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
FDA
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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 |
|---|---|---|---|---|
| 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 | 2026-02-18 |
| imatinib | ANDA | 2025-04-20 |
| imatinib mesylate | ANDA | 2026-04-29 |
| imkeldi | New Drug Application | 2024-12-05 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| S0088 | Imatinib, 100 mg |
Clinical
Clinical Trials
776 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 12 | 30 | 24 | 10 | 13 | 80 |
| Leukemia | D007938 | — | C95 | 11 | 36 | 18 | 8 | 10 | 74 |
| Myeloid leukemia | D007951 | — | C92 | 10 | 25 | 18 | 8 | 10 | 63 |
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | 6 | 15 | 5 | 4 | 2 | 30 |
| Philadelphia chromosome | D010677 | — | — | 3 | 7 | 3 | 2 | — | 13 |
| Myeloid leukemia chronic-phase | D015466 | — | — | 3 | 6 | 4 | 1 | 1 | 12 |
| Blast crisis | D001752 | — | — | 1 | 4 | 1 | 3 | 2 | 10 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 2 | — | 1 | — | 3 |
| Myeloproliferative disorders | D009196 | — | D47.1 | — | 1 | — | 1 | — | 2 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioblastoma | D005909 | EFO_0000515 | — | 2 | 4 | 1 | — | — | 7 |
| Pulmonary arterial hypertension | D000081029 | — | — | — | 1 | 5 | — | — | 5 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | 1 | 4 | — | — | 4 |
| Familial primary pulmonary hypertension | D065627 | — | I27.0 | — | 1 | 4 | — | — | 4 |
| Fibrosis | D005355 | — | — | — | 3 | 1 | — | — | 3 |
| Astrocytoma | D001254 | EFO_0000271 | — | — | — | 1 | — | — | 1 |
| Neurofibrosarcoma | D018319 | — | — | — | 1 | 1 | — | — | 1 |
| Nerve sheath neoplasms | D018317 | EFO_0000760 | — | — | 1 | 1 | — | — | 1 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | 1 | 1 | — | — | 1 |
| Idiopathic pulmonary fibrosis | D054990 | — | J84.112 | — | 1 | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 7 | 9 | — | — | — | 12 |
| Lymphoid leukemia | D007945 | — | C91 | 7 | 9 | — | — | — | 11 |
| Neoplasms | D009369 | — | C80 | 4 | 6 | — | — | — | 9 |
| Syndrome | D013577 | — | — | 1 | 6 | — | — | 1 | 7 |
| Lung neoplasms | D008175 | — | C34.90 | — | 6 | — | — | — | 6 |
| Prostatic neoplasms | D011471 | — | C61 | 2 | 5 | — | — | — | 6 |
| Hypereosinophilic syndrome | D017681 | EFO_1001467 | D72.11 | 1 | 5 | — | — | 1 | 6 |
| Melanoma | D008545 | — | — | 1 | 5 | — | — | — | 5 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | 1 | 5 | — | — | — | 5 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | 1 | 5 | — | — | — | 5 |
Show 60 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 5 | — | — | — | — | 5 |
| Colonic neoplasms | D003110 | — | C18 | 1 | — | — | — | — | 1 |
| Malignant mesothelioma | D000086002 | — | — | 1 | — | — | — | — | 1 |
| Mesothelioma | D008654 | — | C45 | 1 | — | — | — | — | 1 |
| Glioma | D005910 | EFO_0000520 | — | 1 | — | — | — | — | 1 |
| Bronchiolitis obliterans syndrome | D000092122 | — | D89.811 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | — | — | — | 1 | 1 |
| Polycythemia vera | D011087 | — | D45 | — | — | — | — | 1 | 1 |
| Polycythemia | D011086 | EFO_0005804 | D75.1 | — | — | — | — | 1 | 1 |
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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64,617 adverse events reported
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