Berlin, Germany, November 10, 2026
Bayer has announced that the U.S. Food and Drug Administration (FDA) has approved asundexian 50 mg tablets, marketed under the brand name Sunharbo®, to reduce the risk of recurrent stroke in eligible adults following a recent non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA). The medicine is approved for use in combination with antiplatelet therapy and represents an important development in secondary stroke prevention. Asundexian is an oral, once-daily Factor XIa (FXIa) inhibitor designed to reduce pathological blood clot formation by selectively targeting a component of the coagulation pathway. The FDA decision follows Priority Review designation and is supported by positive results from the global Phase III OCEANIC-STROKE clinical trial, which demonstrated a significant reduction in ischemic stroke compared with antiplatelet therapy alone, without an increase in major bleeding as measured by the International Society on Thrombosis and Haemostasis (ISTH) criteria. According to Bayer, the approval introduces a new treatment option for patients who remain at risk of another stroke despite existing prevention strategies.
FDA Approval Supported by Phase III OCEANIC-STROKE Results
The FDA approval is based on the pivotal OCEANIC-STROKE Phase III clinical trial, a randomized, double-blind, placebo-controlled, multicenter study involving 12,327 participants worldwide. The trial evaluated asundexian 50 mg administered once daily alongside antiplatelet treatment, compared with placebo alongside antiplatelet treatment, in patients who had experienced a recent non-cardioembolic ischemic stroke or high-risk TIA. The primary efficacy endpoint was the time to the occurrence of an ischemic stroke, while the primary safety endpoint assessed ISTH-defined major bleeding. The results showed that asundexian, when combined with antiplatelet therapy, reduced the risk of ischemic stroke by 26% compared with antiplatelet therapy alone. Importantly, the rate of ISTH-defined major bleeding was similar between the asundexian and placebo groups. The treatment effect was also consistent across several important patient subgroups, including age, sex, type of initial cerebrovascular event, stroke severity and planned antiplatelet treatment. These findings provided the clinical evidence supporting the FDA’s regulatory decision and demonstrate the potential value of targeting Factor XIa in patients requiring additional protection against recurrent ischemic events.
New FXIa Inhibitor Targets Blood Clot Formation
Asundexian works by selectively inhibiting Factor XIa, a protein involved in the blood coagulation cascade. Factor XIa contributes to the development and growth of pathological blood clots, which can obstruct blood vessels and cause ischemic events such as stroke. Unlike some established anticoagulant approaches, the FXIa pathway is considered to have a more limited role in normal blood clot formation required to stop bleeding following an injury. By selectively targeting this pathway, asundexian is designed to reduce harmful thrombosis while potentially preserving normal hemostasis. This mechanism is particularly relevant in secondary stroke prevention, where clinicians must balance the need to prevent another clot-related event against the risk of bleeding complications. The similar rate of major bleeding observed in OCEANIC-STROKE compared with placebo is therefore an important finding. However, patients receiving the medicine must follow the approved prescribing information, including its instructions for combination use with antiplatelet therapy. The approval marks an important milestone for Factor XIa-targeted anticoagulant research and provides clinical validation for a new approach to reducing recurrent ischemic stroke risk.
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Bayer Expands Global Development and Stroke Prevention
The approval strengthens Bayer’s cardiovascular and cerebrovascular medicine portfolio and adds a new treatment option for patients at risk of recurrent stroke. Despite available prevention strategies, recurrent stroke remains a significant public health challenge. Bayer cited evidence indicating that approximately one in five survivors of non-cardioembolic ischemic stroke may experience another stroke within five years. Recurrent events can result in additional disability, reduced quality of life and increased healthcare needs. Asundexian has also received marketing approval from China’s National Medical Products Administration (NMPA), while regulatory applications in additional markets are under review. The company is continuing to work with health authorities internationally to support broader access. The OCEANIC-STROKE results were published in The New England Journal of Medicine, adding peer-reviewed evidence to the regulatory development program. For Bayer, the approval represents a significant achievement in its efforts to develop innovative treatments for cardiovascular and cerebrovascular diseases. Sunharbo is approved for a defined secondary stroke prevention population, and its use should follow the FDA-approved indication and prescribing information.
Source: Bayer press release
