Bayer has reported encouraging top line data from the Phase III OCEANIC-STROKE study evaluating asundexian, a once-daily investigational, oral Factor XIa (FXIa) inhibitor, for secondary stroke prevention.
FXIa is a protein present in the blood coagulation pathway and plays different roles in thrombosis and haemostasis.
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The double-blind, multicentre, randomised, global, placebo-controlled trial enrolled more than 12,300 participants to assess the safety and efficacy of asundexian 50mg combined with antiplatelet therapy for secondary stroke prevention.
OCEANIC-STROKE met its main safety and efficacy endpoints in participants who experienced a non-cardioembolic ischemic stroke or a high-risk transient ischemic attack.
The study showed that this combination significantly lowered the risk of ischemic stroke compared to placebo.
No increase in International Society on Thrombosis and Haemostasis (ISTH) major bleeding was seen in the asundexian group compared to placebo, both along with antiplatelet therapy.
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By GlobalDataThe company plans to present detailed OCEANIC-STROKE results at a future scientific congress.
Bayer Pharmaceuticals research and development head Christian Rommel said: “We are excited by these positive top line findings which highlight the potential of Factor XIa inhibition as a new way to help protect patients from a recurrent stroke.
“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.”
The US Food and Drug Administration (FDA) has granted fast track designation to asundexian for potential use in stroke prevention after non-cardioembolic ischemic stroke.
Asundexian remains investigational and has not been approved for any indication in any country.
In October 2025, Bayer-owned BlueRock Therapeutics’ cell therapy showed clinically meaningful improvements in an early-phase Parkinson’s disease study.
