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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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Novartis Pharmaceuticals
Top 200 Pharmaceuticals by Retail Sales
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
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YTD
1Y
2Y
5Y
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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 Application2025-06-18
imatinibANDA2024-04-20
imatinib mesylateANDA2025-09-18
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
769 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938—C951————1
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—1————1
Myeloid leukemiaD007951—C921————1
Indications Without Phase
No data
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
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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
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 54,770 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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64,860 adverse events reported
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