Global health sciences giant Bayer has announced the publication of full results from its global Phase III OCEANIC-STROKE trial in The New England Journal of Medicine. The results spotlight its investigational Factor XIa inhibitor asundexian as a potential advance in secondary stroke prevention.
The study evaluated asundexian (50 mg), a once-daily oral anticoagulant candidate, versus placebo—both given alongside standard antiplatelet therapy—in patients following a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA).
The goal: prevent recurrent ischemic stroke in a high-risk population where residual risk remains significant.
“The full published findings of OCEANIC-STROKE in the New England Journal of Medicine provide the global stroke community with a clearer understanding of the favorable net clinical benefit observed with asundexian across a broad and representative patient population," said Mike Sharma, Principal Investigator of the OCEANIC-STROKE study.
The NEJM publication builds on data presented at the American Heart Association’s International Stroke Conference 2026 in New Orleans, where asundexian demonstrated a 26% reduction in ischemic stroke risk.
Importantly, this benefit came without an observed increase in ISTH major bleeding. The effect remained consistent across patient subgroups, including age, sex, stroke subtype, NIHSS score, and background therapies such as single or dual antiplatelet treatment.
Beyond stroke reduction alone, the publication highlights three net clinical benefit outcomes showing improvements across combined endpoints, including ischemic stroke or major bleeding, broader cardiovascular outcomes, and composite measures including mortality and disabling stroke.
"This foundational body of scientific evidence reflects our continued commitment to address high unmet medical needs," said Christian Rommel, Global Head of Research and Development, Bayer Pharmaceuticals. “It is a remarkable contribution to clinical research of secondary stroke prevention.”
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