A study demonstrating the effectiveness of the new drug Pivlaz (ingredient: clazosentan) for patients with aneurysmal subarachnoid hemorrhage has been published in the Journal of Korean Neurosurgical Society (JKNS). JKNS is an SCIE-ranked international journal, and the study was published online on January 20, 2025.
Logo of Pivlaz
Handok and Nxera Pharma Korea have been collaborating on clinical trials and the licensure of Pivlaz in Korea since 2008. The drug obtained approval from the Ministry of Food and Drug Safety on December 7, 2023. Handok is responsible for marketing, sales, and distribution of Pivlaz in Korea.
The study is the first to compare the effectiveness of clazosentan and the existing treatment nimodipine in patients with subarachnoid hemorrhage. Professor Lee Sung-ho from the Department of Neurosurgery at Seoul National University Hospital, Professor Choi Kyu-sun from the Department of Neurosurgery at Hanyang University Medical Center (lead author), and Professor Park Ik-seong from the Department of Neurosurgery at Bucheon St. Mary's Hospital (corresponding author) analyzed six existing clinical studies to evaluate the effectiveness and safety of the two drugs.
The researchers categorized patients into clazosentan, nimodipine, and placebo groups and compared the risk of cerebral vasospasm, cerebral vasospasm-related morbidity, and all-cause mortality within six weeks. The results showed that, compared to both placebo and nimodipine, clazosentan significantly reduced the incidence of cerebral vasospasm after subarachnoid hemorrhage and lowered morbidity and mortality. Nimodipine, on the other hand, showed no significant difference compared to placebo.
“It is important to use appropriate prophylactic agents within two weeks after aneurysmal subarachnoid hemorrhage,” said Choi. “Despite existing treatments, ischemic neurological disorders due to cerebral vasospasm continue to occur, and this study highlights the need for new treatment options.”