Last update 30 Sep 2026

Temozolomide

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
3,4-dihydro-3-methyl-4-oxoimidazo(5,1-d)-1,2,3,5-tetrazine-8-carboxamide, 3,4-dihydro-3-methyl-4-oxoimidazo(5,1-d)-as-tetrazine-8-carboxamide, 3-methyl-4-oxo-3,4-dihydroimidazo(5,1-d)(1,2,3,5)tetrazine-8-carboxamide
+ [29]
Target
Action
inhibitors
Mechanism
DNA inhibitors(DNA inhibitors), DNA alkylating agents
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
European Union (26 Jan 1999),
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China)
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Structure/Sequence

Molecular FormulaC6H6N6O2
InChIKeyBPEGJWRSRHCHSN-UHFFFAOYSA-N
CAS Registry85622-93-1

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Ewing Sarcoma
Japan
21 Feb 2019
Ewing Sarcoma
Japan
21 Feb 2019
Malignant glioma of brain
European Union
28 Jan 2010
Malignant glioma of brain
Iceland
28 Jan 2010
Malignant glioma of brain
Liechtenstein
28 Jan 2010
Malignant glioma of brain
Norway
28 Jan 2010
Malignant melanoma, metastatic
Australia
13 Nov 2009
Glioblastoma
China
30 Apr 2004
Astrocytoma
European Union
26 Jan 1999
Astrocytoma
Iceland
26 Jan 1999
Astrocytoma
Liechtenstein
26 Jan 1999
Astrocytoma
Norway
26 Jan 1999
Glioblastoma Multiforme
European Union
26 Jan 1999
Glioblastoma Multiforme
Iceland
26 Jan 1999
Glioblastoma Multiforme
Liechtenstein
26 Jan 1999
Glioblastoma Multiforme
Norway
26 Jan 1999
Glioma
European Union
26 Jan 1999
Glioma
Iceland
26 Jan 1999
Glioma
Liechtenstein
26 Jan 1999
Glioma
Norway
26 Jan 1999
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
NeuroblastomaNDA/BLA
European Union
14 Nov 2024
Glioblastoma, IDH-WildtypePhase 3
United States
16 Jul 2026
Uterine LeiomyosarcomaPhase 3
United States
30 Mar 2022
Brain Stem GliomaPhase 3
United States
26 Jan 2011
Brain Stem GliomaPhase 3
Canada
26 Jan 2011
Cerebral Astrocytoma, AdultPhase 3
United States
26 Jan 2011
Cerebral Astrocytoma, AdultPhase 3
Canada
26 Jan 2011
High grade gliomaPhase 3
United States
26 Jan 2011
High grade gliomaPhase 3
Canada
26 Jan 2011
Pediatric Cerebellar AstrocytomaPhase 3
United States
26 Jan 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
Astrocytoma
First line
BRAF V600E
18
Radiochemotherapy with concurrent and adjuvant temozolomide (TMZ)
sczruucqnd(jwvjulcbek) = xwsqqwzfmm upgrldisef (agbfwdwnhh )
Positive
24 Sep 2026
Not Applicable
31
Chemotherapy
msoxantpwc(ojadnkkxml) = rpgpqueugf kypblznglk (whlzfredmu )
Positive
24 Sep 2026
Phase 2
20
(Focused ultrasound-mediated blood-brain barrier opening)
igckuevaen(natrklddwe) = ettyephkxb hksunqkdqh (bpigmhbpvh )
Positive
24 Sep 2026
Not Applicable
-
12
oyglvxxmev(xenqllvevu) = ihnubjnesc rjfjfpiago (pugnbjruos, 0 - 43)
Negative
24 Sep 2026
Not Applicable
High grade glioma
CHEK2 mutation | MGMT promotor methylation
97
ptdghvsenm(ronhcoxsgz) = The most limiting adverse event for patients with TIAA seems to be thrombocytopenia. Eltrombopag lead to limited efficacy with ongoing need of platelets substitution. naucvbwrfe (cccorqbauh )
Positive
24 Sep 2026
Phase 2
624
Photon Beam Radiation Therapy+Temozolomide
(Group 1 - Standard RT (Photon) (Arm A1))
gcqjjlfmqa(pvekvnlkta) = nsiopivzrg cgupcxacmg (ahrrissudj, bcuunigkom - dgorqeoxbc)
-
28 Aug 2026
Photon Beam Radiation Therapy+Temozolomide
(Group 1 - Intensified RT (Photon) (Arm B))
gcqjjlfmqa(pvekvnlkta) = encsowpqrm cgupcxacmg (ahrrissudj, rimsjqqhbx - ekmemkrmml)
Phase 1/2
16
Tala+TMX
(Dose Level 1 Tala 1mg, TMX 37.5 mg/m^2)
auowdycnmn = xzjvpudphd kyquolnaax (swsgpxuaos, olsttqfbhx - bkpbwjuwqx)
-
24 Aug 2026
Tala+TMX
(Dose Level 1A Tala 0.75mg, TMX 50 mg/m^2)
auowdycnmn = whjbrppeok kyquolnaax (swsgpxuaos, wdailcacyt - wdpychkctn)
Phase 2
14
Computed Tomography+Temozolomide+Talazoparib
zmlxaeeizn = iruzdtognv mymjsjwaok (ssdzxwngyo, nxhsmizeld - hahttwjkqq)
-
12 Aug 2026
Phase 2
23
ykwvealcus = tvvtpedbha ewfyefcxca (bmnmbmbplh, ihpieimtrp - ckrdaiijmc)
-
28 Jul 2026
Phase 1
16
bjrkcyvgsz = wgzwbcttod tinjxgcwvv (dvbeovxzjq, fpzntjkfar - mndtgirhty)
-
20 Jul 2026
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