Drug
Asundexian is an investigational oral factor XIa inhibitor; it is not FDA approved.
Sources: 2 registered trials
0 experts have reacted so far. We show the split once 3 have.
Expert labels are toward OCEANIC-STROKE's result, from named public quotes (n=0). As of Oct 22, 2026.
Mechanism: factor XIa inhibitor · Synapse curated drug list
Dosing is left to the label.
Primary results of the trial behind the evidence on asundexian, as each trial’s own publication reports it.
Left of the line at 1 favours the intervention; square size tracks trial size.Favours the interventionNo significant differenceFavours the comparator
OCEANIC-AFprimary efficacy: stroke or systemic embolism
asundexian vs apixaban · 14,810 patients · N Engl J Med 2025
In high-risk patients with atrial fibrillation
Primary outcome: whether asundexian is at least noninferior to apixaban for the prevention of stroke or systemic embolism
HR 3.79 (2.46–5.83)
OCEANIC-AFprimary safety: major bleeding
asundexian vs apixaban · 14,810 patients · N Engl J Med 2025
In high-risk patients with atrial fibrillation
Primary outcome: whether asundexian is superior to apixaban with respect to major bleeding events
HR 0.32 (0.18–0.55)
Results are quoted from each trial’s primary publication abstract (PubMed); the trial name links to the paper. Ratios below 1 favour the intervention.
Registered trials with asundexian in an arm, past phase 1 with at least 50 participants: the largest in each indication, newest first. Trials that give it only as the comparator are tagged; trials that give it in every arm are listed last.
A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke
NCT05643573 · Phase 3 · Terminated · 14,830 participants · started 2022
NCT05686070 · Phase 3 · Completed · 12,327 participants · started 2023
Source: ClinicalTrials.gov registry records.
Class membership: Synapse curated drug classes
A clinical question appears here only when its condition matches this topic, an outcome and a comparator were extracted from the studies, at least two studies and a patient count are on file, and the certainty is low or higher.
Supports benefit, no benefit shown, and mixed describe the direction of the measured effect. No benefit shown means the evidence does not support a benefit. It is not a finding of harm. Too little evidence means the question did not clear that bar.
Study count, RCT count, and patient count are separate. The patient total adds only studies that are linked into a study family and whose sample size is not flagged as implausible. A reversal is listed only when at least one randomized trial sits on each side of the change.
The overview is drafted from the guideline recommendations, trials, papers, and questions on this page, and every sentence has to cite one of them. It stays unverified until an NPI-verified clinician or a Synapse admin approves it. Approving records that person's name.