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
Trade Name
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Gleevec, Imatinib, Imkeldi (discontinued: Gleevec, Imatinib)
Drug Products
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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 |
|---|---|---|---|---|
| GLEEVEC | Novartis | N-021588 RX | 2003-04-18 | 2 products, RLD, RS |
| IMKELDI | Shorla Pharma | N-219097 RX | 2024-11-22 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| gleevec | New Drug Application | 2024-07-22 |
| imatinib | ANDA | 2024-04-20 |
| imatinib mesylate | ANDA | 2025-04-09 |
| imkeldi | New Drug Application | 2024-12-05 |
Agency Specific
FDA
EMA
No data
Patent Expiration
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HCPCS
Code | Description |
|---|---|
| S0088 | Imatinib, 100 mg |
Clinical
Clinical Trials
760 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 |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 1 | — | — | — | — | 1 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 1 | — | — | — | — | 1 |
| Myeloid leukemia | D007951 | — | C92 | 1 | — | — | — | — | 1 |
Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Imatinib |
| INN | imatinib |
| 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 class | tyrosine kinase inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cc1ccc(NC(=O)c2ccc(CN3CCN(C)CC3)cc2)cc1Nc1nccc(-c2cccnc2)n1 |
Identifiers
| PDB | — |
| CAS-ID | 152459-95-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL941 |
| ChEBI ID | 45783 |
| PubChem CID | 5291 |
| DrugBank | DB00619 |
| UNII ID | BKJ8M8G5HI (ChemIDplus, GSRS) |
Target
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Gleevec – Novartis
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Safety
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67,358 adverse events reported
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