(21174) Relative bioavailability study to investigate the pharmacokinetics of a single oral dose of asundexian administered as 50 mg pediatric formulation in comparison to 50 mg tablet (adult formulation) in fasted state and to investigate the effect of a high-fat, high-calorie meal on the 50 mg pediatric formulation in healthy adult participants

Start Date06 May 2026

Sponsor / Collaborator

Bayer AG

CTIS2023-509447-28-00

/ Not yet recruitingPhase 1

A study to learn about the amount of asundexian in the blood when healthy participants take different types of asundexian tablets

Start Date26 Jul 2024

Sponsor / Collaborator

Bayer AG

CTIS2023-509488-26-00

/ CompletedPhase 1

A study to learn how asundexian affects the amount of metformin in the blood when healthy participants take them together

Start Date18 Jul 2024

Sponsor / Collaborator

Bayer AG

100 Clinical Results associated with Asundexian

100 Translational Medicine associated with Asundexian

100 Patents (Medical) associated with Asundexian

Literatures (Medical) associated with Asundexian

16 Apr 2026·NEW ENGLAND JOURNAL OF MEDICINE

Asundexian for Secondary Stroke Prevention

Article

Author: Staikov, Ivan ; Hirano, Teruyuki ; Turuspekova, Saule T. ; Amaya, Pablo ; Eikelboom, John W. ; Saver, Jeffrey L. ; Sampaio Silva, Gisele ; Neumann, Christoph ; Keller, Lars ; Veltkamp, Roland ; Lemmens, Robin ; Mundl, Hardi ; Campbell, Bruce C.V. ; Tsivgoulis, Georgios ; Zini, Andrea ; Masjuan, Jaime ; Shoamanesh, Ashkan ; Demchuk, Andrew M. ; Sylaja, P.N. ; Bereczki, Daniel ; Coutinho, Jonathan M. ; Leker, Ronen R. ; Knoflach, Michael ; Mikulik, Robert ; Hoo, Fan Kee ; Smith, Eric E. ; Matijošaitis, Vaidas ; Robinson, Thompson ; Ferro, José M. ; Lindgren, Arne G. ; Sandset, Else Charlotte ; Muehlhofer, Eva ; Heenan, Laura ; Putaala, Jukka ; Kasner, Scott E. ; Miglane, Evija ; Christensen, Hanne ; Sheth, Kevin N. ; Colorado, Pablo ; Lee, I-Hui ; Sharma, Mukul ; Joundi, Raed A. ; De Marchis, Gian Marco ; Kovar, Martin ; Slowik, Agnieszka ; van der Worp, H. Bart ; Xu, Lizhen ; Amarenco, Pierre ; Dong, Qiang ; Cordonnier, Charlotte ; Ozturk, Serefnur ; Schulze, Karleen ; Bae, Hee-Joon ; Turcani, Peter

BACKGROUND:

Patients with noncardioembolic ischemic stroke or transient ischemic attack (TIA) are at risk for recurrent stroke. Low factor XI levels are associated with a reduced risk of ischemic stroke. Asundexian inhibits activated factor XI. Whether the addition of asundexian to antiplatelet therapy would be superior to antiplatelet therapy alone for the secondary prevention of ischemic stroke is unclear.

METHODS:

In this phase 3, double-blind trial, we randomly assigned patients within 72 hours after the onset of a noncardioembolic ischemic stroke or high-risk TIA to receive asundexian (50 mg once daily) or placebo, in addition to planned dual or single antiplatelet therapy. Patients had at least one of the following: a nonlacunar infarct on imaging, a history of atherosclerosis, or evidence of atherosclerotic plaque at any location on cerebrovascular imaging. The primary efficacy outcome was ischemic stroke. The composite of death from cardiovascular causes, myocardial infarction, or stroke was a key secondary outcome. The primary safety outcome was major bleeding.

