# FDA approves stroke-prevention pill asundexian

> A new daily medication targeting blood clotting reduces the risk of second strokes by 26 percent without increasing bleeding.
- Title: FDA approves stroke-prevention pill asundexian · TIME
- Summary: A new daily medication targeting blood clotting reduces the risk of second strokes by 26 percent without increasing bleeding.
- Keywords: asundexian, sunharbo, fda approval, stroke prevention, ischemic stroke, bayer, factor xia, antiplatelet therapy, TIME
- Source: TIME — https://time.com/article/2026/11/12/new-pill-could-reduce-risk-second-stroke
- Author: Alice Park
- Published: 2026-11-12T19:59:40.721+00:00
- Read time: 1 min
- Topics: asundexian, sunharbo, fda approval, stroke prevention, ischemic stroke, bayer, factor xia, antiplatelet therapy, news, world
## FDA approves new stroke drug
On November 9, the U.S. Food and Drug Administration approved asundexian, a daily pill targeting blood clotting to reduce stroke risk in certain patients.
## How the drug works and who it helps
Asundexian, sold as Sunharbo, is approved for people who have recently had an ischemic stroke caused by blood clots or a transient ischemic attack from temporary blockage.
## Study shows 26 percent risk reduction
In Bayer's trial, the drug combined with aspirin reduced the risk of an additional stroke by 26% in just over a year compared to placebo plus aspirin.
## No increase in bleeding risk
The 26% reduction in stroke risk occurred without any significant increase in bleeding events. Dr. Ashkan Shoamanesh says this solves a longstanding challenge in stroke treatment.

> We used to always have a challenging balancing act. Here we have the major benefits without the bleeding risk, so there is a large amount of excitement.
## Benefits consistent across patient groups
The drug benefited patients regardless of age, geography, medical history or type of ischemic stroke, according to Shoamanesh, who co-led the trial.
## Lifelong treatment expected
Asundexian will be available starting in November. Shoamanesh expects patients will need to take the daily pills for the rest of their lives to maintain stroke protection.

> So we expect this to be a lifelong drug based on the data. And we expect this will be the new standard of care.
## Key takeaway

The FDA approved asundexian on November 9 to reduce recurrent stroke risk in patients who have had an ischemic stroke or transient ischemic attack.