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    Chemistry

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    Also known as: 1108743-60-7, Rxdx-101, Nms-e628, Rozlytrek, Entrectinib (rxdx-101), Entrectinib(rxdx-101)
    Molecular Formula
    C31H34F2N6O2
    Molecular Weight
    560.6  g/mol
    InChI Key
    HAYYBYPASCDWEQ-UHFFFAOYSA-N
    FDA UNII
    L5ORF0AN1I
    Entrectinib
    Entrectinib is an orally bioavailable inhibitor of the tyrosine kinases tropomyosin receptor kinases (Trk) A, B and C, C-ros oncogene 1 (ROS1) and anaplastic lymphoma kinase (ALK), with potential antineoplastic activity. Upon administration, entrectinib binds to and inhibits TrkA, TrkB, TrkC, ROS1 and ALK. Inhibition of these kinases may result in a disruption of TrkA-, TrkB-, TrkC-, ROS1-, and ALK-mediated signaling. This leads to an induction of apoptosis and an inhibition of tumor cell proliferation in tumor cells that express these kinases. TrkA, TrkB, TrkC, ROS1 and ALK are overexpressed in a variety of cancer cell types.
    1 2D Structure

    Entrectinib

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    N-[5-[(3,5-difluorophenyl)methyl]-1H-indazol-3-yl]-4-(4-methylpiperazin-1-yl)-2-(oxan-4-ylamino)benzamide
    2.1.2 InChI
    InChI=1S/C31H34F2N6O2/c1-38-8-10-39(11-9-38)25-3-4-26(29(19-25)34-24-6-12-41-13-7-24)31(40)35-30-27-17-20(2-5-28(27)36-37-30)14-21-15-22(32)18-23(33)16-21/h2-5,15-19,24,34H,6-14H2,1H3,(H2,35,36,37,40)
    2.1.3 InChI Key
    HAYYBYPASCDWEQ-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CN1CCN(CC1)C2=CC(=C(C=C2)C(=O)NC3=NNC4=C3C=C(C=C4)CC5=CC(=CC(=C5)F)F)NC6CCOCC6
    2.2 Other Identifiers
    2.2.1 UNII
    L5ORF0AN1I
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. N-(5-(3,5-difluorobenzyl)-1h-indazol-3-yl)-4-(4-methyl-1-piperazinyl)-2-(tetrahydro-2h-pyran-4-ylamino)benzamide

    2. Nms-e628

    3. Rozlytrek

    4. Rxdx-101

    2.3.2 Depositor-Supplied Synonyms

    1. 1108743-60-7

    2. Rxdx-101

    3. Nms-e628

    4. Rozlytrek

    5. Entrectinib (rxdx-101)

    6. Entrectinib(rxdx-101)

    7. L5orf0an1i

    8. N-(5-(3,5-difluorobenzyl)-1h-indazol-3-yl)-4-(4-methylpiperazin-1-yl)-2-((tetrahydro-2h-pyran-4-yl)amino)benzamide

    9. Benzamide, N-(5-((3,5-difluorophenyl)methyl)-1h-indazol-3-yl)-4-(4-methyl-1-piperazinyl)-2-((tetrahydro-2h-pyran-4-yl)amino)-

    10. N-(5-(3,5-difluorobenzyl)-1h-indazol-3-yl)-4-(4-methylpiperazin-1yl)-2-(tetrahydro-2h-pyran-4-ylamino)benzamide

    11. N-[5-[(3,5-difluorophenyl)methyl]-1h-indazol-3-yl]-4-(4-methylpiperazin-1-yl)-2-(oxan-4-ylamino)benzamide

    12. Benzamide, N-[5-[(3,5-difluorophenyl)methyl]-1h-indazol-3-yl]-4-(4-methyl-1-piperazinyl)-2-[(tetrahydro-2h-pyran-4-yl)amino]-