RESULTS:

Among 12,327 patients who underwent randomization (6162 to the asundexian group and 6165 to the placebo group), the incidence of ischemic stroke was lower in the asundexian group than in the placebo group (6.2% vs. 8.4%; cause-specific hazard ratio, 0.74; 95% confidence interval [CI], 0.65 to 0.84; P<0.001). The incidence of the composite of death from cardiovascular causes, myocardial infarction, or stroke was lower in the asundexian group than in the placebo group. The incidence of major bleeding was similar in the asundexian group and the placebo group (1.9% and 1.7%, respectively; cause-specific hazard ratio, 1.10; 95% CI, 0.85 to 1.44). The incidence of adverse events was 69.3% in the asundexian group and 70.1% in the placebo group; the incidence of serious adverse events was 19.2% and 19.5%, respectively.

CONCLUSIONS:

Among patients with noncardioembolic ischemic stroke or high-risk TIA treated with antiplatelet therapy, asundexian at a daily dose of 50 mg resulted in lower risks of ischemic stroke and major cardiovascular events than placebo, without a higher risk of major bleeding. (Funded by Bayer; OCEANIC-STROKE ClinicalTrials.gov number, NCT05686070.).

01 Apr 2026·BIOORGANIC CHEMISTRY

Development of selective NBD-based fluorescent probes for in vitro detection of factor XIa and Thrombus imaging

Article

Author: Yang, Han ; Zou, Meijuan ; Li, Qing ; Zhou, Fengjiao ; Zhuang, Xinyu ; Zhao, Xingyu ; Li, Ruixing

Factor XIa (FXIa) is a promising target for safer anticoagulants. Herein, a series of NBD-based fluorescent probes (FNC2-FNC6) were developed by linking an FXIa inhibitor scaffold to an NBD fluorophore via alkyl chains of varying lengths. Molecular dynamics simulations revealed that shorter linkers, especially a two‑carbon chain, stabilize NBD binding in the FXIa pocket, enhancing fluorescence. Among these probes, FNC2 displayed potent FXIa inhibition (Ki = 14.2 nM) and selectivity over related proteases. It exhibited linear fluorescence increase upon FXIa binding (R² = 0.9952; LOD = 1.19 μg/mL), enabling accurate quantification in immunoglobulin products (recovery: 94.41%-103.76%; RSD < 2%). FNC2 visualized FXIa in human plasma clots with 2.7-fold higher signal than free NBD, suppressed dose-dependently by asundexian. This structure-guided approach yields selective probes for FXIa detection and thrombus imaging.

01 Mar 2026·Health Science Reports

Asundexian Versus Apixaban in Patients With Atrial Fibrillation

Article

Author: Perveen, Abida ; Joshi, Neeraj ; Kotte, Mounika ; Malik, Jahanzeb ; Saeed, Zara ; Zehra, Syeda Ariba ; Talat, Fawad ; Tariq, Sumyya ; Kumari, Kanta ; Habib, Awais ; Taj, Osama ; Kumari, Pushpa ; Zumaran, Rocio Pun ; Hameed, Zeeshan

ABSTRACT:

Background:

Anticoagulation therapy is central to the prevention of thromboembolic disorders but is limited by bleeding complications associated with traditional agents such as warfarin and direct oral anticoagulants (DOACs). Factor XIa inhibition has emerged as a novel strategy aimed at reducing thrombotic risk while preserving hemostasis. Asundexian, a selective Factor XIa inhibitor, represents a promising advancement in this evolving therapeutic landscape.

Methods:

This narrative review synthesizes available preclinical and clinical evidence on Asundexian, with a focus on its pharmacological mechanism, efficacy, safety profile, and potential clinical applications. Key data from major clinical trials, including PACIFIC‐AF and PACIFIC‐STROKE, were reviewed to evaluate its role in contemporary anticoagulation therapy.

Results:

Clinical trial evidence indicates that Asundexian effectively reduces the incidence of stroke and systemic embolism in patients with atrial fibrillation and those at risk of recurrent ischemic stroke. Importantly, these benefits are achieved with a lower risk of major bleeding compared to conventional anticoagulants. Asundexian's fixed dosing regimen, oral administration, and lack of routine coagulation monitoring enhance treatment convenience and patient adherence. Emerging data also suggest potential applicability in other conditions requiring long‐term anticoagulation, such as venous thromboembolism and acute coronary syndrome.

Conclusion:

Asundexian offers a novel and potentially safer approach to anticoagulation by selectively targeting Factor XIa, balancing thromboembolic protection with reduced bleeding risk. While early clinical results are encouraging, further large‐scale and long‐term studies are required to establish its safety and efficacy across diverse patient populations. Asundexian has the potential to redefine standards of care in anticoagulation therapy and improve patient outcomes.

