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Asundexian, an oral, once-daily Factor XIa inhibitor reduces the risk of secondary stroke, in combination with antiplatelet therapy and is the first approved drug in a new class of Factor XIa inhibitors worldwide
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Regulatory approval follows the U.S. Food and Drug Administration (FDA)’s Priority Review designation and is based on positive data from the pivotal, global Phase III OCEANIC-STROKE study1
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Despite available secondary stroke prevention strategies, approximately one in five stroke survivors who had a non-cardioembolic ischemic stroke will have another one within five years,1,2 with secondary strokes often causing more devastating outcomes than first strokes3
Berlin, November 10, 2026 – Bayer announced today that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for asundexian, 50 mg tablets, under the brand name Sunharbo®. The product is indicated in combination with antiplatelet therapy to reduce the risk of stroke in adults with recent non-cardioembolic ischemic stroke (National Institutes of Health Stroke Scale ≤15) or high-risk transient ischemic attack (TIA). Reducing the risk of another stroke after an initial event is often referred to as secondary stroke prevention. Sunharbo® (asundexian) is the first approved FXIa inhibitor worldwide.
“For those who survive a stroke, the risk of another potentially devastating event is highest in the days and weeks after the initial event, and that risk persists over time,” said Ashkan Shoamanesh, M.D., Co-principal Investigator of the OCEANIC-STROKE clinical study and Senior Scientist at Population Health Research Institute, a Joint Institute of Hamilton Health Sciences and McMaster University, Ontario, Canada. “I believe asundexian introduces an important new addition to post-stroke care that can be used to help patients reduce the risk of a secondary stroke.”
Stroke Burden
Stroke affects approximately 12 million people worldwide each year,5 including 795,000 individuals in the U.S.4 It remains the second leading cause of death and the third leading cause of death and disability combined worldwide5 and has been recognized as an urgent global public health challenge, including by the World Health Assembly, which adopted the first-ever resolution on stroke in May 2026.5
In the U.S., between 1990 and 2021, the prevalence of ischemic stroke increased by approximately 66%, with stroke-related mortality rising by 16%.6 Despite current guideline recommendations for stroke prevention, a significant proportion of survivors experience another stroke.7,8 Approximately one in ten non-cardioembolic ischemic stroke survivors will have another stroke within one year,9 and one in five will have another stroke within five years.1,2
Preventing stroke is a major priority for stroke survivors and often considered as valuable as preventing death.10
“This FDA approval represents a bold step forward in post-stroke care and is based on compelling clinical evidence from our successfully completed OCEANIC-STROKE study. Asundexian is the first drug approved in a new class of Factor XIa inhibitors worldwide,” said Christian Rommel, Ph.D., Global Head of Research and Development at Bayer`s Pharmaceuticals Division. “Stroke requires substantial healthcare resource utilization and presents a significant economic and personal burden. At Bayer, our priority is advancing innovations like asundexian to help close gaps in care and reduce the burden of secondary stroke.”
Asundexian has also recently been approved by China’s National Medical Products Administration (NMPA) and has been submitted by Bayer for marketing authorization in additional markets around the world. These applications are currently under review, while Bayer continues to work with health authorities worldwide to bring asundexian to patients in other regions.
Key Clinical Trial Findings Supporting FDA Approval
The FDA approval is based on positive data from the pivotal, global Phase III OCEANIC-STROKE study, the first successfully completed Phase III study of a Factor XIa inhibitor in combination with antiplatelet therapy (dual antiplatelet therapy, DAPT or single antiplatelet therapy, SAPT) demonstrating superiority in reducing ischemic stroke, compared to DAPT/SAPT alone, with similar rate of ISTH (International Society on Thrombosis and Hemostasis) major bleeding between placebo and asundexian, in patients after a non-cardioembolic stroke or high-risk TIA. Key findings demonstrated.1
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Asundexian 50 mg in combination with antiplatelet therapy, significantly reduced ischemic stroke by 26 percent in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA), compared to antiplatelet therapy alone.
