• Posted March 20, 2025

New Clot-Busting Drug Quicker And As Effective In Treating Stroke

A newly approved clot- busting drug for stroke works as well as a decades-old medication still used by most U.S. hospitals, and can be delivered even more quickly, a new study says.

Tenecteplase (TNKase) is the first new clot-busting drug to be approved in nearly 30 years, with the U.S. Food and Drug Administration (FDA) giving it the thumbs-up earlier this month.

And now, research shows that tenecteplase works just as well as the standard clot-busting drug alteplase used to treat strokes, according to findings published recently in JAMA Network Open.

“In treatment of acute ischemic stroke, there is the saying that ‘time is brain.’ The longer patients go without effective treatment, the more brain cells die, and the worse their outcome will be,” lead researcher Dr. Justin Rousseau, an assistant professor of neurology with UT Southwestern Medical Center in Dallas, said in a news release.

“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,” Rousseau said.

Each year, nearly 800,000 people in the U.S. have a stroke, and this most often occurs because a blood clot has blocked blood flow to the brain (an ischemic stroke), researchers said in background notes.

Alteplase was approved in 1996 to help treat strokes by dissolving these clots quickly, but the drug has significant disadvantages, researchers said.

Alteplase is delivered with a rapid initial dose followed by a slow-drip infusion over the next hour, researchers said. This is a complicated process that can cause interruptions or delays in treatment.

By comparison, tenecteplase is delivered with a single, seconds-long injection, researchers said. The new drug was approved for use in stroke in early March, but has already been on the market for treatment of clot-caused heart attacks and sometimes used as an off-label stroke treatment.

For the new study, researchers compared nearly 9,500 patients who received tenectplase for stroke to more than 70,000 who got alteplase between July 2020 and June 2022.

Both groups had nearly identical outcomes in terms of functional independence, freedom from disability, discharge to home rather than a rehab facility, and ability to walk without assistance.

The drugs also had comparable safety measures, researchers said.

But using the more easily administered tenecteplase could allow more flexibility in stroke treatment, researchers said. For example, patients might be able to get clot-removing surgery more quickly.

In fact, among patients who proceeded to clot-removing surgery, tenecteplase appeared to perform better -- improving the chances that people would be discharged home and decreasing the rates of in-hospital deaths or discharge to a hospice.

“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,” researchers concluded in their study.

“This study supports tenecteplase as a reasonable alternative to alteplase, with practical advantages for tenecteplase preparation and administration.”

More information

The Mayo Clinic has more on stroke treatments.

SOURCE: UT Southwestern Medical Center, news release, March 12, 2025