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.

openfdaRegulatory33 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	Chronic Eosinophilic Leukemia, Not Otherwise Specified	Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown.	approved	Nov 22, 2024	openfda

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 16 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 201–250 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
PDGFRA D842V3
Imatinib	Gastrointestinal Stromal Tumor

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 19 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

PDGFRA Mutation2
Imatinib	Gastrointestinal Stromal Tumor	Predictive	B	Supports Sensitivity Response	1	submitted	EID11331 In this retrospective survey among referral centers and collaborative groups with experience in conducting clinical studies in sarcoma and/or GISTs in Europe, 58 patients were included with advanced P… (full text at CIViC) PMID 22718859 · Cassier et al., 2012 · Open in CIViC	civic
〃	Gastrointestinal Stromal Tumor	Predictive	C	Supports Sensitivity Response	3	accepted	EID2487 This prospective study of 127 patients with metastatic gastrointestinal stromal tumors (GISTs) examined the relationship between kinase (KIT and PDGFRA) genotype and treatment outcome for patients enr… (full text at CIViC) PMID 14645423 · Heinrich et al., 2003 · Open in CIViC	civic

PDGFRA V561D2
Imatinib	Gastrointestinal Stromal Tumor	Predictive	C	Supports Sensitivity Response	1	accepted	EID2474 This case study examines one patient from a larger cohort of 397 patients with incurable (i.e. metastatic or unresectable) CD117-positive Gastrointestinal stromal tumors (GISTs) enrolled in the North … (full text at CIViC) PMID 18955451 · Heinrich et al., 2008 · Open in CIViC	civic
〃	Malignant NeoplasmALIAS	Predictive	D	Does Not Support Resistance	2	accepted	EID2454 In an in vitro study of imatinib sensitivity, PDGFRA V561D was cloned into a plasmid by site-directed mutagenesis of PDGFRA WT cDNA. Chinese hamster ovary cells were transiently transfected with the p… (full text at CIViC) PMID 14645423 · Heinrich et al., 2003 · Open in CIViC	civic

KIT L576P3
Dasatinib + Imatinib + NilotinibSubstitutes	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	accepted	EID303 Ba/F3 cells harboring the KIT L576P mutation are sensitive to nilotinib, imatinib and lower concentrations of dasatinib. PMID 17372901 · Antonescu et al., 2007 · Open in CIViC	civic
Dasatinib + ImatinibSubstitutes	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	2	accepted	EID4141 In an in vitro study, COS-7 cells expressing KIT L576P activating mutation demonstrated sensitivity to imatinib and dasatinib treatments. Sensitivity was determined by assessing reduced mutant KIT aut… (full text at CIViC) PMID 25317746 · Vita et al., 2014 · Open in CIViC	civic
Imatinib + Nilotinib + SorafenibSubstitutes	Melanoma	Predictive	D	Supports Resistance	3	accepted	EID34 The melanoma cell line WM3211 (derived from an acral lentiginous melanoma), which harbors the L576P mutation, is not sensitive to imatinib, nilotinib, and sorafenib. Molecular modeling indicated the L… (full text at CIViC) PMID 19671763 · Woodman et al., 2009 · Open in CIViC	civic

KIT EXPRESSION2
Imatinib	Malignant Endometrial NeoplasmCURATED_BROADER	Predictive	C	Supports Sensitivity Response	2	accepted	EID1024 Case Report of a 42-year old patient with low-grade endometrial stromal sarcoma. IHC was focally positive for CD117. Imatinib mesylate led to complete metabolic response (PET-CT). PMID 18607592 · Kalender et al., 2009 · Open in CIViC	civic
〃	Malignant Endometrial NeoplasmCURATED_BROADER	Predictive	C	Supports Sensitivity Response	2	accepted	EID1025 Case Report of a 41-year old patient with high-grade stromal endometrial sarcoma and a large abdominal and retroperitoneal mass progressing after chemotherapy. IHC for c-Kit was positive and treatment… (full text at CIViC) PMID 16487996 · Salvatierra et al., 2006 · Open in CIViC	civic

ABL1 M244V + ABL1 Fusion2
Imatinib	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	3	accepted	EID2638 A panel of 16 mutations seen in imatinib CML patents were used to evaluate the effectiveness of drug binding. All mutations were compared with non-mutated BCR-ABL protein and evaluated for antiprolife… (full text at CIViC) PMID 15930265 · O'Hare et al., 2005 · Open in CIViC	civic
Bafetinib + ImatinibSubstitutes	Malignant NeoplasmALIAS	Predictive	D	Supports Resistance	3	accepted	EID7850 In an in vitro study, a Ba/F3 cell line stably expressing the M244V mutation in the ABL1 portion of the BCR-ABL1 fusion protein was associated with resistance to imatinib and bafetinib (INNO-406) trea… (full text at CIViC) PMID 18191450 · Deguchi et al., 2008 · Open in CIViC	civic