Bayer has announced positive topline results from the global Phase III study OCEANIC-STROKE, with its investigational, once daily, oral FXIa inhibitor asundexian. The study met its primary efficacy and safety endpoints. Asundexian 50 mg once daily significantly reduced the risk of ischaemic stroke compared to placebo, both in combination with antiplatelet therapy, in patients after a non-cardioembolic ischaemic stroke or high-risk ischaemic attack. There was no increase in the risk of ISTH major bleeding in patients treated with asundexian compared to placebo, both in combination with standard of care, which included single and dual antiplatelet therapy. Detailed results of OCEANIC-STROKE will be presented at an upcoming scientific congress in 2026.
Each year, approximately 12 million people worldwide will experience a stroke. Of these, 20-30% will be a recurrent stroke.1,2 Despite available secondary stroke prevention options, the risk of secondary stroke remains high. Up to one in five stroke survivors will have another stroke within five years.3 Stroke is the second leading cause of death globally, and recurrent ischaemic strokes tend to be more disabling and carry a higher mortality risk than the first stroke.2,4,5
“As clinicians, we see every day how devastating a recurrent stroke can be for patients and their families2,” said 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. “Even with currently available therapies, the risk of another stroke remains high, and each recurrence can have profound consequences. The topline results from OCEANIC-STROKE indicate that asundexian may become a new treatment option to reduce this risk – representing a potential major step forward in secondary stroke prevention.”
“We are excited by these positive topline findings which highlight the potential of Factor XIa inhibition as a new way to help protect patients from a recurrent stroke,” said Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division. “This marks an important milestone in Bayer’s longstanding commitment to advancing innovation in thrombosis prevention. We extend our sincere gratitude to the investigators, patients, and colleagues whose dedication made this milestone possible.”
Asundexian has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) as a potential treatment for stroke prevention in patients after a non-cardioembolic ischaemic stroke.6 Asundexian is an investigational compound and has not been approved by any health authority for use in any country for any indication.
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