIa-linked inflammatory indications such as idiopathic pulmonary fibrosis and previously COVID-19.

Brand names

Andembry

Other names

Immunoglobulin G4, anti-(human blood-coagulation factor XIIa) (human monoclonal CSL312 gamma4-chain), disulfide with human monoclonal CSL312 lambda-chain, dimer