News (Medical) associated with Asundexian

19 May 2026

·www.biospace.com

Bayer Granted Priority Review by U.S. FDA for Asundexian in Patients After a Non-Cardioembolic Ischemic Stroke or Transient Ischemic Attack

KEY FACTS: Regulatory submission is based on positive results from the Phase III OCEANIC-STROKE study OCEANIC-STROKE met the primary efficacy outcome of time to first occurrence of ischemic stroke and the primary safety outcome of time to ISTH (International Society on Thrombosis and Haemostasis) major bleeding WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer: WHAT’S HAPPENING Bayer today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) and granted Priority Review designation for its investigational oral Factor XIa (FXIa) inhibitor, asundexian, for the prevention of secondary stroke in patients following a non-cardioembolic ischemic stroke or transient ischemic attack (TIA). The NDA is based on positive results from the global, pivotal Phase III OCEANIC-STROKE trial. The study results were presented at the International Stroke Conference 2026 in New Orleans and published in The New England Journal of Medicine . BAYER EXECUTIVE COMMENT “Secondary stroke remains a serious and persistent challenge, and the FDA’s Priority Review designation underscores the urgency of advancing potential new approaches in secondary stroke prevention,” said Yesmean Wahdan, M.D., Senior Vice President, U.S. Medical Affairs, Bayer. “We are proud of this important milestone that builds on our long-standing commitment to innovation in anti-thrombotic therapies and look forward to collaborating with the FDA as we work to bring asundexian to patients in need.” In 2023, asundexian was granted Fast Track Designation by the FDA as a potential treatment for stroke prevention in patients after a non-cardioembolic ischemic stroke. The FDA has now granted Priority Review for asundexian, a designation for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition. 1 WHY THIS MATTERS Stroke is the fifth leading cause of death in the United States. 2 Each year, approximately 795,000 people in the United States will experience a stroke. Of these, approximately 87% are ischemic and 23% are recurrent. 3 Despite current guideline recommendations for stroke prevention, a significant proportion of survivors experience another stroke. 4,5 Approximately one in five stroke survivors will have another stroke within five years. 5 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. We have 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 . Find more information at: Health for all, Hunger for none | Bayer United States Follow us on Facebook: Bayer Follow us on LinkedIn: Bayer | Pharmaceuticals Follow us on X: BayerUS Follow us on Instagram: bayerofficial 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 . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. References: U.S. Food and Drug Administration. “Priority Review.” Martin SS, et al. Circulation. 2024;149(8):e347–e913. Virani SS, et al. Circulation. 2021;143:e254–e743 Kolmos M, et al. J Stroke Cerebrovasc Dis. 2021;30(8):105935. Lakshminarayan K, et al. Stroke. 2011;42(6):1556–1562. Contacts Contact for U.S. media inquiries: Sarra Herzog, phone +1 862-460-8764 Email: sarra.herzog@bayer.com Contact for investor inquiries: Bayer Investor Relations Team, phone +49 214 30-72704 Email: ir@bayer.com

