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USDMF
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CEP/COS
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JDMF
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EU WC
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KDMF
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VMF
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EDQM
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USP
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JP
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Others
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Europe
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Canada
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Australia
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South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
US Medicaid
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1. 5-amino-3-(4-(((5-fluoro-2-methoxybenzoyl)amino)methyl)phenyl)-1-((2s)-1,1,1-trifluoropropan-2-yl)pyrazole-4-carboxamide
2. Loxo-305
1. Loxo-305
2. 2101700-15-4
3. Pirtobrutinib [usan]
4. Jna39i7zvb
5. (s)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoropropan-2-yl)-1h-pyrazole-4-carboxamide
6. Ly3527727
7. Rxc-005
8. Ly-3527727
9. 1h-pyrazole-4-carboxamide, 5-amino-3-(4-(((5-fluoro-2-methoxybenzoyl)amino)methyl)phenyl)-1-((1s)-2,2,2-trifluoro-1-methylethyl)-
10. 1h-pyrazole-4-carboxamide, 5-amino-3-[4-[[(5-fluoro-2-methoxybenzoyl)amino]methyl]phenyl]-1-[(1s)-2,2,2-trifluoro-1-methylethyl]-
11. Btk Inhibitor 16
12. Unii-jna39i7zvb
13. Pirtobrutinib [inn]
14. Pirtobrutinib [jan]
15. Loxo305
16. Pirtobrutinib (loxo-305)
17. Pirtobrutinib [who-dd]
18. Chembl4650485
19. Schembl19014257
20. Gtpl11628
21. Glxc-25733
22. Ex-a5016
23. Who 11681
24. Bl180882
25. Hy-131328
26. Cs-0133286
27. Loxo-305;ly 3527727; Rxc-005
28. 5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-((2s)-1,1,1-trifluoropropan-2-yl)-1h-pyrazole-4-carboxamide
29. 5-amino-3-[4-[[(5-fluoro-2-methoxybenzoyl)amino]methyl]phenyl]-1-[(2s)-1,1,1-trifluoropropan-2-yl]pyrazole-4-carboxamide
Molecular Weight | 479.4 g/mol |
---|---|
Molecular Formula | C22H21F4N5O3 |
XLogP3 | 3.3 |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 9 |
Rotatable Bond Count | 7 |
Exact Mass | 479.15805220 g/mol |
Monoisotopic Mass | 479.15805220 g/mol |
Topological Polar Surface Area | 125 Ų |
Heavy Atom Count | 34 |
Formal Charge | 0 |
Complexity | 719 |
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 |
Protein Kinase Inhibitors
Agents that inhibit PROTEIN KINASES. (See all compounds classified as Protein Kinase Inhibitors.)
NDC Package Code : 63419-0739
Start Marketing Date : 2022-02-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 84671-1060
Start Marketing Date : 2025-04-09
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
About the Company : Consistent growth and sustainability is a multidimensional aspiration for all at Macleods, we remained focused on providing quality and affordable medicines to billions of ailing p...
About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products...
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Details:
Jaypirca (pirtobrutinib) is an oral small molecule, BTK inhibitor which being developed for the treatment of adults with R/R chronic lymphocytic leukemia.
Lead Product(s): Pirtobrutinib
Therapeutic Area: Oncology Brand Name: Jaypirca
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 28, 2025
Lead Product(s) : Pirtobrutinib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
CHMP Recommends Lilly’s Jaypirca for Relapsed Chronic Lymphocytic Leukemia
Details : Jaypirca (pirtobrutinib) is an oral small molecule, BTK inhibitor which being developed for the treatment of adults with R/R chronic lymphocytic leukemia.
Product Name : Jaypirca
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 28, 2025
Details:
Under the agreement, Innovent holds the sole commercialization rights for Jaypirca (pirtobrutinib) in Mainland China. It is indicated for the treatment of r/r chronic lymphocytic leukemia.
Lead Product(s): Pirtobrutinib
Therapeutic Area: Oncology Brand Name: Jaypirca
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Innovent Biologics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement December 15, 2024
Lead Product(s) : Pirtobrutinib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Innovent Biologics
Deal Size : Undisclosed
Deal Type : Agreement
Innovent, Lilly Expand Jaypirca® Deal for Mainland China Commercialization
Details : Under the agreement, Innovent holds the sole commercialization rights for Jaypirca (pirtobrutinib) in Mainland China. It is indicated for the treatment of r/r chronic lymphocytic leukemia.
Product Name : Jaypirca
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
December 15, 2024
Details:
Jaypirca (pirtobrutinib) is an oral small molecule, BTK inhibitor which is under phase 3 clinical development for the treatment of chronic/small lymphocytic leukemia & mantle cell lymphoma.
Lead Product(s): Pirtobrutinib
Therapeutic Area: Oncology Brand Name: Jaypirca
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 12, 2023
Lead Product(s) : Pirtobrutinib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Jaypirca (pirtobrutinib) is an oral small molecule, BTK inhibitor which is under phase 3 clinical development for the treatment of chronic/small lymphocytic leukemia & mantle cell lymphoma.
Product Name : Jaypirca
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 12, 2023
Details:
Jaypirca (pirtobrutinib) is a highly selective, reversible inhibitor of the enzyme BTK. BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma.
Lead Product(s): Pirtobrutinib
Therapeutic Area: Oncology Brand Name: Jaypirca
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 27, 2023
Lead Product(s) : Pirtobrutinib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
U.S. FDA Approves Jaypirca™ (pirtobrutinib), the First and Only Non-Covalent (Reversible) BTK In...
Details : Jaypirca (pirtobrutinib) is a highly selective, reversible inhibitor of the enzyme BTK. BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma.
