Temozolomide - PharmaKB

Temodar, Temodal(temozolomide)

Temodal, Temodar, Temomedac, Temozolomide (temozolomide) is a small molecule pharmaceutical. Temozolomide was first approved as Temodal on 1999-01-26. It is used to treat glioblastoma and melanoma in the USA. It has been approved in Europe to treat glioblastoma and glioma.

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369
skin and connective tissue diseases	D017437

Trade Name

FDA

EMA

Temodar, Temozolomide (discontinued: Temodar, Temozolomide)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Temozolomide

Tradename	Company	Number	Date	Products
TEMODAR	Merck & Co	N-022277 RX	2009-02-27	1 products, RLD, RS

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Labels

FDA

EMA

Brand Name	Status	Last Update
temodar	New Drug Application	2024-10-30
temozolomide	ANDA	2025-05-23

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
glioblastoma	EFO_0000515	D005909	—
melanoma	—	D008545	—

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

L: Antineoplastic and immunomodulating agents

— L01: Antineoplastic agents

— L01A: Alkylating agents

— L01AX: Other alkylating agents in atc

— L01AX03: Temozolomide

HCPCS

Code	Description
J8700	Temozolomide, oral, 5 mg
J9328	Injection, temozolomide, 1 mg

Clinical

Clinical Trials

1174 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Glioblastoma	D005909	EFO_0000515	—	247	306	64	4	63	578
Glioma	D005910	EFO_0000520	—	109	121	15	3	26	237
Brain neoplasms	D001932	EFO_0003833	C71	69	81	20	1	11	158
Central nervous system neoplasms	D016543	—	—	47	70	11	1	7	120
Astrocytoma	D001254	EFO_0000271	—	58	47	19	1	10	120
Neoplasms	D009369	—	C80	71	52	8	2	2	114
Oligodendroglioma	D009837	EFO_0000631	—	31	26	7	1	4	64

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Gliosarcoma	D018316	—	—	62	60	11	—	1	114
Melanoma	D008545	—	—	36	65	14	—	1	94
Recurrence	D012008	—	—	31	38	6	—	6	67
Nervous system neoplasms	D009423	—	—	18	38	5	—	5	57
Neuroblastoma	D009447	EFO_0000621	—	27	32	2	—	—	51
Sarcoma	D012509	—	—	12	23	2	—	3	36
Medulloblastoma	D008527	—	—	22	16	1	—	—	33
Neoplasm metastasis	D009362	EFO_0009708	—	13	20	3	—	2	32
Lymphoma	D008223	—	C85.9	9	17	2	—	4	29
Ewing sarcoma	D012512	EFO_0000173	—	13	20	1	—	1	28

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Breast neoplasms	D001943	EFO_0003869	C50	6	14	—	—	1	18
Colorectal neoplasms	D015179	—	—	5	11	—	—	—	14
Ovarian neoplasms	D010051	EFO_0003893	C56	7	9	—	—	—	13
Carcinoma	D002277	—	C80.0	2	8	—	—	—	10
Pancreatic neoplasms	D010190	EFO_0003860	C25	4	9	—	—	—	10
Pinealoma	D010871	—	—	7	4	—	—	—	10
Neuroendocrine carcinoma	D018278	—	—	—	9	—	—	—	9
Rhabdoid tumor	D018335	—	—	6	3	—	—	—	8
Liver neoplasms	D008113	EFO_1001513	C22.0	6	2	—	—	—	7
Kidney neoplasms	D007680	EFO_0003865	C64	6	2	—	—	—	7

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Meningioma	D008579	EFO_0003098	D32.9	6	—	—	—	—	6
Craniopharyngioma	D003397	—	—	5	—	—	—	—	5
Subependymal glioma	D018315	EFO_1001197	—	4	—	—	—	—	4
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	C91.0	4	—	—	—	—	4
Adamantinoma	D050398	—	—	3	—	—	—	—	3
Phenylketonurias	D010661	—	E70.0	3	—	—	—	—	3
Mesothelioma	D008654	—	C45	2	—	—	—	—	2
Thymus neoplasms	D013953	—	C37	2	—	—	—	—	2
Teratoma	D013724	—	D28	2	—	—	—	—	2
Blast crisis	D001752	—	—	2	—	—	—	—	2

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Chemoradiotherapy	D059248	—	—	—	—	—	—	1	1
Maximum tolerated dose	D020714	—	—	—	—	—	—	1	1
Intensity-modulated radiotherapy	D050397	—	—	—	—	—	—	1	1
Residual neoplasm	D018365	—	—	—	—	—	—	1	1
Depression	D003863	—	F33.9	—	—	—	—	1	1
Infertility	D007246	EFO_0000545	—	—	—	—	—	1	1
Genetic variation	D014644	EFO_0004828	—	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Temozolomide
INN	temozolomide
Description	Temozolomide is an imidazotetrazine that is 3,4-dihydroimidazo[5,1-d][1,2,3,5]tetrazine which is substituted at positions 3, 4, and 8 by methyl, oxo, and carboxamide groups, respectively. A prodrug for MTIC (5-(3-methyltriaz-1-en-1-yl)-1H-imidazole-4-carboxamide, formed by spontaneous hydrolysis of temozolomide in the body), it is used as an oral alkylating agent for the treatment of newly diagnosed malignant glioblastoma multiforme (concomitantly with radiotherapy) and malignant melanoma. It has a role as an antineoplastic agent, a prodrug and an alkylating agent. It is an imidazotetrazine, a monocarboxylic acid amide and a triazene derivative.
Classification	Small molecule
Drug class	—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	Cn1nnc2c(C(N)=O)ncn2c1=O