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    Chemistry

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    Also known as: Ldk378, 1032900-25-6, Zykadia, Ldk-378, Nvp-ldk378-nx, Ldk 378
    Molecular Formula
    C28H36ClN5O3S
    Molecular Weight
    558.1  g/mol
    InChI Key
    VERWOWGGCGHDQE-UHFFFAOYSA-N
    FDA UNII
    K418KG2GET
    Ceritinib
    Ceritinib is an orally available inhibitor of the receptor tyrosine kinase activity of anaplastic lymphoma kinase (ALK) with antineoplastic activity. Upon administration, ceritinib binds to and inhibits wild-type ALK kinase, ALK fusion proteins and ALK point mutation variants. Inhibition of ALK leads to both the disruption of ALK-mediated signaling and the inhibition of cell growth in ALK-overexpressing tumor cells. 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 variety of tumor cell types.
    Ceritinib is a Kinase Inhibitor. The mechanism of action of ceritinib is as a Tyrosine Kinase Inhibitor, and Cytochrome P450 3A Inhibitor, and Cytochrome P450 2C9 Inhibitor.
    1 2D Structure

    Ceritinib

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    5-chloro-2-N-(5-methyl-4-piperidin-4-yl-2-propan-2-yloxyphenyl)-4-N-(2-propan-2-ylsulfonylphenyl)pyrimidine-2,4-diamine
    2.1.2 InChI
    InChI=1S/C28H36ClN5O3S/c1-17(2)37-25-15-21(20-10-12-30-13-11-20)19(5)14-24(25)33-28-31-16-22(29)27(34-28)32-23-8-6-7-9-26(23)38(35,36)18(3)4/h6-9,14-18,20,30H,10-13H2,1-5H3,(H2,31,32,33,34)
    2.1.3 InChI Key
    VERWOWGGCGHDQE-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=CC(=C(C=C1C2CCNCC2)OC(C)C)NC3=NC=C(C(=N3)NC4=CC=CC=C4S(=O)(=O)C(C)C)Cl
    2.2 Other Identifiers
    2.2.1 UNII
    K418KG2GET
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 5-chloro-n2-(2-isopropoxy-5-methyl-4-(piperidin-4-yl)phenyl)-n4-(2-(isopropylsulfonyl)phenyl)pyrimidine-2,4-diamine

    2. Ldk378

    3. Zykadia

    2.3.2 Depositor-Supplied Synonyms

    1. Ldk378

    2. 1032900-25-6

    3. Zykadia

    4. Ldk-378

    5. Nvp-ldk378-nx

    6. Ldk 378

    7. 5-chloro-n2-(2-isopropoxy-5-methyl-4-(piperidin-4-yl)phenyl)-n4-(2-(isopropylsulfonyl)phenyl)pyrimidine-2,4-diamine

    8. Ceritinib (ldk378)

    9. Ceritinib(ldk378)

    10. K418kg2get

    11. Nvp-ldk-378-nx

    12. Chembl2403108

    13. Chebi:78432

    14. 5-chloro-2-n-(5-methyl-4-piperidin-4-yl-2-propan-2-yloxyphenyl)-4-n-(2-propan-2-ylsulfonylphenyl)pyrimidine-2,4-diamine

    15. 2,4-pyrimidinediamine, 5-chloro-n4-(2-((1-methylethyl)sulfonyl)phenyl)-n2-(5-methyl-2-(1-methylethoxy)-4-(4-piperidinyl)phenyl)-

    16. 5-chloro-2-n-[5-methyl-4-(piperidin-4-yl)-2-(propan-2-yloxy)phenyl]-4-n-[2-(propane-2-sulfonyl)phenyl]pyrimidine-2,4-diamine

    17. 5-chloro-n~2~-[5-methyl-4-(piperidin-4-yl)-2-(propan-2-yloxy)phenyl]-n~4~-[2-(propan-2-ylsulfonyl)phenyl]pyrimidine-2,4-diamine

    18. 5-chloro-n2-(5-methyl-4-(piperidin-4-yl)-2-(propan-2-yloxy)phenyl)-n4-(2-(propane-2-sulfonyl)phenyl)pyrimidine-2,4-diamine

    19. 5-chloro-n2-[2-isopropoxy-5-methyl-4-(4-piperidyl)phenyl]-n4-(2-isopropylsulfonylphenyl)pyrimidine-2,4-diamine

