Temodar

(temozolomide)

ApprovedSmall molecule

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Temozolomide is used to treat certain types of brain cancer, including glioblastoma and anaplastic astrocytoma. It works by damaging cancer cell DNA to stop them from growing and dividing.[2] Temodar is currently approved and in use across 96 indications[4].[1]

Temodar is one of 1153 small molecule programs targeting Pancreatic Neuroendocrine Tumor. It is currently in Approved.

Indications

756

Total Trials

Active Trials

1,152

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Pancreatic Neuroendocrine TumorCompleted

LymphomaUnknown status

Breast CancerTerminated

Colorectal CancerActive, not recruiting

GlioblastomaWithdrawn

Ovarian CancerRecruiting

RhabdomyosarcomaCompleted

Elderly PatientsCompleted

Diffuse Midline GliomaSuspended

Central Nervous System NeoplasmApproved

Pancreatic Neuroendocrine TumorPhase 2

Completed

LymphomaPhase 2

Unknown status

Breast CancerPhase 2

Terminated

Colorectal CancerPhase 2

Active, not recruiting

GlioblastomaPhase 3

Withdrawn

Ovarian CancerPhase 2

Recruiting

RhabdomyosarcomaPhase 2

Completed

Elderly PatientsPhase 2

Completed

Diffuse Midline GliomaPreclinical

Suspended

Central Nervous System NeoplasmApproved

Approved

Showing 10 of 96 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Temodar

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Approved

8 2

Zolymbus

AbbVie

Preclinical

1 3

Lexiscan

Astellas

Preclinical

1 4

Acupan

YYonsei University

Preclinical

1 5

Nubain

AAultman Health Foundation

Preclinical

1 6

Rilvegostomig

AstraZeneca

Preclinical

1 7

Paracetamol

GSK

Preclinical

1 8

Ablavar

LLantheus Medical Imaging

Preclinical

2 9

Naltrexone/bupropion

Novo Nordisk

Preclinical

1 10

Sertraline ODT

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Pancreatic Neuroendocrine Tumor

NCT01824875

Phase 2Recruiting

Locally-Advanced Rectal Cancer

NCT05136326

Phase 1/2Recruiting

Glioblastoma

NCT04443010

Phase 3Active, not recruiting

Glioma

NCT00978458

Phase 2/3Active, not recruiting

Glioblastoma

NCT06105619

Q1 2027

Phase 1/2Active, not recruiting

Glioblastoma

NCT04881032

Clinical

Trials by Indication[1]

Glioblastoma38 trials

Safety Study of XL184 (Cabozantinib) in Combination With Temozolomide and Radiation Therapy in the Initial Treatment of Adults With Glioblastoma

Completed·EExelixis·Phase 1·NCT00960492·26 enrolled

A Study of Avastin (Bevacizumab) and Irinotecan Versus Temozolomide Radiochemistry in Patients With Glioblastoma

Completed· Roche logo

Roche·Phase 2·NCT00967330·182 enrolled

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

Withdrawn·NNRG Oncology·Phase 2/3·NCT04105374

Show 35 more trials

NG101m Adjuvant Therapy in Glioblastoma Patients

Not yet recruiting·NNeuGATE Theranostics·Phase 1/2·NCT04373785·52 enrolled

Integrating Biology for Safe Intensification of Glioblastoma Hypofractionated Treatment on the MR-Linac

Not yet recruiting·NNYU Langone Health·Phase 1·NCT07457307·20 enrolled

A Study of PLB1001 Enteric Capsules in the Treatment of sGBM/IDH Mutant Glioblastoma Patients With the ZM Fusion Gene (FUGEN).

Active, not recruiting·BBeijing Pearl Biotechnology Limited Liability Company·Phase 2/3·NCT06105619·84 enrolled

A Dose Per Fraction Escalation Trial of Hypofractionated IMRT With Temozolomide for Newly Diagnosed Glioblastoma

Completed·UUniversity of Colorado, Denver·Phase 1·NCT00792012·37 enrolled

LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas

Unknown status·—·Phase 1/2·NCT05663125·10 enrolled

Phase II Sorafenib With Radiation and Temozolomide in Newly Diagnosed Glioblastoma or Gliosarcoma

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT02599090

Phase II Study of Temozolomide in Newly Diagnosed Glioblastoma

Terminated·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT00365222·1 enrolled

Phase II Study of Combined Temozolomide and SGT-53 for Treatment of Recurrent Glioblastoma

Terminated·SSynerGene Therapeutics, Inc.·Phase 2·NCT02340156·1 enrolled

Adavosertib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed or Recurrent Glioblastoma

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01849146·74 enrolled

A Study of BBI608 in Combination With Temozolomide in Adult Patients With Recurrent or Progressed Glioblastoma

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 1/2·NCT02315534·34 enrolled

Pembrolizumab and Vorinostat Combined With Temozolomide for Newly Diagnosed Glioblastoma

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT03426891·21 enrolled

Ketogenic Diet With Radiation and Chemotherapy for Newly Diagnosed Glioblastoma

Terminated·SSt. Joseph's Hospital and Medical Center, Phoenix·Phase 1/2·NCT02046187·14 enrolled

Chlorpromazine and Standard of Care in Glioblastoma

Completed·MMohammed Milhem·Phase 1·NCT05190315·10 enrolled

Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma

Completed·CCelldex Therapeutics·Phase 3·NCT01480479·745 enrolled

Radiation Therapy and Temsirolimus or Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT01019434·111 enrolled

Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Methylated Gene Promoter Status

Completed· EMD Serono logo

EMD Serono·Phase 3·NCT00689221·545 enrolled

NovoTTF-200A and Temozolomide Chemoradiation for Newly Diagnosed Glioblastoma

Completed·HHackensack Meridian Health·Phase 1·NCT03232424·12 enrolled

A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma

Completed· Roche logo

Roche·Phase 3·NCT00943826·921 enrolled

PTK787/ZK 222584 in Combination With Temozolomide and Radiation in Patients With Glioblastoma Taking Enzyme-Inducing Anti-Epileptic Drugs

Completed·MMassachusetts General Hospital·Phase 1·NCT00385853·19 enrolled

Neo-adjuvant Treatment With Temozolomide and Bevacizumab Previous to Temozolomide Plus Radiation Plus Bevacizumab Therapy in Unresectable Glioblastoma

Completed·GGrupo Español de Investigación en Neurooncología·Phase 2·NCT01102595·102 enrolled

Temozolomide vs. Temozolomide and Thalidomide Treatment in Recurrent Glioblastoma

Unknown status·UUniversity of Zurich·Phase 2·NCT00521482·40 enrolled

Safety and Efficacy of L19TNF Plus Temozolomide Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma

Recruiting·PPhilogen S.p.A.·Phase 1/2·NCT04443010·226 enrolled

Olaparib and Temozolomide in Treating Patients With Relapsed Glioblastoma

Completed·CCancer Research UK·Phase 1·NCT01390571·34 enrolled

Cisplatin Plus Temozolomide Compared With Temozolomide in Patients With MGMT Promotor Unmethylated Glioblastoma

Unknown status·ZZhongnan Hospital·Phase 1/2·NCT06186440·60 enrolled

Study to Evaluate Ibudilast and TMZ Combo Treatment in Newly Diagnosed and Recurrent Glioblastoma

Completed·MMediciNova·Phase 1/2·NCT03782415·64 enrolled

Autologous CMV-Specific Cytotoxic T Cells and Temozolomide in Treating Patients With Glioblastoma

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT02661282·65 enrolled

Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM)

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT03018288·90 enrolled

Avastin/Radiation (XRT)/Temozolomide (Temodar) Followed by Avastin/Temodar/Topotecan for Glioblastoma

Completed·—·Phase 2·NCT01004874·80 enrolled

A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification

Completed· AbbVie logo

AbbVie·Phase 3·NCT02573324·691 enrolled

Temozolomide Plus Bevacizumab in Supratentorial Glioblastoma in 70 Years and Older Patients With an Impaired Functional Status

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT02898012·70 enrolled

AGuIX Nanoparticles With Radiotherapy Plus Concomitant Temozolomide in the Treatment of Newly Diagnosed Glioblastoma

Active, not recruiting·CCentre Jean Perrin·Phase 1/2·NCT04881032·66 enrolled

Study of Bevacizumab Plus Temodar and Tarceva in Patients With Glioblastoma or Gliosarcoma

Completed·UUniversity of California, San Francisco·Phase 2·NCT00525525·74 enrolled

Tolerability of Cannabis in Patients Receiving Concurrent Chemoradiation for Glioblastoma

Terminated·NNew York State Psychiatric Institute·Phase 1·NCT03246113·1 enrolled

Selinexor (KPT-330) in Combination With Temozolomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT04216329·11 enrolled

Neoadjuvant Chemoradiotherapy With or Without Concurrent Azeliragon in Patients With Newly Diagnosed Glioblastoma

Recruiting·WWashington University School of Medicine·Phase 1·NCT06831526·12 enrolled

Glioma28 trials

Study of NovoTTF-200A Alone and With Temozolomide in Patients With Low-Grade Gliomas

Terminated·SSantosh Kesari·Phase 1·NCT02507232·2 enrolled

Mibefradil Dihydrochloride and Temozolomide in Treating Patients With Recurrent Glioma

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT01480050·28 enrolled

Ultra-low Dose Bevacizumab Plus Temozolomide for Recurrent High-grade Gliomas

Unknown status·HHebei Yanda Hospital·N/A·NCT02416999·30 enrolled

Show 25 more trials

Vorinostat, Temozolomide, or Bevacizumab in Combination With Radiation Therapy Followed by Bevacizumab and Temozolomide in Young Patients With Newly Diagnosed High-Grade Glioma

Completed·NNational Cancer Institute (NCI)·Phase 2/3·NCT01236560·101 enrolled

Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma

Active, not recruiting·EEastern Cooperative Oncology Group·Phase 3·NCT00978458·540 enrolled

A Phase I Study of High-dose L-methylfolate in Combination With Temozolomide and Bevacizumab in Recurrent High Grade Glioma

Completed·VVanderbilt-Ingram Cancer Center·Phase 1·NCT01891747·14 enrolled

The Toca 5 Trial: Toca 511 & Toca FC Versus Standard of Care in Patients With Recurrent High Grade Glioma

Terminated·TTocagen Inc.·Phase 2/3·NCT02414165·403 enrolled

rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-severe Lymphopenic Gliomas Following Radiation and Temozolomide

Active, not recruiting·WWashington University School of Medicine·Phase 1/2·NCT03687957·42 enrolled

Combination Chemotherapy and Radiation Therapy in Treating Younger Patients Who Are Undergoing an Autologous Stem Cell Transplant for Newly Diagnosed Gliomas

Completed·—·N/A·NCT00253487

Autologous Stem Cell Collection and Reinfusion in Newly Diagnosed High Grade Gliomas

Withdrawn·WWashington University School of Medicine·Phase 1·NCT02976441

DB107-RRV, DB107-FC, and Radiation Therapy With or Without Temozolomide (TMZ) for High Grade Glioma

Recruiting·UUniversity of California, San Francisco·Phase 1/2·NCT06504381·70 enrolled

Plerixafor After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed High Grade Glioma

Completed·LLawrence Recht·Phase 1/2·NCT01977677·30 enrolled

Radiation Therapy, Arsenic Trioxide, and Temozolomide in Treating Patients With Newly Diagnosed High-Grade Glioma

Completed·—·Phase 1·NCT00720564·18 enrolled

A Phase III Trial on Adjuvant Temozolomide With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas

Unknown status·SSun Yat-sen University·Phase 3·NCT01765088·300 enrolled

BGB-290 and Temozolomide in Treating Patients With Recurrent Gliomas With IDH1/2 Mutations

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1/2·NCT03914742·67 enrolled

BGB-290 and Temozolomide in Treating Isocitrate Dehydrogenase (IDH)1/2-Mutant Grade I-IV Gliomas

Active, not recruiting·UUniversity of California, San Francisco·Phase 1·NCT03749187·78 enrolled

Lonafarnib and Temozolomide in Treating Patients With Recurrent Primary Supratentorial Gliomas

Unknown status·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 1·NCT00083096·30 enrolled

Prolonged Daily Temozolomide for Low-Grade Glioma

Completed·—·Phase 2·NCT00165360·46 enrolled

Radiation Therapy or Temozolomide in Treating Patients With Gliomas

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00182819·709 enrolled

Temozolomide and Radiation Therapy in Treating Young Patients With Pontine Glioma

Unknown status·CChildren's Cancer and Leukaemia Group·Phase 2·NCT00514397·43 enrolled

O6-Benzylguanine and Temozolomide in Treating Young Patients With Recurrent or Progressive Gliomas or Brain Stem Tumors

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00275002·41 enrolled

Temozolomide in Treating Patients With Low-Grade Glioma

Completed·UUniversity of California, San Francisco·Phase 2·NCT00313729·120 enrolled

Veliparib, Radiation Therapy, and Temozolomide in Treating Younger Patients With Newly Diagnosed Diffuse Pontine Gliomas

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT01514201·66 enrolled

Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH)

Active, not recruiting·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00626990·751 enrolled

Temozolomide and Carmustine in Treating Patients With Anaplastic Glioma

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT00003176·82 enrolled

Enzastaurin and Temozolomide in Treating Patients With Primary Gliomas

Unknown status·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 1·NCT00516607·28 enrolled

Gefitinib Plus Temozolomide in Treating Patients With Malignant Primary Glioma

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT00027625

A Phase II Study of Gliadel, Concomitant Temozolomide and Radiation, Followed By Dose Dense Therapy With Temozolomide For Newly Diagnosed Malignant High Grade Glioma

Unknown status·KKentuckiana Cancer Institute·Phase 2·NCT00660283·20 enrolled

Glioblastoma Multiforme19 trials

Phase I/II Evaluation of Temozolomide and ZARNESTRA (R115777) for Recurrent and Progressive Glioblastoma Multiforme

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT00050986·55 enrolled

Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma Multiforme

Completed·CCelldex Therapeutics·Phase 2·NCT00458601·82 enrolled

Radiation Therapy With or Without Temozolomide in Treating Older Patients With Newly Diagnosed Glioblastoma Multiforme

Completed·CCanadian Cancer Trials Group·Phase 3·NCT00482677·562 enrolled

Show 16 more trials

Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Completed·—·Phase 2·NCT00047294

Hydroxychloroquine, Radiation, and Temozolomide Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1/2·NCT00486603·92 enrolled

Vorinostat, Isotretinoin and Temozolomide in Adults With Recurrent Glioblastoma Multiforme (GBM)

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT00555399·55 enrolled

Dasatinib or Placebo, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Completed·AAlliance for Clinical Trials in Oncology·Phase 1/2·NCT00869401·217 enrolled

Radiation Boost for Newly Diagnosed Glioblastoma Multiforme

Terminated·MMethodist Healthcare·Phase 1/2·NCT00376103·3 enrolled

Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme

Completed·—·Phase 2·NCT00003464·50 enrolled

Tipifarnib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT02227901·19 enrolled

Erlotinib Compared With Temozolomide or Carmustine in Treating Patients With Recurrent Glioblastoma Multiforme

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT00086879·110 enrolled

A Phase I Trial of High-Dose Ascorbate in Glioblastoma Multiforme

Completed·—·Phase 1·NCT01752491·13 enrolled

Temozolomide, Memantine Hydrochloride, Mefloquine, and Metformin Hydrochloride in Treating Patients With Glioblastoma Multiforme After Radiation Therapy

Terminated·MM.D. Anderson Cancer Center·Phase 1·NCT01430351·144 enrolled

Prinomastat Plus Temozolomide Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Completed· Pfizer logo

Pfizer·Phase 2·NCT00004200

CT-322 in Combination With Radiation Therapy and Temozolomide to Treat Newly Diagnosed Glioblastoma Multiforme

