Asundexian

Asundexian is a Factor XIa inhibitor developed by Bayer to prevent stroke.

Clinical trial(s)
Asundexian efficacy and safety in patients have been evaluated in two clinical trial programs: phase IIb PACIFIC and phase III OCEANIC. In the phase IIb PACIFIC clinical trial programs, asundexian consistently showed no difference in bleeding rate compared with placebo and reduced the risk of bleeding compared with apixaban. All three trials in the programs were not powered to show efficacy of asundexian. However, a phase III trial, OCEANIC-AF, 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.