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1. 2649467-58-1
2. 2-pyridinecarboxamide, 4-[[[(2r,3s,4s,5r)-3-(3,4-difluoro-2-methoxyphenyl)tetrahydro-4,5-dimethyl-5-(trifluoromethyl)-2-furanyl]carbonyl]amino]-
3. Suzetrigine [inn]
4. Log73m21h5
5. Schembl23462160
6. Gtpl12630
7. Vx548
8. Ex-a7354
9. Vx-548
10. Compound 7 [wo2021113627a1]
11. Hy-148800
12. Cs-0641183
13. 4-[(2r,3s,4s,5r)-3-(3,4-difluoro-2-methoxyphenyl)-4,5- Dimethyl-5-(trifluoromethyl)oxolane-2- Carboxamido]pyridine-2-carboxamide
14. 4-[[(2r, 3s, 4s, 5r)-3-(3, 4-difluoro-2-methoxyphenyl)-4, 5-dimethyl-5-(trifluoromethyl)oxolane-2-carbonyl]amino]pyridine-2-carboxamide
15. 4-[[(2r,3s,4s,5r)-3-(3,4-difluoro-2-methoxyphenyl)-4,5-dimethyl-5-(trifluoromethyl)oxolane-2-carbonyl]amino]pyridine-2-carboxamide
16. 4-[[[(2r,3s,4s,5r)-3-(3,4-difluoro-2-methoxyphenyl)tetrahydro-4,5-dimethyl-5-(trifluoromethyl)-2-furanyl]carbonyl]amino]-2-pyridinecarboxamide
Molecular Weight | 473.4 g/mol |
---|---|
Molecular Formula | C21H20F5N3O4 |
XLogP3 | 3 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 10 |
Rotatable Bond Count | 5 |
Exact Mass | g/mol |
Monoisotopic Mass | g/mol |
Topological Polar Surface Area | 104 |
Heavy Atom Count | 33 |
Formal Charge | 0 |
Complexity | 741 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 4 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
NDC Package Code : 50909-1910
Start Marketing Date : 2025-01-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (0.25kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 17337-0437
Start Marketing Date : 2024-10-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-12-02
Valid Till : 2025-11-27
Written Confirmation Number : WC-0459
Address of the Firm :
4-((2R,3S,4S,5R)-3-(3,4-difluoro-2-methoxyphenyl)-4,5-dimethyl-5-(trifluoromethyl)tetrahydrofuran-2-
Date of Issue : 2022-12-02
Valid Till : 2025-11-27
Written Confirmation Number : WC-0459
Address of the Firm : Plot No. 25, 25A to 25K, Atchutapuram, Rambilli (M), Visakhapatnam-531011, Andhr...
NDC Package Code : 50909-1910
Start Marketing Date : 2025-01-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (0.25kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 17337-0437
Start Marketing Date : 2024-10-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experience,the company has ...
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
About the Company : Mankind Pharma, came into existence in 1986. In 1991, the company was formed into a legal corporation. However, it actively started working as a fully integrated pharmaceutical com...
About the Company : Founded by chemists with years of working experiences in famous CRO companies in China, Excenen Pharmatech experienced in organic chemistry expecially in medicinal chemistry resear...
About the Company : FandaChem, headquartered in Hangzhou, China, is a reputable supplier and exporter of chemicals with a focus on delivering high-quality products. Our expertise lies in exporting a w...
About the Company : Hefei Home Sunshine Pharmaceutical Technology Co., Ltd.is a high-tech enterprise, which is an integration of R & D, producing and custom synthesis. The products quality is assured ...
Details:
Journavx (suzetrigine) is an investigational oral, selective NaV1.8 inhibitor, which is currently being evaluated for the treatment of adult patients with moderate-to-severe acute pain.
Lead Product(s): Suzetrigine
Therapeutic Area: Neurology Brand Name: Journavx
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 30, 2025
Lead Product(s) : Suzetrigine
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Journavx Gains FDA Approval for Acute Pain Treatment
Details : Journavx (suzetrigine) is an investigational oral, selective NaV1.8 inhibitor, which is currently being evaluated for the treatment of adult patients with moderate-to-severe acute pain.