Unknown status·AAdnexus, A Bristol-Myers Squibb R&D Company·Phase 1·NCT00768911·30 enrolled

Temozolomide + Everolimus in Newly Diagnosed, Recurrent, or Progressive Malignant Glioblastoma Multiforme

Completed·NNCIC Clinical Trials Group·Phase 1·NCT00387400·32 enrolled

Vorinostat, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT00731731·125 enrolled

Temozolomide and Radiation Therapy With or Without Vatalanib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 1/2·NCT00128700·20 enrolled

Temozolomide Plus Carboplatin in Treating Patients With Recurrent Glioblastoma Multiforme

Withdrawn·FFox Chase Cancer Center·Phase 1/2·NCT00021307

Melanoma11 trials

Temozolomide and Sorafenib in Treating Patients With Metastatic or Unresectable Melanoma

Completed·—·Phase 2·NCT00602576·169 enrolled

Trial for Vaccine Therapy With Dendritic Cells in Patients With Metastatic Malignant Melanoma

Terminated·SSteinar Aamdal·Phase 1/2·NCT00961844·15 enrolled

Chemotherapy Followed by Biological Therapy in Treating Patients With Stage IV Melanoma That Cannot be Treated With Surgery

Completed·—·Phase 2·NCT00014092

Show 8 more trials

Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Participants With Advanced Melanoma (MK-3475-002/P08719/KEYNOTE-002)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT01704287·540 enrolled

A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2)

Active, not recruiting·EErasca, Inc.·Phase 3·NCT06346067·78 enrolled

Individualized Temozolomide in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery

Completed·MMayo Clinic·Phase 2·NCT01328535·25 enrolled

Bortezomib and Temozolomide in Treating Patients With Advanced Refractory Solid Tumors or Melanoma

Terminated·VVanderbilt-Ingram Cancer Center·Phase 1/2·NCT00512798·47 enrolled

Sorafenib and Temozolomide in Treating Patients With Stage III or Stage IV Melanoma

Unknown status·GGustave Roussy, Cancer Campus, Grand Paris·Phase 1/2·NCT00811759·58 enrolled

Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV Melanoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00027742

Temozolomide and Thalidomide in Treating Patients With Stage III or Stage IV Melanoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT00005815

Temozolomide and Bevacizumab in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery

Completed·SSwiss Cancer Institute·Phase 2·NCT00568048·62 enrolled

Malignant Glioma10 trials

Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma

Completed·—·Phase 1·NCT00005951

Temozolomide Compared to Procarbazine, Lomustine, and Vincristine in Treating Patients With Recurrent Malignant Glioma

Completed·IInstitute of Cancer Research, United Kingdom·Phase 3·NCT00052455·500 enrolled

Temozolomide Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Malignant Glioma or Recurrent CNS or Other Solid Tumors

Completed·—·Phase 1/2·NCT00005952·30 enrolled

Show 7 more trials

Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma

Unknown status·KKentuckiana Cancer Institute·Phase 2·NCT00283543·40 enrolled

Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma

Completed· AbbVie logo

AbbVie·Phase 1/2·NCT02590263·53 enrolled

Study of Acetazolamide With Temozolomide in Adults With Newly Diagnosed or Recurrent Malignant Glioma

Completed·UUniversity of Chicago·Phase 1·NCT03011671·10 enrolled

Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma

Unknown status·HHerbert Irving Comprehensive Cancer Center·Phase 2·NCT00004204

O6-Benzylguanine-Mediated Tumor Sensitization With Chemoprotected Autologous Stem Cell in Treating Patients With Malignant Gliomas

Terminated·FFred Hutchinson Cancer Center·Phase 1/2·NCT00669669·12 enrolled

The Effects of Continuous 28-day (28/28) Temozolomide Chemotherapy in Subjects With Recurrent Malignant Glioma Who Have Failed the Conventional 5-day (5/28) Treatment (P04601)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00392171·120 enrolled

Imatinib Mesylate and Temozolomide in Treating Patients With Malignant Glioma

Completed·—·Phase 1·NCT00354068·65 enrolled

56 more indications

Metastatic Melanoma6 trials

Biological Therapy and Temozolomide in Treating Patients With Metastatic Melanoma

Unknown status·SSt. Luke's Medical Center·Phase 1·NCT00016055·18 enrolled

Temozolomide and Bevacizumab in Treating Patients With Metastatic Melanoma of the Eye

Unknown status·IInstitut Curie·Phase 2·NCT01217398·35 enrolled

A Study Evaluating Efficacy of ABT-888 in Combination With Temozolomide in Metastatic Melanoma

Completed· AbbVie logo

AbbVie·Phase 2·NCT00804908·346 enrolled

Show 3 more trials

Temozolomide Plus Bevacizumab in Patients With Metastatic Melanoma Involving the Central Nervous System

Completed·MMt. Sinai Medical Center, Miami·Phase 2·NCT01048554·34 enrolled

Gamma-secretase/Notch Signalling Pathway Inhibitor RO4929097 in Combination With Cisplatin, Vinblastine, and Temozolomide in Treating Patients With Recurrent or Metastatic Melanoma

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT01196416·14 enrolled

Temozolomide or Selumetinib in Treating Patients With Metastatic Melanoma of the Eye

