Statement on New England Journal of Medicine Publication of Phase III OCEANIC-STROKE Study Evaluating Asundexian

April 15, 2026

Today, the New England Journal of Medicine published the full results from the global, pivotal Phase III OCEANIC-STROKE study. The study evaluated the investigational Factor XIa inhibitor asundexian in patients following a non-cardioembolic ischemic stroke or high-risk transient ischemic attack. Results from the study were previously presented at the American Heart Association's International Stroke Conference 2026.

"The publication of OCEANIC-STROKE builds on Bayer's legacy of advancing standard-setting studies that have guided the management of thrombotic conditions across a range of disease states," said Sara Hegab, MD, VP, Stroke & Thrombosis, Specialty and Pipeline, U.S. Medical Affairs, Bayer. "This foundational body of evidence reflects our continued commitment to rigorous science and is a class-defining contribution to the field of secondary stroke prevention. We are proud of this achievement and look forward to engaging with regulatory authorities to evaluate the potential role of asundexian for secondary stroke prevention."

The complete publication titled, "Asundexian for Secondary Stroke Prevention" is available on the website of the New England Journal of Medicine.