Product Name : Journavx
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 30, 2025
Details:
VX-548 (suzetrigine) is an investigational oral, selective NaV1.8 inhibitor, which is currently being evaluated for the treatment of patients with painful lumbosacral radiculopathy.
Lead Product(s): Suzetrigine
Therapeutic Area: Neurology Brand Name: VX-548
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 19, 2024
Lead Product(s) : Suzetrigine
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Vertex Announces Phase 2 Results of Suzetrigine for Painful Lumbosacral Radiculopathy
Details : VX-548 (suzetrigine) is an investigational oral, selective NaV1.8 inhibitor, which is currently being evaluated for the treatment of patients with painful lumbosacral radiculopathy.
Product Name : VX-548
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 19, 2024
Details:
VX-548 (suzetrigine) is an investigational oral, selective NaV1.8 inhibitor, which is currently being evaluated for the treatment of patients with moderate-to-severe acute pain.
Lead Product(s): Suzetrigine
Therapeutic Area: Neurology Brand Name: VX-548
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 30, 2024
Lead Product(s) : Suzetrigine
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Vertex Announces FDA Acceptance of Suzetrigine NDA for Acute Pain Treatment
Details : VX-548 (suzetrigine) is an investigational oral, selective NaV1.8 inhibitor, which is currently being evaluated for the treatment of patients with moderate-to-severe acute pain.
Product Name : VX-548
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 30, 2024
Details:
VX-548 (suzetrigine) is an investigational oral, selective NaV1.8 inhibitor, which is currently being evaluated for the treatment of patients with moderate-to-severe acute pain.
Lead Product(s): Suzetrigine
Therapeutic Area: Neurology Brand Name: VX-548
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 18, 2024
Lead Product(s) : Suzetrigine
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Vertex Announces Advancements of Suzetrigine (VX-548) in Acute and Neuropathic Pain
Details : VX-548 (suzetrigine) is an investigational oral, selective NaV1.8 inhibitor, which is currently being evaluated for the treatment of patients with moderate-to-severe acute pain.
Product Name : VX-548
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 18, 2024
Details:
VX-548 (suzetrigine) is a selective NaV1.8 inhibitor, which is being evaluated in phase 3 clinical trials for the treatment of moderate-to-severe acute pain.
Lead Product(s): Suzetrigine
Therapeutic Area: Neurology Brand Name: VX-548
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 30, 2024
Lead Product(s) : Suzetrigine
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Vertex Announces Positive Results from VX-548 Phase 3 study for Moderate-Severe Acute Pain
Details : VX-548 (suzetrigine) is a selective NaV1.8 inhibitor, which is being evaluated in phase 3 clinical trials for the treatment of moderate-to-severe acute pain.
Product Name : VX-548
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 30, 2024
Details:
VX-548 is an investigational oral, selective NaV1.8 inhibitor that is highly selective for NaV1.8. It is under clinical development for the treatment of painful diabetic peripheral neuropathy.
Lead Product(s): Suzetrigine
Therapeutic Area: Neurology Brand Name: VX-548
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 13, 2023
Lead Product(s) : Suzetrigine
Therapeutic Area : Neurology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : VX-548 is an investigational oral, selective NaV1.8 inhibitor that is highly selective for NaV1.8. It is under clinical development for the treatment of painful diabetic peripheral neuropathy.
Product Name : VX-548
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 13, 2023
Details:
VX-548 is an oral, selective NaV1.8 inhibitor that is highly selective for NaV1.8 relative to other NaV channels. NaV1.8 is a voltage-gated sodium channel that plays a critical role in pain signaling in the peripheral nervous system.
Lead Product(s): Suzetrigine
Therapeutic Area: Neurology Brand Name: VX-548
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 22, 2022
Lead Product(s) : Suzetrigine
Therapeutic Area : Neurology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Vertex Advances VX-548 in Acute and Neuropathic Pain
Details : VX-548 is an oral, selective NaV1.8 inhibitor that is highly selective for NaV1.8 relative to other NaV channels. NaV1.8 is a voltage-gated sodium channel that plays a critical role in pain signaling in the peripheral nervous system.
