India Pharma Outlook Team | Tuesday, 25 November 2025
Bayer reported a major step forward today as its experimental drug asundexian reduced the risk of recurrent ischemic stroke without increasing bleeding risk in a global phase III study.
The OCEANIC-STROKE trial hit both its primary efficacy and safety targets, positioning the therapy as a potential new standard in secondary stroke prevention.
The once-daily Factor XIa inhibitor was tested in more than 12,300 patients recovering from a non-cardioembolic stroke or high-risk TIA.
All participants stayed on standard antiplatelet therapy. Even on top of this care, asundexian delivered added protection against ischemic stroke, while showing no rise in ISTH major bleeding compared to placebo. In a field where preventing clots often trades off with bleeding risk, this outcome gives the drug strong momentum.
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“As clinicians, we witness the devastating impact of recurrent strokes daily,” said Mike Sharma, principal investigator of OCEANIC-STROKE and Director of the Stroke Program at Hamilton Health Sciences. “Even with existing therapies, the risk of another stroke remains high. These topline results suggest asundexian could become a vital new option for protecting patients from recurrence.”
Stroke remains a severe global health challenge, affecting about 12 million people each year. Up to 30% of survivors face another stroke, and recurrent events often lead to greater disability and higher mortality. That need keeps pressure on the industry to find safer, more effective prevention options.
Christian Rommel, Head of R&D at Bayer Pharmaceuticals, noted that the results strengthen confidence in Factor XIa inhibition as a fresh direction in thrombosis research.
Asundexian currently holds FDA Fast Track status but is not yet approved in any country. Full trial details will be presented at an upcoming scientific meeting, where the data is expected to draw significant industry attention.
