US EditionInvestigational Anti-Clotting Drug Reduces Risk of Second Ischemic Stroke without Bleeding Concerns
The OCEANIC-STROKE trial involving 12,327 participants showed asundexian lowered recurrent ischemic stroke risk by 26% without raising major bleeding incidents.
- Final OCEANIC‑STROKE results released Thursday show asundexian reduced recurrent ischemic stroke risk by 26% in more than 12,300 participants during the International Stroke Conference in New Orleans.
- The trial randomized patients within 72 hours of stroke or high-risk TIA to asundexian 50 mg daily plus antiplatelet therapy or placebo plus antiplatelet therapy, to test its FXIa mechanism and safety.
- The trial's secondary endpoints revealed that major bleeding per ISTH criteria occurred in 1.9% of patients, with symptomatic intracranial hemorrhage at 0.7%, and a significant reduction in disabling/fatal strokes to 2.1%.
- The FDA has granted fast‑track designation for asundexian for secondary stroke prevention, Bayer will begin regulatory discussions, and investigators said it could become an important option if approved.
- Amid competing FXIa programs, asundexian faces a mixed backdrop after failing a Phase 3 atrial fibrillation trial, while milvexian and antibody FXIa candidates advance and global stroke burden nears 12 million annually.
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Bayer Reveals Data That Could Make Stroke Prevention Drug Its Next Blockbuster Product
Bayer’s asundexian, a Factor XIa inhibitor, reduced the risk of secondary stroke by 26% without increasing bleeding risk in a Phase 3 clinical trial. The once-daily pill is at the front of an emerging class of medicines that includes drug candidates from Regeneron Pharmaceuticals and partners Bristol Myers Squibb and Johnson & Johnson. The post Bayer Reveals Data That Could Make Stroke Prevention Drug Its Next Blockbuster Product appeared first …
Investigational anti-clotting drug reduces risk of second ischemic stroke without bleeding concerns
An investigational anti-clotting medication, asundexian, demonstrated a reduction in the risk of a second ischemic (clot-caused) stroke without raising bleeding concerns, according to a preliminary late-breaking science presentation at the American Stroke Association's International Stroke Conference 2026.
Medical Xpress
NewMediaWireNew medication may reduce chances of a second clot-caused stroke without bleeding risk
An investigational anti-clotting medication, asundexian, has demonstrated a reduction in the risk of a second ischemic (clot-caused) stroke without raising bleeding concerns, according to a preliminary late-breaking science presentation at the American Stroke Association's International Stroke Conference 2026.
MedPage Today
Anti-Aging, Acupuncture and Health NewsNext-Generation Factor XIa Cuts Recurrent Stroke Risk by 26%
(MedPage Today) -- NEW ORLEANS -- Factor XIa (FXIa) inhibition for secondary stroke prevention got a major win in the large OCEANIC-STROKE placebo-controlled trial. Among adults with acute non-cardioembolic ischemic stroke or high-risk transient...
A new drug may help prevent second strokes without raising bleeding risk
A stroke can change a person’s life in an instant, and for many survivors, the fear of having another stroke never fully goes away. Doctors know that once someone has had a stroke, the risk of a second one is much higher. In fact, nearly one in four stroke survivors will experience another stroke at […] The post A new drug may help prevent second strokes without raising bleeding risk appeared first on Knowridge Science Report.
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