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    Chemistry

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    Also known as: 936091-26-8, Tg-101348, Tg101348, Sar302503, Sar-302503, N-(tert-butyl)-3-((5-methyl-2-((4-(2-(pyrrolidin-1-yl)ethoxy)phenyl)amino)pyrimidin-4-yl)amino)benzenesulfonamide
    Molecular Formula
    C27H36N6O3S
    Molecular Weight
    524.7  g/mol
    InChI Key
    JOOXLOJCABQBSG-UHFFFAOYSA-N
    FDA UNII
    6L1XP550I6
    Fedratinib
    Fedratinib is an orally bioavailable, small-molecule, ATP-competitive inhibitor of Janus-associated kinase 2 (JAK2) and FMS-like tyrosine kinase 3 (FLT3; CD135; STK1; FLK2), with potential antineoplastic activity. Upon oral administration, fedratinib competes with wild-type JAK2 as well as mutated forms for ATP binding, which may result in inhibition of JAK2 activation, inhibition of the JAK-STAT signaling pathway, inhibition of tumor cell proliferation and induction of tumor cell apoptosis. JAK2 is the most commonly mutated gene in bcr-abl-negative myeloproliferative disorders (MPDs). In addition, fedratinib targets, binds to and inhibits the activity of FLT3. This inhibits uncontrolled FLT3 signaling and results in the inhibition of proliferation in tumor cells overexpressing FLT3. FLT3, a class III receptor tyrosine kinase (RTK), is overexpressed or mutated in most B-lineage neoplasms and in acute myeloid leukemias and plays a key role in tumor cell proliferation.
    1 2D Structure

    Fedratinib

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    N-tert-butyl-3-[[5-methyl-2-[4-(2-pyrrolidin-1-ylethoxy)anilino]pyrimidin-4-yl]amino]benzenesulfonamide
    2.1.2 InChI
    InChI=1S/C27H36N6O3S/c1-20-19-28-26(30-21-10-12-23(13-11-21)36-17-16-33-14-5-6-15-33)31-25(20)29-22-8-7-9-24(18-22)37(34,35)32-27(2,3)4/h7-13,18-19,32H,5-6,14-17H2,1-4H3,(H2,28,29,30,31)
    2.1.3 InChI Key
    JOOXLOJCABQBSG-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=CN=C(N=C1NC2=CC(=CC=C2)S(=O)(=O)NC(C)(C)C)NC3=CC=C(C=C3)OCCN4CCCC4
    2.2 Other Identifiers
    2.2.1 UNII
    6L1XP550I6
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Fedratinib Dihydrochloride Monohydrate

    2. Fedratinib Hydrochloride

    3. Fedratinib Hydrochloride Monohydrate

    4. Inrebic

    5. N-tert-butyl-3-((5-methyl-2-((4-(2-pyrrolidin-1-ylethoxy)phenyl)amino)pyrimidin-4-yl)amino) Benzenesulfonamide Dihydrochloride Monohydrate

    6. N-tert-butyl-3-(5-methyl-2-(4-(2-(pyrrolidin-1-yl)ethoxy)phenylamino) Pyrimidin-4-ylamino)benzenesulfonamide

    7. Sar-302503

    8. Sar-302503a

    9. Sar302503

    10. Sar302503a

    11. Tg-101348

    12. Tg101348

    2.3.2 Depositor-Supplied Synonyms

    1. 936091-26-8

    2. Tg-101348

    3. Tg101348

    4. Sar302503

    5. Sar-302503

    6. N-(tert-butyl)-3-((5-methyl-2-((4-(2-(pyrrolidin-1-yl)ethoxy)phenyl)amino)pyrimidin-4-yl)amino)benzenesulfonamide

    7. Inrebic

    8. Sar 302503

    9. Tg 101348

    10. Fedratinib (sar302503, Tg101348)

    11. N-(1,1-dimethylethyl)-3-[[5-methyl-2-[[4-[2-(1-pyrrolidinyl)ethoxy]phenyl]amino]-4-pyrimidinyl]amino]benzenesulfonamide

    12. Tg101348 (sar302503)

    13. Chembl1287853

    14. 6l1xp550i6

    15. 936091-26-8 (free Base)

