Bayer’s investigational, once-daily, oral Factor XIa inhibitor asundexian reduced the risk of recurrent ischemic stroke by 26% in a pivotal trial.
In the Phase III OCEANIC-STROKE study (NCT05686070), 50mg asundexian was pitted against placebo, both in combination with antiplatelet therapy.
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The drug reduced the risk of stroke by 26% in patients who had previously suffered a non-cardioembolic ischemic stroke or high-risk transient ischemic attack, with no increase in the risk of major bleeding as defined by the ISTH (International Society of Thrombosis and Hemostasis).
Efficacy on the primary endpoint was not impacted by age, sex, or index event (stroke or high-risk TIA). Nor was it impacted by stroke subtype, NIHSS (National Institutes of Health Stroke Scale), or acute stroke therapy previously administered.
Asundexian, which was granted Fast Track Designation by the US Food and Drug Administration (FDA) in February 2022, also showed superiority on secondary efficacy endpoints, including cardiovascular death, myocardial infarction (MI) or stroke, and the composite of death from any cause, MI or stroke.
There was no increase in the rate of ISTH major bleeding between the cohorts, meeting the primary safety endpoint. The risk of bleeding was similar between the placebo and treatment arms, meeting the trial’s secondary safety endpoint.
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By GlobalDataIn a joint statement, Dr Mike Sharma, principal investigator of the OCEANIC-STROKE study, and Michael G. DeGroote, chair in stroke prevention at McMaster University, said: “The findings from OCEANIC-STROKE are a notable research achievement, demonstrating a substantial reduction in the risk of stroke with asundexian compared to placebo, alongside a sustained treatment effect and a safety profile with no observed increase in ISTH major bleeding. For clinicians and researchers who have spent decades working to reduce the global burden of secondary stroke, the OCEANIC-STROKE results represent the kind of scientific progress the field has long been striving to achieve.”
Bayer said that OCEANIC-STROKE is the first successfully completed Phase III study of a Factor XIa inhibitor to show improvement above placebo. Data was presented at the International Stroke Conference 2026 in New Orleans.
The study enrolled 12,327 patients who presented with all common stroke subtypes as classified by the TOAST (Trial of Org 10172 in Acute Stroke Treatment) criteria. This included patients with large-artery atherosclerosis (43%), small-vessel occlusion (lacune) (23%), stroke of undetermined etiology (30%), other determined etiology (3%), and cardioembolic stroke (2%).
While the stroke study has been successful, in 2023, Bayer had to terminate a separate trial early evaluating asundexian due to lack of efficacy. The Phase III OCEANIC-AF trial (NCT05643573) aimed to determine asundexian’s use as a treatment for people living with atrial fibrillation in a bid to prevent strokes or systemic embolisms. The Independent Data Monitoring Committee (IDMC) found that asundexian was inferior in terms of efficacy when compared to the control arm of the trial.
Approximately 12 million people worldwide experience a stroke each year, including nearly 800,000 people in the US alone.
According to a GlobalData report, the main drugs used for acute ischemic stroke are AstraZeneca’s Brilinta (ticagrelor) in the US, BMS’s Pravadual (aspirin and pravastatinsodium) in France, and Roche’s Cathflo in Canada. Despite this, there are still a lot of unmet needs for patients who suffer stroke.
GlobalData is the parent company of Clinical Trials Arena.
