Asundexian
Chemical compound
From Wikipedia, the free encyclopedia
Asundexian[1] is a Factor XIa inhibitor developed by Bayer to prevent stroke.[2]
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| Formula | C26H21ClF4N6O4 |
| Molar mass | 592.94 g·mol−1 |
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Clinical trial(s)
Asundexian efficacy and safety in patients have been evaluated in two clinical trial programs: phase IIb PACIFIC and phase III OCEANIC.[3] In the phase IIb PACIFIC clinical trial programs, asundexian consistently showed no difference in bleeding rate compared with placebo[4][5] and reduced the risk of bleeding compared with apixaban.[6] All three trials in the programs were not powered to show efficacy of asundexian.[3] However, a phase III trial, OCEANIC-AF, demonstrated a hazard ratio of 3.8 for stroke or systemic embolism with asundexian vs apixaban, so it was stopped due to a "lack of efficacy." The remaining active study OCEANIC-STROKE was recommended to continue as planned. Bayer is reevaluating the design of the OCEANIC-AFINA based on the findings of the OCEANIC trial.[7]
In February 2026, the OCEANIC-STROKE trial was completed. This was a multicentre, randomised, double-blind, placebo-controlled study involving 12,000 people worldwide who had suffered a non-cardioembolic ischaemic stroke or a transient ischaemic attack. The trial revealed a 26% reduction in the rate of recurrence without major bleeding, a typical complication of antithrombotic drugs.[8][9][10]