Bayer's Asundexian Achieves Key Efficacy and Safety Goals in Pivotal Phase III OCEANIC-STROKE Trial for Secondary Stroke Prevention

Written by Emily J. Thompson, Senior Investment Analyst

Source: Newsfilter

Updated: Nov 23 2025

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Source: Newsfilter

OCEANIC-STROKE Study Results: The Phase III study OCEANIC-STROKE demonstrated that asundexian, a Factor XIa inhibitor, significantly reduces the risk of ischemic stroke when combined with antiplatelet therapy, without increasing the risk of major bleeding compared to placebo.
Implications for Stroke Prevention: Asundexian may offer a new treatment option for secondary stroke prevention, addressing the high recurrence rates of strokes, which affect 20-30% of stroke survivors.
Bayer's Commitment: Bayer plans to engage with health authorities for marketing authorization applications and aims to present detailed results at an upcoming scientific congress, highlighting its dedication to advancing treatments in cardiovascular diseases.
Fast Track Designation: The U.S. FDA has granted Fast Track Designation to asundexian for stroke prevention, indicating its potential significance in the treatment landscape, although it remains an investigational compound not yet approved for use.

About the author

Emily J. Thompson

Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.