Bayer Initiates Phase 3 OCEANIC-AF Trial for Asundexian in Atrial Fibrillation

Bayer today announced the initiation of the Phase 3 OCEANIC-AF trial evaluating asundexian, a novel oral Factor XIa inhibitor, for the prevention of stroke and systemic embolism in patients with atrial fibrillation. The trial will enroll approximately 18,000 patients across multiple countries and compare asundexian to apixaban. Factor XIa inhibitors represent a new class of anticoagulants that may offer improved safety profiles compared to existing therapies by targeting a pathway more specific to pathological clotting. Asundexian has shown promising results in Phase 2 trials with a favorable bleeding profile. The OCEANIC-AF trial is expected to complete enrollment within 18 months.