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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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Chemistry

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Also known as: Loxo-305, 2101700-15-4, Pirtobrutinib [usan], Jna39i7zvb, (s)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoropropan-2-yl)-1h-pyrazole-4-carboxamide, Ly3527727
Molecular Formula
C22H21F4N5O3
Molecular Weight
479.4  g/mol
InChI Key
FWZAWAUZXYCBKZ-NSHDSACASA-N
FDA UNII
JNA39I7ZVB

Pirtobrutinib
Pirtobrutinib is an orally available, selective, non-covalent Bruton's tyrosine kinase (BTK) inhibitor with potential antineoplastic activity. Upon oral administration, pirtobrutinib selectively and reversibly binds to BTK. This prevents both the activation of the B-cell antigen receptor (BCR) signaling pathway and BTK-mediated activation of downstream survival pathways, thereby inhibiting the growth of malignant B-cells that overexpress BTK. Reversible binding of LOXO-305 may preserve antitumor activity in the presence of certain acquired resistance mutations, including C481 mutated BTK, and limit toxicity associated with inhibition of other non-BTK kinases. BTK, a member of the Src-related BTK/Tec family of cytoplasmic tyrosine kinases, is overexpressed or mutated in B-cell malignancies; it plays an important role in the development, activation, signaling, proliferation and survival of B-lymphocytes.
1 2D Structure

Pirtobrutinib

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
5-amino-3-[4-[[(5-fluoro-2-methoxybenzoyl)amino]methyl]phenyl]-1-[(2S)-1,1,1-trifluoropropan-2-yl]pyrazole-4-carboxamide
2.1.2 InChI
InChI=1S/C22H21F4N5O3/c1-11(22(24,25)26)31-19(27)17(20(28)32)18(30-31)13-5-3-12(4-6-13)10-29-21(33)15-9-14(23)7-8-16(15)34-2/h3-9,11H,10,27H2,1-2H3,(H2,28,32)(H,29,33)/t11-/m0/s1
2.1.3 InChI Key
FWZAWAUZXYCBKZ-NSHDSACASA-N
2.1.4 Canonical SMILES
CC(C(F)(F)F)N1C(=C(C(=N1)C2=CC=C(C=C2)CNC(=O)C3=C(C=CC(=C3)F)OC)C(=O)N)N
2.1.5 Isomeric SMILES
C[C@@H](C(F)(F)F)N1C(=C(C(=N1)C2=CC=C(C=C2)CNC(=O)C3=C(C=CC(=C3)F)OC)C(=O)N)N
2.2 Other Identifiers
2.2.1 UNII
JNA39I7ZVB
2.3 Synonyms
2.3.1 MeSH Synonyms

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

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date
2017-08-04
3 Chemical and Physical Properties
Molecular Weight 479.4 g/mol
Molecular Formula C22H21F4N5O3
XLogP33.3
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count9
Rotatable Bond Count7
Exact Mass479.15805220 g/mol
Monoisotopic Mass479.15805220 g/mol
Topological Polar Surface Area125 Ų
Heavy Atom Count34
Formal Charge0
Complexity719
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Protein Kinase Inhibitors

Agents that inhibit PROTEIN KINASES. (See all compounds classified as Protein Kinase Inhibitors.)


Listed Suppliers

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Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Pirtobrutinib

About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale
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Virtual BoothChongqing Sintaho Pharma: A trusted partner globally for chemosynthetic APIs.

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Pirtobrutinib

About the Company : Sintaho Pharmaceutical Co., Ltd., located in Chongqing, China, contributes to being the most dependable partner for global pharmaceutical companies. Sintaho specializes in chemosyn...

Sintaho Pharmaceutical Co., Ltd., located in Chongqing, China, contributes to being the most dependable partner for global pharmaceutical companies. Sintaho specializes in chemosynthetic APIs (application contains oncology, nervous system, and metabolic diseases and etc.,) with a product portfolio ranging from small molecule APIs, ADC compounds (linkers and payloads) to polypeptides, also provides CDMO services of cytotoxic and OEB4/5 grade APIs.
Chongqing Sintaho Pharmaceutical

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Virtual BoothTAPI offers customized CDMO Solutions for API development and manufacturing services.

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Pirtobrutinib

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...

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, driving progress in the pharmaceutical industry. Leveraging our extensive experience and world-class expertise, we deliver one of the most comprehensive API portfolios in the industry. Additionally, we provide tailored CDMO services, harnessing our proficiency in diverse technologies to meet our partners' unique needs, ensuring flexibility and excellence in every project.
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Pirtobrutinib

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...

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 in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs
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Patents & EXCLUSIVITIES

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ABOUT THIS PAGE

Pirtobrutinib Manufacturers

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.

Pirtobrutinib Suppliers

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.

Pirtobrutinib NDC

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).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Pirtobrutinib API and other APIs are published in this directory by the FDA.

Unfinished drugs

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.

Compounded drug products

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 GMP

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.

Pirtobrutinib CoA

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).

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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