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01143402·120 enrolled

Small Cell Lung Cancer5 trials

Temozolomide as Maintenance Therapy in Small Cell Lung Cancer

Unknown status·—·Phase 2·NCT01900951·60 enrolled

An Umbrella Study of Recurrent, Extensive Stage Small Cell Lung Cancer Based on Molecular Typing

Not yet recruiting·—·Phase 1/2·NCT07141771·100 enrolled

Temozolomide as Maintenance Therapy Following Induction Chemotherapy in Extensive Stage Small Cell Lung Cancer

Unknown status·—·Phase 2/3·NCT02772107·132 enrolled

Show 2 more trials

A Study of Fluzoparib (SHR-3162) and Temozolomide With or Without SHR-1316 in Treating Patients With Replapsed Small Cell Lung Cancer

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 1/2·NCT04400188·25 enrolled

HTMC0435 and Temozolomide in Treating Patients With Small Cell Lung Cancer

Unknown status·SShanghai Yidian Pharmaceutical Technology Development Co., Ltd.·Phase 1/2·NCT05728619·64 enrolled

Pancreatic Neuroendocrine Tumor4 trials

Temozolomide With or Without Capecitabine in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors

Active, not recruiting·EECOG-ACRIN Cancer Research Group·Phase 2·NCT01824875·144 enrolled

Temozolomide and Pazopanib Hydrochloride in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors That Cannot Be Removed By Surgery

Completed·NNorthwestern University·Phase 1/2·NCT01465659·29 enrolled

Capecitabine, Temozolomide, and Bevacizumab for Metastatic or Unresectable Pancreatic Neuroendocrine Tumors

Completed·SShaheen Shagufta·Phase 2·NCT01525082·20 enrolled

Show 1 more trial

RAD001 and Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors

Completed·—·Phase 1/2·NCT00576680·43 enrolled

Breast Cancer4 trials

Temozolomide as a Prophylaxis Against Brain Recurrence in Participants With Metastatic Breast Cancer (P05225 AM2)

Terminated· Merck & Co. logo

Merck & Co.·Phase 2·NCT00638963·6 enrolled

Irinotecan and Temozolomide in Treating Patients With Breast Cancer Who Have Received Previous Treatment for Brain Metastases

Completed·UUniversity of California, San Francisco·Phase 2·NCT00617539·30 enrolled

Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer

Completed· AbbVie logo

AbbVie·Phase 2·NCT01506609·294 enrolled

Show 1 more trial

Radiation Therapy With or Without Temozolomide in Treating Women With Brain Metastases and Breast Cancer

Unknown status·IInstitut Curie·Phase 2·NCT00875355·100 enrolled

Temozolomide4 trials

Temodal (Temozolomide) Post Marketing Surveillance Protocol (Study P05557AM2)

Completed· Merck & Co. logo

Merck & Co.··NCT00723827·682 enrolled

Safety of TAS-102 in Combination With Temozolomide for Metastatic Pancreatic NETs

Terminated·UUniversity of Wisconsin, Madison·Phase 1·NCT02943733·18 enrolled

A Phase I Study of ABT-888, an Oral Inhibitor of Poly(ADP-ribose) Polymerase and Temozolomide in Children With Recurrent/Refractory CNS Tumors

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00994071·9 enrolled

Show 1 more trial

Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide

Completed·—·Phase 1·NCT00629343·27 enrolled

Radiation Therapy4 trials

Gliadel Wafer, Temozolomide and Radiation Therapy for Newly Diagnosed GBM

Terminated·MMethodist Healthcare·Phase 2·NCT00548938·40 enrolled

Radiation Therapy and Temozolomide Followed by Temozolomide and Poly ICLC in Treating Patients With Newly Diagnosed GBM

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT00262730·97 enrolled

Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases

Completed·WWake Forest University Health Sciences·Phase 2·NCT00049361

Show 1 more trial

Radiation Therapy Combined With Either Gefitinib or Temozolomide in Pats With NSCLC and Brain Metastases

Completed·SSwiss Cancer Institute·Phase 2·NCT00238251·59 enrolled

Neuroblastoma4 trials

Clinical Analysis of Naxitamab (hu3F8) in the Treatment of Pediatric High Risk or Refractory/ Relapsed Neuroblastoma

Recruiting·SSun Yat-Sen University Cancer Center·Phase 2·NCT06013618·120 enrolled

Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Dinutuximab in Treating Younger Patients With Refractory or Relapsed Neuroblastoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01767194·73 enrolled

N2003-01: Irinotecan, Temozolomide, and Cefixime in Treating Young Patients With Recurrent or Resistant Neuroblastoma

Completed·—·Phase 1·NCT00093353·30 enrolled

Show 1 more trial

Irinotecan and Temozolomide in Treating Young Patients With Recurrent Neuroblastoma

Completed·CChildren's Oncology Group·Phase 2·NCT00311584·59 enrolled

Newly Diagnosed3 trials

Zactima With Temodar During Radiation Treatment for Newly Diagnosed Stage IV Brain Tumors

Completed·PPatrick Y. Wen, MD·Phase 1/2·NCT00441142·119 enrolled

Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM

Recruiting·—·Phase 1·NCT02287428·56 enrolled

Phase II/III Trial of CCRT With or Without JP001 for Newly Diagnosed GBM

Unknown status·JJohnpro Biotech, Inc.·Phase 2/3·NCT03008148·288 enrolled

Rhabdomyosarcoma3 trials

FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma

Recruiting·UUniversity of Birmingham·Phase 1/2·NCT04625907·1,672 enrolled

Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01055314·175 enrolled

Treatment of Newly Diagnosed Rhabdomyosarcoma Using Molecular Risk Stratification and Liposomal Irinotecan Based Therapy in Children With Intermediate and High Risk Disease

