Bayer Group’s pharmaceutical division has presented the results of a Phase III study of a factor XIa inhibitor drug for the prevention of recurrent stroke, which demonstrated a significant reduction in ischaemic stroke after non-cardioembolic ischaemic stroke or high-risk transient ischaemic attack.
The drug demonstrated a 26% reduction in the risk of recurrent stroke, the company said in a press release.
The study evaluated an oral preparation of factor Xia (FXIa) asundexian (50 mg) to be taken once daily.
Results from the global pivotal phase III OCEANIC-STROKE study are published in the New England Journal of Medicine. The publication expands on data presented at the American Heart Association’s 2026 International Stroke Conference in New Orleans, USA, which showed that asundexian significantly reduced ischaemic stroke by 26% in patients after non-cardioembolic ischaemic stroke or high-risk transient ischaemic attack, without increasing the risk of major bleeding. These results were consistent regardless of age, gender, stroke subtype, stroke scale and other factors.
The company noted that this is the first successfully completed Phase III study of a factor XIa inhibitor to demonstrate a benefit in reducing ischaemic stroke compared to placebo when both drugs were combined with antiplatelet therapy.
At the same time, the company clarified to Interfax-Ukraine that “questions about the availability of the drug on local markets are being addressed in accordance with the company’s global procedures and regulatory requirements.”
“Now we cannot comment on specific timelines, at the same time the company is consistently working on making innovative developments available to patients, including through further regulatory steps in Ukraine”, – commented in Bayer in Ukraine plans regarding the possibility of registration of the drug on the local market.
Each year, approximately 12 million people worldwide experience a stroke, of which 20-30% will have a recurrent stroke. Despite the available options to prevent secondary stroke, its risk remains high: approximately one in five stroke survivors will have another stroke within five years.
Stroke is the second leading cause of death worldwide, and recurrent ischaemic strokes tend to be more disabling and carry a higher mortality risk than a first stroke.
Bayer is reportedly forecasting growth in its pharmaceutical business from 2027, improving operating margins to 30% by 2030 and plans to develop five key therapeutic areas, including cardiology, in particular secondary stroke prevention, comprehensive treatment of chronic kidney disease, oncology, including treatment of metastatic hormone-sensitive prostate cancer, women’s health and menopause symptom management, among others.
Bayer is an international company active in the healthcare and agriculture sectors. In fiscal year 2025, the Bayer Group employed more than 88,000 employees and generated sales of more than EUR45.6 billion. R&D expenditure excluding special items totalled more than EUR5.8 billion.