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1. Clazosentan Disodium
2. Clazosentan Disodium Salt
3. Clazosentan Sodium [jan]
4. Clazosentan Disodium Salt [mi]
5. 0l77pk62l1
6. 503271-02-1
7. 2-pyridinesulfonamide, N-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(2-(1h-tetrazol-5-yl)-4-pyridinyl)-4-pyrimidinyl)-5-methyl-, Disodium Salt
8. Unii-0l77pk62l1
9. Dtxsid10198341
10. Q27236935
| Molecular Weight | 621.5 g/mol |
|---|---|
| Molecular Formula | C25H21N9Na2O6S |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 15 |
| Rotatable Bond Count | 11 |
| Exact Mass | 621.11308916 g/mol |
| Monoisotopic Mass | 621.11308916 g/mol |
| Topological Polar Surface Area | 183 Ų |
| Heavy Atom Count | 43 |
| Formal Charge | 0 |
| Complexity | 911 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 3 |
Drugs in Development
Details:
Handok is responsible for commercialization of Pivlaz (clazosentan sodium), approved in South Korea for preventing cerebral vasospasm in patients with aneurysmal subarachnoid hemorrhage.
Lead Product(s): Clazosentan Sodium
Therapeutic Area: Neurology Brand Name: Pivlaz
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: HANDOK
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement April 14, 2024
Lead Product(s) : Clazosentan Sodium
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : HANDOK
Deal Size : Undisclosed
Deal Type : Agreement
Nxera Pharma Announces Exclusive Supply Agreement with Handok for Pivlaz™
Details : Handok is responsible for commercialization of Pivlaz (clazosentan sodium), approved in South Korea for preventing cerebral vasospasm in patients with aneurysmal subarachnoid hemorrhage.
Brand Name : Pivlaz
Molecule Type : Small molecule
Upfront Cash : Undisclosed
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 Brand Name: Pivlaz
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2023
Lead Product(s) : Clazosentan Sodium
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Sosei Group Announces Marketing Approval for PIVLAZ™ (clazosentan sodium) 150 mg in South Korea
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.
Brand Name : Pivlaz
Molecule Type : Small molecule
Upfront Cash : 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 Brand Name: Pivlaz
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Sosei Heptares
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition July 20, 2023
Lead Product(s) : Clazosentan Sodium
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Sosei Heptares
Deal Size : Undisclosed
Deal Type : Acquisition
Sosei Heptares Acquires Idorsia’s Pharmaceuticals Business in Japan and APAC (ex-China), Acceler...
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.
Brand Name : Pivlaz
Molecule Type : Small molecule
Upfront Cash : Undisclosed
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 Brand Name: ACT-108475
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 06, 2023
Lead Product(s) : Clazosentan Sodium
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 a...
Brand Name : ACT-108475
Molecule Type : Small molecule
Upfront Cash : 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 Brand Name: Pivlaz
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 20, 2022
Lead Product(s) : Clazosentan Sodium
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Idorsia Receives Japanese PMDA Approval of PIVLAZ (clazosentan sodium) 150 mg
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 hemor...
Brand Name : Pivlaz
Molecule Type : Small molecule
Upfront Cash : 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 Brand Name: ACT-108475
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2021
Lead Product(s) : Clazosentan Sodium
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Idorsia Submits NDA for Clazosentan to Japanese PMDA
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.
Brand Name : ACT-108475
Molecule Type : Small molecule
Upfront Cash : 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 Brand Name: ACT-108475
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 23, 2020
Lead Product(s) : Clazosentan Sodium
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Idorsia Announces Positive Results of the Two Japanese Registration Studies with Clazosentan
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).
Brand Name : ACT-108475
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 23, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
NEWS #PharmaBuzz
16 Apr 2024
// BIOSPECTRUM ASIA
https://www.biospectrumasia.com/news/25/24084/nxera-pharma-inks-deal-with-handok-to-distribute-pivlaz-in-south-korea.html
14 Apr 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/04/14/2862478/0/en/Nxera-Pharma-Announces-Exclusive-Supply-and-Distribution-Agreement-with-Handok-for-PIVLAZ-in-South-Korea.html
07 Dec 2023
// GLOBENEWSWIRE
https://www.globenewswire.com//news-release/2023/12/07/2792220/0/en/Sosei-Group-Announces-Marketing-Approval-for-PIVLAZ-clazosentan-sodium-150-mg-in-South-Korea.html
07 Feb 2023
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2023/02/06/2601762/0/de/Idorsia-announces-th[…]patients-following-aneurysmal-subarachnoid-hemorrhage.html
20 Apr 2022
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2022/04/20/2425136/0/de/PIVLAZ-clazosentan-Idorsia-s-first-commercial-product-now-available-for-patients-in-Japan.html
04 Apr 2022
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2022/04/04/2415246/0/de/The-Journal-of-Neurosurgery-reports-impact-of-clazosentan-on-cerebral-vasospasm-related-morbidity-and-all-cause-mortality-after-aneurysmal-subarachnoid-hemorrhage.html
Market Place
ABOUT THIS PAGE
A Clazosentan Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clazosentan Sodium, including repackagers and relabelers. The FDA regulates Clazosentan Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clazosentan Sodium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Clazosentan Sodium supplier is an individual or a company that provides Clazosentan Sodium active pharmaceutical ingredient (API) or Clazosentan Sodium finished formulations upon request. The Clazosentan Sodium suppliers may include Clazosentan Sodium API manufacturers, exporters, distributors and traders.
Clazosentan Sodium Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Clazosentan Sodium GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Clazosentan Sodium GMP manufacturer or Clazosentan Sodium GMP API supplier for your needs.
A Clazosentan Sodium CoA (Certificate of Analysis) is a formal document that attests to Clazosentan Sodium's compliance with Clazosentan Sodium specifications and serves as a tool for batch-level quality control.
Clazosentan Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Clazosentan Sodium CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Clazosentan Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Clazosentan Sodium EP), Clazosentan Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Clazosentan Sodium USP).
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