TheraRadar
Data updated: May 26, 2026

TEMOZOLOMIDE

Alkylating Activity
Oncology Approved 2010-03-01

TEMOZOLOMIDE is indicated for the treatment of Glioblastoma; Anaplastic Astrocytoma.

Source: FDA Label • EXTROVIS • Alkylating Drug
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How TEMOZOLOMIDE Works

Temozolomide is a prodrug that undergoes rapid nonenzymatic conversion at physiologic pH to the reactive compound 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide (MTIC). The cytotoxicity of MTIC is primarily attributed to the alkylation (methylation) of DNA at the O6 and N7 positions of guanine. This DNA damage triggers cellular cytotoxicity, effectively inhibiting the proliferation of susceptible cancer cells.

Source: FDA Label
16
Indications
--
Phase 3 Trials
16
Years on Market

Details

Status
Discontinued
First Approved
2010-03-01
Routes
ORAL
Dosage Forms
CAPSULE

Companies

EXTROVIS DEVA HOLDING AS ACCORD HLTHCARE AMNEAL PHARMS HERITAGE ANI PHARMS Sun Pharma CHEMI SPA NIVAGEN PHARMS INC CHARTWELL HETERO LABS LTD V WATSON LABS TEVA EIRGEN Apotex RISING ZYDUS PHARMS
Active Ingredient: TEMOZOLOMIDE

TEMOZOLOMIDE Approval History

2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
365 FDA actions from 2010 to 2026
Jan 2026 SUPPL
Label · Labeling
Jul 2025 SUPPL
Label · Labeling
Aug 2024 SUPPL
Label · Labeling

What TEMOZOLOMIDE Treats

2 indications

TEMOZOLOMIDE is approved for 2 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Glioblastoma
  • Anaplastic Astrocytoma
Source: FDA Label

TEMOZOLOMIDE Boxed Warning

IMPORTANT DISPENSING INFORMATION For every patient, dispense Temozolomide capsules, USP in a separate vial or in its original package, making sure each container lists the strength per capsule and that patients take the appropriate number of capsules from each package or vial. Please see the dispensing instructions below for more information....

TEMOZOLOMIDE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

JOBEVNE
BIOCON BIOLOGICS
2025 8 indic.
AVZIVI
BIO-THERA SOLUTIONS
2023 8 indic.
Unlock 8 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in TEMOZOLOMIDE's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TEMOZOLOMIDE treats. First-in-class if their pivotal trials read out positive.

Tiragolumab MTIG7192A / RG6058 ~ Mixed — Ph3 readout
Hoffmann-La Roche
TIGIT · monoclonal antibody (anti-TIGIT) · 10 Phase 3 trials
Brigimadlin BI 907828
Boehringer Ingelheim
MDM2 · small-molecule MDM2-p53 inhibitor · 3 Phase 3 trials

Drugs Similar to TEMOZOLOMIDE

3 of 10

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

TEMODAR
TEMOZOLOMIDE
2 shared
Merck
Shared indications:
GlioblastomaAnaplastic Astrocytoma
ALYMSYS
BEVACIZUMAB-MALY
1 shared
AMNEAL PHARMS LLC
Shared indications:
Glioblastoma
AVZIVI
BEVACIZUMAB-TNJN
1 shared
BIO-THERA SOLUTIONS LTD
Shared indications:
Glioblastoma
View all 10 similar drugs Pro
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Clinical Trial Registry

