FDA

TNKase approved for acute ischemic stroke

March 7, 2025

FDA approved TNKase (tenecteplase), a tissue plasminogen activator, for the treatment of acute ischemic stroke (AIS) in adults.

The drug is also approved to reduce the risk of death associated with acute ST elevation MI (STEMI) in adults.

Efficacy

Approval was based on data from the registry-linked, multicenter, parallel group, open-label, randomized AcT trial (NCT03889249) that evaluated the non-inferiority of tenecteplase vs. alteplase in treating patients with acute AIS who presented with a disabling neurologic deficit. A total of 1,147 patients were treated within 3 hours of symptom onset and were included in the intent to treat (ITT) population.

Patients were randomized (1:1) to receive a single IV bolus of tenecteplase or a one-hour infusion of 0.9 mg/kg alteplase. Efficacy was assessed as a pre-defined favorable clinical outcome based on the proportion of patients that were treated within 3 hours of symptom onset who achieved a modified Rankin Scale score of 0–1 at 90–120 days, as assessed by the Rankin Focused Assessment.

In the ITT population, 36.6% of tenecteplase recipients achieved the primary endpoint vs. 35.9% of alteplase-treated patients (unadjusted risk difference, 0.7%; 95% confidence interval, -4.9% to 6.3%).

Safety

The most common adverse reaction is bleeding.

Recommended dose

For AIS, treatment with TNKase should be initiated as soon as possible and within 3 hours of onset of stroke symptoms. Dosage should be individualized based on the patient’s weight; max. dose is 25 mg (10 mL).

Sources:

Genentech. TNKase (tenecteplase) [package insert]. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/103909s5197lbl.pdf

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