Drug

Temozolomide

Approved · FDA / EMA

Emerging researchLate-stage developmentRising momentum

Also known as (S)-perillyl alcohol temozolomide, Methazolastone, TMZ, Temodar+10 more

(S)-perillyl alcohol temozolomide, Methazolastone, TMZ, Temodar, Temozolamide, Temozolodida, Temozolomid, Temozolomida, Témozolomide, 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, 8-carbamoyl-3-methylimidazo(5,1-d)-1,2,3,5-tetrazin-4(3H)-one, Temozolomidum.

RxNorm37776 ChEMBLCHEMBL810 ATCL01AX03UNIIYF1K15M17Y

Research papers

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Surgical "Window-of-Opportunity" and Phase II Trial of Pembrolizumab, Olaparib and Temozolomide in Recurrent Glioblastoma

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

A First-in-Human Clinical Trial of Pharmacologic Ascorbate and Ferumoxytol Combined With Concomitant Temozolomide and External Beam Radiation Therapy for Newly Diagnosed Glioblastoma

Clinical trial2026-07-20Results posted · ClinicalTrials.gov

A Phase II Randomized Trial of Proton Vs. Photon Therapy (IMRT) for Cognitive Preservation in Patients With IDH Mutant, Low to Intermediate Grade Gliomas

Clinical trial2026-07-15Primary completion · ClinicalTrials.gov

A Phase 3, Multi-regional, Open-label, Randomized Study of Tirabrutinib vs Rituximab and Temozolomide in Participants With Relapsed/Refractory Primary Central Nervous System Lymphoma

Clinical trial2026-07-10Results expected Q4 2027 · ClinicalTrials.gov

Label change: TEMOZOLOMIDE (ANDA204639)

Regulatory2024-07-15FDA

Downregulation of MGMT expression by targeted editing of DNA methylation enhances temozolomide sensitivity in glioblastoma.

Research2023-08-25Neoplasia (New York, N.Y.)

Radiotherapy combined with nivolumab or temozolomide for newly diagnosed glioblastoma with unmethylated MGMT promoter: An international randomized phase III trial.

Research2023-01-01Neuro-oncology

Phase III trial of chemoradiotherapy with temozolomide plus nivolumab or placebo for newly diagnosed glioblastoma with methylated MGMT promoter.

Research2022-11-01Neuro-oncology

Label change: TEMOZOLOMIDE (ANDA204639)

Regulatory2022-01-26FDA

Prognostic and Predictive Biomarkers in Gliomas.

Research2021-09-26International journal of molecular sciences

Label change: TEMOZOLOMIDE (ANDA204639)

Regulatory2020-08-13FDA

Approval: TEMOZOLOMIDE (ANDA204639)

Regulatory2016-11-23FDA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Temozolomide

Aliases & brands

(S)-perillyl alcohol temozolomideMethazolastoneTMZTemodarTemozolamideTemozolodidaTemozolomidTemozolomidaTémozolomide3,4-dihydro-3-methyl-4-oxoimidazo(5,1-d)-1,2,3,5-tetrazine-8-carboxamide3,4-dihydro-3-methyl-4-oxoimidazo(5,1-d)-as-tetrazine-8-carboxamide3-methyl-4-oxo-3,4-dihydroimidazo(5,1-d)(1,2,3,5)tetrazine-8-carboxamide8-carbamoyl-3-methylimidazo(5,1-d)-1,2,3,5-tetrazin-4(3H)-oneTemozolomidum

RxNorm CUI

37776

ChEMBL ID

CHEMBL810

ATC codes

L01AX03

UNII

YF1K15M17Y

Regulatory jurisdictions

fdaemamhra

Regulatory timeline

9 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

1999-01-26

Latest approval

2016-11-23

Authorities

FDA · EMA · MHRA

Total events

fdaU.S. Food and Drug Administration· 4 events

2024-07-15Label change

Label change: TEMOZOLOMIDE (ANDA204639)

Evidence ↗

2022-01-26Label change

Label change: TEMOZOLOMIDE (ANDA204639)

Evidence ↗

2020-08-13Label change

Label change: TEMOZOLOMIDE (ANDA204639)

Evidence ↗

emaEuropean Medicines Agency· 4 events

2011-07-13Approval

Approval: Temozolomide Sun (EMA)

Indication: Temozolomide Sun is indicated for the treatment of: adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as… Show full indication

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.

Evidence ↗

2010-03-15Approval

Approval: Temozolomide Accord (EMA)

Indication: For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment. For the treatment… Show full indication

For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment. For the treatment of 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.

Evidence ↗

2010-01-28Approval

Approval: Temozolomide Teva (EMA)

Evidence ↗

mhraMedicines and Healthcare products Regulatory Agency· 1 event

2014-12-11Safety communicationSafety

Drug Safety Update: Temozolomide: risk of hepatic injury, including fatal hepatic failure—updated warnings and monitoring guidance

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).