Drug · Small Molecule

Imatinib Mesylate

CI-DRUG-00000296Explore in graph →NCIt C1687 CHEMBL1642 CIViC Approved

Regulatory

Approvals (26)

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

openfdaRegulatory26 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2016-08-25 (see label)	approved	Aug 25, 2016	openfda
US FDA	—	Efficacy supplement 2015-01-30 (see label)	approved	Jan 30, 2015	openfda
US FDA	—	Efficacy supplement 2013-01-25 (see label)	approved	Jan 25, 2013	openfda
US FDA	—	Efficacy supplement 2012-01-31 (see label)	approved	Jan 31, 2012	openfda
US

Data updated 2 days 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	6	2	21	188	26	US	Apr 18, 2003	May 7, 1993
Leukemia	Approved	Phase 4	3	0	9	74	3	US	Apr 18, 2003	May 7, 1993
Malignant Central Nervous System Neoplasm	Phase3	Phase 3	0	0	1	6	0	—	—	2001-08
Cutaneous Melanoma	Phase2	Phase 2	0	0	0	2	0	—

Curated evidence

Clinical evidence (100)

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

civicCuratedShowing 1–50 of 100 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 D816H1
Imatinib Mesylate	Acute Myeloid Leukemia

Clinical trials

Trials with this intervention (188)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 51–100 of 188 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
NCT00055874	Imatinib Mesylate With or Without Interferon Alfa or Cytarabine Compared With Interferon Alfa Followed by Donor Stem Cell Transplant in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia	completed	Phase 3	1,551	Heidelberg UniversityOTHER	2	May 3, 2018	clinicaltrials
NCT00080665	Docetaxel and Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Breast Cancer

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 Monomethanesulfonate, CGP 57148, CGP57148, CGP 57148B, CGP57148B, Gleevec, GLEEVEC, Glivec, Imarech, Imat, Imatinib accord, Imatinib actavis, Imatinib (as mesilate), Imatinib koanaa, Imatinib medac, Imatinib mesilate, Imatinib Mesylate, IMATINIB MESYLATE 400 MG, Imatinib methane sulfonate, Imatinib methanesulfonate, Imatinib teva, Imatinib teva b.v., Imkeldi, NSC-716051, Qti571, QTI-571, QTI571, STI 571, STI571

Data updated 22 hours agoSource updated unknown

Identifiers

Codes (0)

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

Data not yet available

No cross-reference code recorded yet beyond the record identifiers above.

Regulatory status is jurisdiction-specific and time-bound. Nothing on this page is a treatment recommendation.

ABL1 E255K + ABL1 Fusion7
Dasatinib + Imatinib MesylateSubstitutes	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	3	accepted	EID6214 In an in vitro study, stochastic mutations in the ABL1 region of a stably expressed p210 BCR-ABL fusion were generated in Ba/F3 cell lines from five independently derived, mutagenized libraries. Dasat… (full text at CIViC) PMID 15705718 · Burgess et al., 2005 · Open in CIViC	civic
Imatinib Mesylate	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	C	Supports Resistance	1	accepted	EID6991 In a study of 39 chronic phase CML patients with BCR-ABL variants, E255K was seen in a single imatinib-resistant patient that was also resistant or intolerant to dasatinib and/or nilotinib treatment. … (full text at CIViC) PMID 22371878 · Khoury et al., 2012 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	C	Supports Resistance	1	accepted	EID7039 In a phase II study of 60 imatinib-resistant patients with BCR-ABL mutations, 6 had E255K mutations PMID 17264298 · Guilhot et al., 2007 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	2	accepted	EID6282 In an in vitro study, stochastic mutations were introduced into the ABL1 region of a stably expressed p210 BCR-ABL fusion in Ba/F3 cells using N-ethyl-N-nitrosourea mutagenesis. Resulting clones were … (full text at CIViC) PMID 16772610 · Bradeen et al., 2006 · Open in CIViC	civic
Dasatinib + Imatinib MesylateCombination	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	2	accepted	EID6193 In an in vitro study, stochastic mutations in the ABL1 region of the p210 BCR-ABL fusion were generated and stably expressed in Ba/F3 cell lines from mutagenized libraries. Combination therapy with 10… (full text at CIViC) PMID 15705718 · Burgess et al., 2005 · Open in CIViC	civic
Dasatinib + Imatinib Mesylate + NilotinibSubstitutes	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	2	accepted	EID6194 In an in vitro study, stochastic mutations were introduced into the ABL1 region of a stably expressed p210 BCR-ABL fusion in Ba/F3 cells using N-ethyl-N-nitrosourea mutagenesis. Resulting clones were … (full text at CIViC) PMID 16772610 · Bradeen et al., 2006 · Open in CIViC	civic
Imatinib Mesylate + NilotinibSubstitutes	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	C	Supports Resistance	3	accepted	EID6232 In this open-label, phase II registration trial, patients that were imatinib resistant or intolerant underwent nilotinib monotherapy. Within 12 months of nilotinib therapy, there was no significant di… (full text at CIViC) PMID 19652056 · Hughes et al., 2009 · Open in CIViC	civic

