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    Chemistry

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    Also known as: 1197953-54-0, Alunbrig, Ap-26113, Brigatinib [usan], Brigatinib (ap-26113), Hyw8db273j
    Molecular Formula
    C29H39ClN7O2P
    Molecular Weight
    584.1  g/mol
    InChI Key
    AILRADAXUVEEIR-UHFFFAOYSA-N
    FDA UNII
    HYW8DB273J
    Brigatinib
    Brigatinib is an orally available inhibitor of receptor tyrosine kinases anaplastic lymphoma kinase (ALK) and the epidermal growth factor receptor (EGFR) with potential antineoplastic activity. Brigatinib binds to and inhibits ALK kinase and ALK fusion proteins as well as EGFR and mutant forms. This leads to the inhibition of ALK kinase and EGFR kinase, disrupts their signaling pathways and eventually inhibits tumor cell growth in susceptible tumor cells. In addition, AP26113 appears to overcome mutation-based resistance. ALK belongs to the insulin receptor superfamily and plays an important role in nervous system development; ALK dysregulation and gene rearrangements are associated with a series of tumors. EGFR is overexpressed in a variety of cancer cell types.
    Brigatinib is a Kinase Inhibitor. The mechanism of action of brigatinib is as a Tyrosine Kinase Inhibitor, and Cytochrome P450 3A Inducer.
    1 2D Structure

    Brigatinib

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    5-chloro-4-N-(2-dimethylphosphorylphenyl)-2-N-[2-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]phenyl]pyrimidine-2,4-diamine
    2.1.2 InChI
    InChI=1S/C29H39ClN7O2P/c1-35-15-17-37(18-16-35)21-11-13-36(14-12-21)22-9-10-24(26(19-22)39-2)33-29-31-20-23(30)28(34-29)32-25-7-5-6-8-27(25)40(3,4)38/h5-10,19-21H,11-18H2,1-4H3,(H2,31,32,33,34)
    2.1.3 InChI Key
    AILRADAXUVEEIR-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CN1CCN(CC1)C2CCN(CC2)C3=CC(=C(C=C3)NC4=NC=C(C(=N4)NC5=CC=CC=C5P(=O)(C)C)Cl)OC
    2.2 Other Identifiers
    2.2.1 UNII
    HYW8DB273J
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Alunbrig

    2. Ap26113

    2.3.2 Depositor-Supplied Synonyms

    1. 1197953-54-0

    2. Alunbrig

    3. Ap-26113

    4. Brigatinib [usan]

    5. Brigatinib (ap-26113)

    6. Hyw8db273j

    7. Ap 26113

    8. (2-((5-chloro-2-((2-methoxy-4-(4-(4-methylpiperazin-1-yl)piperidin-1-yl)phenyl)amino)pyrimidin-4-yl)amino)phenyl)dimethylphosphine Oxide

    9. 5-chloro-4-n-(2-dimethylphosphorylphenyl)-2-n-[2-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]phenyl]pyrimidine-2,4-diamine

    10. 2,4-pyrimidinediamine, 5-chloro-n4-(2-(dimethylphosphinyl)phenyl)-n2-(2-methoxy-4-(4-(4-methyl-1-piperazinyl)-1-piperidinyl)phenyl)-

    11. 5-chloro-n4-(2-(dimethylphosphoryl)phenyl)-n2-(2-methoxy-4-(4-(4-methylpiperazin-1- Yl)piperidin-1-yl)phenyl)pyrimidine-2,4-diamine

    12. 2,4-pyrimidinediamine, 5-chloro-n4-[2-(dimethylphosphinyl)phenyl]-n2-[2-methoxy-4-[4-(4-methyl-1-piperazinyl)-1-piperidinyl]phenyl]-

    13. 5-chloro-n~4~-[2-(dimethylphosphoryl)phenyl]-n~2~-{2-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]phenyl}pyrimidine-2,4-diamine

    14. Unii-hyw8db273j

    15. Brigatiib

    16. Alunbrig (tn)

    17. 5-chloro-n4-(2-(dimethylphosphoryl)phenyl)-n2-(2-methoxy-4-(4-(4-methylpiperazin-1-yl)piperidin-1-yl)phenyl)pyrimidine-2,4-diamine

