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Molecular Weight | 380.4 g/mol |
---|---|
Molecular Formula | C19H14F2N6O |
XLogP3 | 1.4 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 7 |
Rotatable Bond Count | 2 |
Exact Mass | 380.11971542 g/mol |
Monoisotopic Mass | 380.11971542 g/mol |
Topological Polar Surface Area | 84.2 A^2 |
Heavy Atom Count | 28 |
Formal Charge | 0 |
Complexity | 826 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 2 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
NDC Package Code : 46014-1140
Start Marketing Date : 2018-10-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
About the Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and chemical products, cat...
Details:
Talzenna (talazoparib), an oral PARP inhibitor in combination with Xtandi (enzalutamide) is approved for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC).
Lead Product(s): Talazoparib,Enzalutamide
Therapeutic Area: Oncology Brand Name: Talzenna
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 13, 2025
Lead Product(s) : Talazoparib,Enzalutamide
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Pfizer's TALZENNA® + XTANDI® Boosts Survival in Metastatic Prostate Cancer
Details : Talzenna (talazoparib), an oral PARP inhibitor in combination with Xtandi (enzalutamide) is approved for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC).
Product Name : Talzenna
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 13, 2025
Details:
Talzenna (talazoparib) combined with Xtandi (enzalutamide) is approved by EMA for treating metastatic castration-resistant prostate cancer (mCRPC).
Lead Product(s): Talazoparib,Enzalutamide
Therapeutic Area: Oncology Brand Name: Talzenna
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 01, 2024
Lead Product(s) : Talazoparib,Enzalutamide
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
European Commission Approves Pfizer’s TALZENNA® with XTANDI®
Details : Talzenna (talazoparib) combined with Xtandi (enzalutamide) is approved by EMA for treating metastatic castration-resistant prostate cancer (mCRPC).
Product Name : Talzenna
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 01, 2024
Details:
Talzenna (talazoparib) is a PARP inhibitor, which is approved for the treatment of BRCA gene mutation-positive castration-resistant prostate cancer with distant metastases.
Lead Product(s): Talazoparib
Therapeutic Area: Oncology Brand Name: Talzenna
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 02, 2024
Lead Product(s) : Talazoparib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Chugai Gets Approval for FoundationOne CDx as Companion Diagnostic for Talazoparib
Details : Talzenna (talazoparib) is a PARP inhibitor, which is approved for the treatment of BRCA gene mutation-positive castration-resistant prostate cancer with distant metastases.
Product Name : Talzenna
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 02, 2024
Details:
Talzenna (talazoparib) is an oral inhibitor of PARP, which plays a role in DNA damage repair combination with XTANDI (enzalutamide) for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
Lead Product(s): Talazoparib,Enzalutamide
Therapeutic Area: Oncology Brand Name: Talzenna
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: TFS Trial Form Support
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 20, 2023
Lead Product(s) : Talazoparib,Enzalutamide
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : TFS Trial Form Support
Deal Size : Inapplicable
Deal Type : Inapplicable
Pfizer’s TALZENNA in Combination with XTANDI Receives U.S. FDA Approval
Details : Talzenna (talazoparib) is an oral inhibitor of PARP, which plays a role in DNA damage repair combination with XTANDI (enzalutamide) for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistan...
Product Name : Talzenna
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 20, 2023
Details:
Talzenna (talazoparib) is an oral PARP inhibitor, which plays a role in DNA damage repair. Preclinical studies have demonstrated that TALZENNA blocks PARP enzyme activity and traps PARP at the site of DNA damage, leading to cancer cell apoptosis.
Lead Product(s): Talazoparib,Enzalutamide
Therapeutic Area: Oncology Brand Name: Talzenna
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 16, 2023
Lead Product(s) : Talazoparib,Enzalutamide
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Pfizer Announces Positive TALZENNA® and XTANDI® Combination Data from Phase 3 TALAPRO-2 Study
Details : Talzenna (talazoparib) is an oral PARP inhibitor, which plays a role in DNA damage repair. Preclinical studies have demonstrated that TALZENNA blocks PARP enzyme activity and traps PARP at the site of DNA damage, leading to cancer cell apoptosis.
Product Name : Talzenna
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 16, 2023
Details:
CX-5461 (pidnarulex) stabilizes the DNA G-quadruplexes of cancer cells which leads to disruption of the cell's replication fork. Pidnarulex demonstrated clinically significant and lasting benefits in patients with specific tumor biomarkers, such as BRCA1/2 and PALB2 mutations.
Lead Product(s): Pidnarulex,Talazoparib
Therapeutic Area: Oncology Brand Name: CX-5461
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 31, 2022
Lead Product(s) : Pidnarulex,Talazoparib
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : CX-5461 (pidnarulex) stabilizes the DNA G-quadruplexes of cancer cells which leads to disruption of the cell's replication fork. Pidnarulex demonstrated clinically significant and lasting benefits in patients with specific tumor biomarkers, such as BRCA1...
Product Name : CX-5461
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 31, 2022
Details:
ART4215 is first selective, oral, small molecule inhibitor of Polθ polymerase domain to enter clinic. Polθ, a DNA polymerase, is a tumor-specific DDR target involved in MMEJ that is overexpressed in many tumors and found in low levels in healthy tissue.