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This reduction was observed with similar rate of bleeding, as defined by the ISTH (International Society on Thrombosis and Hemostasis) bleeding classification, between placebo and asundexian.
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Treatment effect for the primary endpoint was consistent across key subgroups (including age, sex, type of index event, non-cardioembolic stroke subtypes, stroke severity, and planned antiplatelet therapy) supporting its potential use across a broad patient population.
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The full results from OCEANIC-STROKE have been published in The New England Journal of Medicine
About OCEANIC-STROKE
The Phase III OCEANIC-STROKE study investigated the efficacy and safety of the selective, once-daily oral Factor XIa inhibitor asundexian 50 mg in combination with antiplatelet therapy, compared to placebo (antiplatelet therapy alone), for risk reduction of ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA). OCEANIC-STROKE is a multicenter, international, randomized, placebo-controlled, double-blind, parallel group and event-driven study, that randomized 12,327 participants worldwide. The primary efficacy endpoint was time to ischemic stroke; the primary safety endpoint was ISTH major bleeding.
About FXIa Inhibitors and Asundexian
Factor XIa (FXIa) is a protein in the blood coagulation pathway with different roles in hemostasis and thrombosis. FXIa is thought to contribute to the formation of pathological thrombus growth and vessel blockage. However, FXIa has a minor role in the formation of a hemostatic plug that seals the leak at the site of vessel injury.
Asundexian is the first approved FXIa inhibitor. It selectively inhibits FXIa, allowing to reduce pathological clot formation with similar rate of (ISTH) major bleeding compared to placebo, by uncoupling hemostasis from pathological thrombosis.
About Bayer’s Commitment in Cardiovascular and Cerebrovascular Medicine
Bayer is a leader in cardiology and is advancing a portfolio of innovative treatments in cardiovascular (CV) and cerebrovascular diseases of high unmet medical need. The company has set a clear focus on developing therapies to treat such diseases (e.g. stroke, heart failure, cardiomyopathies, and chronic kidney disease) and it is our ambition to take a leading role in the care of patients with these diseases. Bayer is actively shaping the future of cardiology and neurology with a robust and diversified pipeline, strategically positioned to address critical unmet needs and drive significant long-term value. Bayer’s portfolio already includes several innovative products and compounds in various stages of preclinical and clinical development.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to support efforts to master major challenges presented by a growing and aging global population and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros.
1 Lowe D, et al. Presented at: 11th European Stroke Organisation Conference. 21–23 May 2025; Helsinki, Finland. Presentation ESOC25-216.
2 Gaist D, et al. Presented at: 11th European Stroke Organisation Conference. 21–23 May 2025; Helsinki, Finland. Presentation ESOC25-215.
3 Feigin VL, et al. Pragmatic solutions to reduce the global burden of stroke: a World Stroke Organization-Lancet Neurology Commission. Lancet Neurol. 2023;22(12):1160-1206.
4 Palaniappan LP, et al. 2026 heart disease and stroke statistics: a report of US and global data from the American Heart Association. Circulation. 2026;153(9):e275-906.
5 World Health Organization. Seventy-ninth World Health Assembly – Daily update: 22 May 2026. 2026. Available at: https://www.who.int/news/item/22-05-2026-seventy-ninth-world-health-assembly-daily-update-22-may-20…. Last accessed: September 2026.
6 Park JH, et al. Burden of stroke in the United States of America, 1990-2021: A systematic analysis for the US burden of disease study 2021. Front Neurol. 2025;16:1609508.
7 Hankey GJ. Secondary stroke prevention. Lancet Neurol. 2014;13(2):178–194.
8 Kolmos M, et al. Recurrent Ischemic Stroke – A Systematic Review and Meta-Analysis. J Stroke Cerebrovasc Dis. 2021;30(8):105935.
9 Kasner S, et al. Presented at: World Stroke Congress. 22–24 October 2025; Barcelona, Spain.
10 Hanger HC, et al. Stroke patients' views on stroke outcomes: death versus disability. Clinical rehabilitation. 2000 Aug;14(4):417-24