Bayer’s Asundexian FXIa Inhibitor Demonstrates Reduction in Ischemic Stroke in OCEANIC-STROKE Study

April 17, 2026—The results from the OCEANIC-STROKE study were published by Mukul Sharma, MD, et al in The New England Journal of Medicine (NEJM; 2026;394:1467-1479).

As stated in NEJM, the study investigated the safety and efficacy of administering the oral factor XIa inhibitor asundexian (Bayer) at a daily dose of 50 mg in addition to antiplatelet therapy to reduce the risk of recurrent ischemic stroke in patients after a noncardioembolic ischemic stroke or high-risk transient ischemic attack (TIA). The multicenter, international, randomized, double-blinded, placebo-controlled, parallel-group, event-driven phase 3 trial enrolled 12,327 patients after a noncardioembolic ischemic stroke or high-risk TIA.

Patients in OCEANIC-STROKE were randomized within 72 hours after the onset of a noncardioembolic ischemic stroke or high-risk TIA to receive asundexian 50 mg once daily (n = 6,162) or placebo (n = 6,165) in addition to planned dual or single antiplatelet therapy.

In NEJM, the investigators concluded that treatment with asundexian resulted in lower risks of ischemic stroke and major cardiovascular events than placebo, without a higher risk of major bleeding.

As summarized in the NEJM abstract of the study, the investigators reported the following data for the asundexian group versus the placebo group:

• For the primary efficacy outcome, the incidence of ischemic stroke was 6.2% versus 8.4% (cause-specific hazard ratio [csHR], 0.74; 95% CI, 0.65 to 0.84; P < .001).
• In a key secondary outcome, the incidence of the composite of death from cardiovascular causes, myocardial infarction, or stroke was lower in the asundexian group versus the placebo group.
• For the primary safety outcome, the incidence of major bleeding was 1.9% versus 1.7% (csHR, 1.10; 95% CI, 0.85 to 1.44).
• The incidence of adverse events was 69.3% versus 70.1%.
• The incidence of serious adverse events was 19.2% versus 19.5%.

Asundexian is an investigational compound and has not been approved by any health authority for use in any country for any indication, advised the OCEANIC-STROKE investigators in NEJM.

The initial data from the OCEANIC-STROKE study were presented on February 5 at the American Heart Association’s International Stroke Conference 2026 in New Orleans, Louisiana, and reported later that month.