Product Name : Jaypirca
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 27, 2023
Details:
Jaypirca® (pirtobrutinib) is a non-covalent (reversible) BTK inhibitor. It is approved for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
Lead Product(s): Pirtobrutinib
Therapeutic Area: Oncology Brand Name: Jaypirca
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 12, 2023
Lead Product(s) : Pirtobrutinib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Jaypirca® (pirtobrutinib) Now Approved by U.S. FDA for the Treatment of Adult Patients with Chron...
Details : Jaypirca® (pirtobrutinib) is a non-covalent (reversible) BTK inhibitor. It is approved for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
Product Name : Jaypirca
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 12, 2023
Details:
Jaypirca (pirtobrutinib) is a small molecule and a highly selective non-covalent inhibitor of Bruton’s tyrosine kinase (BTK). Its high selectivity has been associated with lower discontinuation rates due to adverse events and a lower incidence of atrial fibrillation.
Lead Product(s): Pirtobrutinib
Therapeutic Area: Oncology Brand Name: Jaypirca
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 02, 2023
Lead Product(s) : Pirtobrutinib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Jaypirca™ (pirtobrutinib) Now Available from Onco360 for the Treatment of Adult Patients with Re...
Details : Jaypirca (pirtobrutinib) is a small molecule and a highly selective non-covalent inhibitor of Bruton’s tyrosine kinase (BTK). Its high selectivity has been associated with lower discontinuation rates due to adverse events and a lower incidence of atria...
Product Name : Jaypirca
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 02, 2023
Details:
Pirtobrutinib (LOXO-305), is an investigational, highly selective, reversible (non-covalent) inhibitor of Bruton's tyrosine kinase (BTK). Pirtobrutinib was developed to reversibly bind BTK, deliver consistently high target coverage regardless of BTK turnover rate.
Lead Product(s): Pirtobrutinib,Rituximab,Venetoclax
Therapeutic Area: Oncology Brand Name: Jaypirca
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 12, 2022
Lead Product(s) : Pirtobrutinib,Rituximab,Venetoclax
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Pirtobrutinib (LOXO-305), is an investigational, highly selective, reversible (non-covalent) inhibitor of Bruton's tyrosine kinase (BTK). Pirtobrutinib was developed to reversibly bind BTK, deliver consistently high target coverage regardless of BTK turn...
Product Name : Jaypirca
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 12, 2022
Details:
Data will be presented from BRUIN Phase 1b study of pirtobrutinib, an investigational, highly selective, non-covalent (reversible) BTK inhibitor, in combination with venetoclax, a CDK4/6 inhibitor with and without rituximab in relapsed/refractory chronic lymphocytic leukemia.
Lead Product(s): Pirtobrutinib,Rituximab,Venetoclax
Therapeutic Area: Oncology Brand Name: Jaypirca
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 03, 2022
Lead Product(s) : Pirtobrutinib,Rituximab,Venetoclax
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lilly Announces Details of Presentations at 2022 American Association for Cancer Research (AACR)
Details : Data will be presented from BRUIN Phase 1b study of pirtobrutinib, an investigational, highly selective, non-covalent (reversible) BTK inhibitor, in combination with venetoclax, a CDK4/6 inhibitor with and without rituximab in relapsed/refractory chronic...
Product Name : Jaypirca
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 03, 2022
Details:
Pirtobrutinib (LOXO-305), is an investigational, highly selective, reversible (non-covalent) Bruton's tyrosine kinase (BTK) inhibitor to treat chronic lymphocytic leukemia.
Lead Product(s): Pirtobrutinib
Therapeutic Area: Oncology Brand Name: Jaypirca
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 11, 2022
Lead Product(s) : Pirtobrutinib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Pirtobrutinib (LOXO-305), is an investigational, highly selective, reversible (non-covalent) Bruton's tyrosine kinase (BTK) inhibitor to treat chronic lymphocytic leukemia.
Product Name : Jaypirca
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 11, 2022
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PharmaCompass offers a list of Pirtobrutinib 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 Pirtobrutinib manufacturer or Pirtobrutinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pirtobrutinib manufacturer or Pirtobrutinib supplier.
PharmaCompass also assists you with knowing the Pirtobrutinib API Price utilized in the formulation of products. Pirtobrutinib API Price is not always fixed or binding as the Pirtobrutinib Price is obtained through a variety of data sources. The Pirtobrutinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Pirtobrutinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pirtobrutinib, including repackagers and relabelers. The FDA regulates Pirtobrutinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pirtobrutinib 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 Pirtobrutinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pirtobrutinib supplier is an individual or a company that provides Pirtobrutinib active pharmaceutical ingredient (API) or Pirtobrutinib finished formulations upon request. The Pirtobrutinib suppliers may include Pirtobrutinib API manufacturers, exporters, distributors and traders.
click here to find a list of Pirtobrutinib 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 Pirtobrutinib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pirtobrutinib 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 Pirtobrutinib 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 Pirtobrutinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pirtobrutinib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pirtobrutinib suppliers with NDC on PharmaCompass.
Pirtobrutinib 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 Pirtobrutinib 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 Pirtobrutinib GMP manufacturer or Pirtobrutinib GMP API supplier for your needs.
A Pirtobrutinib CoA (Certificate of Analysis) is a formal document that attests to Pirtobrutinib's compliance with Pirtobrutinib specifications and serves as a tool for batch-level quality control.
Pirtobrutinib CoA mostly includes findings from lab analyses of a specific batch. For each Pirtobrutinib 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.
Pirtobrutinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Pirtobrutinib EP), Pirtobrutinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pirtobrutinib USP).