Hoffmann-La Roche (Roche Canada) announced this week that Health Canada has granted market authorisation for its TNKase brand of tenecteplase—a thrombolytic agent—in the treatment of adults with acute ischaemic stroke. This market authorisation came into effect on 13 November 2025.
Treatment with the drug is intended to be initiated within 4.5 hours from the onset of acute ischaemic stroke symptoms and after exclusion of intracranial haemorrhage (ICH), a company press release details. Roche says it will also be introducing a new 25mg vial configuration in the coming months to support the approval of TNKase in acute ischaemic stroke.
The company states in its release that this “important approval” makes TNKase the first stroke medicine to be authorised by Health Canada for nearly 27 years, with the regulator having cleared Roche’s alteplase-based thrombolytic—ACTIVASE rt-PA—in 1999.
The approval of TNKase in stroke treatment is based on the AcT trial—a multicentre, open-label, parallel-group, registry-linked randomised controlled trial conducted at 22 primary and comprehensive stroke centres across Canada. Patients were eligible for inclusion if they were aged 18 years or older with a diagnosis of ischaemic 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 on a 1:1 basis to either intravenous tenecteplase or alteplase.
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 ischaemic stroke.
“The approval of tenecteplase for acute ischaemic stroke marks an important moment in Canadian stroke care and exemplifies how innovative, investigator-initiated research can directly improve patient outcomes,” said AcT principal investigator Bijoy Menon (University of Calgary, Calgary, Canada). “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.”
