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Details:
Handok is exclusively responsible for the promotion, marketing, sales and distribution of Pivlaz (clazosentan sodium), the first drug approved in South Korea for the prevention of Cerebral Vasospasm in patients with Aneurysmal Subarachnoid Hemorrhage, in South Korea.
Lead Product(s): Clazosentan Sodium
Therapeutic Area: Neurology Product Name: Pivlaz
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: HANDOK
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement April 14, 2024
Details:
South Korea approved PIVLAZ™ (clazosentan sodium), an ETAR antagonist, for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction, and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH) securing.
Lead Product(s): Clazosentan Sodium
Therapeutic Area: Neurology Product Name: Pivlaz
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2023
Details:
Through the acquisition, Sosei also gains assignment of Pivlaz (clazosentan), for the treatment of cerebral vasospasm, and license rights to daridorexant in the Asia Pacific (ex-China) region.
Lead Product(s): Clazosentan Sodium
Therapeutic Area: Neurology Product Name: Pivlaz
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sosei Heptares
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition July 20, 2023
Details:
ACT-108475 (clazosentan) is a fast-acting, endothelin A (ETA) receptor antagonist, that Idorsia has developed as a continuous intravenous infusion for the prevention of clinical deterioration due to delayed cerebral ischemia (DCI) in patients following aSAH.
Lead Product(s): Clazosentan Sodium
Therapeutic Area: Neurology Product Name: ACT-108475
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 06, 2023
Details:
PIVLAZ (clazosentan sodium), a selective endothelin A receptor antagonist received Japanese PMDA approval on the basis of statistically significant result from the Japanese Phase 3 program for the prevention of cerebral vasospasm after subarachnoid hemorrhage treatment.
Lead Product(s): Clazosentan Sodium
Therapeutic Area: Neurology Product Name: Pivlaz
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 20, 2022
Details:
A Phase 2 study in Japanese and Korean patients showed that 10 mg/hr of clazosentan administered by continuous intravenous infusion significantly reduced vasospasm and vasospasm-related morbidity and mortality events.
Lead Product(s): Clazosentan Sodium
Therapeutic Area: Neurology Product Name: ACT-108475
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2021
Details:
Both studies demonstrated that clazosentan reduced the occurrence of cerebral vasospasm-related morbidity and all-cause mortality within 6 weeks post-aSAH with statistical significance (p<0.01 for both studies).
Lead Product(s): Clazosentan Sodium
Therapeutic Area: Neurology Product Name: ACT-108475
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 23, 2020
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