Sosei Group Corporation announced that PIVLAZ (clazosentan sodium) 150 mg has received marketing approval from the Ministry of Food and Drug Safety (MFDS) in South Korea for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction, and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH) securing. The MFDS approval is based on scientific and clinical data from an extensive Japanese Phase 3 program submitted by Idorsia Pharmaceuticals Korea ("IPK"), a Sosei Group company. The trials, which involved patients who had undergone clipping surgery or coiling treatment for aSAH, showed that PIVLAZ significantly reduced the incidence of cerebral vasospasm-related complications and all-cause mortality within six weeks of aneurysmal subarACHnoid hemorrhage.

The trials also confirmed the safety profile of PIVLAZ. In South Korea, the Marketing Authorization of PIVLAZ is held by IPK and will become commercially available to patients in early 2025. PIVLAZ received marketing approval in Japan in January 2022 and was launched in April 2022 by Idorsia Pharmaceuticals Japan ("IPJ"), also a Sosei Group company".

PIVLAZ has been used in approximately 8,900 patients in Japan as of November 2023. Aneurysmal subarachnoids hemorrhage is a condition involving sudden life-threatening bleeding occurring in the subarachnoid space. The company is leveraging these capabilities to generate and advance a broad and deep pipeline of novel medicines across multiple therapeutic areas, including neurology, immunology, gastroenterology and inflammatory diseases.

The company intend to develop these opportunities for patients in Japan and globally both internally and through partnerships with global biopharmaceutical companies and emerging technology companies.