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REGN4461 is a fully human monoclonal antibody developed by Regeneron Pharmaceuticals that targets coagulation Factor XI (FXI). It is designed to prevent venous thromboembolism (VTE) by inhibiting the intrinsic pathway of the coagulation cascade. Factor XI is a key component in the amplification of thrombin generation; however, its role in normal hemostasis is relatively limited compared to its role in pathological thrombosis. Consequently, inhibiting FXI is hypothesized to provide effective anticoagulation with a significantly lower risk of clinical bleeding compared to traditional therapies like heparin or direct oral anticoagulants (DOACs). REGN4461 has been evaluated in Phase 2 clinical trials for the prevention of VTE in patients undergoing major orthopedic surgery, such as total knee arthroplasty.
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