Product Name : VX-548
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 22, 2022
Details:
VX-548 was generally well tolerated in both studies. Most adverse events (AEs) were mild to moderate and there were no serious adverse events (SAEs) related to VX-548. Fewer patients discontinued treatment in the mid- and high-dose VX-548 arms than in the placebo group.
Lead Product(s): Suzetrigine
Therapeutic Area: Neurology Brand Name: VX-548
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 31, 2022
Lead Product(s) : Suzetrigine
Therapeutic Area : Neurology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : VX-548 was generally well tolerated in both studies. Most adverse events (AEs) were mild to moderate and there were no serious adverse events (SAEs) related to VX-548. Fewer patients discontinued treatment in the mid- and high-dose VX-548 arms than in th...
Product Name : VX-548
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 31, 2022
Details:
The Phase 2 studies are randomized, double-blind, placebo-controlled trials that will evaluate multiple doses of VX-548 in patients with acute pain following bunionectomy surgery or abdominoplasty surgery.
Lead Product(s): Suzetrigine
Therapeutic Area: Neurology Brand Name: VX-548
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 19, 2021
Lead Product(s) : Suzetrigine
Therapeutic Area : Neurology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Vertex Initiates Phase 2 Clinical Trial Program for VX-548 for the Treatment of Acute Pain
Details : The Phase 2 studies are randomized, double-blind, placebo-controlled trials that will evaluate multiple doses of VX-548 in patients with acute pain following bunionectomy surgery or abdominoplasty surgery.
Product Name : VX-548
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 19, 2021
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Patents & EXCLUSIVITIES
Patent Expiration Date : 2040-12-04
US Patent Number : 11834441
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 219209
Patent Use Code : U-4125
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2040-12-04
Exclusivity Code : NCE
Exclusivity Expiration Date : 2030-01-30
Application Number : 219209
Product Number : 1
Exclusivity Details :
ABOUT THIS PAGE
29
PharmaCompass offers a list of Suzetrigine 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 Suzetrigine manufacturer or Suzetrigine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Suzetrigine manufacturer or Suzetrigine supplier.
PharmaCompass also assists you with knowing the Suzetrigine API Price utilized in the formulation of products. Suzetrigine API Price is not always fixed or binding as the Suzetrigine Price is obtained through a variety of data sources. The Suzetrigine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Suzetrigine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Suzetrigine, including repackagers and relabelers. The FDA regulates Suzetrigine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Suzetrigine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Suzetrigine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Suzetrigine supplier is an individual or a company that provides Suzetrigine active pharmaceutical ingredient (API) or Suzetrigine finished formulations upon request. The Suzetrigine suppliers may include Suzetrigine API manufacturers, exporters, distributors and traders.
click here to find a list of Suzetrigine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Suzetrigine written confirmation (Suzetrigine WC) is an official document issued by a regulatory agency to a Suzetrigine manufacturer, verifying that the manufacturing facility of a Suzetrigine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Suzetrigine APIs or Suzetrigine finished pharmaceutical products to another nation, regulatory agencies frequently require a Suzetrigine WC (written confirmation) as part of the regulatory process.
click here to find a list of Suzetrigine suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Suzetrigine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Suzetrigine API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Suzetrigine as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Suzetrigine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Suzetrigine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Suzetrigine suppliers with NDC on PharmaCompass.
Suzetrigine 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 Suzetrigine 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 Suzetrigine GMP manufacturer or Suzetrigine GMP API supplier for your needs.
A Suzetrigine CoA (Certificate of Analysis) is a formal document that attests to Suzetrigine's compliance with Suzetrigine specifications and serves as a tool for batch-level quality control.
Suzetrigine CoA mostly includes findings from lab analyses of a specific batch. For each Suzetrigine 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.
Suzetrigine may be tested according to a variety of international standards, such as European Pharmacopoeia (Suzetrigine EP), Suzetrigine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Suzetrigine USP).