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    Nilotinib

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    Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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    xyz-pharma-m-2024-10-07

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    Aarti Pharmalabs Nilotinib

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    Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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    Also known as: 923288-95-3, Nilotinib hydrochloride anhydrous, Nilotinib hcl, 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamide hydrochloride, Nilotinib (hydrochloride), K37n7byx3x
    Molecular Formula
    C28H23ClF3N7O
    Molecular Weight
    566.0  g/mol
    InChI Key
    VTGGYCCJUPYZSX-UHFFFAOYSA-N
    FDA UNII
    K37N7BYX3X
    Nilotinib
    Nilotinib Hydrochloride Anhydrous is the hydrochloride salt of nilotinib, an orally bioavailable aminopyrimidine-derivative Bcr-Abl tyrosine kinase inhibitor with antineoplastic activity. Designed to overcome imatinib resistance, nilotinib binds to and stabilizes the inactive conformation of the kinase domain of the Abl protein of the Bcr-Abl fusion protein, resulting in the inhibition of the Bcr-Abl-mediated proliferation of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) cells. This agent also inhibits the receptor tyrosine kinases platelet-derived growth factor receptor (PDGF-R) and c-kit, a receptor tyrosine kinase mutated and constitutively activated in most gastrointestinal stromal tumors (GISTs). With a binding mode that is energetically more favorable than that of imatinib, nilotinib has been shown to have an approximately 20-fold increased potency in kinase and proliferation assays compared to imatinib.
    1 2D Structure

    Nilotinib

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    4-methyl-N-[3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[(4-pyridin-3-ylpyrimidin-2-yl)amino]benzamide;hydrochloride
    2.1.2 InChI
    InChI=1S/C28H22F3N7O.ClH/c1-17-5-6-19(10-25(17)37-27-33-9-7-24(36-27)20-4-3-8-32-14-20)26(39)35-22-11-21(28(29,30)31)12-23(13-22)38-15-18(2)34-16-38;/h3-16H,1-2H3,(H,35,39)(H,33,36,37);1H
    2.1.3 InChI Key
    VTGGYCCJUPYZSX-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=C(C=C(C=C1)C(=O)NC2=CC(=CC(=C2)C(F)(F)F)N3C=C(N=C3)C)NC4=NC=CC(=N4)C5=CN=CC=C5.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    K37N7BYX3X
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 4-methyl-n-(3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-pyridin-3-ylpyrimidin-2-yl)amino)benzamide

    2. Amn 107

    3. Amn-107

    4. Amn107

    5. Benzamide, 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, Hydrochloride (1:1)

    6. Benzamide, 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, Hydrochloride, Hydrate

    7. Benzamide, 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, Hydrochloride, Hydrate (1:1:2)

    8. Benzamide, 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, Hydrochloride, Hydrate (1:2:2)

    9. Benzamide, 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, Hydrochloride, Hydrate (2:2:3)

    10. Nilotinib

    11. Nilotinib Dihydrochloride Dihydrate

    12. Nilotinib Hydrochloride Anhydrous

    13. Nilotinib Hydrochloride Dihydrate

    14. Nilotinib Hydrochloride Hydrate

    15. Nilotinib Hydrochloride Monohydrate

    16. Nilotinib Hydrochloride Sesquihydrate

    17. Tasigna

    2.3.2 Depositor-Supplied Synonyms

    1. 923288-95-3

    2. Nilotinib Hydrochloride Anhydrous

    3. Nilotinib Hcl

    4. 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamide Hydrochloride

    5. Nilotinib (hydrochloride)

    6. K37n7byx3x

    7. 4-methyl-n-[3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[(4-pyridin-3-ylpyrimidin-2-yl)amino]benzamide;hydrochloride

    8. Benzamide, 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, Hydrochloride (1:1)

    9. Nilotinib (as Hydrochloride)

    10. Unii-k37n7byx3x

    11. Amn 107 Hydrochloride

    12. Amn-107 Hcl

    13. Schembl434496

    14. Dtxsid60238968

    15. Bcp29532

    16. Hy-10159b

    17. S5205

    18. Ccg-270077

    19. Nilotinib Hydrochloride [vandf]

    20. Bn164657

    21. Nilotinib Hydrochloride Monohydrate- Bio-x

    22. Cs-0085192

    23. Nilotinib Hydrochloride [orange Book]

    24. Nilotinib Hydrochloride Anhydrous [who-dd]

    25. Q27281888

    26. Nilotinib Hcl;amn 107; Amn107; Amn-107; Nilotinib Hydrochloride Anhydrous

    27. 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamidehydrochloride

    28. 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-(4-(pyridin-3-yl)pyrimidin-2-ylamino)benzamide Hydrochloride

    29. 4-methyl-n-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide Hydrochloride

    2.4 Create Date
    2007-04-02
    3 Chemical and Physical Properties
    Molecular Weight 566.0 g/mol
    Molecular Formula C28H23ClF3N7O
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count9
    Rotatable Bond Count6
    Exact Mass565.1604706 g/mol
    Monoisotopic Mass565.1604706 g/mol
    Topological Polar Surface Area97.6 Ų
    Heavy Atom Count40
    Formal Charge0
    Complexity817
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2

    API Reference Price

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LTD","customerCountry":"INDIA","quantity":"4.76","actualQuantity":"4.757","unit":"KGS","unitRateFc":"2800","totalValueFC":"13476.3","currency":"USD","unitRateINR":"235060","date":"08-Feb-2024","totalValueINR":"1118180.42","totalValueInUsd":"13476.3","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"2039455","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"PHARMACEUTICAL CO LTDNO.9 JINYANG ROADSDNF China","customerAddress":"101, SITARAM MANSION,"}]
    02-Feb-2021
    27-Nov-2024
    KGS
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    Average Price (USD/KGS)

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    Drugs in Development

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    AZURITY Wins FDA Approval for DANZITEN™ Tablets with No Mealtime Restrictions

    Details:

    Danziten (nilotinib), an oral BCR-ABL kinase inhibitor, it is indicated for treating adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia.


