• Bayer is proceeding with Phase 3 trials for asundexian, an oral Factor XIa inhibitor, despite it failing to meet primary efficacy endpoints in Phase 2 studies for ischemic stroke and acute myocardial infarction.
• The OCEANIC trial program will assess asundexian in up to 30,000 patients with atrial fibrillation, non-cardioembolic ischemic stroke, or high-risk transient ischemic attack.
• Phase 2 PACIFIC studies showed asundexian's safety profile was comparable to placebo, without increased bleeding, supporting its continued development despite the lack of efficacy.
• Bristol-Myers Squibb and Johnson & Johnson are also developing a Factor XIa inhibitor, milvexian, which showed promising results in secondary stroke prevention, intensifying competition in this drug class.