    13. N-{5-[(3,5-difluorophenyl)methyl]-1h-indazol-3-yl}-4-(4-methylpiperazin-1-yl)-2-[(oxan-4-yl)amino]benzamide

    14. Entrectinib [inn]

    15. Unii-l5orf0an1i

    16. Entrectinib [usan:inn]

    17. Rozlytrek (tn)

    18. Ymx

    19. Entrectinib, 95%

    20. Kinome_2659

    21. Entrectinib [mi]

    22. Entrectinib [jan]

    23. Entrectinib; Nms-e628

    24. Entrectinib [usan]

    25. Entrectinib [who-dd]

    26. Entrectinib (jan/usan/inn)

    27. Gtpl8290

    28. Schembl3512601

    29. Chembl1983268

    30. Nms-e-628

    31. Entrectinib [orange Book]

    32. Nms-e628;rxdx-101

    33. Dtxsid101026450

    34. Hms3886h21

    35. Bcp16174

    36. Ex-a2261

    37. Mfcd28129099

    38. Nsc774769

    39. Nsc800095

    40. S7998

    41. Zinc43204146

    42. Ccg-270048

    43. Db11986

    44. Nsc-774769

    45. Nsc-800095

    46. Sb17194

    47. Ncgc00484067-01

    48. Ncgc00484067-02

    49. Ncgc00484067-03

    50. Ac-31286

    51. As-75092

    52. Da-47850

    53. Hy-12678

    54. B5859

    55. Ft-0736318

    56. D10926

    57. A856078

    58. Q25323953

    59. S900006830

    60. Rxdx101; Rxdx 101; Rxdx-101; Nms E628; Nms-e628;nms E628

    61. N-(5-(3,5-difluorobenzyl)-1h-indazol-3-yl)-4-(4-methyl-1-piperazinyl)-2-(tetrahydro-2h-pyran-4-ylamino)benzamide

    62. N-(5-(3,5-difluorobenzyl)-1h-indazol-3-yl)-4-(4-methylpiperazin-1-yl)-2-(tetrahydro-2h-pyran-4-ylamino)benzamide

    63. N-[5-(3,5-difluoro-benzyl)-1h-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-pyran-4-ylamino)-benzamide

    64. N-{5-[(3,5-difluorophenyl)methyl]-3h-indazol-3-ylidene}-4-(4-methylpiperazin-1-yl)-2-[(oxan-4-yl)amino]benzamide

    2.4 Create Date
    2009-02-09
    3 Chemical and Physical Properties
    Molecular Weight 560.6 g/mol
    Molecular Formula C31H34F2N6O2
    XLogP35.7
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count7
    Exact Mass560.27113067 g/mol
    Monoisotopic Mass560.27113067 g/mol
    Topological Polar Surface Area85.5 Ų
    Heavy Atom Count41
    Formal Charge0
    Complexity847
    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 Indication

    Entrectinib is indicated for the treatment of metastatic ROS1-positive non-small cell lung cancer in adults. Entrectinib is also indicated in adults and children over 12 years old for the treatment of NTRK gene fusion-positive solid tumors which have metastasized or for which surgical resection is likely to result in severe morbidity and for which has progressed on previous therapies or for which no comparable alternative therapies are available.

    FDA Label

    Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion,

    - who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and

    - who have not received a prior NTRK inhibitor

    - who have no satisfactory treatment options.

    Rozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1 positive, advanced non small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Entrectinib and its active metabolite suppress several pathways which contribute to cell survival and proliferation. This suppression shifts the balance in favor of apoptosis thereby preventing cancer cell growth and shrinking tumors.

    5.2 MeSH Pharmacological Classification

    Protein Kinase Inhibitors

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

    5.3 ATC Code

    L01EX14

    L - Antineoplastic and immunomodulating agents

    L01 - Antineoplastic agents

    L01E - Protein kinase inhibitors

    L01EX - Other protein kinase inhibitors

    L01EX14 - Entrectinib

    5.4 Absorption, Distribution and Excretion

    Absorption

    Entrectinib has a Tmax of 4-5 h after administration of a single 600 mg dose. Food does not produce a significant effect on the extent of absorption.

    Route of Elimination

    After a single radio-labeled dose of entrectinib, 83% of radioactivity was present in the feces and 3% in the urine. Of the dose in the feces, 36% was present as entrectinib and 22% as M5.

    Volume of Distribution

    Entrectinib has an apparent volume of distribution of 551 L. The active metabolite, M5, has an apparent volume of distribution of 81.1 L. Entrectinib is known to cross the blood-brain barrier.

    Clearance

    The apparent clearance of entrectinib is 19.6 L/h while the apparent clearance of the active metabolite M5 is 52.4 L/h.

    5.5 Metabolism/Metabolites

    CYP3A4 is responsible for 76% of entrectinib metabolism in humans including metabolism to the active metabolite, M5. M5 has similar pharmacological activity to entrectinib and exists at approximately 40% of the steady state concentration of the parent drug. In rats, six in vivo metabolites have been identified including N-dealkylated, N-oxide, hydroxylated, and glucuronide conjugated metabolites.

    5.6 Biological Half-Life

    Entrectinib has a half-life of elimination of 20 h. The active metabolite, M5, has a half-life of 40 h.

    5.7 Mechanism of Action

    Entrectinib is a tyrosine kinase inhibitor which acts on several receptors. It functions as an ATP competitor to inhibit tropomyosin receptor tyrosine kinases (TRK) TRKA, TRKB, TRKC, as well as proto-oncogene tyrosine-protein kinase ROS1 and anaplastic lymphoma kinase (ALK). TRK receptors produce cell proliferation via downstream signalling through the mitogen activated protein kinase, phosphoinositide 3-kinase, and phospholipase C-. ALK produces similar signalling with the addition of downstream JAK/STAT activation. Inhibition of these pathways suppresses cancer cell proliferation and shifts the balance in favor of apoptosis resulting in shrinking of tumor volume.

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    ABOUT THIS PAGE

    Entrectinib Manufacturers

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

    Entrectinib Suppliers

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

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

    Entrectinib 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 Entrectinib as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Entrectinib GMP

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

    Entrectinib CoA

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

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

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