Bayer’s Asundexian Reduced Recurrent Ischemic Stroke in OCEANIC-STROKE

February 19, 2026—Bayer recently reported that its oral factor XIa inhibitor asundexian reduced the risk of recurrent ischemic stroke in patients after noncardioembolic ischemic stroke or high-risk transient ischemic attack (TIA), meeting the primary efficacy endpoint of the phase 3 OCEANIC-STROKE trial, according to the company’s announcement.

In the randomized trial, asundexian 50 mg once daily on top of antiplatelet therapy was associated with a 26% relative risk reduction in ischemic stroke compared with placebo (cause-specific hazard ratio [csHR], 0.74; 95% CI, 0.65-0.84; P < .0001). The treatment effect was consistent across key subgroups, including age, sex, index event, stroke subtype, and stroke severity. There was no increase in the primary safety endpoint of International Society on Thrombosis and Haemostasis (ISTH) major bleeding with asundexian versus placebo (1.9% vs 1.7%; HR, 1.10; 95% CI, 0.85-1.44).

OCEANIC-STROKE was a multicenter, international, randomized, double-blinded, placebo-controlled, parallel-group, event-driven phase 3 trial that enrolled 12,327 patients after a noncardioembolic ischemic stroke or high-risk TIA. Participants were randomized to receive asundexian 50 mg once daily or placebo in addition to background antiplatelet therapy.

Beyond the primary endpoint, asundexian reduced the risk of stroke of any kind, including ischemic and hemorrhagic stroke, compared with placebo (6.6% vs 8.8%; csHR, 0.74; 95% CI, 0.65-0.84; P < .0001). Other secondary endpoints were also met, including composite outcomes of cardiovascular death, myocardial infarction, or stroke, and of all-cause death, myocardial infarction, or stroke, according to Bayer.

Noncardioembolic stroke remains associated with a substantial risk of recurrence despite antiplatelet therapy. An oral factor XIa inhibitor added to standard antiplatelet therapy may offer additional ischemic protection without increasing major bleeding, a central challenge in secondary stroke prevention.

According to Bayer, asundexian has been granted Fast Track designation by the FDA as a potential treatment for stroke prevention in patients after a noncardioembolic ischemic stroke. Asundexian is an investigational compound and has not been approved by any health authority for use in any country for any indication.