Recruiting·SSt. Jude Children's Research Hospital·Phase 2·NCT06023641·135 enrolled

Non-Small Cell Lung Cancer3 trials

Temozolomide in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-small Cell Lung Cancer

Completed·FFox Chase Cancer Center·Phase 2·NCT00005037·51 enrolled

Radiation Therapy and Stereotactic Radiosurgery With or Without Temozolomide or Erlotinib in Treating Patients With Brain Metastases Secondary to Non-Small Cell Lung Cancer

Terminated·NNational Cancer Institute (NCI)·Phase 3·NCT00096265·126 enrolled

Temozolomide for Treatment of Brain Metastases From Non-Small Cell Lung Cancer (Study P03247)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00076856·95 enrolled

Ewing sarcoma3 trials

Irinotecan and Temozolomide for Ewing Sarcoma

Unknown status·PPeking University People's Hospital·Phase 2·NCT03359005·60 enrolled

ESP1/SARC025 Global Collaboration: A Phase I Study of a Combination of the PARP Inhibitor, Niraparib and Temozolomide and/or Irinotecan Patients With Previously Treated, Incurable Ewing Sarcoma

Completed·SSarcoma Alliance for Research through Collaboration·Phase 1·NCT02044120·34 enrolled

Irinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT01864109·83 enrolled

Refractory Solid Tumors3 trials

Temsirolimus, Irinotecan Hydrochloride, and Temozolomide in Treating Younger Patients With Relapsed or Refractory Solid Tumors

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01141244·72 enrolled

A Phase Ib Trial of Eribulin in Combination With Irinotecan and Temozolamide in Children With Relapsed or Refractory Solid Tumors

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT06006273·48 enrolled

Metformin in Children With Relapsed or Refractory Solid Tumors

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT01528046·26 enrolled

Low Grade Glioma2 trials

Trial in Low Grade Glioma Patients: Wait or Treat

Terminated·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT03763422·19 enrolled

Everolimus With and Without Temozolomide in Adult Low Grade Glioma

Terminated·UUniversity of California, San Francisco·Phase 2·NCT02023905·27 enrolled

Relapsed or Refractory2 trials

Talabostat Combined With Temozolomide or Carboplatin in Treating Young Patients With Relapsed or Refractory Brain Tumors or Other Solid Tumors

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 1·NCT00303940·26 enrolled

Vorinostat and Temozolomide in Treating Young Patients With Relapsed or Refractory Primary Brain Tumors or Spinal Cord Tumors

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01076530·27 enrolled

Ewing's Sarcoma2 trials

Aerosol L9-NC and Temozolomide in Ewing's Sarcoma

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT00492141·10 enrolled

Phase I Study of Olaparib and Temozolomide for Ewings Sarcoma or Rhabdoomyosarcoma

Completed·MMassachusetts General Hospital·Phase 1·NCT01858168·49 enrolled

Lymphoma2 trials

Rituximab, Temozolomide, and Methylprednisolone in Treating Patients With Recurrent Primary CNS Non-Hodgkin's Lymphoma

Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT00248534·16 enrolled

Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Primary CNS Lymphoma

Completed·UUniversity of California, San Francisco·N/A·NCT00416819·10 enrolled

Liver Cancer1 trial

ABT-888 and Temozolomide for Liver Cancer

Terminated·GGeorgetown University·Phase 2·NCT01205828·16 enrolled

Central Nervous System Lymphoma1 trial

Rituximab, Lenalidomide Combined With Methotrexate and Temozolomide For Primary Central Nervous System Lymphoma

Recruiting·HHenan Cancer Hospital·Phase 2·NCT04737889·30 enrolled

First-line Treatment1 trial

Extensive Stage Sclc Patients Who Were Benefit From First-line Treatment Accept Temozolomide Maintain Therapeutic

Unknown status·YYunpeng Liu·Phase 2·NCT02972320·60 enrolled

Advanced Solid Tumors1 trial

A Safety Study in Participants With Advanced Solid Tumors

Terminated· Eli Lilly logo

Eli Lilly·Phase 1·NCT01284335·234 enrolled

Recurrent or Refractory Solid Tumors1 trial

Erlotinib and Temozolomide in Treating Young Patients With Recurrent or Refractory Solid Tumors

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00077454·95 enrolled

Locally-advanced Rectal Cancer1 trial

Preoperative Chemoradiotherapy With CApecitabine and Temozolomide in MGMT Silenced, MSS, Locally Advanced RecTal Cancer

Recruiting·FFondazione IRCCS Istituto Nazionale dei Tumori, Milano·Phase 2·NCT05136326·21 enrolled

Neuroendocrine Tumors1 trial

Bevacizumab in Combination With Temozolomide in Patients With Neuroendocrine Tumors

Completed·—·Phase 2·NCT00137774·34 enrolled

Soft Tissue Sarcoma1 trial

Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma

Unknown status·HHerbert Irving Comprehensive Cancer Center·Phase 2·NCT00003718·25 enrolled

