The Korean Stroke Society has urged the government to introduce the drug tenecteplase, a treatment for hyperacute stroke, in Korea.

On Monday, the stroke group called for a change in the stroke treatment environment in Korea, saying that a research team led by Professor Bae Hee-joon of the Department of Neurology at Seoul National University College of Medicine has published a paper with clinical evidence for the use of tenecteplase.

Tenecteplase is characterized by a simpler administration method, longer duration of action, and lower bleeding side effects compared to alteplase, an existing treatment.

“Currently, tenecteplase has many advantages over the existing intravenous thrombolytic agents,” Professor Bae said. "Based on the clinical evidence, the need for and indications for tenecteplase administration have been presented. We believe that tenecteplase will help improve the prognosis of patients with cerebral infarction in Korea."

Tenecteplase is an intravenous thrombolytic agent for the initial treatment of patients with cerebral infarction, an improved version of the existing drug alteplase. It was approved by the U.S. Food and Drug Administration (FDA) in June 2000 for the thrombolytic treatment of patients with myocardial infarction. It was approved in Korea in 2003 for the same indication.

In a study comparing the efficacy of tenecteplase to conventional intravenous thrombolytic therapy in patients with hyperacute cerebral infarction, the proportion of patients with an excellent prognosis at 90 days was similar (40 percent vs. 37 percent). Mortality at 90 days was also not significantly different, at 14 percent vs. 15 percent. Symptomatic cerebral hemorrhage was also similar between tenecteplase and traditional IV thrombolytic agents (2.9 percent vs. 3.0 percent). Still, the incidence of any cerebral hemorrhage was lower with tenecteplase (16 percent vs. 22 percent).

Tenecteplase also has advantages in terms of dosing method and timing.

Because it has a longer half-life and stronger thrombolytic activity than intravenous thrombolytic agents, it can be administered in a single 5-10 second bolus infusion, which is a clinical advantage in terms of simplifying the treatment process and saving time. Traditional intravenous thrombolytic agents require a bolus infusion of 10 percent of the total dose over one minute, followed by a 90 percent infusion over one hour, which limits the treatment process.

Intravenous thrombolysis is an essential first-line treatment for acute stroke patients who present to the hospital within 4.5 hours of symptom onset, and about 10 percent of all stroke patients in Korea receive intravenous thrombolysis. This treatment alone can improve symptoms and reduce sequelae in about 30 percent of patients. The availability of tenecteplase will facilitate this process and help treat patients with stroke, according to the stroke society.

Tenecteplase is currently recommended as an intravenous thrombolytic for acute cerebral infarction in guidelines in Europe, Australia, Thailand, China, the United States, and other countries. In Korea, the approval process has been underway since August 2024, led by the Ministry of Food and Drug Safety.

“According to the Korean Stroke Society's annual report, about 10 percent of all stroke patients receive IV thrombolysis,” said Dr. Kim Gyeong-moon, president of the Korean Stroke Society and professor of neurology at Sungkyunkwan University College of Medicine. “Considering that there are 110,000 to 150,000 new stroke cases per year, of which about 80 percent are cerebral infarction, about 8,000 to 10,000 patients receive IV thrombolysis annually."

If tenecteplase can be used clinically, it will significantly help in the treatment and rapid transfer of patients with cerebral infarction in the acute phase. It is already rapidly replacing intravenous thrombolysis in the United States, Europe, and major Asian countries. Clinical application of tenecteplase in Korea is needed as soon as possible, Lee emphasized.