Bayer Outlines Next Steps for Asundexian After Positive Phase III Stroke Data

Bayer has confirmed its plans to advance asundexian following positive results from the Phase III OCEANIC-STROKE trial (NCT05686070). In the pivotal study, the once-daily oral Factor XIa inhibitor reduced the risk of recurrent ischemic stroke by 26% versus placebo when added to antiplatelet therapy, without increasing ISTH-defined major bleeding. Benefits were consistent across age, sex, stroke subtype, and prior therapies, and extended to key secondary endpoints including cardiovascular death, myocardial infarction, and stroke.

The trial enrolled 12,327 patients across all major TOAST-classified stroke subtypes, making it the first successful Phase III study of a Factor XIa inhibitor to outperform placebo. Data were presented at the International Stroke Conference 2026.

While Bayer previously discontinued the OCEANIC-AF trial due to inferior efficacy versus standard care in atrial fibrillation, the company views the stroke data as supporting continued development in secondary stroke prevention. With limited options from firms such as AstraZeneca, Bristol Myers Squibb, and Roche, asundexian could address a significant unmet need.

09-02-2026