Health Canada authorizes TNKase® (tenecteplase) for the treatment of Acute Ischemic Stroke (AIS)

The approval marks the first new stroke treatment authorized in nearly 27 years, offering an additional option for managing acute ischemic stroke in Canada.

MISSISSAUGA, ON, Dec. 17, 2025 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is proud to announce that Health Canada has granted market authorization for TNKase® (tenecteplase), a thrombolytic (clot-dissolving) agent, effective November 13, 2025 for the treatment of acute ischemic stroke (AIS) in adults. Treatment is to be initiated within 4.5 hours from the onset of AIS symptoms and after exclusion of intracranial haemorrhage. Roche will also be introducing a new 25 mg vial configuration in the coming months to support the approval of TNKase for AIS.  This important approval marks TNKase as the first stroke medicine authorized by Health Canada in nearly 27 years.^{1, 6}

Stroke is 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.²

The approval of TNKase for the treatment of stroke 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. 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 h of symptom onset, and eligible for thrombolysis per Canadian guidelines. Eligible patients were randomly assigned (1:1) to either intravenous tenecteplase or alteplase.³

Based on the results of the AcT trial, 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.⁴

"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."

This approval underscores Roche Canada's ongoing commitment to advancing stroke care and neurology research. By supporting innovative research and delivering new treatment options, we aim to improve outcomes and simplify care for Canadians affected by acute ischemic stroke. Through continued collaboration with healthcare partners, we strive to address the significant burden of stroke and support patients, families, and healthcare systems across the country.

About the Health Canada Authorization ^1,3
The approval is based on a large, multicenter, non-inferiority study demonstrating TNKase is comparable to Activase^® (alteplase) in acute ischemic stroke (AIS) patients in terms of safety and efficacy. The AcT trial (Alteplase Compared to Tenecteplase in Patients With Acute Ischemic Stroke) specifically compared TNKase to Activase for treating AIS patients who presented with a disabling neurological deficit. The investigator-initiated study was conducted by the University of Calgary, funded by the Canadian Institute of Health Research, and involved patient enrollment at 22 stroke centers across Canada.

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). 

About TNKase (tenecteplase) ¹
TNKase (tenecteplase) is a tissue plasminogen activator, or clot-dissolving (thrombolytic) medicine, administered as a single, five-second intravenous (IV) 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.

TNKase (tenecteplase for injection) is indicated for:

• Intravenous use in adults for the treatment of acute ischemic stroke (AIS). Treatment is to be initiated within 4.5 hours from the onset of AIS symptoms and after exclusion of intracranial haemorrhage.
• Intravenous use in adults for the lysis of suspected occlusive coronary artery thrombi associated with evolving transmural and myocardial infarction to reduce the mortality associated with acute myocardial infarction (AMI). Treatment should be initiated as soon as possible after the onset of AMI symptoms.

The drug works by starting a tissue plasminogen activator that breaks down fibrin, a component of blood clots. Common adverse reactions include bleeding and hypersensitivity.

About Acute Ischemic Stroke ⁵
A stroke occurs when blood flow carrying essential oxygen and nutrients is interrupted to a part of the brain, resulting in damage to neurons. Strokes can be caused by either a blockage in a blood vessel (ischemic stroke) or the rupture of a blood vessel (hemorrhagic stroke).

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.

Roche's Commitment In Stroke & Neurology
Roche is dedicated to advancing science and developing innovative solutions to address some of the most pressing challenges in neurology, including stroke care. With decades of experience in neuroscience, we have been deeply committed to improving the lives of patients and supporting healthcare systems in addressing the significant burden of neurological disorders. Our work has helped shape the standard of care, and we continue to build on this legacy by investing in research, technologies, and transformative medicines. By focusing on earlier diagnosis and advancing treatment options, we strive to make a meaningful difference for patients, their families, and the healthcare community across Canada. 

About Roche Canada
At Roche Canada, patients and science are at the heart of everything we do. Our passion for science and our commitment to relentlessly pursuing the impossible for patients have made us one of the world's leading pharmaceutical, in-vitro diagnostics, and diabetes care management companies.

With our combined strength in diagnostics and pharmaceuticals, we're driving healthcare forward, while ensuring we deliver meaningful benefits for patients and a sustainable healthcare system. Because we're committed to making quality healthcare accessible to everyone. And we're adding our expertise in new areas, such as artificial intelligence, real world data collection and analysis and collaborating with many different sectors and industries.

Having the courage to reinvent ourselves and question the status quo is what patients and the healthcare system expect from Roche - and our commitment is as strong today as it was on the  first day of our Canadian journey in 1931. Today, Roche Canada employs almost 2,000 people  across the country through its Pharmaceuticals division in Mississauga, Ontario as well as its Diagnostics division in Laval, Québec.

For more information, please visit www.RocheCanada.com or follow Roche Canada on LinkedIn.

References
[1] TNKase Product Monograph - November 13, 2025

[2] NIH. Estimating the Number of Hospital or Emergency Department Presentations for Stroke in Canada. Available at https://pubmed.ncbi.nlm.nih.gov/36536997/ . Accessed on November 25, 2025

[3] NIH. Intravenous tenecteplase compared with alteplase for acute ischaemic stroke in Canada (AcT). Available at https://pubmed.ncbi.nlm.nih.gov/35779553/ . Accessed on November 25, 2025

[4] Canadian Stroke Best Practices. 5. Acute Ischemic Stroke Treatment. Available at https://www.strokebestpractices.ca/recommendations/acute-stroke-management/acute-ischemic-stroke-treatment . Accessed on November 25, 2025

[5] Heart & Stroke. Types of Stroke. Available at https://www.heartandstroke.ca/stroke/what-is-stroke/types-of-stroke . Accessed on November 25, 2025

[6] Health Canada. Notice of Compliance Information - ACTIVASE RT-PA. Available at https://health-products.canada.ca/noc-ac/nocInfo?no=1593 . Accessed on Nov 28, 2025

SOURCE Hoffmann-La Roche Limited (Roche Canada)

Media Contact: Seraphina Opel, Communications Manager, Hoffmann-La Roche Limited (Roche Canada), 800-561-1759, [email protected]