Bayer has reported encouraging topline findings from its global phase 3 OCEANIC-STROKE study, evaluating the investigational oral Factor XIa inhibitor asundexian.
The trial met its primary efficacy and safety endpoints, demonstrating a significant reduction in the risk of ischaemic stroke without increasing major bleeding compared to placebo, both in combination with antiplatelet therapy.
The study involved patients who had experienced a non-cardioembolic ischaemic stroke or high-risk ischaemic attack. Asundexian 50 mg once daily was tested alongside standard of care, which included single and dual antiplatelet therapy. Bayer confirmed that detailed results will be presented at a scientific congress in 2026.
Each year, around 12 million people worldwide suffer a stroke, with up to 30% experiencing a recurrence. Despite existing prevention options, the risk of secondary stroke remains high, with one in five survivors likely to have another within five years.
Stroke is the second leading cause of death globally, and recurrent ischaemic strokes are often more disabling and carry greater mortality risk than first strokes.
Mike Sharma, principal investigator of the Population Health Research Institute OCEANIC-STROKE study, explained: “As clinicians, we see every day how devastating a recurrent stroke can be for patients and their families. 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.”
Christian Rommel, Head of Research and Development at Bayer’s Pharmaceuticals Division, said: “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.”
He added: “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 US Food and Drug Administration but remains investigational and is not yet approved for use in any country.
