Health Canada Approves TNKase for Acute Ischemic Stroke, First New Stroke Treatment in Nearly 27 Years
核心洞察
Health Canada has authorized TNKase (tenecteplase) for treating acute ischemic stroke in adults, marking the first new stroke treatment approved in nearly 27 years.
The approval is based on the AcT trial, a multicenter randomized controlled trial conducted at 22 stroke centers across Canada that demonstrated TNKase's comparable safety and efficacy to alteplase.
TNKase offers significant clinical advantages with its single five-second intravenous bolus administration, compared to alteplase which requires a bolus followed by a 60-minute infusion.
Health Canada has granted market authorization for TNKase (tenecteplase), a thrombolytic agent for treating acute ischemic stroke (AIS) in adults, effective November 13, 2025. This approval represents the first new stroke medicine authorized by Health Canada in nearly 27 years, offering Canadian healthcare providers an additional treatment option for managing acute ischemic stroke.
The authorization requires treatment initiation within 4.5 hours from symptom onset and after exclusion of intracranial hemorrhage. Roche Canada will introduce a new 25 mg vial configuration in the coming months to support the AIS indication.
Clinical Trial Evidence
The approval is based on the AcT trial (Alteplase Compared to Tenecteplase in Patients With Acute Ischemic Stroke), a multicenter, open-label, parallel-group, registry-linked, randomized controlled trial conducted at 22 primary and comprehensive stroke centers across Canada. The investigator-initiated study was conducted by the University of Calgary and funded by the Canadian Institute of Health Research.
Patients were eligible for inclusion if they were aged 18 years or older, with a diagnosis of ischemic stroke causing disabling neurological deficit, presenting within 4.5 hours of symptom onset, and eligible for thrombolysis per Canadian guidelines. Eligible patients were randomly assigned (1:1) to either intravenous tenecteplase or alteplase.
The large, multicenter, non-inferiority study demonstrated that TNKase is comparable to Activase (alteplase) in acute ischemic stroke patients in terms of safety and efficacy. Based on these results, TNKase has been incorporated into the Canadian Stroke Best Practices recommendations as an alternative option for intravenous thrombolysis administration in all eligible patients undergoing treatment for acute ischemic stroke.
Clinical Advantages and Administration
TNKase (tenecteplase) is a tissue plasminogen activator administered as a single, five-second intravenous bolus. This administration method is faster and simpler compared to the standard-of-care, Activase (alteplase), which requires an IV bolus followed by a 60-minute infusion.
The drug works by activating tissue plasminogen activator that breaks down fibrin, a component of blood clots. Common adverse reactions include bleeding and hypersensitivity.
Disease Burden and Clinical Impact
Stroke represents one of the leading causes of death and the number one cause of long-term disability in adults. Each year, approximately 109,000 strokes occur in Canada, which is roughly one stroke every five minutes. Currently, around one million Canadians are living with the long-term effects of a stroke, and this number continues to grow due to an aging population and increase in risk factors among younger individuals.
Ischemic stroke is the most common type, accounting for approximately 85% of all strokes. During an acute ischemic stroke, brain damage happens quickly and progresses rapidly. Each moment without intervention leads to irreversible loss of nervous tissue, highlighting the critical importance of immediate medical care.
Expert Commentary
"The approval of tenecteplase for acute ischemic stroke marks an important moment in Canadian stroke care and exemplifies how innovative, investigator-initiated research can directly improve patient outcomes," says Dr. Bijoy Menon, Professor and Head of Neurology at the Department of Clinical Neurosciences at the Cumming School of Medicine, University of Calgary and Principal Investigator of the AcT Trial. "The AcT trial, led through the University of Calgary with support from the Hotchkiss Brain Institute and the Canadian Institutes of Health Research, provided the pivotal evidence for this approval. Tenecteplase is already advancing stroke care, simplifying treatment, accelerating delivery, and expanding access across Canada."
Additional Indications
In addition to its approval for AIS, TNKase is also authorized by Health Canada for use in adults to treat suspected occlusive coronary artery thrombi associated with evolving transmural myocardial infarction. This indication aims to reduce mortality following acute myocardial infarction (AMI), with treatment to be initiated as soon as possible after the onset of AMI symptoms.