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Reza Shojaei: FDA Approval Marks Milestone for Factor XIa-Targeted Therapy

Reza Shojaei/LinkedIn

Nov 11, 2026, 13:01

Reza Shojaei: FDA Approval Marks Milestone for Factor XIa-Targeted Therapy

Reza Shojaei, Chief Operating Officer at Canadian Plasma Resources, shared a post on LinkedIn:

“A new target in blood clotting. A new chapter in stroke prevention.

On November 9, the FDA approved Sunharbo (asundexian), its first Factor XIa inhibitor.

For those following coagulation science, this is a milestone worth watching.

Who is it for?

Adults after a recent mild-to-moderate non-cardioembolic ischemic stroke, where the clot did not originate in the heart, or a high-risk transient ischemic attack (TIA).

It is used alongside antiplatelet therapy.

What did the evidence show?

In OCEANIC-STROKE, involving 12,327 adults, asundexian reduced ischemic stroke risk by 26 percent relative to placebo.

Both groups received antiplatelet therapy.

The bleeding findings deserve equal attention:

Major bleeding rates were similar overall, but the FDA reported increased major bleeding with Sunharbo in patients older than 75 and during the first 90 days.

Gastrointestinal bleeding was also more common.

It is not approved for stroke prevention in atrial fibrillation.

My takeaway: this approval gives coagulation science a new clinical foothold and makes patient selection central to the conversation.

What will matter most as this reaches clinical practice: patient selection, bleeding surveillance, or access?

Read the FDA announcement.”

Reza Shojaei: FDA Approval Marks Milestone for Factor XIa-Targeted Therapy