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WHY THIS MATTERS
Two late-breaking analyses from the Phase III OCEANIC-STROKE study will provide additional depth to the primary efficacy and safety results.
BAYER EXECUTIVE COMMENT
“OCEANIC-STROKE represents an effort in secondary stroke prevention research, and these new analyses highlight the depth of insights that can be generated from this large global study,” said Sara Hegab, MD, VP, Stroke & Thrombosis, Specialty and Pipeline, U.S. Medical Affairs, Bayer. “We are pleased to share these data with the stroke community, alongside additional analyses that reflect how stroke is experienced and managed in clinical practice. These findings contribute to a deeper understanding of stroke and reflect Bayer’s continued commitment to advancing research in stroke care.”
Bayer late-breaking presentations from the Phase III OCEANIC-STROKE study at ESOC 2026 include:
Late Breaker 1: Incident Ischaemic Stroke in the Randomised, Placebo-controlled, Event-driven OCEANIC-STROKE Trial of Asundexian for Secondary Stroke Prevention: Severity, Treatment and Outcomes
Additional Bayer sub-analyses from the Phase III OCEANIC-STROKE study at ESOC 2026 include:
Bayer additional presentations at ESOC 2026 include:
Health and Social Care Costs of Recurrent Stroke: Long-Term Follow-Up of a Population-Based Cohort
To view the complete program, please visit the European Stroke Organisation Conference website.
About OCEANIC-STROKE
The Phase III OCEANIC-STROKE study investigated the efficacy and safety of the oral Factor XIa inhibitor asundexian 50 mg once-daily compared to placebo, for prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA) in combination with antiplatelet therapy. It 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
Factor XIa (FXIa) is a protein in the blood coagulation pathway, also known as the blood clotting process, with different roles in hemostasis (normal clotting to stop bleeding) and thrombosis (harmful clot formation that can block blood vessels). FXIa has a minor role in the formation of a hemostatic plug (a clot that seals a blood vessel injury) that seals the leak at the site of vessel injury. However, FXIa is thought to contribute to the formation of pathological thrombus growth (abnormal clot growth) and vessel blockage.
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 innovative 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 help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power 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. For more information, go to www.bayer.com.
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
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