Find Clazosentan Sodium manufacturers, exporters & distributors on PharmaCompass

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Synopsis

ACTIVE PHARMA INGREDIENTS

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Chemistry

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Also known as: Clazosentan disodium, Clazosentan disodium salt, Clazosentan sodium [jan], Clazosentan disodium salt [mi], 0l77pk62l1, 503271-02-1
Molecular Formula
C25H21N9Na2O6S
Molecular Weight
621.5  g/mol
InChI Key
PZNSONUYVNYXJZ-UHFFFAOYSA-N
FDA UNII
0L77PK62L1

Clazosentan Sodium
1 2D Structure

Clazosentan Sodium

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
disodium;[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-[2-(1,2,3-triaza-4-azanidacyclopenta-2,5-dien-5-yl)pyridin-4-yl]pyrimidin-4-yl]-(5-methylpyridin-2-yl)sulfonylazanide
2.1.2 InChI
InChI=1S/C25H21N9O6S.2Na/c1-15-7-8-20(27-14-15)41(36,37)32-24-21(40-19-6-4-3-5-18(19)38-2)25(39-12-11-35)29-22(28-24)16-9-10-26-17(13-16)23-30-33-34-31-23;;/h3-10,13-14,35H,11-12H2,1-2H3;;/q-2;2*+1
2.1.3 InChI Key
PZNSONUYVNYXJZ-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC1=CN=C(C=C1)S(=O)(=O)[N-]C2=C(C(=NC(=N2)C3=CC(=NC=C3)C4=NN=N[N-]4)OCCO)OC5=CC=CC=C5OC.[Na+].[Na+]
2.2 Other Identifiers
2.2.1 UNII
0L77PK62L1
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

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

2.4 Create Date
2011-05-05
3 Chemical and Physical Properties
Molecular Weight 621.5 g/mol
Molecular Formula C25H21N9Na2O6S
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count15
Rotatable Bond Count11
Exact Mass621.11308916 g/mol
Monoisotopic Mass621.11308916 g/mol
Topological Polar Surface Area183 Ų
Heavy Atom Count43
Formal Charge0
Complexity911
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3

API SUPPLIERS

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01

CARBOGEN AMCIS AG

Switzerland

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PEGS Boston Summit
Not Confirmed
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CARBOGEN AMCIS AG

Switzerland

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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PEGS Boston Summit
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC KDMF arrow-down VMF Others AUDIT
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KDMF

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01

CARBOGEN AMCIS AG

Switzerland
BPI Europe
Not Confirmed
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CARBOGEN AMCIS AG

Switzerland
arrow
BPI Europe
Not Confirmed

Clazosentan Sodium

Registrant Name : Nexera Pharma Korea Co., Ltd.

Registration Date : 2023-12-07

Registration Number : No. 5734-1-ND

Manufacturer Name : Carbogen Amcis AG

Manufacturer Address : Gebaude 171, 173 and 177, Hauptstrasse 171 Bubendorf, 4416, Switzerland

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Drugs in Development

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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: Approved FDFProduct Type: Other Small Molecule

Sponsor: HANDOK

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement April 14, 2024

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China Battery Fair
Not Confirmed
China Battery Fair
Not Confirmed

Details : Handok is responsible for commercialization of Pivlaz (clazosentan sodium), approved in South Korea for preventing cerebral vasospasm in patients with aneurysmal subarachnoid hemorrhage.

Product Name : Pivlaz

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

April 14, 2024

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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: ACT-108475

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Sosei Heptares

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition July 20, 2023

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02

China Battery Fair
Not Confirmed
China Battery Fair
Not Confirmed

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.

Product Name : ACT-108475

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

July 20, 2023

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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: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 12, 2023

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03

China Battery Fair
Not Confirmed
China Battery Fair
Not Confirmed

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.

Product Name : Pivlaz

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

July 12, 2023

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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: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 02, 2023

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04

China Battery Fair
Not Confirmed
China Battery Fair
Not Confirmed

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...

Product Name : ACT-108475

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

June 02, 2023

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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: ACT-108475

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 20, 2022

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05

China Battery Fair
Not Confirmed
China Battery Fair
Not Confirmed

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...

Product Name : ACT-108475

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

January 20, 2022

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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: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 03, 2021

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06

China Battery Fair
Not Confirmed
China Battery Fair
Not Confirmed

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.

Product Name : ACT-108475

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

January 03, 2021

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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: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 23, 2020

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07

China Battery Fair
Not Confirmed
China Battery Fair
Not Confirmed

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).

Product Name : ACT-108475

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

November 23, 2020

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Looking for 503271-02-1 / Clazosentan Sodium API manufacturers, exporters & distributors?

Clazosentan Sodium manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Clazosentan Sodium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Clazosentan Sodium manufacturer or Clazosentan Sodium supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Clazosentan Sodium manufacturer or Clazosentan Sodium supplier.

PharmaCompass also assists you with knowing the Clazosentan Sodium API Price utilized in the formulation of products. Clazosentan Sodium API Price is not always fixed or binding as the Clazosentan Sodium Price is obtained through a variety of data sources. The Clazosentan Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Clazosentan Sodium

Synonyms

Clazosentan disodium, Clazosentan disodium salt, Clazosentan sodium [jan], Clazosentan disodium salt [mi], 0l77pk62l1, 503271-02-1

Cas Number

503271-02-1

Unique Ingredient Identifier (UNII)

0L77PK62L1

Clazosentan Sodium Manufacturers

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.

Clazosentan Sodium Suppliers

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.

click here to find a list of Clazosentan Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Clazosentan Sodium KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Clazosentan Sodium Drug Master File in Korea (Clazosentan Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Clazosentan Sodium. The MFDS reviews the Clazosentan Sodium KDMF as part of the drug registration process and uses the information provided in the Clazosentan Sodium KDMF to evaluate the safety and efficacy of the drug.

After submitting a Clazosentan Sodium KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Clazosentan Sodium API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Clazosentan Sodium suppliers with KDMF on PharmaCompass.

Clazosentan Sodium GMP

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.

Clazosentan Sodium CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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