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Bayer’s Asundexian Met Primary Efficacy and Safety Endpoints in Landmark Phase III OCEANIC-STROKE Study in Secondary Stroke Prevention
BERLIN, November 23, 2025--Bayer today 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 ischemic stroke compared to placebo, both in combination with antiplatelet therapy, in patients after a non-cardioembolic ischemic stroke or high-risk ischemic attack. There was no increase
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[{"type":"text","content":"Not intended for UK Media","length":25,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"OCEANIC-STROKE demonstrates superiority of asundexian with antiplatelet therapy, showing significant reduction in ischemic stroke risk, without increasing ISTH major bleeding rate, compared to placebo with antiplatelet therapy","length":226,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"OCEANIC-STROKE is the first successfully completed Phase III study of a Factor XIa inhibitor","length":92,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Bayer will globally engage with health authorities in preparation for the submission of marketing authorization applications and looks forward to presenting the results at an upcoming scientific congress","length":203,"tagName":"p","attribs":{}}]}],"tagName":"ul","bulletedList":true,"length":521,"olType":false},{"type":"text","content":"BERLIN, November 23, 2025--(BUSINESS WIRE)--Bayer today 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 ischemic stroke compared to placebo, both in combination with antiplatelet therapy, in patients after a non-cardioembolic ischemic stroke or high-risk ischemic attack. There was no increase in the risk of ISTH major bleeding in patients treated with asundexian compared to placebo, both in combination with antiplatelet therapy. Detailed results of OCEANIC-STROKE will be presented at an upcoming scientific congress.","length":745,"tagName":"p"},{"type":"text","content":"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. One in five stroke survivors will have another stroke within five years.3 Stroke is the second leading cause of death globally, and recurrent ischemic strokes tend to be more disabling and carry a higher mortality risk than the first stroke.2,4,5","length":471,"tagName":"p"},{"type":"text","content":""As clinicians, we see every day how devastating a recurrent stroke can be for patients and their families2,&qu...