06 May 2026

·www.bayer.com

Bayer announces new late-breaking data from OCEANIC-STROKE trial of asundexian

Data evaluates the frequency, severity, and disability of ischemic strokes in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack KEY FINDINGS The Phase III OCEANIC-STROKE study, previously published in The New England Journal of Medicine, met the primary efficacy outcome of time to first occurrence of ischemic stroke and the primary safety outcome of time to ISTH (International Society on Thrombosis and Haemostasis) major bleeding New analyses from OCEANIC-STROKE trial evaluate stroke severity and disability in patients treated with investigational asundexian who experienced an ischemic stroke during the trial compared to placebo, both in combination with antiplatelet therapy In a new analysis, acute treatment with intravenous thrombolysis (IVT) / endovascular treatment (EVT) and fatality outcomes of incident ischemic strokes were examined in patients taking asundexian compared to placebo; the analysis provides interesting insights but was not designed to provide statistical confirmatory evidence LinkedIn Email Facebook X WHAT’S HAPPENING WHIPPANY, N.J., May 6, 2026 — Bayer today announced late-breaking data from new analyses of the landmark Phase III OCEANIC-STROKE study of asundexian compared to placebo, both in combination with antiplatelet therapy. The study, presented at the European Stroke Organisation Conference (ESOC) 2026 in Maastricht, the Netherlands, analyzed the frequency, severity, and disability of ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack. Among patients who experienced an ischemic stroke during the study: The proportion of patients with a National Institutes of Health Stroke Scale (NIHSS) score ≥8 was lower with asundexian than placebo (22.9% vs 30.3%; p=0.045). Patients taking asundexian had numerically fewer disabling strokes (2.1% vs 3.0%; csHR 0.69; 95% CI 0.55–0.87) compared to placebo. WHY THIS MATTERS Stroke is the fifth leading cause of death in the United States.1 Each year, approximately 795,000 people in the United States will experience a stroke. Of these, approximately 87% are ischemic and 23% are recurrent.2 Despite current guideline recommended treatment options for stroke prevention, a significant proportion of survivors experience another stroke.3,4 Approximately one in five stroke survivors will have another stroke within five years.4 OCEANIC-STROKE STUDY ANALYSES DESIGN In OCEANIC-STROKE, 902 incident ischemic strokes occurred during the study (asundexian, n=384 [6.2%]; placebo, n=518 [8.4%]) and were evaluated for stroke severity and whether they were classified as disabling / fatal. Stroke severity was assessed using the National Institutes of Health Stroke Scale (NIHSS) during hospitalization and stratified by score (≤3, 4–7, and ≥8). Disabling stroke was defined as a modified Rankin Scale (mRS) ≥3 or a ≥1 point increase in mRS for patients with a baseline mRS ≥3. KEY FINDINGS OF NEW ANALYSES FROM OCEANIC-STROKE TRIAL Stroke severity: Among incident ischemic strokes, moderate-to-high severity strokes (NIHSS ≥8) occurred in 88 patients (22.9%) in the asundexian group and 157 patients (30.3%) in the placebo group. Disabling / fatal stroke risk: The occurrence of disabling stroke was 2.1% (n=128) in the asundexian group and 3.0% (n=185) in the placebo group (csHR, 0.69; 95% CI: 0.55–0.87). Acute intervention: Of the ischemic strokes that did occur, 40 patients (10.4%) required acute intervention (intravenous thrombolysis [IVT] and/or endovascular treatment [EVT]) in the asundexian group, and 82 patients (15.8%) required acute intervention (IVT and / or EVT) in the placebo group. Ischemic stroke treated with EVT use: In patients who experienced an incident ischemic stroke, 27 patients (0.4%) required EVT in the asundexian group and 44 patients (0.7%) required EVT in the placebo group (csHR, 0.61; 95% CI: 0.38–0.99). Ischemic stroke with fatal outcomes: In patients who experienced an incident ischemic stroke, 16 patients (0.3%) experienced fatal outcomes in the asundexian group, and 28 patients (0.5%) experienced fatal outcomes in the placebo group (csHR, 0.57; 95% CI: 0.31-1.06). BAYER EXECUTIVE COMMENT“Stroke is one of the most pressing global health challenges, with serious and lasting consequences for patients, families, and healthcare systems around the world,” said Sara Hegab, MD, VP, Stroke & Thrombosis, Specialty and Pipeline, U.S. Medical Affairs, Bayer. “OCEANIC-STROKE reflects the strength of Bayer’s capabilities to take on complex global health challenges like stroke and the impact we hope to offer to patients. The insights from this study will continue to contribute to a deeper understanding of secondary stroke and the outcomes associated with these events.” 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, both in combination with antiplatelet therapy, for prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA). 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 first occurrence of ischemic stroke; the primary safety endpoint was time to ISTH major bleeding. About FXIaFactor 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 MedicineBayer is a leader in cardiology and is advancing a portfolio of innovative treatments in cardiovascular (CV) and cerebrovascular diseases of high unmet medical need. We have 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 BayerBayer 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 45.3 billion euros. R&D expenses amounted to 5.8 billion euros. Contact for U.S. media inquiries:Sarra Herzog, phone +1 862-460-8764Email: sarra.herzog@bayer.com Contact for investor inquiries:Bayer Investor Relations Team, phone +49 214 30-72704Email: ir@bayer.com www.bayer.com/en/investors/ir-team 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. References: LinkedIn Email Facebook X

