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imatinib

Trade name: gleevec

Small moleculeapprovedOrphan Drug FDAFast Track FDA

Approved

May 10, 2001

Imatinib (GLEEVEC®) is a tyrosine kinase inhibitor and antineoplastic agent that inhibits the BCR-ABL tyrosine kinase, the constitutive abnormal tyrosine kinase created by the Philadelphia chromosome abnormality in chronic myeloid leukaemia (CML). It inhibits proliferation and induces apoptosis in BCR-ABL positive cell lines as well as fresh leukemic cells from Philadelphia chromosome positive CML. Imatinib (GLEEVEC®) inhibits colony formation in assays using ex vivo peripheral blood and bone marrow samples from CML patients. It is also an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF) and stem cell factor (SCF), c-kit, and inhibits PDGF- and SCF-mediated cellular events. In vitro, imatinib (GLEEVEC®) inhibits proliferation and induces apoptosis in gastrointestinal stromal tumor (GIST) cells, which express an activating c-kit mutation. — NCATS

Clinical trial activity

519 trials · 380 clinical orgs · 18 marketing orgs

Phase 1
136
Phase 2
398
Phase 3
87
Phase 4
19

Earliest trial started Apr 1, 1993 (NCT00002514)

Timeline

1990s

  1. Jan 1, 1993

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2000

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2000

    Novartis — Earliest Phase 2 Sponsor(trial)

  3. Jan 31, 2001

    Orphan Drug Designation

  4. May 10, 2001

    Novartis — Earliest FDA Approval

  5. May 10, 2001

    Novartis — NDA Organization

2010s

  1. Dec 3, 2015

    Sun Pharmaceuticals — Marketing Organization

  2. Aug 4, 2016

    Teva — Marketing Organization

  3. Aug 5, 2016

    Apotex — Marketing Organization

  4. Jun 21, 2017

    Mylan — Marketing Organization

  5. Jul 13, 2018

    West-Ward Pharmaceutical — Marketing Organization

  6. Jul 13, 2018

    Hikma — Marketing Organization

  7. Aug 13, 2018

    Dr. Reddy's Laboratories — Marketing Organization

  8. Jan 17, 2019

    Shilpa Medicare Ltd. — Marketing Organization

  9. Jan 17, 2019

    Wockhardt — Marketing Organization

  10. Jan 17, 2019

    Chartwell Pharmaceuticals — Marketing Organization

  11. Feb 8, 2019

    Esteve Labs — Marketing Organization

  12. Feb 8, 2019

    Amneal Pharmaceuticals — Marketing Organization

  13. Feb 8, 2019

    Allied Pharmaceutical Services — Marketing Organization

  14. Mar 1, 2019

    Natco Pharma — Marketing Organization

2020s

  1. Apr 8, 2020

    Zydus Discovery DMCC — Marketing Organization

  2. Jul 23, 2020

    Eugia Pharma — Marketing Organization

  3. Jun 21, 2022

    Qilu Pharmaceutical Co., Ltd. — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedFast trackMay 10, 2001

Chemistry & pharmacology

Loading structure…

SMILES

Cc1ccc(NC(=O)c2ccc(CN3CCN(C)CC3)cc2)cc1Nc1nccc(-c2cccnc2)n1
Mol. weight
493.62 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 4-(4-methyl-piperazin-1-ylmethyl)-n-[4-methyl-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-phenyl]-benzamide
  • 4-(4-methyl-piperazin-1-ylmethyl)-n-[4-methyl-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-phenyl]-benzamide
  • alpha-(4-methyl-1-piperazinyl)-3'-((4-(3-pyridyl)-2-pyrimidinyl)amino)-p-toluidide
  • alpha-(4-methyl-1-piperazinyl)-3'-((4-(3-pyridyl)-2-pyrimidinyl)amino)-p-toluidide
  • cgp57148
  • cgp-57148
  • cgp57148b
  • cgp-57-148b
  • gleevec
  • gleevec
  • gleevec
  • gleevec
  • gleevec
  • glivec
  • glivec
  • glivec
  • imatinib
  • imatinib
  • imatinib
  • imatinib
  • imatinib
  • imatinib
  • imatinib
  • imatinib
  • imatinib
  • imatinib
  • imatinib
  • imatinib mesilate
  • imatinib mesilate
  • imatinib mesilate
  • imatinib mesilate
  • imatinib mesylate
  • imatinib mesylate
  • imatinib mesylate
  • imatinib mesylate
  • imatinib mesylate
  • imatinib methansulfonate
  • imatinib methansulfonate
  • imatinibum
  • imatinibum
  • st571
  • sti571
  • sti571
  • sti571
  • sti 571
  • sti 571
  • sti-571
  • sti-571
  • sti-571
  • synthetic tumor-specific breakpoint peptide vaccine
  • tnx-201
  • tnx-201