    20. 5-chloro-n4-[2-[(1-methylethyl)sulfonyl]phenyl]-n2-[5-methyl-2-(1-methylethoxy)-4-(4-piperidinyl)phenyl]-2,4-pyrimidinediamine

    21. 5-chloro-n4-[2-[(1methylethyl)sulfonyl]phenyl]-n2-[5-methyl-2-(1-methylethoxy)-4-(4-piperidinyl)phenyl]-2,4-pyrimidinediamine;5-chloro-n4-[2-[(1methylethyl)sulfonyl]phenyl]-n2-[5-methyl-2-(1-methylethoxy)-4-(4-piperidinyl)phenyl]-2,4-pyrimidinediamine

    22. Ceritinib [usan:inn]

    23. Unii-k418kg2get

    24. Ceritinibum

    25. Ceritinib[mi]

    26. 5-chloro-n2-[5-methyl-4-(piperidin-4-yl)-2-(propan-2-yloxy)phenyl]-n4-[2-(propane-2-sulfonyl)phenyl]pyrimidine-2,4-diamine

    27. Zykadia (tn)

    28. Ldk378 Certinib

    29. Ceritinib; Ldk378

    30. Ldk378(ceritinib)

    31. Ceritinib [inn]

    32. Ceritinib [jan]

    33. Eritinib (ldk378)

    34. Ceritinib [mi]

    35. Ceritinib [usan]

    36. Ceritinib [vandf]

    37. Ceritinib [who-dd]

    38. Ceritinib (jan/usan/inn)

    39. Gtpl7397

    40. Schembl1014329

    41. Ceritinib [orange Book]

    42. Dtxsid10725373

    43. Ex-a187

    44. Hms3652h22

    45. Hms3673i17

    46. Hms3747a11

    47. Amy10314

    48. Bcp07611

    49. Bdbm50436850

    50. Mfcd26142648

    51. Nsc776422

    52. Nsc777193

    53. Nsc800072

    54. Zinc96272772

    55. Akos025396438

    56. Ccg-264762

    57. Cs-1406

    58. Db09063

    59. Gs-6356

    60. Nsc-776422

    61. Nsc-777193

    62. Nsc-800072

    63. Sb16490

    64. Compound 15b [pmid 23742252]

    65. Ncgc00351603-10

    66. Ncgc00351603-13

    67. Ncgc00351603-15

    68. Ac-27469

    69. Hy-15656

    70. Ft-0697208

    71. S7083

    72. Sw219725-1

    73. D10551

    74. A852144

    75. J-690011

    76. Q21011233

    77. N-{2-methyl-5-[(methylamino)methyl]phenyl}-4-[(4-phenyl-2-quinazolinyl)amino]benzamide

    78. 4mk

    79. 5-chloro-n(2)-{5-methyl-4-(piperidin-4-yl)-2-[(propan-2-yl)oxy]phenyl}-n(4)-[2-(propane-2-sulfonyl)phenyl]pyrimidine-2,4-diamine

    80. 5-chloro-n2-(2-isopropoxy-5-methyl-4-piperidin-4-yl-phenyl)-n4-[2-(propane-2-sulfonyl)-phenyl]-pyrimidine-2,4-diamine

    81. 5-chloro-n2-(5-methyl-4-(piperidin-4-yl)-2-(propan-2-yloxy)phenyl)-n4-(2-(propane-2- Sulfonyl)phenyl)pyrimidine-2,4-diamine

    82. 5-chloro-n4-(2-((1-methylethyl)sulfonyl)phenyl)-n2-(5-methyl-2-(1-methylethoxy)-4- (piperidin-4-yl)phenyl)pyrimidine-2,4-diamine

    83. Ceritinib;5-chloro-n2-[2-isopropoxy-5-methyl-4-(4-piperidyl)phenyl]-n4-(2-isopropylsulfonylphenyl)pyrimidine-2,4-diamine;ceritinib

    84. N-{2-[(5-chloro-2-{[2-isopropoxy-5-methyl-4-(piperidin-4-yl)phenyl]amino}pyrimidin-4-yl)amino]phenyl}propane-2-sulfonamide

    2.4 Create Date
    2012-07-16
    3 Chemical and Physical Properties
    Molecular Weight 558.1 g/mol
    Molecular Formula C28H36ClN5O3S
    XLogP36.4
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count9
    Exact Mass557.2227389 g/mol
    Monoisotopic Mass557.2227389 g/mol
    Topological Polar Surface Area114 Ų
    Heavy Atom Count38
    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 Indication

