Bristol Myers Squibb and Janssen Initiate Phase 3 LIBREXIA-STROKE Trial for Milvexian

Bristol Myers Squibb and Janssen today announced the initiation of the Phase 3 LIBREXIA-STROKE trial evaluating milvexian, an oral Factor XIa inhibitor, for secondary prevention in patients with ischemic stroke or transient ischemic attack. The trial will enroll approximately 15,000 patients and compare milvexian to aspirin. Milvexian represents a novel approach to stroke prevention by targeting Factor XIa, which plays a key role in pathological clot formation while having a more limited role in normal hemostasis. Phase 2 data showed promising efficacy with a favorable bleeding profile. The LIBREXIA-STROKE trial is expected to complete enrollment within 24 months.