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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Events

FDA approval date

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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	2025-01-09

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

1146 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	—	232	299	63	4	62	557
Glioma	D005910	EFO_0000520	—	95	121	17	2	25	224
Neoplasms	D009369	—	C80	82	66	5	1	2	130
Central nervous system neoplasms	D016543	—	—	46	69	11	1	7	119
Brain neoplasms	D001932	EFO_0003833	C71	53	62	11	1	11	118
Astrocytoma	D001254	EFO_0000271	—	41	36	16	1	9	93
Neuroblastoma	D009447	EFO_0000621	—	22	32	2	1	—	47
Oligodendroglioma	D009837	EFO_0000631	—	16	20	5	1	2	42

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Nervous system neoplasms	D009423	—	—	44	62	11	—	7	110
Melanoma	D008545	—	—	36	68	15	—	1	98
Gliosarcoma	D018316	—	—	41	46	7	—	—	78
Recurrence	D012008	—	—	37	39	5	—	6	75
Sarcoma	D012509	—	—	17	24	2	—	2	40
Lymphoma	D008223	—	C85.9	10	20	1	—	4	32
Lung neoplasms	D008175	—	C34.90	7	27	3	—	2	31
Neoplasm metastasis	D009362	EFO_0009708	—	11	20	2	—	2	30
Neuroendocrine tumors	D018358	EFO_1001901	D3A.8	5	24	2	—	1	29
Medulloblastoma	D008527	—	—	15	15	1	—	—	26

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Carcinoma	D002277	—	C80.0	6	15	—	—	—	18
Breast neoplasms	D001943	EFO_0003869	C50	5	13	—	—	1	17
Colorectal neoplasms	D015179	—	—	5	11	—	—	—	14
Ovarian neoplasms	D010051	EFO_0003893	C56	6	8	—	—	—	12
Pancreatic neoplasms	D010190	EFO_0003860	C25	3	8	—	—	—	9
Neuroendocrine carcinoma	D018278	—	—	1	8	—	—	—	9
Pinealoma	D010871	—	—	5	4	—	—	—	8
Liver neoplasms	D008113	EFO_1001513	C22.0	6	2	—	—	—	7
Kidney neoplasms	D007680	EFO_0003865	C64	6	2	—	—	—	7
Uveal neoplasms	D014604	EFO_1001230	—	1	6	—	—	—	6

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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	5	—	—	—	—	5
Craniopharyngioma	D003397	—	—	4	—	—	—	—	4
Adamantinoma	D050398	—	—	4	—	—	—	—	4
Lymphopenia	D008231	—	D72.810	2	—	—	—	—	2
Mesothelioma	D008654	—	C45	2	—	—	—	—	2
Thymus neoplasms	D013953	—	C37	2	—	—	—	—	2
Brain diseases	D001927	—	G93.40	2	—	—	—	—	2
Phenylketonurias	D010661	—	E70.0	2	—	—	—	—	2
Malignant mesothelioma	D000086002	—	—	1	—	—	—	—	1
Urinary bladder neoplasms	D001749	—	C67	1	—	—	—	—	1

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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