Medulloblastoma1 trial

Study of Vismodegib in Combination With Temozolomide Versus Temozolomide Alone in Patients With Medulloblastomas With an Activation of the Sonic Hedgehog Pathway

Terminated·CCentre Leon Berard·Phase 1/2·NCT01601184·24 enrolled

Leiomyosarcoma1 trial

Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma

Unknown status·HHerbert Irving Comprehensive Cancer Center·Phase 2·NCT00033709

Malignancies1 trial

Talazoparib and Temozolomide in Treating Younger Patients With Refractory or Recurrent Malignancies

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT02116777·40 enrolled

Efficacy1 trial

Randomised Study to Compare the Efficacy of AZD6244 vs TMZ

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00338130·239 enrolled

Acute Leukemia1 trial

Veliparib and Temozolomide in Treating Patients With Acute Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01139970·66 enrolled

Lung Cancer1 trial

Safety and Tolerability of Low-Dose Temozolomide During Whole Brain Radiation in Patients With Cerebral Metastases From Non-Small-Cell Lung Cancer (Study P04071)(TERMINATED)

Terminated· Merck & Co. logo

Merck & Co.·Phase 2·NCT00266812·35 enrolled

Malignant Brain Tumors1 trial

Study of IDO Inhibitor and Temozolomide for Adult Patients With Primary Malignant Brain Tumors

Completed·NNewLink Genetics Corporation·Phase 1/2·NCT02052648·160 enrolled

Brain Tumors1 trial

FMISO-PET in Brain Tumors and SCS Effect

Terminated·—·Phase 2·NCT01868906·6 enrolled

Brain Metastases1 trial

Temozolomide in Treating Patients With Brain Metastases

Completed·—·Phase 2·NCT00005954

Locally Advanced or Metastatic Solid Tumors1 trial

PARP Inhibitor BMN-673 and Temozolomide or Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic Solid Tumors

Completed·JJonsson Comprehensive Cancer Center·Phase 1·NCT02049593·44 enrolled

Patients With Advanced Solid Tumors1 trial

Methoxyamine and Temozolomide in Treating Patients With Advanced Solid Tumors

Completed·—·Phase 1·NCT00892385·66 enrolled

Acute Myeloid Leukemia1 trial

Temozolomide Plus Vorinostat in Relapse/Refractory Acute Myeloid Leukemia (AML)

Completed·SSteven E. Coutre·Phase 2·NCT01550224·23 enrolled

Stem Cell Transplantation1 trial

Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Brain Tumor

Withdrawn·NNYU Langone Health·Phase 2·NCT00003273

Anaplastic Astrocytoma1 trial

SCH 52365 Phase II Clinical Study: A Study on the Efficacy and Safety of Monotherapy With SCH 52365 in Patients With First Relapsed Anaplastic Astrocytoma (Study P03745)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00783393·32 enrolled

Chemoradiotherapy1 trial

HSRT and IMRT Chemoradiotherapy for Newly Diagnosed GBM

Unknown status·HHuashan Hospital·Phase 1/2·NCT04547621·50 enrolled

Leukemia1 trial

Temozolomide and VNP40101M in Treating Patients With Relapsed or Refractory Leukemias

Completed·VVion Pharmaceuticals·Phase 1·NCT00098436·25 enrolled

Bevacizumab1 trial

Bevacizumab Beyond Progression (BBP)

Completed·—·Phase 2·NCT01740258·68 enrolled

Safety and Efficacy1 trial

Study of the Safety and Efficacy of MK-4827 Given With Temozolomide in Participants With Advanced Cancer (MK-4827-014 AM1)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01294735·19 enrolled

Anaplastic Oligodendroglioma1 trial

Temozolomide in Treating Patients With Anaplastic Oligodendroglioma

Completed·—·Phase 2·NCT00003465·60 enrolled

Germ Cell Tumor1 trial

Temozolomide in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to Cisplatin

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00006043

Chemotherapy1 trial

Temozolomide in Concomitant Radiochemotherapy Followed by Sequential Temozolomide Chemotherapy - Observational Program (Study P04816)

Completed· Merck & Co. logo

Merck & Co.··NCT00725010·64 enrolled

Astrocytoma1 trial

Phase III Trial of Primary Radio- or Chemotherapy in Malignant Astrocytoma of the Elderly

Completed·HHeidelberg University·Phase 3·NCT01502241·412 enrolled

Neurocognitive Function1 trial

Quality of Life and Neurocognitive Functioning

Completed·IInstitut du Cancer de Montpellier - Val d'Aurelle·N/A·NCT03257618·26 enrolled

Central Nervous System Tumor1 trial

RRx-001 Given With Irinotecan and Temozolomide for Pediatric Patients With Recurrent or Progressive Malignant Solid and Central Nervous System Tumors

Terminated·EEpicentRx, Inc.·Phase 1·NCT04525014·2 enrolled

Colorectal Cancer1 trial

A Study of ABT-888 in Combination With Temozolomide for Colorectal Cancer

Completed·GGeorgetown University·Phase 2·NCT01051596·75 enrolled

Avutometinib1 trial

5G-RUBY: Avutometinib and Defactinib in Malignant Brain Tumours

Recruiting·IInstitute of Cancer Research, United Kingdom·Phase 1/2·NCT06630260·182 enrolled

Metastatic Prostate Cancer1 trial

A Study Combining ABT-888, Oral PARP Inhibitor, With Temozolomide in Patients With Metastatic Prostate Cancer

