Drug · Small Molecule

Imatinib

CI-DRUG-00000295Explore in graph →NCIt C62035 CHEMBL941 CIViC Approved

Regulatory

Approvals (67)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory17 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2006-10-19 (see label)	approved	Oct 19, 2006	openfda
US FDA	—	Efficacy supplement 2006-10-19 (see label)	approved	Oct 19, 2006

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 12 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	34	20	38	160	67	CA, EU, US	Nov 7, 2001	Aug 9, 1999
Leukemia	Approved	Phase 4	10	4	26	83	6	US	Apr 18, 2003	Aug 9, 1999
Non-Hodgkin Lymphoma	Phase3	Phase 3	0	0	1	2	0	—	—	2016-08
Malignant Breast Neoplasm	Phase2	Phase 2	1	1	0	3	0	—

Curated evidence

Clinical evidence (279)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 151–200 of 279 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
KIT S501_A502INSAY4
Imatinib	Gastrointestinal Stromal Tumor

Clinical trials

Trials with this intervention (174)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 51–100 of 174 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT02352558	A Study of BBI608 in Adult Patients With Advanced, Refractory Hematologic Malignancies	completed	Phase 1	15	Sumitomo Pharma America, Inc.INDUSTRY	1	Nov 14, 2023	clinicaltrials
NCT05286528	Study to Evaluate Chronic Myeloid Leukemia Treatment Landscape and Real-life Treatment Outcomes in Hungary: Analysis of National Health Insurance Fund Database	completed

Molecule

Record

Kind: Small Molecule
Mechanism: Tyrosine-protein kinase ABL inhibitor; Platelet-derived growth factor receptor beta inhibitor; Stem cell growth factor receptor inhibitor; Bcr/Abl fusion protein inhibitor
Targets: 4 genes
UNII: 8A1O1M485B
Aliases: 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide, ACH-IMATINIB, APO-IMATINIB, CGP057148B, CGP-57148B, Glamox, GLEEVEC, GLEEVEC,STI-571, Glivec, GLIVEC, Imatinib, Imatinib Accord, Imatinib Actavis, Imatinib Koanaa, Imatinib medac, Imatinib Mesylate, IMATINIB MESYLATE, IMATINIB MESYLATE 400 MG, IMATINIB MESYLATEGLEEVECGLIVECIMATINIBSTI571CGP 571484-[(4-METHYL-1-PIPERAZINYL)METHYL]-N-[4-METHYL-3-[[4-(3-PYRIDINYL)-2-PYRIMIDINYL]AMINO]-PHENYL]BENZAMIDE, IMATINIB (STI571), Imatinib Teva, Imatinib Teva B.V., IMKELDI, JAMP IMATINIB, MINT-IMATINIB, MYLAN-IMATINIB, NAT-IMATINIB, NSC-743414, NSC-759854, PMS-IMATINIB … (+7)

Data updated 15 hours agoSource updated unknown

Identifiers

Codes (63)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01EA01	IMATINIB

KIT S692L5
Imatinib	Gastrointestinal Stromal Tumor	Predictive	B	Supports Resistance	—	submitted	EID2493 Primary KIT mutations are detected in 75-80% of GIST patients, and primarily occur in exons 9 and 11, wheareas secondary KIT mutations associated with resistance to imatinib are found in exons 13,14, … (full text at CIViC) PMID 16551858 · Wardelmann et al., 2006 · Open in CIViC	civic
〃	Gastrointestinal Stromal Tumor	Predictive	B	Supports Resistance	—	submitted	EID2496 Primary KIT mutations are detected in 75-80% of GIST patients, and primarily occur in exons 9 and 11, wheareas secondary KIT mutations associated with resistance to imatinib are found in exons 13,14, … (full text at CIViC) PMID 22089421 · Corless et al., 2011 · Open in CIViC	civic
〃	Gastrointestinal Stromal Tumor	Predictive	B	Supports Resistance	—	submitted	EID2497 Primary KIT mutations are detected in 75-80% of GIST patients, and primarily occur in exons 9 and 11, wheareas secondary KIT mutations associated with resistance to imatinib are found in exons 13,14, … (full text at CIViC) PMID 20043176 · Wang et al., 2010 · Open in CIViC	civic
〃	Gastrointestinal Stromal Tumor	Predictive	D	Supports Resistance	—	submitted	EID2494 Mutations within exons 13 and 14, which encode the ATP binding pocket of the kinase, alter the drug binding site. PMID 16751810 · Tamborini et al., 2006 · Open in CIViC	civic
〃	Gastrointestinal Stromal Tumor	Predictive	D	Supports Resistance	—	submitted	EID2495 Mutations within exon 17, which encodes the activation loop of the kinase, can stabilize the active conformation of the kinase which interferes with drug binding as imatinib binds the kinase in its in… (full text at CIViC) PMID 15363456 · Foster et al., 2004 · Open in CIViC	civic

