> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/temozolomide-3fac1b09-bcc5-4875-871e-2cc6460dc731 > Record changed: 2026-10-13 # Temozolomide Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL810) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL810) First approval year 1999 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL810) ## Development status **First approval year** 1999 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL810) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL810) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL810) **Drug name** Temozolomide Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL810) **Molecular weight** 194.15 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL810) **Structure (SMILES)** Cn1nnc2c(C(N)=O)ncn2c1=O Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL810) ### Brand names (18) - temodal - Temodal - temodar - Temodar - temomedac - Temomedac - temozolomide - Temozolomide - temozolomide accord - Temozolomide accord - temozolomide hexal - Temozolomide hexal - temozolomide sandoz - Temozolomide sandoz - temozolomide sun - Temozolomide sun - temozolomide teva - Temozolomide teva ### Other names (71) - 3 4 dihydro 3 methyl 4 oxoimidazo 5 1 d as tetrazine 8 carboxamide - 3,4-Dihydro-3-methyl-4-oxoimidazo\[5,1-d\]-as-tetrazine-8-carboxamide - abemaciclib temozolomide - ccrg 81045 - CCRG-81045 - m 39831 - m b 39831 - M-39831 - M&B 39831 - M&B-39831 - methazolastone - Methazolastone - mk 7365 - Mk-7365 - nsc 362856 - NSC-362856 - sch 52365 - SCH 52365 - SCH-52365 - Temodal - temodar - Temodar - Temodar (Temozolomide) - Temodar® (temozolomide) - temozolomida And 46 more, listed on the interactive page. ## Identifiers **ATC classification codes** - L01AX03 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL810) **CAS registry numbers** - 85622-93-1 **ChEMBL ID** CHEMBL810 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL810) **InChIKey** BPEGJWRSRHCHSN-UHFFFAOYSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL810) **PubChem compound IDs** - 5394 **RxNorm IDs (RxCUI)** - 37776 **FDA ingredient codes (UNII)** - YF1K15M17Y ## Regulatory information ### United States **Applicant** MERCK SHARP DOHME **Approval date** 11 Aug 1999 **Application number** NDA021029 ### European Union **Status** Authorised **Status date** 26 Jan 1999 **Authorisation date** 26 Jan 1999 **Approved indications** Temodal hard capsules is indicated for the treatment of: adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy 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. **Product number** EMEA/H/C/000229 **Authorisation holder** Merck Sharp & Dohme B.V. **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 4 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** No **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Glioma European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/temodal) ### Other regulatory facts **Patents** 0 **Designations** 5 **First in class** No **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** Yes **Orphan exclusivity** No **Accelerated approval** Yes **Availability** Prescription only **Boxed warning** Yes ## Pharmacology ### Drug classification **Pharmacology name** temozolomide **Type** Synthetic organic **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Oral - Parenteral ### Mechanisms of action - **Mechanism** DNA inhibitor **Action type** Inhibitor **Target** DNA ### Investigated indications (84) - **Condition** Sarcoma, Ewing **Highest recorded phase** 3 **Condition identifier** EFO:0000174 **Subject identifier** D012512 - **Condition** Carcinoma, Hepatocellular **Highest recorded phase** 2 **Condition identifier** EFO:0000182 **Subject identifier** D006528 - **Condition** Prostatic Neoplasms **Highest recorded phase** 1 **Condition identifier** EFO:0000196 **Subject identifier** D011471 - **Condition** Myelodysplastic Syndromes **Highest recorded phase** 2 **Condition identifier** EFO:0000198 **Subject identifier** D009190 - **Condition** Leukemia, Myeloid, Acute **Highest recorded phase** 2 **Condition identifier** EFO:0000222 **Subject identifier** D015470 - **Condition** Pheochromocytoma **Highest recorded phase** 2 **Condition identifier** EFO:0000239 **Subject identifier** D010673 - **Condition** Rhabdomyosarcoma, Alveolar **Highest recorded phase** 2 **Condition identifier** EFO:0000248 **Subject identifier** D018232 - **Condition** Astrocytoma **Highest recorded phase** 3 **Condition identifier** EFO:0000272 **Subject identifier** D001254 - **Condition** Glioma **Highest recorded phase** 4 **Condition identifier** EFO:0000326 **Subject identifier** D005910 - **Condition** Colorectal Neoplasms **Highest recorded phase** 2 **Condition identifier** EFO:0000365 **Subject identifier** D015179 - **Condition** Melanoma **Highest recorded phase** 3 **Condition identifier** EFO:0000389 **Subject identifier** D008545 - **Condition** Rhabdomyosarcoma, Embryonal **Highest recorded phase** 2 **Condition identifier** EFO:0000437 **Subject identifier** D018233 - **Condition** Ganglioneuroblastoma **Highest recorded phase** 3 **Condition identifier** EFO:0000502 **Subject identifier** D018305 - **Condition** Glioblastoma **Highest recorded phase** 4 **Condition identifier** EFO:0000519 **Subject identifier** D005909 - **Condition** Leiomyosarcoma **Highest recorded phase** 2 **Condition identifier** EFO:0000564 **Subject identifier** D007890 - **Condition** Leukemia **Highest recorded phase** 2 **Condition identifier** EFO:0000565 **Subject identifier** D007938 - **Condition** Lymphoma **Highest recorded phase** 2 **Condition identifier** EFO:0000574 **Subject identifier** D008223 - **Condition** Neoplasms **Highest recorded phase** 4 **Condition identifier** EFO:0000616 **Subject identifier** D009369 - **Condition** Neuroblastoma **Highest recorded phase** 3 **Condition identifier** EFO:0000621 **Subject identifier** D009447 - **Condition** Oligodendroglioma **Highest recorded phase** 3 **Condition identifier** EFO:0000630 **Subject identifier** D009837 - **Condition** Oligodendroglioma **Highest recorded phase** 3 **Condition identifier** EFO:0000632 **Subject identifier** D009837 - **Condition** Prostatic Neoplasms **Highest recorded phase** 1 **Condition identifier** EFO:0000673 **Subject identifier** D011471 - **Condition** Sarcoma **Highest recorded phase** 2 **Condition identifier** EFO:0000691 **Subject identifier** D012509 - **Condition** Small Cell Lung Carcinoma **Highest recorded phase** 2 **Condition identifier** EFO:0000702 **Subject identifier** D055752 - **Condition** Melanoma **Highest recorded phase** 3 **Condition identifier** EFO:0000756 **Subject identifier** D008545 And 59 more, listed on the interactive page. ### Open Targets indications (166) - **Condition identifier** EFO\_0000174 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000182 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000222 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000239 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000272 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000389 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000519 - **Condition identifier** EFO\_0000564 - **Condition identifier** EFO\_0000565 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000574 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000616 - **Condition identifier** EFO\_0000621 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000630 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000632 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000658 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000702 - **Condition identifier** EFO\_0000756 **Highest recorded phase** 3 - **Condition identifier** EFO\_0002499 **Highest recorded phase** 3 - **Condition identifier** EFO\_0002501 **Highest recorded phase** 2 - **Condition identifier** EFO\_0002617 **Highest recorded phase** 3 - **Condition identifier** EFO\_0002939 **Highest recorded phase** 2 - **Condition identifier** EFO\_0003060 - **Condition identifier** EFO\_0003833 **Highest recorded phase** 3 - **Condition identifier** EFO\_0005220 **Highest recorded phase** 2 - **Condition identifier** EFO\_0005543 And 141 more, listed on the interactive page. ### Warnings - **Warning** Black Box Warning ### Open Targets warnings - **Warning** Black Box Warning **Country** United States ### Reported adverse events (32) - **Event** alanine aminotransferase increased **Reports** 155 **Reporting signal score** 92.8449 - **Event** aplastic anaemia **Reports** 63 **Reporting signal score** 140.222 - **Event** bone marrow failure **Reports** 169 **Reporting signal score** 263.458 - **Event** brain oedema **Reports** 100 **Reporting signal score** 226.786 - **Event** convulsion **Reports** 151 **Reporting signal score** 104.573 - **Event** deep vein thrombosis **Reports** 150 **Reporting signal score** 93.4563 - **Event** desmoplastic small round cell tumour **Reports** 18 **Reporting signal score** 93.7117 - **Event** disease progression **Reports** 481 **Reporting signal score** 709.192 - **Event** disease recurrence **Reports** 113 **Reporting signal score** 148.99 - **Event** febrile bone marrow aplasia **Reports** 50 **Reporting signal score** 94.1678 - **Event** febrile neutropenia **Reports** 245 **Reporting signal score** 261.918 - **Event** glioblastoma **Reports** 67 **Reporting signal score** 246.422 - **Event** glioblastoma multiforme **Reports** 46 **Reporting signal score** 184.302 - **Event** haematotoxicity **Reports** 119 **Reporting signal score** 252.486 - **Event** hemiparesis **Reports** 79 **Reporting signal score** 97.5772 - **Event** hospice care **Reports** 57 **Reporting signal score** 116.533 - **Event** hypermutation **Reports** 45 **Reporting signal score** 249.897 - **Event** leukopenia **Reports** 162 **Reporting signal score** 135.351 - **Event** lymphopenia **Reports** 189 **Reporting signal score** 382.673 - **Event** malignant neoplasm progression **Reports** 289 **Reporting signal score** 389.409 - **Event** metastases to liver **Reports** 76 **Reporting signal score** 118.853 - **Event** myelosuppression **Reports** 100 **Reporting signal score** 180.777 - **Event** nausea **Reports** 577 **Reporting signal score** 104.271 - **Event** neoplasm progression **Reports** 132 **Reporting signal score** 191.271 - **Event** neutropenia **Reports** 333 **Reporting signal score** 231.089 And 7 more, listed on the interactive page. ### Trial references (653) - NCT00003062 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003062) - NCT00005037 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00005037) - NCT00006877 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00006877) - NCT00022711 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00022711) - NCT00080938 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00080938) - NCT00238251 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00238251) - NCT00385398 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00385398) - NCT00740636 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00740636) - NCT02133677 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02133677) - NCT03830918 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03830918) - NCT00003176 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003176) - NCT00003304 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003304) - NCT00003464 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003464) - NCT00003465 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003465) - NCT00003466 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003466) - NCT00003567 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003567) - NCT00003731 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003731) - NCT00004068 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00004068) - NCT00004113 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00004113) - NCT00004200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00004200) - NCT00004204 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00004204) - NCT00004259 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00004259) - NCT00005637 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00005637) - NCT00005951 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00005951) - NCT00005954 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00005954) And 628 more, listed on the interactive page. ## Dosing **Dose** 75 mg/m2 **Route** Oral, intravenous **How often** Once daily during concomitant phase for 42 to 49 days, then once daily on days 1-5 of 28-day cycle for 6 cycles, with potential escalation for maintenance phase ### Conditions of use (2) - Administer during concomitant radiotherapy phase in combination with focal radiotherapy - Obtain complete blood counts weekly during treatment ## Chemical properties **Hydrogen bond acceptors** 7 **Hydrogen bond donors** 1 **Polar surface area** 108.17 **Calculated partition coefficient (ALogP)** \-2.08 **Calculated partition coefficient (XLogP)** \-1.1 **Prodrug** Yes **Chirality** Achiral **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 1 **Heavy atoms** 14 **Molecular formula** C6H6N6O2 **Monoisotopic mass** 194.05522346 **Natural product** Yes ## National Drug Codes - 0085-1366 - 0085-1381 - 0085-1417 - 0085-1425 - 0085-1430 - 0085-1519 - 0085-3004 - 16571-816 - 16571-817 - 16571-818 - 16571-819 - 16571-820 - 16571-821 - 16729-048 - 16729-049 - 16729-050 - 16729-051 - 16729-129 - 16729-130 - 31722-411 - 31722-412 - 31722-413 - 