Factor XIa Inhibitor Asundexian Shown to Reduce Ischemic Stroke Risk Without Increasing Major Bleeding

For people with noncardioembolic ischemic stroke or high-risk transient ischemic attack (TIA), once-daily treatment with asundexian (Bayer, Berlin, Germany) 50 mg in combination with antiplatelet therapy was shown to significantly reduce risk of ischemic stroke compared with placebo in combination with antiplatelet therapy. According to results of the phase 3 OCEANIC-STROKE study (NCT05686070), the reduction in ischemic stroke risk was achieved without an increase in International Society on Thrombosis and Haemostasis (ISTH) major bleeding. Bayer announced these findings in a press release, noting that the data would be presented at an upcoming scientific congress.

Asundexian is designed to inhibit factor XIa (FXIa), a potential anticoagulation strategy under investigation to reduce thrombus formation while minimizing effects on hemostasis. OCEANIC-STROKE was a multicenter, randomized, double-blind, placebo-controlled, parallel-group, event-driven study evaluating asundexian treatment for secondary stroke prevention in combination with standard antiplatelet therapy. The study included over 12,300 participants with acute noncardioembolic stroke or high-risk TIA who were randomized to receive daily treatment with asundexian 50 mg or placebo and followed until a prespecified number of ischemic stroke events occurred. According to Bayer, the study met its primary efficacy and safety end points, with asundexian treatment reducing ischemic stroke risk without an increase in ISTH major bleeding.

“As clinicians, we see every day how devastating a recurrent stroke can be for patients and their families,” said Mike Sharma, MD, Principal Investigator of the Population Health Research Institute (PHRI) OCEANIC-STROKE study. “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.”

Source: Bayer. Bayer’s asundexian met primary efficacy and safety endpoints in landmark phase III OCEANIC-STROKE study in secondary stroke prevention. Businesswire. Published November 23, 2025. Accessed November 24, 2025. https://www.businesswire.com/news/home/20251123638167/en/Bayers-Asundexian-Met-Primary-Efficacy-and-Safety-Endpoints-in-Landmark-Phase-III-OCEANIC-STROKE-Study-in-Secondary-Stroke-Prevention