The FDA has approved tenecteplase (TNKase), a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke in adults, marking the first approval of a stroke thrombolytic in nearly 30 years. TNKase is administered as a single five-second intravenous bolus, offering a simplified alternative to alteplase (Activase), which requires an initial bolus followed by a 60-minute infusion.

The approval is based on a large multi-center non-inferiority study demonstrating that TNKase is comparable to Activase in acute ischemic stroke (AIS) patients in terms of safety and efficacy. The AcT (Alteplase compared to Tenecteplase) trial compared TNKase to Activase in treating patients with acute ischemic stroke who presented with a disabling neurological deficit. This investigator-initiated study was conducted by the University of Calgary, was funded by the Canadian Institute of Health Research, and enrolled patients across 22 stroke centers in Canada.

"Today's approval is a significant step forward and underscores our commitment to advancing stroke treatment options for patients," said Levi Garraway, MD, PhD, Genentech's chief medical officer and head of Global Product Development. "TNKase provides a faster and simpler administration, which can be critical for anyone who is dealing with an acute stroke."

Genentech, a member of the Roche Group, has developed both FDA-approved thrombolytic agents for AIS. TNKase is also FDA-approved for the treatment of acute ST-elevation myocardial infarction (STEMI) in adults. With this approval, the company plans to introduce a new 25 mg vial configuration in the coming months to support tenecteplase use in stroke management.

Reference: 

Genentech. FDA Approves Genentech’s TNKase® in Acute Ischemic Stroke in Adults. Published March 3, 2025. Accessed March 3, 2025. https://www.gene.com/media/press-releases/15053/2025-03-03/fda-approves-genentechs-tnkase-in-acute-