Clinical ResultPhase 3

29 Apr 2026

·www.biospace.com

Bayer to Present 13 Abstracts From Its Stroke Franchise at ESOC 2026, Including Two Late-breaking Analyses From the Phase III OCEANIC-STROKE Trial of Asundexian

KEY FACTS Two late-breaking presentations from the landmark OCEANIC-STROKE study will provide new insights into ischemic strokes that occurred during the trial, as well as the net clinical benefit analysis Additional data to be presented at ESOC 2026 include analyses of intracranial hemorrhage and predictors of recurrent ischemic stroke from OCEANIC-STROKE Nine real-world analyses to provide insights into stroke care and patient outcomes WHAT’S HAPPENING WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer today announced that a broad set of data from its stroke franchise will be presented at the 2026 European Stroke Organisation Conference (ESOC), including new late-breaking analyses from its global, landmark Phase III OCEANIC-STROKE study of asundexian, an investigational oral Factor XIa inhibitor. In total, 13 abstracts will be presented, including four OCEANIC-STROKE sub-analyses. Additionally, Bayer will present nine real-world analyses examining stroke outcomes and patterns of care. The congress takes place May 6-8 in Maastricht, the Netherlands. 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 Presenter: Mike Sharma, MD, McMaster University, Population Health Research Institute (PHRI) Official Welcome & Large Clinical Trials Wednesday, May 6, 2026; 11:47 – 11:57 CEST Peking Room Late Breaker 2: Net Benefit and Time Course of Benefit of Asundexian for Secondary Stroke Prevention in the OCEANIC-STROKE Randomised, Placebo-controlled Clinical Trial Presenter: Mike Sharma, MD, McMaster University, Population Health Research Institute (PHRI) Late Breaking Trials Across the Stroke Care Continuum Friday, May 8, 2026; 09:24 – 09:33 CEST Peking Room Additional Bayer sub-analyses from the Phase III OCEANIC-STROKE study at ESOC 2026 include: Intracranial Haemorrhage in Patients with Non-cardioembolic Ischaemic Stroke or High-risk TIA: Insights from the OCEANIC-STROKE Randomised Trial of Asundexian for Secondary Stroke Prevention Presenter: Ashkan Shoamanesh, MD, Co-Principal Investigator of OCEANIC-STROKE study and PHRI senior scientist Paper Poster Session Wednesday, May 6, 2026; 13:00 – 13:00 CEST Predictors of Recurrent Ischaemic Stroke in Patients with Non-cardioembolic Ischaemic Stroke: Insights from the OCEANIC-STROKE Randomised Trial of Asundexian for Secondary Stroke Prevention Presenter: Ashkan Shoamanesh, MD, Co-Principal Investigator of OCEANIC-STROKE study and PHRI senior scientist Paper Poster Session Wednesday, May 6, 2026; 13:00 – 13:00 CEST Bayer additional presentations at ESOC 2026 include: The Impact of Recurrent Ischaemic Stroke on Length of Stay and All-cause Costs in Patients with Non-cardioembolic Ischaemic Stroke in Japan: Observations from Arise Presenter: Ashkan