    Ceritinib is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved under accelerated approval based on tumor response rate and duration of response. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

    FDA Label

    Zykadia is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) previously treated with crizotinib.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Antineoplastic Agents

    Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)

    Protein Kinase Inhibitors

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

    5.2 FDA Pharmacological Classification
    5.2.1 Active Moiety
    CERITINIB
    5.2.2 FDA UNII
    K418KG2GET
    5.2.3 Pharmacological Classes
    Cytochrome P450 3A Inhibitors [MoA]; Kinase Inhibitor [EPC]; Tyrosine Kinase Inhibitors [MoA]; Cytochrome P450 2C9 Inhibitors [MoA]
    5.3 ATC Code

    L01XE

    L01XE28

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    L - Antineoplastic and immunomodulating agents

    L01 - Antineoplastic agents

    L01E - Protein kinase inhibitors

    L01ED - Anaplastic lymphoma kinase (alk) inhibitors

    L01ED02 - Ceritinib

    5.4 Absorption, Distribution and Excretion

    Absorption

    After oral administration of ceritinib, peak concentrations were achieved after approximately 4 to 6 hours.

    Route of Elimination

    Following oral administration of a single 750 mg radiolabeled ceritinib dose, 92.3% of the administered dose was recovered in the feces (with 68% as unchanged parent compound) while 1.3% of the administered dose was recovered in the urine.

    Volume of Distribution

    The apparent volume of distribution (Vd/F) is 4230 L following a single 750 mg dose.

    Clearance

    The geometric mean apparent clearance (CL/F) of ceritinib was lower at steady-state (33.2 L/h) after 750 mg daily dosing than after a single 750 mg dose (88.5 L/h).

    5.5 Metabolism/Metabolites

    In vitro studies demonstrated that CYP3A was the major enzyme involved in the metabolic clearance of ceritinib. Following oral administration of a single 750 mg radiolabeled ceritinib dose, ceritinib as the parent compound was the main circulating component (82%) in human plasma.

    5.6 Biological Half-Life

    The terminal half life is 41 hours.

    5.7 Mechanism of Action

    Ceritinib inhibits Anaplastic lymphoma kinase (ALK) also known as ALK tyrosine kinase receptor or CD246 (cluster of differentiation 246), which is an enzyme that in humans is encoded by the ALK gene. About 4-5% of NSCLCs have a chromosomal rearrangement that generates a fusion gene between EML4 (echinoderm microtubule-associated protein-like 4) and ALK (anaplastic lymphoma kinase), which results in constitutive kinase activity that contributes to carcinogenesis and seems to drive the malignant phenotype. Ceritinib exerts its therapeutic effect by inhibiting autophosphorylation of ALK, ALK-mediated phosphorylation of the downstream signaling protein STAT3, and proliferation of ALK-dependent cancer cells. Ceritinib has been shown to inhibit in vitro proliferation of cell lines expressing EML4-ALK and NPM-ALK fusion proteins and demonstrated dose-dependent inhibition of EML4-ALK-positive NSCLC xenograft growth in mice and rats.

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    ABOUT THIS PAGE

    Ceritinib Manufacturers

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

    Ceritinib Suppliers

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

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

    Ceritinib USDMF

    A Ceritinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Ceritinib active pharmaceutical ingredient (API) in detail. Different forms of Ceritinib DMFs exist exist since differing nations have different regulations, such as Ceritinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Ceritinib DMF submitted to regulatory agencies in the US is known as a USDMF. Ceritinib USDMF includes data on Ceritinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ceritinib USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Ceritinib suppliers with USDMF on PharmaCompass.

    Ceritinib WC

    A Ceritinib written confirmation (Ceritinib WC) is an official document issued by a regulatory agency to a Ceritinib manufacturer, verifying that the manufacturing facility of a Ceritinib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ceritinib APIs or Ceritinib finished pharmaceutical products to another nation, regulatory agencies frequently require a Ceritinib WC (written confirmation) as part of the regulatory process.

    click here to find a list of Ceritinib suppliers with Written Confirmation (WC) on PharmaCompass.

    Ceritinib 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 Ceritinib as an active pharmaceutical ingredient (API).

    Finished drug products

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

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    Ceritinib GMP

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

    Ceritinib CoA

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

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

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