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.

emaRegulatory7 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	—	Imatinib Koanaa is indicated for the treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment. adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy. adult patients with relapsed or refractory Ph+ ALL as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR? rearrangement. The effect of Imatinib on the outcome of bone marrow transplantation has not been determined. Imatinib Koanaa is indicated for the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery. In adult and paediatric patients, the effectiveness of Imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic GIST and DFSP and on recurrence-free survival in adjuvant GIST. The experience with Imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1). Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.

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 17 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 101–150 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 D816V1
Imatinib	Chronic Myeloid Leukemia, BCR-ABL1 Positive

Clinical trials

Trials with this intervention (174)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 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
NCT06090669	Imatinib to Increase RUNX1 Activity in Participants With Germline RUNX1 Deficiency	recruiting	Phase 1	75	National Cancer Institute (NCI)NIH	1	Sep 28, 2026	clinicaltrials
NCT06124157	A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)

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 20 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 Exon 11 Mutation3
Imatinib	Gastrointestinal Stromal Tumor	Predictive	A	Supports Sensitivity Response	4	accepted	EID654 This prospective study of 127 pretreatment patients with metastatic gastrointestinal stromal tumors (GISTs) examined the relationship between kinase (KIT and PDGFRA) genotype and treatment outcome for… (full text at CIViC) PMID 14645423 · Heinrich et al., 2003 · Open in CIViC	civic
〃	Gastrointestinal Stromal Tumor	Predictive	B	Supports Sensitivity Response	4	accepted	EID2471 This prospective study of 397 patients with incurable (i.e. metastatic or unresectable) CD117-positive Gastrointestinal stromal tumors (GISTs) examined the relationship between KIT genotype and treatm… (full text at CIViC) PMID 18955451 · Heinrich et al., 2008 · Open in CIViC	civic
〃	Gastrointestinal Stromal Tumor	Predictive	E	Supports Sensitivity Response	2	submitted	EID7071 ;lkakdklfsk fdkdsfkdfskdf PMID 14645423 · Heinrich et al., 2003 · Open in CIViC	civic

KIT Exon 9 Mutation3
Imatinib	Gastrointestinal Stromal Tumor	Predictive	A	Supports Sensitivity Response	4	accepted	EID1221 In a phase III clinical trial comparing different doses of imatinib in GIST patients, KIT exon 9 mutations were associated with significantly improved progression free survival (P=0.0013) and a 61% re… (full text at CIViC) PMID 16624552 · Debiec-Rychter et al., 2006 · Open in CIViC	civic
〃	Gastrointestinal Stromal Tumor	Predictive	B	Supports Sensitivity Response	3	accepted	EID2466 This prospective study of 127 patients with metastatic gastrointestinal stromal tumors (GISTs) examined the relationship between KIT genotype and treatment outcome for patients enrolled in a randomize… (full text at CIViC) PMID 14645423 · Heinrich et al., 2003 · Open in CIViC	civic
〃	Gastrointestinal Stromal Tumor	Predictive	B	Supports Reduced Sensitivity	2	accepted	EID2477 This prospective study of 397 patients with incurable (i.e. metastatic or unresectable) CD117-positive Gastrointestinal stromal tumors (GISTs) examined the relationship between KIT genotype and treatm… (full text at CIViC) PMID 18955451 · Heinrich et al., 2008 · Open in CIViC	civic

KIT EXPRESSION2
Imatinib	Gastrointestinal Stromal Tumor	Predictive	B	Supports Sensitivity Response	2	accepted	EID2480 In a prospective phase III study (SWOG S0033/CALGB 150105) of 407 patients with gastrointestinal stromal tumors (GISTs), 397 patients were observed to be CD117-positive (i.e. KIT-positive) and 10 pati… (full text at CIViC) PMID 18955451 · Heinrich et al., 2008 · Open in CIViC	civic
〃	Gastrointestinal Stromal Tumor	Predictive	B	Supports Resistance	—	submitted	EID2488 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

KIT K550_W557del2
Imatinib	Gastrointestinal Stromal Tumor	Predictive	D	Supports Sensitivity Response	—	submitted	EID2395 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	2	accepted	EID4583 In an in vitro study, an IL3 independent Ba/F3 cell line expressing KIT K550_W557del primary activating mutation demonstrated sensitivity to imatinib (IC50: 13nmol/L), sunitinib (IC50: 5nmol/L), regor… (full text at CIViC) PMID 25239608 · Garner et al., 2014 · Open in CIViC	civic

KIT Mutation2
Imatinib	Gastrointestinal Stromal Tumor	Predictive	A	Supports Sensitivity Response	4	submitted	EID11282 In this phase II, randomized, open-label trial, 147 patients with histologically confirmed, unresectable or metastatic gastrointestinal stromal tumour that expressed CD117 were enrolled. Patients were… (full text at CIViC) PMID 12181401 · Demetri et al., 2002 · Open in CIViC	civic
Imatinib + PictilisibCombination	Gastrointestinal Stromal Tumor	Predictive	D	Supports Sensitivity Response	2	accepted	EID919 Human GISTs with different KIT mutations were grafted in 136 nude muce. Mice were then treated with control, imatinib, GDC-0941, or GDC-0941 + imatinib. The combination showed superior antitumor effic… (full text at CIViC) PMID 23231951 · Floris et al., 2013 · Open in CIViC	civic