    Lead Product(s): Nilotinib

    Therapeutic Area: Oncology Brand Name: Danziten

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 14, 2024

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    Azurity Pharma

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    Lead Product(s) : Nilotinib

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    AZURITY Wins FDA Approval for DANZITEN™ Tablets with No Mealtime Restrictions

    Details : Danziten (nilotinib), an oral BCR-ABL kinase inhibitor, it is indicated for treating adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia.

    Brand Name : Danziten

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    November 14, 2024

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    Xspray Pharma’s XS003 Study Shows Lower Dose Bioavailability vs. Tasigna

    Details:

    XS003 (nilotinib), an oral BCR-ABL kinase inhibitor, is designed to overcome crystalline formulation limitations. In the study, XS003 shows bioavailability matching Tasigna at a 50% reduced dose.


    Lead Product(s): Nilotinib

    Therapeutic Area: Oncology Brand Name: XS003

    Study Phase: Phase IProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 09, 2024

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    Lead Product(s) : Nilotinib

    Therapeutic Area : Oncology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Xspray Pharma’s XS003 Study Shows Lower Dose Bioavailability vs. Tasigna

    Details : XS003 (nilotinib), an oral BCR-ABL kinase inhibitor, is designed to overcome crystalline formulation limitations. In the study, XS003 shows bioavailability matching Tasigna at a 50% reduced dose.

    Brand Name : XS003

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    July 09, 2024

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    Aurobindo Pharma Arm Signs Pact with Medicines Patent Pool to Develop Anti-Cancer Drug

    Details:

    The agreement aims to to develop and market an anti-cancer drug, Tasigna (nilotinib), a transduction inhibitor, used for treatment of chronic myeloid leukemia.


    Lead Product(s): Nilotinib

    Therapeutic Area: Oncology Brand Name: Tasigna-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Aurobindo Pharma

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement June 23, 2023

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    Lead Product(s) : Nilotinib

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Aurobindo Pharma

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Aurobindo Pharma Arm Signs Pact with Medicines Patent Pool to Develop Anti-Cancer Drug

    Details : The agreement aims to to develop and market an anti-cancer drug, Tasigna (nilotinib), a transduction inhibitor, used for treatment of chronic myeloid leukemia.

    Brand Name : Tasigna-Generic

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    June 23, 2023

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    KeifeRx Completes $6 Million Series A Financing and Enhances Board of Directors

    Details:

    Proceeds from the financing will advance pipeline of optimized, low dose, orally delivered tyrosine kinase inhibitors including Nilotinib BE for the treatment of multiple neurodegenerative diseases.


    Lead Product(s): Nilotinib

    Therapeutic Area: Neurology Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Small molecule

    Sponsor: Undisclosed

    Deal Size: $6.0 million Upfront Cash: Undisclosed

    Deal Type: Series A Financing December 08, 2021

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    Lead Product(s) : Nilotinib

    Therapeutic Area : Neurology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : $6.0 million

    Deal Type : Series A Financing

    DEALS_DEV arrow-down

    KeifeRx Completes $6 Million Series A Financing and Enhances Board of Directors

    Details : Proceeds from the financing will advance pipeline of optimized, low dose, orally delivered tyrosine kinase inhibitors including Nilotinib BE for the treatment of multiple neurodegenerative diseases.

    Brand Name : Undisclosed

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    December 08, 2021

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    01

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    Nilotinib HCl

    Drug Cost (USD) : 375,995,128

    Year : 2022

    Prescribers : 3024

    Prescriptions : 25750

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    Nilotinib HCl

    Drug Cost (USD) : 352,216,339

    Year : 2021

    Prescribers : 3114

    Prescriptions : 25986

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    Company :

    Nilotinib HCl

    Drug Cost (USD) : 339,500,199

    Year : 2020

    Prescribers : 3148

    Prescriptions : 26481

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    Brand Name : Tasigna

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    Company :

    Nilotinib HCl

    Drug Cost (USD) : 318,637,020

    Year : 2019

    Prescribers : 3387

    Prescriptions : 26746

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    Brand Name : Tasigna

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    Nilotinib HCl

    Drug Cost (USD) : 346,488,392

    Year : 2018

    Prescribers : 3966

    Prescriptions : 31475

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    Nilotinib HCl

    Drug Cost (USD) : 348,087,826

    Year : 2017

    Prescribers : 4040

    Prescriptions : 34606

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    Nilotinib HCl

    Drug Cost (USD) : 307,612,237

    Year : 2016

    Prescribers : 3932

    Prescriptions : 33201

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    Drug Cost (USD) : 260,371,665

    Year : 2015

    Prescribers : 3648

    Prescriptions : 30213

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    NILOTINIB HCL

    Drug Cost (USD) : 204,569,988

    Year : 2014

    Prescribers : 3306

    Prescriptions : 25711

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