Drug · Small Molecule

Temozolomide

CI-DRUG-00000583Explore in graph →NCIt C1244 CHEMBL810 CIViC Approved

Regulatory

Approvals (68)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

emaRegulatory7 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	Glioblastoma	Temozolomide Sun is indicated for the treatment of: adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment; children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.	approved	Jul 13, 2011	ema

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 11 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	197	99	78	770	68	CA, EU, US	Jan 26, 1999	1997-07
Malignant Central Nervous System Neoplasm	Approved	Phase 4	116	49	48	355	15	EU, US	Jan 26, 1999	1997-11
Malignant Lung Neoplasm	Phase3	Phase 3	6	2	2	28	0	—	—	1997-07
Malignant Colon Neoplasm	Phase3	Phase 3	1	1	1	2

Curated evidence

Clinical evidence (36)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–36 of 36 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
ATRX Underexpression1
PCV Regimen + Temozolomide

Clinical trials

Trials with this intervention (781)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 781 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT01824875	Temozolomide With or Without Capecitabine in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors	completed	Phase 2	144	ECOG-ACRIN Cancer Research GroupNETWORK	1	Sep 29, 2026	clinicaltrials
NCT05685004	Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM)	active not recruiting

Molecule

Record

Kind: Small Molecule
Mechanism: DNA inhibitor
UNII: YF1K15M17Y
Aliases: 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 8-carbamoyl-3-methylimidazo[5,1-d]-1,2,3,5-tetrazin-4(3H)-one, ACH-TEMOZOLOMIDE, ACT TEMOZOLOMIDE, APO-TEMOZOLOMIDE, CCRG-81045, Gliotem, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, JAMP TEMOZOLOMIDE, M-39831, M And B 39831, MAR-TEMOZOLOMIDE, M & B 39831, M&B 39831, Methazolastone, Mk-7365, NSC-362856, RP-46161, SCH 52365, TARO-TEMOZOLOMIDE, Temcad, Temizole, Temodal, Temodar, Temomedac, Temozolomida, Temozolomide, Temozolomide accord, Temozolomide hexal, Temozolomide sandoz … (+4)

Data updated 14 hours agoSource updated unknown

Identifiers

Codes (98)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01AX03	TEMOZOLOMIDE
DIN (Health Canada)	02241093

SLFN11 EXPRESSION2
Niraparib + TemozolomideCombination	Ewing Sarcoma	Predictive	D	Supports Sensitivity Response	3	submitted	EID5884 SLFN11 is an ETS transcription factor response gene and a predictive marker for therapeutic response to topoisomerase I inhibitors and temozolomide-PARP inhibitor combinations in ETS-activated cancers… (full text at CIViC) PMID 25779942 · Tang et al., 2015 · Open in CIViC	civic
Talazoparib + TemozolomideCombination	Lung Small Cell Carcinoma	Predictive	D	Supports Sensitivity Response	3	submitted	EID5883 SLFN11 is a relevant predictive biomarker of sensitivity to PARP inhibitor monotherapy in SCLC as well as combinatorial therapy with TMZ. PMID 27440269 · Lok et al., 2017 · Open in CIViC	civic

ATM Mutation2
Temozolomide	GlioblastomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	accepted	EID452 Glioblastoma cell lines were shown to have increased sensitivity to Temozolomide when siRNA-induced ATM knockdown was applied. PMID 23960094 · Eich et al., 2013 · Open in CIViC	civic
〃	Melanoma	Predictive	D	Supports Sensitivity Response	3	accepted	EID453 Melanoma cell lines were shown to have increased sensitivity to Temozolomide when siRNA-induced ATM knockdown was applied. PMID 23960094 · Eich et al., 2013 · Open in CIViC	civic

MGMT Promoter Methylation2
Lomustine + TemozolomideCombination	GlioblastomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	3	submitted	EID7303 In a small Phase 3 trial, patients with newly diagnosed glioblastoma with methylation of the MGMT promoter randomely assigned to lomustine plus temozolomide in addition to radiotherapy (n=66) or temoz… (full text at CIViC) PMID 30782343 · Herrlinger et al., 2019 · Open in CIViC	civic
Temozolomide	GlioblastomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	5	accepted	EID307 In a randomized clinical trial, patients with MGMT promoter methylation benefitted from temozolomide. This benefit was also methylation status dependent, as those without methylation did not see incre… (full text at CIViC) PMID 15758010 · Hegi et al., 2005 · Open in CIViC	civic

MGMT Underexpression5
Temozolomide	GlioblastomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID2899 In this study, patients with low MGMT expression, compared with patients with high MGMT expression, had a significantly higher response rate (55% v 7%, respectively; P = .004) and improved PFS (median… (full text at CIViC) PMID 17442989 · Chinot et al., 2007 · Open in CIViC	civic
〃	GlioblastomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID2903 In 41 glioblastomas treated with temozolomide (TMZ) therapy (MGMT-immunopositive: n = 22, negative: n = 19), both progression free survival and overall survival were significantly better in MGMT-immun… (full text at CIViC) PMID 21331613 · Watanabe et al., 2011 · Open in CIViC	civic
〃	High-Grade Glioma, NOS	Predictive	B	Supports Sensitivity Response	3	accepted	EID2901 This study showed that low MGMT mRNA expression was strongly predictive for prolonged time to progression, treatment response, and length of survival in univariate and multivariate models (p<0.0001). … (full text at CIViC) PMID 21365007 · Kreth et al., 2011 · Open in CIViC	civic
〃	Neuroendocrine Tumor	Predictive	B	Supports Sensitivity Response	2	accepted	EID2904 Among those patients who received temozolomide-based therapy in this study, the median progression-free survival for patients whose tumors showed intact MGMT expression was 9.3 months compared with 19… (full text at CIViC) PMID 19118063 · Kulke et al., 2009 · Open in CIViC	civic
〃	OligodendrogliomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	2	accepted	EID2902 In this study, loss of chromosome 1p and low MGMT protein expression were associated with objective response (P < .003 and P < .04, respectively). However, only 54% of the study group had evaluation o… (full text at CIViC) PMID 16541434 · Levin et al., 2006 · Open in CIViC	civic

IDH1 R132C3
Temozolomide	Brain GliomaUNRESOLVED	Predictive	B	Supports Sensitivity Response	—	rejected	EID2326 IDH1 mutations at R132H are the most frequent mutations accounting for 70- 90% of all IDH1 mutations in secondary glioblastoma and 5% of primary glioblastomas. PMID 18772396 · Parsons et al., 2008 · Open in CIViC	civic
〃	Brain GliomaUNRESOLVED	Predictive	B	Supports Sensitivity Response	2	accepted	EID2327 In a study of 189 low-grade gliomas, IDH (IDH1 or IDH2) mutations were found in 132 patients (70%). IDH mutations were associated with improved rate of response to temozolomide as compared to patients… (full text at CIViC) PMID 20975057 · Houillier et al., 2010 · Open in CIViC	civic
〃	Brain GliomaUNRESOLVED	Predictive	B	Supports Sensitivity Response	—	rejected	EID2328 Isocitrate dehydrogenases (IDH) are enzymes of the citric acid cycle catalyzing the oxidative decarboxylation of isocitrate to 2-oxoglutarate. IDH1 mutations at R132H are the most frequent mutations a… (full text at CIViC) PMID 21625441 · Krell et al., 2011 · Open in CIViC	civic