Data updated: May 26, 2026
TEMODAR (temozolomide)
Alkylating Activity
Trial Activity: Stable 158 active trials
Oncology
Approved 1999-08-11
Temodar is an alkylating drug used to manage specific types of brain tumors in adults. It helps patients with newly diagnosed glioblastoma when used alongside radiation and as a follow-up maintenance therapy. Additionally, it treats anaplastic astrocytoma, both in newly diagnosed patients and those whose cancer has returned or stopped responding to previous treatments.
How TEMODAR Works
Temodar works by rapidly converting into an active compound called MTIC within the body. This compound attaches to DNA, specifically at the guanine positions, which causes the DNA strands to break. These double-strand breaks ultimately lead to programmed cell death.
Development Insights
National Cancer Institute (NCI) conducting 41 trials (10%)
556 indications explored (Broad Platform)
→ glioblastoma (111 trials)
→ glioblastoma multiforme (45 trials)
→ gliosarcoma (36 trials)
5
Indications
--
Phase 3 Trials
3
Priority Reviews
26
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1999-08-11
- Routes
- ORAL, INTRAVENOUS
- Dosage Forms
- CAPSULE, POWDER
TEMODAR Approval History
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
201 FDA actions from 1999 to 2023 · 3 indication expansions
Sep 2014 SUPPL Priority
Mfg
Mar 2014 SUPPL Priority
Mfg
Oct 2013 SUPPL Priority
Mfg
Mar 2002 SUPPL Priority
Mfg
May 2001 SUPPL Priority
Mfg
Jun 2000 SUPPL Priority
Mfg
What TEMODAR Treats
2 indicationsTEMODAR is approved for 2 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Glioblastoma
- Anaplastic Astrocytoma
Source: FDA Label
TEMODAR Competitive Set
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Indication competitors
10
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What's emerging in TEMODAR's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TEMODAR treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TEMODAR
3 of 10FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
407 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 407 trials
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
TEMODAR FDA Label Details
Indications & Usage
FDA Label (PDF)TEMODAR is indicated for the treatment of Glioblastoma; Anaplastic Astrocytoma.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment