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Drug ReportsImatinib
Gleevec, Glivec(imatinib)
Gleevec, Glivec, Imatinib, Imkeldi (imatinib) is a small molecule pharmaceutical. Imatinib was first approved as Gleevec on 2001-05-10. It is used to treat dermatofibrosarcoma, hypereosinophilic syndrome, lymphoid leukemia, myelodysplastic-myeloproliferative diseases, and myeloid leukemia amongst others in the USA. It has been approved in Europe to treat BCR-ABL positive chronic myelogenous leukemia, dermatofibrosarcoma, gastrointestinal stromal tumors, hypereosinophilic syndrome, and myelodysplastic-myeloproliferative diseases amongst others.
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Commercial
Clinical
Drug
Target
Variants
Financial
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
digestive system diseasesD004066
hemic and lymphatic diseasesD006425
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Gleevec, Imatinib, Imkeldi (discontinued: Gleevec, Imatinib)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Imatinib mesylate
Tradename
Company
Number
Date
Products
GLEEVECNovartisN-021588 RX2003-04-18
2 products, RLD, RS
IMKELDIShorla PharmaN-219097 RX2024-11-22
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
gleevecNew Drug Application2024-07-22
imatinibANDA2024-04-20
imatinib mesylateANDA2025-03-13
imkeldiNew Drug Application2024-12-05
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
myelodysplastic-myeloproliferative diseases—D054437—
systemic mastocytosis—D034721C96.21
myeloid leukemia—D007951C92
hypereosinophilic syndromeEFO_1001467D017681D72.11
lymphoid leukemia—D007945C91
dermatofibrosarcoma—D018223—
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EA: Bcr-abl tyrosine kinase inhibitors
— L01EA01: Imatinib
HCPCS
Code
Description
S0088
Imatinib, 100 mg
Clinical
Clinical Trials
759 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938—C9556162522256319
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—50128442257277
Myeloid leukemiaD007951—C9244116381948244
Gastrointestinal stromal tumorsD046152EFO_0000505C49.A277830528157
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.01847142676
Myeloid leukemia chronic-phaseD015466——18371061176
Lymphoid leukemiaD007945—C911943112670
Philadelphia chromosomeD010677——1230153353
Blast crisisD001752——101612328
Covid-19D000086382—U07.1—442—10
Show 13 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C8019281—651
RecurrenceD012008——5122—219
SarcomaD012509——3153——18
Myeloid leukemia accelerated phaseD015465——771——13
LymphomaD008223—C85.9491——12
HypertensionD006973EFO_0000537I10147—212
Pulmonary arterial hypertensionD000081029——137—110
Graft vs host diseaseD006086—D89.81143——8
GlioblastomaD005909EFO_0000515—242——8
Familial primary pulmonary hypertensionD065627—I27.0—37——8
Show 22 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SyndromeD013577——312——115
MelanomaD008545——513———14
Lung neoplasmsD008175—C34.90311———13
Myeloid leukemia acuteD015470—C92.058——112
CarcinomaD002277—C80.068———11
Neoplasm metastasisD009362EFO_0009708—37——111
Prostatic neoplasmsD011471—C6147———10
Hypereosinophilic syndromeD017681EFO_1001467D72.1127——19
Myelomonocytic leukemia chronicD015477—C93.134——18
Myelomonocytic leukemia juvenileD054429—C93.334——18
Show 163 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———11————11
Acute diseaseD000208——1———12
Hodgkin diseaseD006689—C812————2
Leukemia myeloid chronic atypical bcr-abl negativeD054438—C92.22————2
Myelodysplastic-myeloproliferative diseasesD054437——2————2
Castration-resistant prostatic neoplasmsD064129——1————1
AnemiaD000740EFO_0004272D64.91————1
Plasma cell neoplasmsD054219——1————1
Hiv infectionsD015658EFO_0000764B201————1
Papillary thyroid cancerD000077273——1————1
Show 44 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal insufficiencyD051437—N19————11
Mouth neoplasmsD009062EFO_0003868C06.9————11
FatigueD005221—R53.83————11
Disease-free survivalD018572EFO_0000409—————11
Germ-line mutationD018095——————11
MucositisD052016EFO_1001898—————11
Mental disordersD001523EFO_0000677F91.9————11
Triple negative breast neoplasmsD064726——————11
Chronic renal insufficiencyD051436—N18————11
Kidney diseasesD007674EFO_0003086N08————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameImatinib
INNimatinib
Description
Imatinib is a benzamide obtained by formal condensation of the carboxy group of 4-[(4-methylpiperazin-1-yl)methyl]benzoic acid with the primary aromatic amino group of 4-methyl-N(3)-[4-(pyridin-3-yl)pyrimidin-2-yl]benzene-1,3-diamine. Used (as its mesylate salt) for treatment of chronic myelogenous leukemia and gastrointestinal stromal tumours. It has a role as an apoptosis inducer, a tyrosine kinase inhibitor and an antineoplastic agent. It is a N-methylpiperazine, a member of pyridines, a member of benzamides, an aromatic amine and a member of pyrimidines. It is functionally related to a benzamide.
Classification
Small molecule
Drug classtyrosine kinase inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Cc1ccc(NC(=O)c2ccc(CN3CCN(C)CC3)cc2)cc1Nc1nccc(-c2cccnc2)n1
Identifiers
PDB—
CAS-ID152459-95-5
RxCUI—
ChEMBL IDCHEMBL941
ChEBI ID45783
PubChem CID5291
DrugBankDB00619
UNII IDBKJ8M8G5HI (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Gleevec – Novartis
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 51,961 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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67,358 adverse events reported
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