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07171203Phase 1Dec 31, 2025University of California, San Diego
NCT06889168Phase 1Oct 31, 2025Columbia University, Department of Defense, Medical University of South Carolina
NCT07022743Phase 2Jul 1, 2025Obafemi Awolowo University
NCT06643143Phase 2Jun 30, 2025Inhibikase Therapeutics, Inc.
NCT06962254Phase 1May 10, 2025China Medical University
NCT06655246Phase 1Jan 31, 2025Kura Oncology, Inc.
NCT06841640Phase 1/Phase 2 (Phase 2)Jan 15, 2025AeroRx Therapeutics Inc., Medicines Evaluation Unit Ltd
NCT06692491Phase 2Jan 1, 2025Peking University
NCT06626984Phase 1/Phase 2 (Phase 2)Dec 1, 2024Medical Research Council, Queen's University, Belfast
NCT06682169Phase 3Nov 30, 2024Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
NCT06090669Phase 1Jan 3, 2024National Cancer Institute (NCI)
NCT06119789Phase 2Nov 30, 2023Helse Fonna, Helse Forde, Helse Møre og Romsdal HF, Nordland Hospital, Northern Norway Regional Health Authority, Sorlandet Hospital HF, Sykehuset Innlandet HF, Sykehuset Ostfold, The Hospital of Vestfold, University Hospital of North Norway, University of Bergen, University of Oslo, University of Stavanger
NCT05970900Phase 3Oct 1, 2023Fujian Medical University
NCT06051409Phase 3Sep 2, 2023Ascentage Pharma Group Inc., Jiao Tong University, Suzhou Medical College
NCT06061094Phase 2Jul 14, 2023German Federal Ministry of Education and Research, J. W. Goethe University
NCT05816785Early Phase 1 (Phase 1)Apr 18, 2023National Cancer Institute (NCI), University of Wisconsin
NCT05722795N/AFeb 6, 2023Lund University, University of Gothenburg, Vastra Gotaland Region
NCT05751733N/AFeb 1, 2023Central South University, Suzhou Suncadia Biopharmaceuticals Co., Ltd.
NCT05493215Phase 2Jan 31, 2023University of Kentucky
NCT05623774Phase 1Nov 30, 2022Celerion, Inhibikase Therapeutics, Inc.
Showing 20 of 519 trials
Page 1 / 26

Organizations

Research & Development (380)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
NovartisFor profit1527052000
National Cancer Institute (NCI)Government1014541993
University of Texas at HoustonAcademic/Hospital403242001
Harvard UniversityAcademic/Hospital15932002
University of WashingtonAcademic/Hospital11912001
Cornell UniversityAcademic/Hospital10622002
Duke UniversityAcademic/Hospital10822003
University of UlsanAcademic/Hospital10942005
Oregon Health and Science UniversityAcademic/Hospital9622001
Peking UniversityAcademic/Hospital9632008
Bristol-Myers SquibbFor profit8732005
University of BolognaAcademic/Hospital8622000
University of PittsburghAcademic/Hospital8422001
European Organisation for Research and Treatment of CancerAcademic/Hospital7622000
Indiana UniversityAcademic/Hospital7622003
Gruppo Italiano Malattie EMatologiche dell'AdultoAcademic/Hospital6632001
Karolinska InstituteAcademic/Hospital6422004
Southwest Oncology GroupAcademic/Hospital6022000
University of ParisAcademic/Hospital6432002
Cancer and Leukemia Group B (CALGB)Academic/Hospital5012002
380 organizations
Page 1 / 19

Marketing (25)

OrganizationOrg typeRelationshipDate
Allied Pharmaceutical ServicesFor profitMKTGFeb 8, 2019
Amneal PharmaceuticalsFor profitMKTGFeb 8, 2019
ApotexFor profitMKTGAug 5, 2016
ApotexFor profitSYNAug 5, 2016
Chartwell PharmaceuticalsFor profitMKTGJan 17, 2019
Dr. Reddy's LaboratoriesFor profitMKTGAug 13, 2018
Dr. Reddy's LaboratoriesFor profitSYNAug 13, 2018
Esteve LabsFor profitMKTGFeb 8, 2019
Esteve LabsFor profitSYNFeb 8, 2019
Eugia PharmaFor profitMKTGJul 23, 2020
HikmaFor profitMKTGJul 13, 2018
HikmaFor profitSYNJul 13, 2018
MylanFor profitMKTGJun 21, 2017
MylanFor profitSYNJun 21, 2017
Natco PharmaFor profitMKTGMar 1, 2019
NovartisFor profitNDAMay 10, 2001
Qilu Pharmaceutical Co., Ltd.For profitMKTGJun 21, 2022
Shilpa Medicare Ltd.For profitMKTGJan 17, 2019
Shilpa Medicare Ltd.For profitMKTGJan 17, 2019
Sun PharmaceuticalsFor profitMKTGDec 3, 2015
Sun PharmaceuticalsFor profitSYNDec 3, 2015
TevaFor profitMKTGAug 4, 2016
West-Ward PharmaceuticalFor profitMKTGJul 13, 2018
WockhardtFor profitMKTGJan 17, 2019
Zydus Discovery DMCCFor profitMKTGApr 8, 2020