    16. N-tert-butyl-3-(5-methyl-2-(4-(2-(pyrrolidin-1-yl)ethoxy)phenylamino)pyrimidin-4-ylamino)benzenesulfonamide

    17. Benzenesulfonamide, N-(1,1-dimethylethyl)-3-((5-methyl-2-((4-(2-(1-pyrrolidinyl)ethoxy)phenyl)amino)-4-pyrimidinyl)amino)-

    18. N-tert-butyl-3-(5-methyl-2-(4-(2-pyrrolidin-1-yl-ethoxy)-phenylamino)-pyrimidin-4-ylamino)-benzenesulfonamide

    19. N-tert-butyl-3-{[5-methyl-2-({4-[2-(pyrrolidin-1-yl)ethoxy]phenyl}amino)pyrimidin-4-yl]amino}benzenesulfonamide

    20. Fedratinib [usan]

    21. Fedratinib [usan:inn]

    22. Unii-6l1xp550i6

    23. C27h36n6o3s

    24. 2ta

    25. Fedratinib [mi]

    26. Fedratinib [inn]

    27. Fedratinib (usan/inn)

    28. Tg101348(fedratinib)

    29. Fedratinib [who-dd]

    30. Fedratinib (tg101348)

    31. Mls006011155

    32. N-tert-butyl-3-[[5-methyl-2-[4-(2-pyrrolidin-1-ylethoxy)anilino]pyrimidin-4-yl]amino]benzenesulfonamide

    33. Schembl263741

    34. Gtpl5716

    35. Chebi:91408

    36. Dtxsid90239483

    37. Ex-a170

    38. Hms3295i03

    39. Hms3656l19

    40. Hms3744g17

    41. Hms3868l03

    42. Bcp02300

    43. Bdbm50332294

    44. Mfcd12922515

    45. Nsc767600

    46. Nsc800099

    47. S2736

    48. Zinc19862646

    49. Akos015842621

    50. Ccg-264990

    51. Cs-0052

    52. Db12500

    53. Ex-5961

    54. Nsc-767600

    55. Nsc-800099

    56. Sb14604

    57. Ncgc00244252-01

    58. Ncgc00244252-07

    59. Ac-30260

    60. As-16248

    61. Da-40258

    62. Hy-10409

    63. Smr004702929

    64. Db-079623

    65. Ft-0705969

    66. Ft-0763396

    67. Ft-0766818

    68. Sw218187-2

    69. A25534

    70. D10630

    71. F17372

    72. 091d268

    73. J-523769

    74. Q7670147

    75. Brd-k12502280-001-01-5

    76. 945381-69-1

    77. N-tert-butyl-3-((5-methyl-2-(4-(2-(pyrrolidin-1-yl)ethoxy)anilino(pyrimidin-4-yl)amino)benzenesulfonamide

    78. N-tert-butyl-3-{[5-methyl-2-({4-[2-(pyrrolidin-1-yl)ethoxy]phenyl}amino)pyrimidin-4-yl]amino}benzene-1-sulfonamide

    79. Sar302503, N-tert-butyl-3-(5-methyl-2-(4-(2-(pyrrolidin-1-yl)ethoxy)phenylamino)pyrimidin-4-ylamino)benzenesulfonamide

    2.4 Create Date
    2007-09-03
    3 Chemical and Physical Properties
    Molecular Weight 524.7 g/mol
    Molecular Formula C27H36N6O3S
    XLogP34.8
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count9
    Rotatable Bond Count11
    Exact Mass524.25696021 g/mol
    Monoisotopic Mass524.25696021 g/mol
    Topological Polar Surface Area117 Ų
    Heavy Atom Count37
    Formal Charge0
    Complexity787
    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

    Fedratinib is indicated to treat adults with primary or secondary myelofibrosis that is either intermediate-2 or high risk.

    Inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are Janus Associated Kinase (JAK) inhibitor nave or have been treated with ruxolitinib.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Fedratinib is a kinase inhibitor that inhibits cell division and induces apoptosis. Patients taking fedratinib may experience anemia, thrombocytopenia, gastrointestinal toxicity, hepatic toxicity, or elevated amylase and lipase. These effects should be managed by reducing the dose, temporarily stopping the medication, or providing transfusions on a case by case basis.

