November 23, 2025 — Leads & Copy —
Bayer AG announced positive topline results from its global Phase III OCEANIC-STROKE study, evaluating the investigational oral FXIa inhibitor asundexian for preventing ischemic stroke. The study met its primary efficacy and safety endpoints, demonstrating that asundexian 50 mg once daily significantly reduces the risk of ischemic stroke compared to placebo.
The trial included patients who had experienced a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA). Participants in both the asundexian and placebo groups also received antiplatelet therapy.
The study found that asundexian did not increase the risk of ISTH major bleeding compared to placebo. Detailed results from the OCEANIC-STROKE trial will be presented at an upcoming scientific congress.
Dr. Mike Sharma, principal investigator of the Population Health Research Institute (PHRI) OCEANIC-STROKE study, noted the devastating impact of recurrent strokes on patients and families. He emphasized that despite available therapies, the risk of another stroke remains high, with profound consequences for each recurrence.
Dr. Sharma said the topline results from OCEANIC-STROKE suggest that asundexian could become a new treatment option for reducing the risk of recurrent stroke. It would represent a potential major step forward in secondary stroke prevention.
Dr. Christian Rommel, Head of Research and Development at Bayer’s Pharmaceuticals Division, expressed excitement about the positive findings. He highlighted the potential of Factor XIa inhibition as a new way to protect patients from recurrent stroke and noted that this marks an important milestone in Bayer’s commitment to innovation in thrombosis prevention.
The U.S. Food and Drug Administration (FDA) has granted asundexian Fast Track Designation as a potential treatment for stroke prevention in patients after a non-cardioembolic ischemic stroke. However, asundexian is an investigational compound and has not been approved by any health authority for use in any country for any indication.
The OCEANIC-STROKE study enrolled over 12,300 patients in a multicenter, international, randomized, placebo-controlled, double-blind, parallel group, and event-driven design.
Factor XIa (FXIa) is a protein in the blood coagulation pathway with different roles in hemostasis and thrombosis. Asundexian is a direct inhibitor of FXIa. It is theorized to reduce thrombus formation that can lead to vessel stenosis or blockage, without a significant increase in major bleeding. Asundexian is currently being evaluated as a potential treatment option in thrombosis prevention.
Bayer is focused on developing innovative therapies to treat cardiovascular diseases such as stroke, heart failure, cardiomyopathies, and chronic kidney disease. The company aims to transform its portfolio into precision cardiology, addressing the high cardiovascular disease burden, and driving long-term growth. Bayer’s portfolio already includes several innovative products and compounds in various stages of preclinical and clinical development.
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. The Bayer brand stands for trust, reliability, and quality throughout the world.
Mike Sharma, MD, principal investigator of the Population Health Research Institute (PHRI) OCEANIC-STROKE study, Senior Scientist at PHRI (a joint institute of McMaster University and Hamilton Health Sciences), Director of the Stroke Program at Hamilton Health Sciences, and Michael G. DeGroote Chair in Stroke Prevention at McMaster University.
Find more information at https://pharma.bayer.com/
Source: Bayer
