Genentech’s TNKase Approved by FDA to Treat Acute Ischemic Stroke in Adults

March 3, 2025—Genentech, a member of the Roche Group, announced that the FDA has approved the company’s TNKase (tenecteplase) thrombolytic for the treatment of acute ischemic stroke (AIS) in adults.

According to the company, TNKase is delivered as a single 5-second intravenous (IV) bolus, a faster and simpler administration compared to the FDA-approved standard-of-care for AIS, Activase (alteplase), which is administered as an IV bolus followed by a 60-minute infusion. Genentech is also the developer of Activase.

Genentech stated that it will be introducing a new 25-mg vial configuration in the coming months to support the approval of TNKase for AIS.

According to the company, the latest FDA approval is based on the AcT trial of alteplase compared to tenecteplase in treating patients with AIS who presented with a disabling neurological deficit. The large, multicenter, noninferiority study demonstrated that TNKase is comparable to Activase in AIS patients in terms of safety and efficacy, reported Genentech.

Genentech stated that the investigator-initiated AcT study enrolled patients across 22 stroke centers in Canada. It was conducted by the University of Calgary in Calgary, Canada, and was funded by the Canadian Institute of Health Research.

The company noted that TNKase is also FDA approved for the treatment of acute ST-elevation myocardial infarction in adults. This approval was received in 2000.

Alteplase and tenecteplase are marketed and supplied by Genentech in the United States and Canada under the brands Activase and TNKase, respectively. In all countries except the United States, Canada, and Japan, Boehringer Ingelheim market alteplase and tenecteplase under the brand names Actilyse and Metalyse, respectively, advised the company.