    18. 5-chloro-n4-[2-(dimethylphosphoryl)phenyl]-n2-{2-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]phenyl}pyrimidine-2,4-diamine

    19. 6gy

    20. Brigatinib [mi]

    21. Brigatinib [inn]

    22. Brigatinib [jan]

    23. Brigatinib (jan/usan)

    24. Brigatinib [usan:inn]

    25. Brigatinib; Ap26113

    26. Brigatinib (ap26113)

    27. Brigatinib [who-dd]

    28. 5-chloro-n4-[2-(dimethylphosphinyl)phenyl]-n2-[2-methoxy-4-[4-(4-methyl-1-piperazinyl)-1-piperidinyl]phenyl]-2,4-pyrimidinediamine

    29. Gtpl7741

    30. Brigatinib [orange Book]

    31. Chembl3545311

    32. Schembl11916361

    33. Ex-a775

    34. Dtxsid501027929

    35. Amy10294

    36. Bcp17214

    37. Bdbm50185140

    38. Mfcd29472221

    39. Nsc784728

    40. Nsc787457

    41. Akos030257612

    42. Zinc148723177

    43. Cs-4278

    44. Db12267

    45. Nsc-784728

    46. Nsc-787457

    47. Sb40412

    48. Compound 11q [pmid: 27144831]

    49. Ncgc00483924-01

    50. (2-((5-chloro-2-((2-methoxy-4-(4-(4-methylpiperazin-1-yl)piperidin-1-yl)phenyl)amino)pyrimidin-4-yl)amino)phenyl)dimethyl-,delta5-phosphanone

    51. Ac-29958

    52. As-75176

    53. Hy-12857

    54. Db-118419

    55. Ft-0700112

    56. S8229

    57. J3.535.964h

    58. D10866

    59. Q27456393

    60. (2-((5-chloro-2-((2-methoxy-4-(4-(4-methylpiperazin-1-yl)piperidin-1-yl)phenyl)amino)pyrimidin-4-yl)amino)phenyl)dimethyl-,.delta.5-phosphanone

    2.4 Create Date
    2012-11-30
    3 Chemical and Physical Properties
    Molecular Weight 584.1 g/mol
    Molecular Formula C29H39ClN7O2P
    XLogP34.6
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count9
    Rotatable Bond Count8
    Exact Mass583.2591382 g/mol
    Monoisotopic Mass583.2591382 g/mol
    Topological Polar Surface Area85.9 Ų
    Heavy Atom Count40
    Formal Charge0
    Complexity835
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 1  
    Drug NameALUNBRIG
    Active IngredientBRIGATINIB
    CompanyARIAD (Application Number: N208772. Patents: 9012462, 9273077, 9611283)

    4.2 Drug Indication

    The anaplastic lymphoma kinase positive, metastatic non-small cell lung cancer (ALK+ NSCLC), represents only 3-5% of the NSCLC cancer cases, but the ALK mutation, overexpression and presence in several oncogenic fusion proteins in solid and hematologic tumors have pointed out the importance as well as its potential as a cancer therapy target. The ALK-related cases of NSCLC are associated with the presence of the fusion gene EML4-ALK which fused the ALK protein with the echinoderm microtubule-associated protein like-4 whose original function is the correct formation of microtubules. The presence of the aberrant fusion protein results in abnormal signaling that provokes increased cell growth, proliferation and survival. Crizotinib is indicated for the treatment of such cases but the presence of ALK kinase domain mutations confer resistance to the treatment. Thus, brigatinib is indicated for the treatment of patients with ALK+ NSCLC with intolerance to Crizotinib.

    FDA Label

    Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)positive advanced nonsmall cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.

    Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase ALKpositive advanced NSCLC previously treated with crizotinib.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Brigitanib inhibits proliferation and in vitro viability of cells expressing the fusion protein EML4-ALK as well as 17 crizotinib-resistant ALK mutants. Its action is expanded to cells expressing EGFR deletions, ROS1-L2026M, FLT3-F691L and FLT3-D835Y. Brigitanib presents a dose-dependent inhibition of tumor growth, tumor burden and prolonged survival in mice EML4-ALK xenograft models. Time course of Brigatinib and exposure-response studies are still unknown.