Shoamanesh, MD, Co-Principal Investigator of OCEANIC-STROKE study and PHRI senior scientist Paper Poster Session Wednesday, May 6, 2026; 13:00 – 13:00 CEST Evaluating Real-World Outcomes of Single Versus Dual Antiplatelet Therapy After an Ischaemic Stroke: Mortality and Major Adverse Cardiovascular Events Presenter: Steven Caproni, PharmD, Senior Scientific Director, U.S. Medical Affairs at Bayer Paper Poster Session Wednesday, May 6, 2026; 13:00 – 13:00 CEST Analysis of Characteristics and Clinical Outcomes After Ischaemic Stroke by NIHSS Nationally Representative US Electronic Health Records Database Presenter: Matthew Reeves, PhD, Professor of Epidemiology and Biostatistics, Michigan State University ePosters Session Wednesday, May 6, 2026; 08:00 – 15:00 CEST Health and Social Care Costs of Recurrent Stroke: Long-Term Follow-Up of a Population-Based Cohort Presenter: Ramon Luengo-Fernandez, DPhil, Senior Health Economist, The National Perinatal Epidemiology Unit Paper Poster Session Wednesday, May 6, 2026; 13:00 – 13:00 CEST Functional, Quality-Of-Life, and Life-Expectancy Consequences of Recurrent Stroke: 10-Year Follow-Up of a Population-Based Cohort Presenter: Ramon Luengo-Fernandez, DPhil, Senior Health Economist, The National Perinatal Epidemiology Unit Paper Poster Session Wednesday, May 6, 2026; 13:00 – 13:00 CEST Inconsistent Definitions and Unseen Impacts: A Living Systematic Review of Impairments Following Transient Ischaemic Attack (TIA) and Minor Stroke Presenter: Birgitte Hede Ebbesen, PhD-student, Department of Physiotherapy and Occupational Therapy, Aalborg University Hospital Paper Poster Session Wednesday, May 6, 2026; 13:00 – 13:00 CEST Characteristics and Clinical Outcomes in Patients with TIA by Abcd² Score: A Retrospective Observational Study of a Representative US EHR Database Presenter: Thanh Nguyen, MD, Neurologist and Director of Interventional Neurology/ Neuroradiology at Boston Medical Center Paper Poster Session Thursday, May 7, 2026; 13:00 – 13:00 CEST Medication Patterns by Stroke Severity in Non-Cardioembolic Ischaemic Stroke: Findings from a Large, Nationally Representative US-Based Retrospective Observational Database Presenter: Sean Savitz, MD, Professor, Department of Neurology, McGovern Medical School, UTHealth Paper Poster Session Thursday, May 7, 2026; 13:00 – 13:00 CEST 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 . Find more information at: Health for all, Hunger for none | Bayer United States Follow us on Facebook: Bayer Follow us on LinkedIn: Bayer | Pharmaceuticals Follow us on X: BayerUS Follow us on Instagram: bayerofficial 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 . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires. Contacts Contact for U.S. media inquiries: Sarra Herzog, phone +1 862-460-8764 Email: sarra.herzog@bayer.com Contact for investor inquiries: Bayer Investor Relations Team, phone +49 214 30-72704 Email: ir@bayer.com

