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1. Bms 742413
2. Bms-742413
3. N-(3-(7-methyl-1h-indazol-5-yl)-1-(4-(1-methylpiperidin-4-yl)-1-oxopropan-2-yl))-4-(2-oxo-1,2-dihydroquinolin-3-yl)piperidine-1-carboxamide
1. Vazegepant
2. Bms-742413
3. Bhv-3500
4. Zavegepant [usan]
5. Odu3zaz94j
6. Bms-742413-01
7. 1337918-83-8
8. Chembl2397415
9. N-[(2r)-3-(7-methyl-1h-indazol-5-yl)-1-[4-(1-methylpiperidin-4-yl)piperazin-1-yl]-1-oxopropan-2-yl]-4-(2-oxo-1h-quinolin-3-yl)piperidine-1-carboxamide
10. 1-piperidinecarboxamide, 4-(1,2-dihydro-2-oxo-3-quinolinyl)-n-((1r)-1-((7-methyl-1h-indazol-5-yl)methyl)-2-(4-(1-methyl-4-piperidinyl)-1-piperazinyl)-2-oxoethyl)-
11. 4-(1,2-dihydro-2-oxo-3-quinolinyl)-n-((1r)-1-((7-methyl-1h-indazol-5-yl)methyl)-2-(4-(1-methyl-4-piperidinyl)-1-piperazinyl)-2-oxoethyl)-1-piperidinecarboxamide
12. Zavegepant [inn]
13. Unii-odu3zaz94j
14. Vazegepant [who-dd]
15. Schembl107428
16. Gtpl11513
17. Ex-a6698
18. Bdbm50436107
19. Bms742413
20. Who 11512
21. Hy-134992
22. Cs-0168642
Molecular Weight | 638.8 g/mol |
---|---|
Molecular Formula | C36H46N8O3 |
XLogP3 | 3.1 |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 6 |
Rotatable Bond Count | 6 |
Exact Mass | 638.36928736 g/mol |
Monoisotopic Mass | 638.36928736 g/mol |
Topological Polar Surface Area | 117 Ų |
Heavy Atom Count | 47 |
Formal Charge | 0 |
Complexity | 1160 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 1 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
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API Imports and Exports
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Average Price (USD/KGS) |
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Details:
Pfizer has given Royalty Pharma an accelerated milestone payment following the US approval of its migraine nasal spray, Zavzpret (zavegepant). Zavzpret was approved by the U.S. FDA, which provides another important new treatment option for migraine patients.
Lead Product(s): Zavegepant HCl
Therapeutic Area: Neurology Brand Name: Zavzpret
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Pfizer Inc
Deal Size: $475.0 million Upfront Cash: Undisclosed
Deal Type: Agreement March 15, 2023
Lead Product(s) : Zavegepant HCl
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : $475.0 million
Deal Type : Agreement
Royalty Pharma Nabs $475M Milestone from Pfizer upon Migraine Nasal Spray
Details : Pfizer has given Royalty Pharma an accelerated milestone payment following the US approval of its migraine nasal spray, Zavzpret (zavegepant). Zavzpret was approved by the U.S. FDA, which provides another important new treatment option for migraine patie...
Brand Name : Zavzpret
Molecule Type : Small molecule
Upfront Cash : Undisclosed
March 15, 2023
Details:
Zavzpret (zavegepant) is a calcitonin gene-related peptide receptor antagonist. CGRP antagonists have been shown pain relief during migraine induced headaches.
Lead Product(s): Zavegepant HCl
Therapeutic Area: Neurology Brand Name: Zavzpret
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 10, 2023
Lead Product(s) : Zavegepant HCl
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Pfizer’s ZAVZPRET™ (zavegepant) Migraine Nasal Spray Receives FDA Approval
Details : Zavzpret (zavegepant) is a calcitonin gene-related peptide receptor antagonist. CGRP antagonists have been shown pain relief during migraine induced headaches.
Brand Name : Zavzpret
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 10, 2023
Details:
Complete data from the Phase 3 BHV3500 (zavegepant) nasal spray study highlight its ultra-rapid pain relief in as little as 15 minutes that lasts through 48 hours after a single dose.
Lead Product(s): Zavegepant HCl
Therapeutic Area: Neurology Brand Name: BHV-3500
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 13, 2022
Lead Product(s) : Zavegepant HCl
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Complete data from the Phase 3 BHV3500 (zavegepant) nasal spray study highlight its ultra-rapid pain relief in as little as 15 minutes that lasts through 48 hours after a single dose.
Brand Name : BHV-3500
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 13, 2022
Details:
In the pivotal studies, BHV3500 (zavegepant) was statistically superior to placebo on the coprimary regulatory endpoints of superiority to placebo at 2 hours for pain freedom and freedom from the migraine-associated most bothersome.
Lead Product(s): Zavegepant HCl
Therapeutic Area: Neurology Brand Name: BHV-3500
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 23, 2022
Lead Product(s) : Zavegepant HCl
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : In the pivotal studies, BHV3500 (zavegepant) was statistically superior to placebo on the coprimary regulatory endpoints of superiority to placebo at 2 hours for pain freedom and freedom from the migraine-associated most bothersome.
Brand Name : BHV-3500
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 23, 2022
Details:
Biohaven plans to file a NDA for BHV-3500 (zavegepant) with the USFDA in 1Q2022,showed ultra-rapid pain relief at the earliest measured time point of 15 minutes and sustained efficacy through 48 hours after a single intranasal dose.
