Investigational Asundexian Shows Reduction in Ischemic Stroke

Asundexian, an investigational once-daily oral Factor XIa inhibitor, reduced ischemic stroke in patients after a noncardioembolic ischemic stroke or high-risk transient ischemic attack compared with the placebo and in combination with antiplatelet therapy in the OCEANIC-STROKE (NCT05686070) trial.¹

“A stroke is a life-changing event for patients and a major public health burden,” Mike Sharma, MD, Michael G DeGroote Chair in stroke prevention at McMaster University, said in a news release. “The findings from OCEANIC-STROKE are a notable research achievement, demonstrating a substantial reduction in the risk of stroke with asundexian compared to placebo, alongside a sustained treatment effect and a safety profile with no observed increase in ISTH major bleeding.”

About the OCEANIC-STROKE Trial

The OCEANIC-STROKE trial is a large-scale, international phase 3 clinical study designed to evaluate the safety and efficacy of asundexian. This multicenter, randomized, double-blind, and placebo-controlled study spans 703 sites across 37 countries. It specifically targets adults who have recently experienced a noncardioembolic ischemic stroke (with an NIH Stroke Scale/Score of 15 or less) or a high-risk transient ischemic attack.^2,3

Eligible participants were randomized within 72 hours of symptom onset to receive either a 50 mg daily dose of asundexian or a matching placebo. Crucially, this treatment is administered in addition to standard-of-care antiplatelet therapy. To ensure balanced groups, the randomization is stratified based on whether the patient's background treatment involves single or dual antiplatelet therapy.^2,3

The trial was event-driven, designed to continue until 830 participants experienced a new ischemic stroke. The primary efficacy end point as the time to the first occurrence of ischemic stroke, while the primary safety end point was the incidence of major bleeding as defined by the International Society of Thrombosis and Haemostasis. To provide deeper insights into the drug's impact, the study includes an MRI substudy involving approximately 1,000 participants to track imaging markers such as incident infarcts and microbleeds.^2,3

Results of the Study

Investigators found that asundexian significantly reduced ischemic stroke by 26%, which was presented at the International Stroke Conference 2026 in New Orleans, Louisiana. In addition to the primary end point, investigators noted that asundexian reduced the risk of any stroke by 26% compared with the placebo, which was the secondary end point.¹

Furthermore, asundexian also met the composite end point of cardiovascular death, myocardial infarction (MI), or stroke and the composite of death from any cause, MI, or stroke.¹

“The consistent reduction in secondary events with asundexian across all types of strokes included in the trial is particularly striking,” Ashkan Shoamanesh, MD, co-principal investigator of OCEANIC-STROKE study, said in the news release.¹ “OCEANIC-STROKE was deliberately designed with the goal of making the findings generalizable to the many ways stroke presents in clinical practice. These results provide confidence that, if approved, asundexian could become an important option for secondary stroke prevention across a broad range of stroke patients.”

For the safety analysis, investigators noted there were no increases in the rate of ISTH major bleeding between asundexian and the placebo at 1.9% and 1.7%, respectively. Additionally, they noted the prespecified secondary safety end point of risk of bleeding was similar to the placebo arm.¹

The FDA granted asundexian fast track designation as a potential treatment for stroke prevention in patients after a noncardioembolic ischemic stroke.¹

READ MORE: Cardiology Resource Center

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REFERENCES

1. Bayer's asundexian demonstrated a substantial 26% reduction in stroke after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack, with no increase in ISTH major bleeding versus placebo. News release. February 5, 2026. Accessed February 9, 2026. https://www.bayer.com/en/us/news-stories/asundexian-after-a-non-cardioembolic-ischemic-stroke

2. Sharma M, Dong Q, Hirano T, et al. Rationale, design and baseline characteristics of participants in the OCEANIC-STROKE trial of FXIa inhibition for secondary stroke prevention. Eur Stroke J. 2026;11(1):aakaf017. doi:10.1093/esj/aakaf017

3. A study to test asundexian for preventing a stroke caused by a clot in participants after an acute ischemic stroke or after a high-risk ischemic attack, a so-called mini stroke. ClinicalTrials.gov: NCT05686070. Updated November 12, 2025. Accessed February 9, 2026. https://clinicaltrials.gov/study/NCT05686070