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Sajja Venkatesh: FDA Approved Asundexian, the First Factor XIa Inhibitor

Sajja Venkatesh/LinkedIn

Nov 14, 2026, 09:11

Sajja Venkatesh: FDA Approved Asundexian, the First Factor XIa Inhibitor

Sajja Venkatesh, Interventional Neurologist, FNB-NeuroVascular Intervention at Apollo Hospitals, shared on LinkedIn:

“FDA approved Asundexian (Sunharbo), the first Factor XIa inhibitor.

It is the first new oral antithrombotic mechanism for secondary stroke prevention in years.

Here is why it matters.

Indication:

Once-daily 50 mg, with antiplatelet therapy, to reduce stroke risk in adults after a recent non-cardioembolic ischemic stroke (NIHSS ≤15) or high-risk TIA.

Evidence:

OCEANIC-STROKE

A phase 3, randomized, double-blind, placebo-controlled trial.

Patients were randomized within 72 hours of symptom onset.

12,327 patients were randomized.

Ischemic stroke: 6.2% vs 8.4% (HR 0.74; 95% CI 0.65–0.84).
ISTH major bleeding: 1.9% vs 1.7% (HR 1.10; 95% CI 0.85–1.44).

The mechanism is the point.

FXIa inhibition is meant to cut pathologic thrombosis while largely preserving hemostasis.

Cautions:

Major bleeding was higher in patients over 75 and in the first 90 days. GI bleeding was more frequent.
Not recommended with combined P-gp and strong CYP3A4 inducers (e.g., carbamazepine), or in moderate or severe hepatic impairment.
Withhold at least 24 hours before elective procedures and for at least 24 hours after thrombolysis.
Not approved for atrial fibrillation.

For those of us who see these patients in the acute window, this is a real new option.

Which patients would you start it in first?”

Sajja Venkatesh