Bayer has presented the results of its phase 3 Oceanic-Stroke study, in which its oral medication asundexian reduced secondary ischemic stroke by 26% compared to a placebo, at the International Stroke Conference 2026.
OCEANIC-STROKE is the first successfully completed phase 3 study of a Factor XIa inhibitor which demonstrated superiority in reducing recurrent ischemic stroke compared to placebo. Bayer had previously release topline results from the study back in November 2025.
The clinical trial was carried out in patients who had previously suffered a non-cardioembolic ischemic stroke or a high-risk transient ischemic attack. Patients on the treatment and on the placebo also received antiplatelet therapy. There was no increase in ISTH major bleeding with the treatment and the drug had a similar risk of minor bleeding hemorrhagic stroke, symptomatic intracranial hemorrhage, and fatal bleeding as the placebo.
Asundexian, a direct inhibitor of FXIa, is theorized to reduce thrombus formation that may lead to vessel stenosis or blockage, without a significant increase in major bleeding. It has been granted fast track designation by the FDA as a potential treatment for stroke prevention in patients after a non-cardioembolic ischemic stroke.
Bayer says it plans to submit the data from the OCEANIC-STROKE trial to health authorities for marketing approval.