# Bayer Asundexian regulatory approvals

> Developing situation record from CLSTR: https://clstr.news/situations/bayer-asundexian-regulatory-approvals
> Updated: 2026-11-09T22:26:55.000Z. Sources: 10. Developments: 2.

Bayer has received regulatory approvals for its blood thinner, asundexian, marketed under the brand name Sunharbo. The medication is a factor XIa inhibitor designed to reduce the risk of recurrent ischemic stroke.

In October 2026, China’s National Medical Products Administration approved the drug for the prevention of secondary ischemic strokes, marking the first approval in the country for this class of inhibitors. Clinical data from the OCEANIC-STROKE study indicated that the treatment significantly reduced stroke occurrence compared to a placebo.

In November 2026, the US Food and Drug Administration granted approval for asundexian for adults following a noncardioembolic ischemic stroke or a high-risk transient ischemic attack. The FDA approval was based on the OCEANIC-STROKE trial results, which showed reduced stroke risk without a statistically significant increase in major bleeding. The trial, involving over 12,000 participants, showed asundexian reduced the relative risk of ischemic stroke by 26 percent compared to a placebo. However, the FDA noted an increased risk of major bleeding in patients over 75 and during the first 90 days of treatment, with diarrhea noted as a common adverse reaction.

This milestone is seen as a strategic move for Bayer to offset declining revenues from older medicines like Xarelto and Eylea. While analysts suggest the drug has blockbuster potential, some note that market reach may be limited by its specific indication, which covers approximately 40 percent of stroke cases.

## Timeline

### 2026-11-09: Bayer receives FDA approval for Sunharbo stroke prevention drug

The US FDA has approved Bayer’s Sunharbo (asundexian), the first factor XIa inhibitor, to reduce recurrent stroke risk in adults following specific types of ischemic strokes or high-risk TIAs.

10 sources. https://clstr.news/cluster/fda-approves-bayer-blood-thinner-sunharbo-for-stroke-prevention

### 2026-10-26: Bayer receives Chinese approval for blood thinner Asundexian

Bayer's blood thinner Asundexian has received approval from Chinese regulators for stroke prevention, offering a potential multi-billion euro growth driver for the company.

2 sources. https://clstr.news/cluster/bayer-receives-chinese-approval-for-blood-thinner-asundexian

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Cite as: Bayer Asundexian regulatory approvals. CLSTR, https://clstr.news/situations/bayer-asundexian-regulatory-approvals