ABL1 E255V + ABL1 Fusion4
Imatinib Mesylate	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	C	Supports Resistance	1	accepted	EID6986 In a study of 39 chronic phase CML patients with BCR-ABL variants, E255V was seen in a single imatinib-resistant patient that was also resistant or intolerant to dasatinib and/or nilotinib treatment. … (full text at CIViC) PMID 22371878 · Khoury et al., 2012 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	C	Supports Resistance	2	submitted	EID7245 In a phase II study of 60 imatinib-resistant patients with BCR-ABL mutations, 2 had E255V mutations. PMID 17264298 · Guilhot et al., 2007 · Open in CIViC	civic
Imatinib Mesylate + NilotinibSubstitutes	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	C	Supports Resistance	3	accepted	EID6971 In this open-label, phase II registration trial, patients that were imatinib resistant or intolerant underwent nilotinib monotherapy. Within 12 months of nilotinib therapy, there was no significant di… (full text at CIViC) PMID 19652056 · Hughes et al., 2009 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	2	accepted	EID2851 In an in vitro study, a Ba/F3-p210BCR-ABL1 cell line was ENU-mutated and exposed to graded concentrations of imatinib, nilotinib or dasatinib to identify resistance mutations. The E255V mutation in th… (full text at CIViC) PMID 16772610 · Bradeen et al., 2006 · Open in CIViC	civic

ABL1 E355G + ABL1 Fusion2
Imatinib Mesylate	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	C	Supports Resistance	1	accepted	EID7036 In a phase II study of 60 imatinib-resistant patients with BCR-ABL mutations, 4 had E355G mutations PMID 17264298 · Guilhot et al., 2007 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	2	accepted	EID6255 In an in vitro study, stochastic mutations were introduced into the ABL1 region of a stably expressed p210 BCR-ABL fusion in Ba/F3 cells using N-ethyl-N-nitrosourea mutagenesis. Resulting clones were … (full text at CIViC) PMID 16772610 · Bradeen et al., 2006 · Open in CIViC	civic

ABL1 F317L + ABL1 Fusion3
Imatinib Mesylate	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	C	Supports Resistance	3	accepted	EID6978 In a study of 39 chronic phase CML patients with BCR-ABL variants, F317L was seen in 8 imatinib resistant patients that were also resistant or intolerant to dasatinib and/or nilotinib treatment. Nine … (full text at CIViC) PMID 22371878 · Khoury et al., 2012 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	C	Supports Resistance	1	accepted	EID7045 In a phase II study of 60 imatinib-resistant patients with BCR-ABL mutations, 4 had F317L mutations PMID 17264298 · Guilhot et al., 2007 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	2	accepted	EID6252 In an in vitro study, stochastic mutations were introduced into the ABL1 region of a stably expressed p210 BCR-ABL fusion in Ba/F3 cells using N-ethyl-N-nitrosourea mutagenesis. Resulting clones were … (full text at CIViC) PMID 16772610 · Bradeen et al., 2006 · Open in CIViC	civic

ABL1 F359C + ABL1 Fusion5
Imatinib Mesylate	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	C	Supports Resistance	1	accepted	EID6985 In a study of 39 chronic phase CML patients with BCR-ABL variants, F359C was seen in two imatinib-resistant patients that were also resistant or intolerant to dasatinib and/or nilotinib treatment. Nin… (full text at CIViC) PMID 22371878 · Khoury et al., 2012 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	C	Supports Resistance	1	accepted	EID7035 In a phase II study of 60 imatinib-resistant patients with BCR-ABL mutations, 2 had F359C mutations PMID 17264298 · Guilhot et al., 2007 · Open in CIViC	civic
Imatinib Mesylate + NilotinibCombination	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	2	accepted	EID6239 In an in vitro study, stochastic mutations were introduced into the ABL1 region of a stably expressed p210 BCR-ABL fusion in Ba/F3 cells using N-ethyl-N-nitrosourea mutagenesis. Resulting clones were … (full text at CIViC) PMID 16772610 · Bradeen et al., 2006 · Open in CIViC	civic
Imatinib Mesylate + NilotinibSubstitutes	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	C	Supports Resistance	3	accepted	EID6233 In this open-label, phase II registration trial, patients that were imatinib resistant or intolerant underwent nilotinib monotherapy. Within 12 months of nilotinib therapy, there was no significant di… (full text at CIViC) PMID 19652056 · Hughes et al., 2009 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	2	accepted	EID2854 In an in vitro study, a Ba/F3-p210BCR-ABL1 cell line was ENU-mutated and exposed to graded concentrations of imatinib, nilotinib or dasatinib to identify resistance mutations. The F359C mutation in th… (full text at CIViC) PMID 16772610 · Bradeen et al., 2006 · Open in CIViC	civic