405 trials
Trial Sponsor ID Phase Status Title
NCT06172296 NCI-2023-08530 NCI-2023-08530, ANBL2131 Ph 3 recruiting Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
NCT05691491 NCI-2022-10211 NCI-2022-10211, 10572 Ph 1, Ph 2 recruiting Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness
NCT05432804 NCI-2022-05066 NCI-2022-05066, PHII-222 Ph 1, Ph 2 recruiting Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
NCT07104032 IGNITE ONO-4059-17 Ph 3 recruiting IGNITE: Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)
NCT03528642 NCI-2018-00876 NCI-2018-00876, 10218 Ph 1 active not recruiting Telaglenastat With Radiation Therapy and Temozolomide in Treating Patients With IDH-Mutated Diffuse Astrocytoma or Anaplastic Astrocytoma
NCT04394858 NCI-2020-03379 NCI-2020-03379, A021804 Ph 2 active not recruiting Testing the Addition of an Anticancer Drug, Olaparib, to the Usual Chemotherapy (Temozolomide) for Advanced Neuroendocrine Cancer
NCT02308527 BEACON RG_11-087 2012-000072-42 Ph 2 completed Activity Study of Bevacizumab With Temozolomide ± Irinotecan for Neuroblastoma in Children
NCT05432791 results posted NCI-2022-05065 NCI-2022-05065, A092104 Ph 2, Ph 3 active not recruiting Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working
NCT05096481 CONNECT1906 R01FD007283 Ph 2 recruiting PEP-CMV Vaccine Targeting CMV Antigen to Treat Newly Diagnosed Pediatric HGG and DIPG and Recurrent Medulloblastoma
NCT04337177 VAL-10-001 Ph 1 active not recruiting Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors
NCT04901702 ONITT NCI-2021-02843 Ph 1, Ph 2 recruiting Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma
NCT04164199 BGB-A317-290-LTE1 2019-002554-23, 2023-508883-31-00 Ph 3 active not recruiting Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies
NCT03970447 GBM AGILE GCAR-7213 Ph 2, Ph 3 recruiting A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma
NCT04105374 NRG-BN006 NCI-2019-04562, NRG-BN006 Ph 2, Ph 3 withdrawn Testing the Addition of an Anti-cancer Viral Gene Therapy, Toca 511/Toca FC, to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed Glioblastoma
NCT03180502 NRG-BN005 NCI-2017-00203, NRG-BN005 Ph 2 active not recruiting Proton Beam or Intensity-Modulated Radiation Therapy in Preserving Brain Function in Patients With IDH Mutant Grade II or III Glioma
NCT05095376 NRG-BN011 NCI-2021-10331, NRG-BN011 Ph 3 active not recruiting Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine) to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Methylated Glioblastoma
NCT07569042 NBM-BMX-005 Ph 1, Ph 2 recruiting A Rollover Study of NBM-BMX in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma
NCT06995872 10001842 001842-C Ph 1 recruiting Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Children and Young Adults With Relapsed/Refractory Neuroblastoma
NCT05629702 ARISTOCRAT RG_21-001 2021-005214-34, ISRCTN Ph 2 recruiting ARISTOCRAT: Blinded Trial of Temozolomide +/- Cannabinoids
NCT03491683 GBM-001 Ph 1, Ph 2 active not recruiting INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM)
NCT03581292 results posted NCI-2018-01361 NCI-2018-01361, ACNS1721 Ph 2 active not recruiting Veliparib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Malignant Glioma Without H3 K27M or BRAFV600 Mutations
NCT07452458 NRG-CC017 NCI-2025-09197, NRG-CC017 Ph 3 not yet recruiting Temporally-Modulated Pulsed Radiation Therapy Versus Standard Radiation Therapy for the Treatment of Newly Diagnosed, IDH Wildtype, MGMT-Unmethylated Glioblastoma
NCT02595424 results posted EA2142 NCI-2015-00547, EA2142 Ph 2 active not recruiting Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced Poorly Differentiated (G3) Non-Small Cell Gastrointestinal Neuroendocrine Carcinomas
NCT04200443 results posted 20664 STU00210699, NU 19S01 Ph 2 active not recruiting Cabozantinib and Temozolomide for the Treatment of Unresectable or Metastatic Leiomyosarcoma or Other Soft Tissue Sarcoma
NCT06410248 NU 23C05 NCI-2024-02351, STU00220426 Ph 1 recruiting Triapine in Combination With Temozolomide for the Treatment of Patients With Recurrent Glioblastoma
