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Imatinib mesylate

Gleevec, Glivec, Imatinib, Imkeldi (imatinib mesylate) is a small molecule pharmaceutical. Imatinib mesylate was first approved as Gleevec on 2001-05-10. It is used to treat blast crisis, dermatofibrosarcoma, gastrointestinal neoplasms, hypereosinophilic syndrome, and lymphoid 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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Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369
digestive system diseases	D004066
hemic and lymphatic diseases	D006425
immune system diseases	D007154
signs and symptoms pathological conditions	D013568

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Drug Products

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New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

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FDA

EMA

Brand Name	Status	Last Update
gleevec	New Drug Application	2024-07-22
imatinib	ANDA	2024-04-20
imatinib mesylate	ANDA	2025-01-07
imkeldi	New Drug Application	2024-12-05

Indications

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Agency Specific

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Patent Expiration

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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

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Clinical

Clinical Trials

757 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Leukemia	D007938	—	C95	56	162	53	22	55	319
Bcr-abl positive chronic myelogenous leukemia	D015464	EFO_0000340	—	50	128	44	22	57	277
Myeloid leukemia	D007951	—	C92	43	115	38	19	48	243
Gastrointestinal stromal tumors	D046152	EFO_0000505	C49.A	27	78	30	5	28	157
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	—	18	47	15	2	5	76
Myeloid leukemia chronic-phase	D015466	—	—	18	37	10	6	11	76
Lymphoid leukemia	D007945	—	C91	19	44	12	2	5	71
Philadelphia chromosome	D010677	—	—	12	30	15	3	3	53
Blast crisis	D001752	—	—	10	16	1	2	3	28
Covid-19	D000086382	—	—	—	4	4	2	—	10

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Neoplasms	D009369	—	C80	19	28	1	—	6	51
Recurrence	D012008	—	—	5	12	2	—	2	19
Sarcoma	D012509	—	—	3	15	3	—	—	18
Myeloid leukemia accelerated phase	D015465	—	—	7	7	1	—	—	13
Lymphoma	D008223	—	C85.9	4	9	1	—	—	12
Hypertension	D006973	EFO_0000537	I10	1	4	7	—	2	12
Pulmonary arterial hypertension	D000081029	—	—	1	3	7	—	1	10
Glioblastoma	D005909	EFO_0000515	—	2	4	2	—	—	8
Familial primary pulmonary hypertension	D065627	—	I27.0	—	3	7	—	—	8
Non-hodgkin lymphoma	D008228	—	C85.9	3	4	1	—	—	7

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Syndrome	D013577	—	—	3	12	—	—	1	15
Melanoma	D008545	—	—	5	13	—	—	—	14
Lung neoplasms	D008175	HP_0100526	C34.90	3	11	—	—	—	13
Myeloid leukemia acute	D015470	—	C92.0	5	8	—	—	1	12
Carcinoma	D002277	—	C80.0	6	8	—	—	—	11
Neoplasm metastasis	D009362	EFO_0009708	—	3	7	—	—	1	11
Prostatic neoplasms	D011471	—	C61	4	7	—	—	—	10
Hypereosinophilic syndrome	D017681	EFO_1001467	D72.11	2	7	—	—	1	9
Myelomonocytic leukemia chronic	D015477	—	C93.1	3	4	—	—	1	8
Myelomonocytic leukemia juvenile	D054429	—	C93.3	3	4	—	—	1	8

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	11	—	—	—	—	11
Acute disease	D000208	—	—	1	—	—	—	1	2
Hodgkin disease	D006689	—	C81	2	—	—	—	—	2
Leukemia myeloid chronic atypical bcr-abl negative	D054438	—	C92.2	2	—	—	—	—	2
Myelodysplastic-myeloproliferative diseases	D054437	—	—	2	—	—	—	—	2
Castration-resistant prostatic neoplasms	D064129	—	—	1	—	—	—	—	1
Anemia	D000740	HP_0001903	D64.9	1	—	—	—	—	1
Plasma cell neoplasms	D054219	—	—	1	—	—	—	—	1
Hiv infections	D015658	EFO_0000764	B20	1	—	—	—	—	1
Papillary thyroid cancer	D000077273	—	—	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Renal insufficiency	D051437	HP_0000083	N19	—	—	—	—	1	1
Mouth neoplasms	D009062	EFO_0003868	C06.9	—	—	—	—	1	1
Fatigue	D005221	HP_0012378	R53.83	—	—	—	—	1	1
Disease-free survival	D018572	EFO_0000409	—	—	—	—	—	1	1
Germ-line mutation	D018095	—	—	—	—	—	—	1	1
Mental disorders	D001523	EFO_0000677	F91.9	—	—	—	—	1	1
Triple negative breast neoplasms	D064726	—	—	—	—	—	—	1	1
Liver neoplasms	D008113	EFO_1001513	C22.0	—	—	—	—	1	1
Chronic renal insufficiency	D051436	—	N18	—	—	—	—	1	1
Kidney diseases	D007674	EFO_0003086	N08	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Imatinib mesylate
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)	CS(=O)(=O)O.Cc1ccc(NC(=O)c2ccc(CN3CCN(C)CC3)cc2)cc1Nc1nccc(-c2cccnc2)n1