TNKase (Tenecteplase) Becomes First Stroke Medicine Approved by FDA in Almost 30 Years

The FDA has approved Genentech’s TNKase (tenecteplase) for the treatment of acute ischemic stroke in adults, marking a milestone as the first new stroke medicine approved in nearly three decades.

TNKase, a clot-dissolving agent, offers a faster and simpler alternative to current treatment options, delivered as a single five‐second intravenous (IV) bolus. This breakthrough could mean quicker intervention for stroke care when every second counts.

The CDC identifies stroke — 87% of which are ischemia strokes — as the fifth leading cause of death and a major contributor to long-term disability in the US. Acute ischemic stroke occurs when a blood clot obstructs a cerebral artery, depriving brain tissue of oxygen and nutrients, which leads to rapid neuronal death and functional deficits, and is associated with an overall mortality rate of roughly 15% to 20%.

While market analysis projects that the global acute ischemic stroke market will exceed $50 billion by 2032, a presidential advisory from the American Heart Association estimated that per‐person costs for stroke — roughly $35,000 in 2022 dollars — will nearly triple healthcare spending from 2020 to 2050.

Pricing data indicate that the price of TNKase is around $8,672 for a 50 mg IV injection for cash-paying customers, though prices can vary based on pharmacy and location.

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TNKase works by initiating a biochemical reaction that breaks down fibrin, a protein that acts like the scaffolding holding blood clots together. By dissolving these clots, TNKase helps restore blood flow to the brain, reducing the risk of permanent damage.

TNKase is already approved for treating acute ST-elevation myocardial infarction, another critical cardiovascular emergency.

The approval was based on the robust AcT trial, a large multi‐center non‐inferiority study that compared TNKase with alteplase (Activase), the standard treatment approved in 1996.

Researchers enrolled patients across 22 stroke centers in Canada, funded by the Canadian Institute of Health Research. In contrast to Activase’s administration — an initial IV bolus followed by a 60‐minute infusion — TNKase’s single, five‐second injection could streamline treatment protocols and reduce delays.

While TNKase carries risks such as bleeding and hypersensitivity, these are managed within strict clinical guidelines.

Meanwhile, the broader stroke care landscape is evolving rapidly.

Recent developments include Penumbra’s study enrollment and Targed Biopharmaceuticals’ Phase I trial for a novel thrombolytic agent.

The Brainomix-Medtronic partnership will integrate Brainomix advanced, AI-driven imaging analysis with Medtronic’s interventional devices, aiming to enhance the accuracy of stroke diagnosis and streamline treatment decisions in clinical settings in Western Europe.

Promising Phase II data from Revalesio’s Phase II/III trial in acute ischemic stroke patients revealed improvements in neurological recovery, likely driven by the agent’s anti-inflammatory effects and its potential to enhance microcirculation in the brain.

Genentech plans to introduce a new 25 mg vial configuration to further support TNKase’s use in both hospital and pre-hospital settings, positioning the drug as a key player in a dynamic field.