Lead Product(s): Zavegepant HCl
Therapeutic Area: Neurology Brand Name: BHV-3500
Study Phase: Phase II/ Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 06, 2021
Lead Product(s) : Zavegepant HCl
Therapeutic Area : Neurology
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Biohaven plans to file a NDA for BHV-3500 (zavegepant) with the USFDA in 1Q2022,showed ultra-rapid pain relief at the earliest measured time point of 15 minutes and sustained efficacy through 48 hours after a single intranasal dose.
Brand Name : BHV-3500
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 06, 2021
Details:
Zavegepant is a high affinity, selective and structurally unique, third generation, CGRP receptor antagonist in development for both migraine and non-migraine CGRP-mediated diseases.
Lead Product(s): Zavegepant HCl
Therapeutic Area: Neurology Brand Name: BHV-3500
Study Phase: Phase II/ Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 29, 2021
Lead Product(s) : Zavegepant HCl
Therapeutic Area : Neurology
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Zavegepant is a high affinity, selective and structurally unique, third generation, CGRP receptor antagonist in development for both migraine and non-migraine CGRP-mediated diseases.
Brand Name : BHV-3500
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 29, 2021
Details:
Zavegepant is a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist in development for both migraine and non-migraine indications including COVID-19 associated lung inflammation.
Lead Product(s): Zavegepant HCl
Therapeutic Area: Neurology Brand Name: BHV-3500
Study Phase: Phase II/ Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 10, 2020
Lead Product(s) : Zavegepant HCl
Therapeutic Area : Neurology
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Zavegepant is a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist in development for both migraine and non-migraine indications including COVID-19 associated lung inflammation.
Brand Name : BHV-3500
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 10, 2020
Details:
Funding will advance the Biohaven's CGRP receptor antagonist program through the development of zavegepant (vazegepant). The zavegepant program encompasses intranasal zavegepant as well as oral zavegepant for migraine prevention and non-migraine indications.
Lead Product(s): Zavegepant HCl
Therapeutic Area: Neurology Brand Name: BHV-3500
Study Phase: Phase II/ Phase IIIProduct Type: Small molecule
Sponsor: Royalty Pharma
Deal Size: $450.0 million Upfront Cash: Undisclosed
Deal Type: Funding August 07, 2020
Lead Product(s) : Zavegepant HCl
Therapeutic Area : Neurology
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Royalty Pharma
Deal Size : $450.0 million
Deal Type : Funding
Biohaven and Royalty Pharma Announce Funding Agreement
Details : Funding will advance the Biohaven's CGRP receptor antagonist program through the development of zavegepant (vazegepant). The zavegepant program encompasses intranasal zavegepant as well as oral zavegepant for migraine prevention and non-migraine indicati...
Brand Name : BHV-3500
Molecule Type : Small molecule
Upfront Cash : Undisclosed
August 07, 2020
Details:
Biohaven plans to study intranasal vazegepant, a high affinity, selective and structurally unique, small molecule CGRP receptor antagonist, in pulmonary complications of COVID-19 disease.
Lead Product(s): Zavegepant HCl
Therapeutic Area: Infections and Infectious Diseases Brand Name: BHV-3500
Study Phase: Phase II/ Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 09, 2020
Lead Product(s) : Zavegepant HCl
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Biohaven Receives FDA May Proceed Letter to Begin Phase 2 Trial of Intranasal Vazegepant
Details : Biohaven plans to study intranasal vazegepant, a high affinity, selective and structurally unique, small molecule CGRP receptor antagonist, in pulmonary complications of COVID-19 disease.
Brand Name : BHV-3500
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 09, 2020
Details:
The Company addressed all issues raised by the FDA and will advance the 10 mg dose of intranasal vazegepant into a double-blind, placebo-controlled Phase 3 clinical trial.
Lead Product(s): Zavegepant HCl
Therapeutic Area: Neurology Brand Name: BHV-3500
Study Phase: Phase II/ Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 23, 2020
Lead Product(s) : Zavegepant HCl
Therapeutic Area : Neurology
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Biohaven to Advance Vazegepant into Phase 3 for the Acute Treatment of Migrain
Details : The Company addressed all issues raised by the FDA and will advance the 10 mg dose of intranasal vazegepant into a double-blind, placebo-controlled Phase 3 clinical trial.
Brand Name : BHV-3500
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 23, 2020
Regulatory Info : RX
Registration Country : USA
Brand Name : ZAVZPRET
Dosage Form : SPRAY, METERED;NASAL
Dosage Strength : EQ 10MG BASE/SPRAY
Packaging :
Approval Date : 2023-03-09
Application Number : 216386
Regulatory Info : RX
Registration Country : USA
Market Place
Reply
21 May 2024
Patents & EXCLUSIVITIES
ABOUT THIS PAGE
A Zavegepant HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zavegepant HCl, including repackagers and relabelers. The FDA regulates Zavegepant HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zavegepant HCl 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 Zavegepant HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zavegepant HCl supplier is an individual or a company that provides Zavegepant HCl active pharmaceutical ingredient (API) or Zavegepant HCl finished formulations upon request. The Zavegepant HCl suppliers may include Zavegepant HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Zavegepant HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Zavegepant HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Zavegepant HCl 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 Zavegepant HCl 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 Zavegepant HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Zavegepant HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Zavegepant HCl suppliers with NDC on PharmaCompass.
Zavegepant HCl 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 Zavegepant HCl 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 Zavegepant HCl GMP manufacturer or Zavegepant HCl GMP API supplier for your needs.
A Zavegepant HCl CoA (Certificate of Analysis) is a formal document that attests to Zavegepant HCl's compliance with Zavegepant HCl specifications and serves as a tool for batch-level quality control.
Zavegepant HCl CoA mostly includes findings from lab analyses of a specific batch. For each Zavegepant HCl 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.
Zavegepant HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Zavegepant HCl EP), Zavegepant HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zavegepant HCl USP).
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