NCT06556563 EF-41 EF-41 2024-513550-30-00 Ph 3 recruiting EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
NCT07195591 BRIDGES GTM-105 Ph 3 recruiting Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
NCT01638546 results posted NCI-2012-01130 NCI-2012-01130, CDR0000737062 Ph 2 active not recruiting Temozolomide With or Without Veliparib in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
NCT06012695 NBM-BMX-003 Ph 1, Ph 2 recruiting NBM-BMX Administered Orally to Patients With Solid Tumors or Newly Diagnosed Glioblastoma
NCT07297212 BNT327-10 Ph 2 recruiting A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma
NCT06625047 NOA242 NOA242, 24-007538 Ph 4 completed Comparing Telehealth and In-person Assessments in Glioma Patients Receiving Oral Chemotherapy
NCT02152982 results posted NCI-2014-00616 NCI-2014-00616, A071102 Ph 2, Ph 3 active not recruiting Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
NCT05765812 Debio 0123-GBM-105 2022-502156-31, U1111-1283-6423 Ph 1, Ph 2 recruiting A Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma
NCT03011671 IRB16-0767 Ph 1 active not recruiting Study of Acetazolamide With Temozolomide in Adults With Newly Diagnosed or Recurrent Malignant Glioma
NCT05902169 SONOBIRD SC9-GBM-03 2023-505829-14-00 Ph 3 recruiting Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM
NCT06861244 PNOC031 240830 NCI-2025-01764 Ph 2 recruiting Embryonal Tumor With Multilayered Rosettes
NCT05030298 MC210710 20-013209 Ph 1 recruiting Preoperative Radiosurgery for the Treatment of High Grade Glioma, NeoGlioma Trial
NCT04396860 results posted NCI-2020-03404 NCI-2020-03404, NRG-BN007 Ph 2, Ph 3 completed Testing the Use of the Immunotherapy Drugs Ipilimumab and Nivolumab Plus Radiation Therapy Compared to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Unmethylated Glioblastoma
NCT06743126 SUPRAME IMA203-301 Ph 3 recruiting SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma
NCT06413706 18646 I3Y-MC-JPEH, 2022-502269-13-00 Ph 2 active not recruiting A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy
NCT05698524 0809-22-FB Ph 1 recruiting A Study of Temodar With Abexinostat (PCI-24781) for Patients With Recurrent Glioma
NCT02287428 14-362 51986 Ph 1 active not recruiting Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM
NCT01864109 13-068 Ph 2 active not recruiting Irinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma
NCT04796012 SOL0620MC Ph 1, Ph 2 recruiting VITAS: Atezolizumab in Combination With Chemotherapy for Pediatric Relapsed/Refractory Solid Tumors
NCT06419946 2023-506998-35-00 Ph 3 recruiting Lomustine in Addition to Standard of Care in Patients With MGMT Methylated Glioblastoma
NCT05440786 results posted 18434 J1S-MC-JP04, 2023-506772-28-00 Ph 2 active not recruiting CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma
NCT06541262 BCC021 Ph 1, Ph 2 recruiting Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors
NCT04919382 BTCRC LUN20-462 NCI-2021-05580 Ph 2 recruiting Temozolomide and Atezolizumab for Subsequent Line for the Treatment of Metastatic or Recurrent Small Cell Lung Cancer
NCT03899155 CA209-8TT 2018-004362-34 Ph 2 recruiting Pan Tumor Rollover Study
NCT06388733 IVY P3-24-021 Ph 3 recruiting A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma

Showing 50 of 405 trials

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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

TEMOZOLOMIDE FDA Label Details

Indications & Usage

TEMOZOLOMIDE is indicated for the treatment of Glioblastoma; Anaplastic Astrocytoma.

⚠️ BOXED WARNING

IMPORTANT DISPENSING INFORMATION For every patient, dispense Temozolomide capsules, USP in a separate vial or in its original package, making sure each container lists the strength per capsule and that patients take the appropriate number of capsules from each package or vial. Please see the dispens...

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TEMODAR

Full clinical data, patents, trials, and competitive landscape for temozolomide.

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Data Sources

FDA Approval: ANDA205227 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.