On Mar. 3, 2025, Genentech announced that the U.S. Food and Drug Administration (FDA) has approved TNKase^® (tenecteplase), a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke (AIS) in adults.

This approval of TNKase marks Genentech’s second approval for stroke, reinforcing the company’s long-standing dedication to advancing stroke care as the developer of the only two FDA-approved medicines for AIS, TNKase and Activase^® (alteplase).

TNKase is delivered as a single five-second intravenous (IV) bolus, a faster and simpler administration compared to the standard-of-care, Activase, which is administered as an IV bolus followed by a 60-minute infusion. Genentech will also be introducing a new 25 mg vial configuration in the coming months to support the approval of TNKase for AIS.

Stroke is the fifth leading cause of death, and the leading cause of long-term disability in the United States, affecting more than 795,000 people each year. During an AIS, brain damage occurs and progresses rapidly, meaning every moment without intervention leads to irreversible loss of nervous tissue, making immediate medical care crucial.