    5.2 ATC Code

    L01EJ02

    L - Antineoplastic and immunomodulating agents

    L01 - Antineoplastic agents

    L01E - Protein kinase inhibitors

    L01EJ - Janus-associated kinase (jak) inhibitors

    L01EJ02 - Fedratinib

    5.3 Absorption, Distribution and Excretion

    Absorption

    A 400mg oral dose results in a Cmax of 1804ng/mL and an AUC of 26,870ng/*hr/mL. Fedratinib has a Tmax of 1.75-3 hours. A high fat breakfast does not significantly affect the absorption of fedratinib.

    Route of Elimination

    An oral dose of fedratinib is 77% eliminated in the feces with 23% as unchanged drug. 5% is eliminated in the urine, with 3% as unchanged drug.

    Volume of Distribution

    The apparent volume of distribution is 1770L.

    Clearance

    The clearance of fedratinib is 13L/h.

    5.4 Metabolism/Metabolites

    Fedratinib is metabolized by CYP3A4, CYP2C19, and flavin-containing monooxygenase 3. Beyond that, data regarding the metabolism of fedratinib is not readily available.

    5.5 Biological Half-Life

    The half life of fedratinib is 41 hours with a terminal half life of 114 hours.

    5.6 Mechanism of Action

    Fedratinib is an inhibitor of Janus Activated Kinase 2 (JAK2) and FMS-like tyrosine kinase 3. JAK2 is highly active in myeloproliferative neoplasms like myelofibrosis. Fedratinib's inhibition of JAK2 inhibits phosphorylation of signal transducer and activator of transcription (STAT) 3 and 5, which prevents cell division and induces apoptosis.

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    [{"dataSource":"API Import","activeIngredients":"FEDRATINIB","year":"2021","qtr":"Q2","strtotime":1620757800,"product":"FEDRATINIB DIHYDROCHLORIDE MONOHYDRATE","address":"201\/301, CORPORATE ENCLAVE,B D SAWANT MARG, CHAKALA,","city":"ANDHERI (E), MUMBAI,MAHARASHTRA","supplier":"TEVA PHARMACEUTICAL INDUSTRIES","supplierCountry":"HUNGARY","foreign_port":"BUDAPEST","customer":"TEVA PHARMACEUTICAL INDUSTRIES","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"1500","totalValueFC":"1836.9","currency":"USD","unitRateINR":"134550","date":"12-May-2021","totalValueINR":"134550","totalValueInUsd":"1836.9","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"3922756","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Pharma Grade","supplierPort":"BUDAPEST","supplierAddress":"","customerAddress":"201\/301, CORPORATE ENCLAVE,B D SAWANT MARG, CHAKALA,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1649356200,"product":"FEDRATINIB DIHYDROCHLORIDE MONOHYDRATE","address":"12TH FLOOR, COMMERZ II,,INTERNATIO NAL BUSNESS PARK,OBEROI","city":"GARDEN CITY OFF WESTERN EXPR HIGHWA","supplier":"PLUSCHEM","supplierCountry":"SWITZERLAND","foreign_port":"NA","customer":"TEVA PHARMACEUTICAL INDUSTRIES","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"1500","totalValueFC":"3664.5","currency":"USD","unitRateINR":"138240","date":"08-Apr-2022","totalValueINR":"276480","totalValueInUsd":"3664.5","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"8198607","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"12TH FLOOR, COMMERZ II,,INTERNATIO NAL BUSNESS PARK,OBEROI"}]
    12-May-2021
    08-Apr-2022
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    ABOUT THIS PAGE

    fedratinib hydrochloride Manufacturers

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

    fedratinib hydrochloride Suppliers

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

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

    fedratinib hydrochloride USDMF

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

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

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

    fedratinib hydrochloride KDMF

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

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

    After submitting a fedratinib hydrochloride 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 fedratinib hydrochloride API can apply through the Korea Drug Master File (KDMF).

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

    fedratinib hydrochloride GMP

    fedratinib hydrochloride 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 fedratinib hydrochloride 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 fedratinib hydrochloride GMP manufacturer or fedratinib hydrochloride GMP API supplier for your needs.

    fedratinib hydrochloride CoA

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

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

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