KIT T661I4
Imatinib	Gastrointestinal Stromal Tumor	Predictive	B	Supports Resistance	—	submitted	EID2491 Primary KIT mutations are detected in 75-80% of GIST patients, and primarily occur in exons 9 and 11, wheareas secondary KIT mutations associated with resistance to imatinib are found in exons 13,14, … (full text at CIViC) PMID 22089421 · Corless et al., 2011 · Open in CIViC	civic
〃	Gastrointestinal Stromal Tumor	Predictive	B	Supports Resistance	—	submitted	EID2492 Primary KIT mutations are detected in 75-80% of GIST patients, and primarily occur in exons 9 and 11, wheareas secondary KIT mutations associated with resistance to imatinib are found in exons 13,14, … (full text at CIViC) PMID 20043176 · Wang et al., 2010 · Open in CIViC	civic
〃	Gastrointestinal Stromal Tumor	Predictive	D	Supports Resistance	—	submitted	EID2489 Mutations within exons 13 and 14, which encode the ATP binding pocket of the kinase, alter the drug binding site. PMID 16751810 · Tamborini et al., 2006 · Open in CIViC	civic
〃	Gastrointestinal Stromal Tumor	Predictive	D	Supports Resistance	—	submitted	EID2490 Mutations within exon 17, which encodes the activation loop of the kinase, can stabilize the active conformation of the kinase which interferes with drug binding as imatinib binds the kinase in its in… (full text at CIViC) PMID 15363456 · Foster et al., 2004 · Open in CIViC	civic

KIT T670I2
Imatinib	Gastrointestinal Stromal Tumor	Predictive	C	Supports Resistance	3	accepted	EID2924 147 patients with advanced, unresectable GISTs were enrolled onto a randomized, phase II clinical study of imatinib (CSTI571-B2222). Specimens from 43 pretreatment and/or imatinib-resistant tumors wer… (full text at CIViC) PMID 16954519 · Heinrich et al., 2006 · Open in CIViC	civic
〃	Gastrointestinal Stromal Tumor	Predictive	D	Supports Resistance	5	accepted	EID7416 A preclinical study tested the effects of a tyrosine kinase inhibitor (TKI) on Ba/F3 cell lines with representative primary imatinib-sensitizing mutation del 557-558, which induced IL-3 independent gr… (full text at CIViC) PMID 25239608 · Garner et al., 2014 · Open in CIViC	civic

KIT V559D3
Dasatinib + Imatinib + Nilotinib + SorafenibSubstitutes	Gastrointestinal Stromal Tumor	Predictive	D	Supports Sensitivity Response	4	submitted	EID3033 dasatinib inhibited cell growth of imatinib-sensitive KIT V559D with an IC50 of 27 nmol/L, whereas imatinib, nilotinib, and sorafenib had an IC50 of 63, 44, and 66 nmol/L, respectively. PMID 17699867 · Guo et al., 2007 · Open in CIViC	civic
Imatinib	Gastrointestinal Stromal Tumor	Predictive	C	Supports Sensitivity Response	3	accepted	EID3028 A patient with an uncontrolled relapse of c-kit-positive mesenchymal tumor in descending part of the duodenum had received 400mg Imatinib daily for more than 10 years at the time of publication. He re… (full text at CIViC) PMID 22114577 · Cameron et al., 2011 · Open in CIViC	civic
Imatinib + Ponatinib + RegorafenibSubstitutes	Gastrointestinal Stromal Tumor	Predictive	D	Supports Sensitivity Response	2	accepted	EID4459 In an in vitro kinase study, a KIT V559D primary activating mutant kinase demonstrated sensitivity to imatinib (IC50: 36nmol/L vs. 640nmol/L), regorafenib (IC50: 57nmol/L vs. 533nmol/L), and ponatinib… (full text at CIViC) PMID 25239608 · Garner et al., 2014 · Open in CIViC	civic

KIT V560D2
Imatinib	Gastrointestinal Stromal Tumor	Predictive	D	Supports Sensitivity Response	—	submitted	EID2464 Molecular models predict that deletion of a portion of the juxtamembrane domain relieves steric hindrance and results in higher binding affinity for imatinib. PMID 21364689 · Pierotti et al., 2011 · Open in CIViC	civic
Imatinib + Ponatinib + Regorafenib + SunitinibSubstitutes	Gastrointestinal Stromal Tumor	Predictive	D	Supports Sensitivity Response	3	accepted	EID4127 In an in vitro study, an IL3 independent Ba/F3 cell line expressing KIT V560D primary activating mutation demonstrated sensitivity to imatinib (IC50: 3nmol/L), sunitinib (IC50: 2nmol/L), regorafenib (… (full text at CIViC) PMID 25239608 · Garner et al., 2014 · Open in CIViC	civic