Lead Product(s): ART4215,Talazoparib
Therapeutic Area: Oncology Brand Name: ART4215
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 08, 2022
Lead Product(s) : ART4215,Talazoparib
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Artios initiates Phase 2 study of Polθ Inhibitor ART4215 in Combination with PARP Inhibitor Talaz...
Details : ART4215 is first selective, oral, small molecule inhibitor of Polθ polymerase domain to enter clinic. Polθ, a DNA polymerase, is a tumor-specific DDR target involved in MMEJ that is overexpressed in many tumors and found in low levels in healthy tissue...
Product Name : ART4215
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 08, 2022
Details:
The data from the Phase 1b/2 trial has shown that the ZEN003694 (ZEN-3694) plus talazoparib combination regimen induced durable responses in tumors of TNBC patients which do not harbor mutations in BRCA1/2.
Lead Product(s): ZEN-3694,Talazoparib
Therapeutic Area: Oncology Brand Name: ZEN-3694
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Pfizer Inc
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 05, 2022
Lead Product(s) : ZEN-3694,Talazoparib
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The data from the Phase 1b/2 trial has shown that the ZEN003694 (ZEN-3694) plus talazoparib combination regimen induced durable responses in tumors of TNBC patients which do not harbor mutations in BRCA1/2.
Product Name : ZEN-3694
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 05, 2022
Details:
RP-3500 is a potent and selective oral small molecule inhibitor of ATR being developed for treatment of solid tumors with specific genome instability related genomic alterations including those in the ATM (ataxia-telangiectasia mutated) gene.
Lead Product(s): Camonsertib,Gemcitabine,Talazoparib
Therapeutic Area: Oncology Brand Name: RP-3500
Study Phase: Phase I/ Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 04, 2022
Lead Product(s) : Camonsertib,Gemcitabine,Talazoparib
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Repare Therapeutics to Present New Clinical and Preclinical Data at the 2022 AACR Annual Meeting
Details : RP-3500 is a potent and selective oral small molecule inhibitor of ATR being developed for treatment of solid tumors with specific genome instability related genomic alterations including those in the ATM (ataxia-telangiectasia mutated) gene.
Product Name : RP-3500
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 04, 2022
Details:
RP-3500, orally-administered ataxia telangiectasia and Rad3-related inhibitor currently in Phase 1/2 TRESR trial clinical development in patients with DNA damage repair, loss-of-function and mutant tumors.
Lead Product(s): Camonsertib,Gemcitabine,Talazoparib
Therapeutic Area: Oncology Brand Name: RP-3500
Study Phase: Phase I/ Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 03, 2022
Lead Product(s) : Camonsertib,Gemcitabine,Talazoparib
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : RP-3500, orally-administered ataxia telangiectasia and Rad3-related inhibitor currently in Phase 1/2 TRESR trial clinical development in patients with DNA damage repair, loss-of-function and mutant tumors.
Product Name : RP-3500
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 03, 2022
Regulatory Info :
Registration Country : Norway
Brand Name : Talzenna
Dosage Form : Kapsel, hard
Dosage Strength : 0.1 mg
Packaging : Boks 30item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Brand Name : Talzenna
Dosage Form : Caps
Dosage Strength : 0.25mg
Packaging :
Approval Date :
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Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Talzenna
Dosage Form : Caps
Dosage Strength : 1mg
Packaging :
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Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Australia
Brand Name : Talzenna
Dosage Form :
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Packaging : 30
Approval Date :
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Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Talzenna
Dosage Form :
Dosage Strength :
Packaging : 30
Approval Date :
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Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Talzenna
Dosage Form :
Dosage Strength :
Packaging : 30
Approval Date :
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Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Talzenna
Dosage Form :
Dosage Strength :
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
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06 Feb 2025
ABOUT THIS PAGE
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PharmaCompass offers a list of Talazoparib 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 Talazoparib manufacturer or Talazoparib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Talazoparib manufacturer or Talazoparib supplier.
PharmaCompass also assists you with knowing the Talazoparib API Price utilized in the formulation of products. Talazoparib API Price is not always fixed or binding as the Talazoparib Price is obtained through a variety of data sources. The Talazoparib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Talazoparib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Talazoparib, including repackagers and relabelers. The FDA regulates Talazoparib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Talazoparib 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 Talazoparib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Talazoparib supplier is an individual or a company that provides Talazoparib active pharmaceutical ingredient (API) or Talazoparib finished formulations upon request. The Talazoparib suppliers may include Talazoparib API manufacturers, exporters, distributors and traders.
click here to find a list of Talazoparib 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 Talazoparib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Talazoparib 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 Talazoparib 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 Talazoparib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Talazoparib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Talazoparib suppliers with NDC on PharmaCompass.
Talazoparib 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 Talazoparib 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 Talazoparib GMP manufacturer or Talazoparib GMP API supplier for your needs.
A Talazoparib CoA (Certificate of Analysis) is a formal document that attests to Talazoparib's compliance with Talazoparib specifications and serves as a tool for batch-level quality control.
Talazoparib CoA mostly includes findings from lab analyses of a specific batch. For each Talazoparib 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.
Talazoparib may be tested according to a variety of international standards, such as European Pharmacopoeia (Talazoparib EP), Talazoparib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Talazoparib USP).