    5.2 FDA Pharmacological Classification
    5.2.1 Active Moiety
    BRIGATINIB
    5.2.2 FDA UNII
    HYW8DB273J
    5.2.3 Pharmacological Classes
    Kinase Inhibitor [EPC]; Tyrosine Kinase Inhibitors [MoA]; Cytochrome P450 3A Inducers [MoA]
    5.3 ATC Code

    L01XE43

    L - Antineoplastic and immunomodulating agents

    L01 - Antineoplastic agents

    L01E - Protein kinase inhibitors

    L01ED - Anaplastic lymphoma kinase (alk) inhibitors

    L01ED04 - Brigatinib

    5.4 Absorption, Distribution and Excretion

    Absorption

    Administration of brigatinib at a concentration of 90 mg generates a Cmax of 552 ng/ml and AUC of 8165 ng h/ml while the administration of 180 mg presents a Cmax of 1452 ng/ml and AUC of 20276 ng h/ml. It has a dose proportional exposure with an accumulation ratio on the range of 1.9 to 2.4. Following oral administration of brigatinib, the Tmax is presented in a range from 1 to 4 hours. Consumption of a high-fat meal compared to overnight fasting reduces Cmax by 13% without presenting an effect on AUC.

    Route of Elimination

    The elimination of brigatinib is divided in 65% in feces and 25% in urine. From the elimination in both compartments, the unchanged for of brigatinib represented 41% of the total in feces and 86% in urine.

    Volume of Distribution

    The apparent volume of distribution at steady state is 153 L.

    Clearance

    After oral administration of180 mg of brigatinib, the apparent oral clearance at steady-state is 12.7 L/h.

    5.5 Metabolism/Metabolites

    Brigatinib is metabolized by CYP2C8 (72.4%) and CYP3A4 (27.6%) in human liver microsomes and hepatocytes. The two major metabolites generated are the N-demethylated form and the cysteine conjugated form. Oral administration of radiolabelled brigatinib showed the systemic presence of 91.5% in the unchanged form and 3.5% of the primary metabolite AP26123. The AUC of AP26123 is less than 10% of the AUC of brigatinib and presented an inhibitory effect 3 fold lower.

    5.6 Biological Half-Life

    The half-life of brigatinib at steady-state was 25 hours.

    5.7 Mechanism of Action

    Brigitanib acts as a tyrosine kinase inhibitor with activity against multiple kinases including ALK, ROS1, insulin-like growth factor 1 receptor and against EGFR deletions and point mutations. It acts by inhibiting ALK phosphorylation and the activation of downstream signaling proteins.

    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 180MG

    USFDA APPLICATION NUMBER - 208772

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    DOSAGE - TABLET;ORAL - 30MG

    USFDA APPLICATION NUMBER - 208772

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    DOSAGE - TABLET;ORAL - 90MG

    USFDA APPLICATION NUMBER - 208772

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    ABOUT THIS PAGE

    Brigatinib Manufacturers

    A Brigatinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Brigatinib, including repackagers and relabelers. The FDA regulates Brigatinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Brigatinib 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 Brigatinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Brigatinib Suppliers

    A Brigatinib supplier is an individual or a company that provides Brigatinib active pharmaceutical ingredient (API) or Brigatinib finished formulations upon request. The Brigatinib suppliers may include Brigatinib API manufacturers, exporters, distributors and traders.

    click here to find a list of Brigatinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Brigatinib KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Brigatinib Drug Master File in Korea (Brigatinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Brigatinib. The MFDS reviews the Brigatinib KDMF as part of the drug registration process and uses the information provided in the Brigatinib KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Brigatinib KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Brigatinib API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Brigatinib suppliers with KDMF on PharmaCompass.

    Brigatinib 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 Brigatinib as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Brigatinib 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 Brigatinib 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 Brigatinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Brigatinib NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Brigatinib suppliers with NDC on PharmaCompass.

    Brigatinib GMP

    Brigatinib 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 Brigatinib 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 Brigatinib GMP manufacturer or Brigatinib GMP API supplier for your needs.

    Brigatinib CoA

    A Brigatinib CoA (Certificate of Analysis) is a formal document that attests to Brigatinib's compliance with Brigatinib specifications and serves as a tool for batch-level quality control.

    Brigatinib CoA mostly includes findings from lab analyses of a specific batch. For each Brigatinib 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.

    Brigatinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Brigatinib EP), Brigatinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Brigatinib 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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