The U.S. Food and Drug Administration (FDA) has approved TNKase® (tenecteplase) for acute ischemic stroke treatment in adults on March 3, 2025, according to an announcement from Genentech, a Roche Group member based in South San Francisco, CA. TNKase received its FDA approval as the first new stroke therapy in nearly thirty years, making it a transformative therapy in stroke care.
TNKase is a thrombolytic agent that targets blood clots, obstructing blood flow to the brain during stroke events. The standard medicine Activase® (alteplase) needs a 60-minute intravenous (IV) infusion after an initial bolus. In contrast, TNKase administers its treatment through a rapid five-second IV bolus. The streamlined and rapid manner of TNKase delivery remains critical in stroke treatment because every moment is essential in preventing long-term brain damage.
Dr. Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development at Genentech, enthusiastically announced this new FDA approval of TNKase. “The new FDA approval demonstrates our absolute dedication to delivering better outcomes for patients who have experienced a stroke. TNKase gives medical professionals a quick and efficient treatment choice against acute ischemic stroke that minimizes the destructive effects of this condition.”
Stroke remains the second largest contributor to mortality and long-term disability in the United States, with more than 795,000 affected cases per year. When patients experience acute ischemic stroke (AIS), there is quick brain tissue damage, so doctors must provide timely treatment to reduce brain cell death. The accelerated delivery method of TNKase enhances treatment accessibility, ultimately leading to improved patient outcomes in managing AIS symptoms.
The approval of TNKase was supported by clinical trial evidence from the AcT (Alteplase compared to Tenecteplase) study. The University of Calgary led this Canadian multi-center non-inferiority research involving 22 stroke centers, which compared TNKase with Activase for AIS treatment. The trial results demonstrated that TNKase delivered equivalent safety results and treatment effects as Activase when treating patients with disabling neurological deficits.
The US FDA has already approved TNKase for acute ST-elevation myocardial infarction (STEMI) treatment despite its new application as an acute ischemic stroke therapy.
The new approval brings a 25 mg vial configuration to TNKase, which will soon be available to support the treatment of stroke patients. The medication shows effectiveness in decreasing the incidence of death risk in patients diagnosed with STEMI.
People treated with TNKase commonly experience bleeding side effects that potentially cause severe brain hemorrhaging. The medication presents the risks of allergic reactions, thromboembolism, and cholesterol embolization. The drug has safety constraints against using TNKase on patients with active internal bleeding, recent brain injuries, and major surgical procedures. All patients need to notify their healthcare provider about their medication because blood thinners can further increase bleeding risks.
The FDA approval of TNKase made Genentech the producer of the two complete FDA-approved medicines for acute ischemic stroke while solidifying its position as the leader in stroke treatment progress. The FDA approval of TNKase represents a new clinical possibility for stroke treatment by optimizing its rapid administration since Activase established itself as a standard of care in stroke treatment over 25 years ago.
Stroke care reached a breakthrough with this approval, according to Garraway. “We stand with great pride in delivering cutting-edge treatments to the stroke patient population through our innovative medical approaches that minimize stroke impact.” Genentech is one of the leading biotechnology companies that develops breakthrough medical treatments for crucial health conditions. The pioneering practices at the company have resulted in groundbreaking developments that extend beyond stroke treatments into several medical fields, such as oncology, immunology, and neuroscience. The FDA approval of TNKase marks a crucial development in stroke therapy, offering a faster and more efficient treatment option for millions of patients.
References: Genentech. FDA Approves Genentech’s TNKase® in Acute Ischemic Stroke in Adults. Published March 3, 2025. Accessed March 5, 2025. https://www.gene.com/media/press-releases/15053/2025-03-03/fda-approves-genentechs-tnkase-in-acute