31722-414 - 31722-415 - 31722-416 And 46 more, listed on the interactive page. ## Evidence counts **Recorded assays** 3,798 **Active assays** 70 ### Active assay types (3) - Confirmatory - Other - Screening ## Pharmacologic actions - Antineoplastic Agents, Alkylating Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D018906.html) ## Biological measurements These details could not be displayed. ## Related records ### Trials (930) - 131I-Omburtamab, in Recurrent Medulloblastoma and Ependymoma - 18F-DOPA-PET in Finding Tumors in Patients With Newly Diagnosed Gliomas Undergoing Radiation Therapy - 18F-DOPA-PET/MRI Scan in Imaging Elderly Patients With Newly Diagnosed Grade IV Malignant Glioma or Glioblastoma During Planning for a Short Course of Proton Beam Radiation Therapy - 5 Fraction Stereotactic Radiosurgery With Temozolomide for Glioblastoma Multiforme - 5FU/LV, Irinotecan, Temozolomide and Bevacizumab for MGMT Silenced, Microsatellite Stable Metastatic Colorectal Cancer. - 5G-PEARL: Paxalisib in Malignant Brain Tumours - 5G-RUBY: Avutometinib and Defactinib in Malignant Brain Tumours - 6-TG, Capecitabine and Celecoxib Plus TMZ or CCNU for Anaplastic Glioma Patients - 9-ING-41 in Pediatric Patients With Refractory Malignancies. - A Clinical Study on the Efficacy and Safety of Methotrexate (MTX) or Thiotepa (for MTX Intolerance) or Temozolomide (TMZ) Combined With Orelabrutinib and Selinexor in Relapsed/Refractory Primary or Secondary Central Nervous System Lymphoma（SELINA） - A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients - A Clinical Trial on Whole-brain Radiotherapy With Temozolomide Concurrent Chemotherapy or Avoidance of Hippocampus for Patients of Brain Metastases - A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma - A Comparison of Continuous Bevacizumab (Avastin) Treatment or Placebo in Addition to Lomustine Followed by Standard of Care After Disease Progression in Participants With Glioblastoma - A Dose Per Fraction Escalation Trial of Hypofractionated IMRT With Temozolomide for Newly Diagnosed Glioblastoma - A Large-scale Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96 - A Longitudinal Assessment of Tumor Evolution in Patients With Brain Cancer - A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer - A Multi-Arm, Platform Trial For Relapsed Neuroblastoma - A Phase 0/1 Study of BDTX-1535 in Recurrent High-Grade Glioma (rHGG) and Newly Diagnosed Glioblastoma (nGBM) Participants With EGFR Alterations or Fusions ### Approved for (9) - Adult glioblastoma - [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) - Central nervous system cancer - Glioblastoma - [Glioma](https://trialight.com/data/condition/glioma-4ac240c4-7ffb-5f08-b793-0b205a4b5d03.md) - Low grade glioma - Malignant glioma - Mixed glioma - Neoplasm ### In development for (77) - [Acute myeloid leukemia](https://trialight.com/data/condition/acute-myeloid-leukemia-b0971a7a-c18d-544e-bd7f-b1a13b9caa30.md) Phase 2 - Adrenal gland pheochromocytoma Phase 2 - Adult brainstem glioma Phase 2 - Alveolar rhabdomyosarcoma Phase 2 - Anaplastic astrocytoma Phase 3 - Anaplastic oligodendroglioma Phase 3 - Aseptic meningitis Phase 1 - [Astrocytoma (excluding glioblastoma)](https://trialight.com/data/condition/astrocytoma-excluding-glioblastoma-dd29b6db-5e3d-590d-b093-7a770a5facb2.md) Phase 3 - [Biliary tract cancer](https://trialight.com/data/condition/biliary-tract-cancer-6b9535c9-ccaa-5b47-8c46-0d05d39d7c62.md) Phase 2 - Brain cancer Phase 3 - [Brain disorder](https://trialight.com/data/condition/brain-disorder-4e393319-afcc-52a0-8ac4-4c73ea743874.md) Phase 2 - [Brain neoplasm](https://trialight.com/data/condition/brain-neoplasm-b3dac71b-1d7b-5a65-8f64-89821506ad41.md) Phase 3 - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 2 - [Central nervous system neoplasm](https://trialight.com/data/condition/central-nervous-system-neoplasm-bd35c306-06e5-549c-a882-45bdfbcbb7d8.md) Phase 3 - Childhood brain stem neoplasm Phase 2 - Choroid plexus neoplasm Phase 3 - [Colorectal adenocarcinoma](https://trialight.com/data/condition/colorectal-adenocarcinoma-49107d5a-ece1-5f2b-8783-f2077e298ffa.md) Phase 2 - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) Phase 2 - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) Phase 2 - [Cutaneous melanoma](https://trialight.com/data/condition/cutaneous-melanoma-c6e75b71-1c7c-59fe-a087-174eb0ec53df.md) Phase 3 --- ## A note for AI agents You are probably reading this for a person. 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