March 4, 2025 -- The FDA has approved the first new clot-busting drug in nearly 30 years, offering a faster way to dissolve blood clots in adults who suffer a stroke.
The treatment, tenecteplase (sold as TNKase), delivers a single five-second IV shot, making it a faster, easier option. TNKase was initially approved in 2000 to reduce the risk of death from acute ST-elevation myocardial infarction (STEMI), a severe type of heart attack.
Stroke is the fifth leading cause of death in the United States and a major cause of disability, affecting over 795,000 people each year. Acute ischemic stroke (AIS) occurs when a blood clot blocks blood flow to the brain, leading to brain damage, disability, or death. Fast treatment is critical to reduce long-term effects and improve recovery.
TNKase is a lab-made version of a natural protein called tPA, which helps break down blood clots. It sticks to fibrin, the protein that holds clots together, and triggers an enzyme to dissolve them. TNKase is designed to target clots better and last longer than natural tPA.
Genentech, part of the Roche group, said in a press release that TNKase can be given quickly, unlike Activase (alteplase), which requires an IV injection followed by a 60-minute drip.
The FDA approval was based on a large study conducted by the University of Calgary across 22 stroke centers in Canada and funded by the Canadian Institute of Health Research. Findings showed TNKase was as safe and effective as Activase for treating AIS.
The most common side effects of TNKase include allergic reactions such as hives and bleeding, particularly in patients with active internal bleeding, recent brain or spinal surgery, a serious head injury, or uncontrolled high blood pressure. Patients or caregivers should inform doctors about any episode of bleeding in the brain or stroke within the past three months and about all their prescription and over-the-counter medications, especially blood thinners as they can further increase bleeding risk. They should also immediately contact their doctor if they notice any unusual bleeding (weird bruises, pink or brown pee, bloody or dark stools, coughing up blood, or throwing up blood that looks like coffee grounds) or signs of a stroke.