100 Deals associated with Asundexian

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Ischemic stroke	NDA/BLA	China	Bayer AG	30 Apr 2026
Acute Ischemic Stroke	Phase 3	United States	Bayer AG	26 Jan 2023
Acute Ischemic Stroke	Phase 3	China	Bayer AG	26 Jan 2023
Acute Ischemic Stroke	Phase 3	Japan	Bayer AG	26 Jan 2023
Acute Ischemic Stroke	Phase 3	Argentina	Bayer AG	26 Jan 2023
Acute Ischemic Stroke	Phase 3	Australia	Bayer AG	26 Jan 2023
Acute Ischemic Stroke	Phase 3	Austria	Bayer AG	26 Jan 2023
Acute Ischemic Stroke	Phase 3	Belgium	Bayer AG	26 Jan 2023
Acute Ischemic Stroke	Phase 3	Brazil	Bayer AG	26 Jan 2023
Acute Ischemic Stroke	Phase 3	Bulgaria	Bayer AG	26 Jan 2023

Clinical Result

Indication

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05686070 (OCEANIC-STROKE, Pubmed \| N Engl J Med)	Phase 3	Ischemic Attack, Transient \| Ischemic stroke	12,327	Asundexian 50 mg once daily	qhezmainon(ejondtrxvz) = annwvtltfk shbdybdicd (ieggypfxot ) View more	Positive	16 Apr 2026
				Placebo	qhezmainon(ejondtrxvz) = rntnoeiqhv shbdybdicd (ieggypfxot ) View more
NCT05686070 (OCEANIC-STROKE, Company_Website) Manual	Phase 3	Ischemic Attack, Transient \| Ischemic stroke	12,327	Asundexian	pwodhssggb(isamohubwc) = jmvdpqyljo otpgrjeoqo (dkeahfbvvq ) View more	Positive	05 Feb 2026
				placebo	pwodhssggb(isamohubwc) = lsbrrhqyvo otpgrjeoqo (dkeahfbvvq ) View more
NCT05686070 (OCEANIC-STROKE, Company_Website) Manual	Phase 3	Ischemic stroke	-	Asundexian	sxipbylzfy(qaajhmptox) = Asundexian 50 mg once daily significantly reduced xkiknyibqh (ydahbmhlgq ) Met View more	Positive	23 Nov 2025
				Placebo
NCT05643573 (OCEANIC-AF, Pubmed \| JAMA Cardiol)	Phase 3	Atrial Fibrillation	-	Asundexian	cgtdqcsoju(qlnqddojei) = ghmqhynooz apmybogzqr (nqqqkwhdaj )	Positive	01 Jun 2025
				Apixaban	cgtdqcsoju(qlnqddojei) = gzdfkvuesw apmybogzqr (nqqqkwhdaj )
NCT05643573 (OCEANIC-AF, CTgov)	Phase 3	Stroke \| Atrial Fibrillation \| Systemic embolism	14,830	Apixaban matching placebo+Asundexian (BAY2433334) (Asundexian)	mbumeuycwe = zszhhtlxkc bnsjcvvhwr (rlcxrombco, fsipomrekz - pdjebpxmlf) View more	-	09 Dec 2024
				Asundexian matching placebo+Apixaban (Apixaban)	mbumeuycwe = ilkqunbime bnsjcvvhwr (rlcxrombco, tjxwldixus - yueqquklgk) View more
NCT05643573 (OCEANIC-AF, Pubmed \| N Engl J Med)	Phase 3	Atrial Fibrillation	-	Asundexian 50 mg once daily	nzazsxezbh(pchpfndzmz) = hhrlardsge tkwtsilcal (lqausshdnj ) View more	Negative	01 Sep 2024
				Apixaban	nzazsxezbh(pchpfndzmz) = zeoymceumq tkwtsilcal (lqausshdnj ) View more
NCT05643573 (OCEANIC-AF, NEWS) Manual	Phase 3	Atrial Fibrillation	-	asundexian	nzoxdhukdd(vqpghiayps) = Bayer is stopping a pivotal clinical trial for its experimental treatment for atrial fibrillation at the recommendation of an independent committee that concluded the drug would not be more effective than a Bristol Myers Squibb and Pfizer product widely used to treat the heart condition. twyhsxljpe (eiqqmorkbw )	Negative	20 Nov 2023
				Eliquis
NCT04304508 (PACIFIC-STROKE, CTgov)	Phase 2	Thrombosis \| Acute Ischemic Stroke	1,808	Asundexian (BAY2433334) (Asundexian 10 mg)	pwbwpwfipr = wognsazhkn sxmzphmrvg (soksdmkvbp, tvtykqzlhl - gqveyatxyk) View more	-	19 Apr 2023
				Asundexian (BAY2433334) (Asundexian 20 mg)	pwbwpwfipr = yxpbimxzpb sxmzphmrvg (soksdmkvbp, okormhroub - pvfihkqexa) View more
NCT04304534 (PACIFIC-AMI, CTgov)	Phase 2	Acute myocardial infarction	1,601	Asundexian (BAY2433334) (Asundexian 10 mg)	rtetbpltus = szxkugxvtt qrzcsdsdlk (xgrgxfkqkm, yibcmrxhak - ifttvbubuv) View more	-	05 Apr 2023
				Asundexian (BAY2433334) (Asundexian 20 mg)	rtetbpltus = augugrmifw qrzcsdsdlk (xgrgxfkqkm, kmtlvwtrca - khpmzzdviz) View more
NCT04218266 (PACIFIC-AF, CTgov)	Phase 2	Complication \| Atrial Fibrillation	755	Apixaban+Asundexian (BAY2433334) (Asundexian 20 mg)	iifzovhnag = tcanipbiqs jogzpvwzev (hxzlsgeubx, nfhifkhmex - wzpmgovabb) View more	-	27 Oct 2022
				Apixaban+Asundexian (BAY2433334) (Asundexian 50 mg)	iifzovhnag = lssrbtalsd jogzpvwzev (hxzlsgeubx, mvteycejnd - ycasqwibwu) View more

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