A newly approved clot-busting drug for stroke patients, tenecteplase (TNKase), has shown to be just as effective as the long-standing standard drug, alteplase — with the added benefit of faster administration, according to a recent study published in JAMA Network Open.

The U.S. Food and Drug Administration (FDA) granted approval to tenecteplase earlier this month, marking the first new clot-busting drug for stroke in nearly 30 years.

“In the treatment of acute ischemic stroke, there is the saying that ‘time is brain,’” said lead researcher Dr. Justin Rousseau, assistant professor of neurology at UT Southwestern Medical Center in Dallas. “The longer patients go without effective treatment, the more brain cells die, and the worse their outcome will be. Our study shows that tenecteplase is a safe and effective alternative to traditional treatment with alteplase, and in some cases, it could get patients on the road to recovery faster.”

Stroke is a leading cause of disability and death in the United States, with nearly 800,000 Americans experiencing one each year. The majority of these are ischemic strokes, caused by a blood clot blocking blood flow to the brain.

Alteplase, approved in 1996, has long been the gold standard for treating strokes by dissolving clots. However, it requires a complex administration process — an initial rapid dose followed by a slow-drip infusion over the course of an hour, which can lead to delays in treatment.

Tenecteplase, by contrast, is delivered through a simple, single injection that takes just seconds. Although it has been used for years in treating heart attacks and occasionally used off-label for strokes, its recent FDA approval now makes it an official stroke treatment option.

The study compared nearly 9,500 stroke patients treated with tenecteplase to over 70,000 who received alteplase between July 2020 and June 2022. Both groups had similar outcomes in terms of functional recovery, independence, ability to walk without assistance, and being discharged directly home rather than to rehabilitation facilities.

Safety outcomes were also comparable. However, the researchers noted that tenecteplase’s ease of use could allow for quicker transitions to clot-removing surgeries, improving patient outcomes even further. In fact, among patients who went on to receive clot-removing surgery, those treated with tenecteplase had higher rates of returning home and lower rates of in-hospital death or discharge to hospice care.

“This large, nationwide comparative effectiveness study using data from routine clinical practice demonstrated similar short-term safety and effectiveness outcomes with tenecteplase compared to alteplase in patients with acute ischemic stroke,” the study authors wrote.

The findings, researchers say, support tenecteplase as a practical and efficient alternative to alteplase, with the added advantage of simpler and faster administration — potentially helping save more lives when every second counts.