Completed· AbbVie logo

AbbVie·Phase 1·NCT01085422·35 enrolled

Adult Brainstem Glioma1 trial

First-line Chemotherapy With Temozolomide Alone for Non-enhancing Adult Brainstem Gliomas, With a Diffuse Subtype and Showing Clinical and/or Radiological Infiltrative Pattern of Progression

Unknown status·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT03932981·60 enrolled

Gastric Cancer1 trial

Temozolomide + Nivolumab in MGMT Methylated Oesophagogastric Cancer

Recruiting·UUniversity of Southampton·Phase 2·NCT04984733·18 enrolled

Solid Tumors1 trial

Temozolomide and O6-benzylguanine in Treating Children With Solid Tumors

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00020150

Neoadjuvant Treatment1 trial

A Study on the Safety and Effectiveness of Temozolomide for Neoadjuvant Treatment of PPGL

Unknown status·PPeking Union Medical College Hospital·Phase 2·NCT05885386·20 enrolled

Brain Cancer1 trial

A Longitudinal Assessment of Tumor Evolution in Patients With Brain Cancer

Completed·SSaint John's Cancer Institute·Phase 1·NCT03425292·49 enrolled

Regulatory

FDA Approval Timeline[5]

Aug 11, 1999

TEMODAR

NDA NDA021029

Aug 11, 1999

TEMODAR

NDA NDA021029

May 18, 2001

TEMODAR

NDA NDA021029

Jan 18, 2002

TEMODAR

NDA NDA021029

Mar 5, 2002

TEMODAR

NDA NDA021029

Mar 11, 2003

TEMODAR

NDA NDA021029

Jun 29, 2004

TEMODAR

NDA NDA021029

Jul 15, 2004

TEMODAR

NDA NDA021029

Mar 15, 2005

TEMODAR

NDA NDA021029

Mar 30, 2005

TEMODAR

NDA NDA021029

Apr 22, 2005

TEMODAR

NDA NDA021029

Mar 31, 2006

TEMODAR

NDA NDA021029

Oct 19, 2006

TEMODAR

NDA NDA021029

Feb 27, 2009

TEMODAR

NDA NDA022277

Apr 26, 2010

TEMODAR

NDA NDA022277

Apr 26, 2010

TEMODAR

NDA NDA021029

Feb 4, 2011

TEMODAR

NDA NDA021029

Feb 4, 2011

TEMODAR

NDA NDA022277

Jun 3, 2011

TEMODAR

NDA NDA022277

Jun 3, 2011

TEMODAR

NDA NDA021029

Jan 8, 2013

TEMODAR

NDA NDA021029

Oct 10, 2013

TEMODAR

NDA NDA021029

Mar 20, 2014

TEMODAR

NDA NDA021029

May 5, 2014

TEMODAR

NDA NDA021029

May 5, 2014

TEMODAR

NDA NDA022277

Sep 19, 2014

TEMODAR

NDA NDA021029

Apr 2, 2015

TEMODAR

NDA NDA022277

Apr 2, 2015

TEMODAR

NDA NDA021029

Sep 18, 2015

TEMODAR

NDA NDA021029

Sep 18, 2015

TEMODAR

NDA NDA022277

Feb 12, 2016

TEMODAR

NDA NDA021029

Feb 12, 2016

TEMODAR

NDA NDA022277

Feb 24, 2017

TEMODAR

NDA NDA022277

Feb 24, 2017

TEMODAR

NDA NDA021029

Oct 6, 2017

TEMODAR

NDA NDA021029

Oct 6, 2017

TEMODAR

NDA NDA022277

Nov 22, 2019

TEMODAR

NDA NDA021029

Nov 22, 2019

TEMODAR

NDA NDA022277

Nov 20, 2020

TEMODAR

NDA NDA021029

Nov 20, 2020

TEMODAR

NDA NDA022277

Sep 14, 2023

TEMODAR

NDA NDA022277

Sep 14, 2023

TEMODAR

NDA NDA021029

Sep 14, 2023

TEMODAR

NDA NDA021029

Sep 14, 2023

TEMODAR

NDA NDA022277

Sep 14, 2023

TEMODAR

NDA NDA021029

Sep 14, 2023

TEMODAR

NDA NDA022277

Sources

References

[1]
ClinicalTrials.gov — 756 trial records for temozolomide. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Temodar drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — temozolomide compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for temozolomide. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022277). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Temodar

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Trials by Indication[1]

Glioblastoma38 trials

Glioma28 trials

Glioblastoma Multiforme19 trials

Melanoma11 trials

Malignant Glioma10 trials

Metastatic Melanoma6 trials

Small Cell Lung Cancer5 trials

Pancreatic Neuroendocrine Tumor4 trials

Breast Cancer4 trials

Temozolomide4 trials

Radiation Therapy4 trials

Neuroblastoma4 trials

Newly Diagnosed3 trials

Rhabdomyosarcoma3 trials

Non-Small Cell Lung Cancer3 trials

Ewing sarcoma3 trials

Refractory Solid Tumors3 trials

Low Grade Glioma2 trials

Relapsed or Refractory2 trials

Ewing's Sarcoma2 trials

Lymphoma2 trials

Liver Cancer1 trial

Central Nervous System Lymphoma1 trial

First-line Treatment1 trial

Advanced Solid Tumors1 trial

Recurrent or Refractory Solid Tumors1 trial

Locally-advanced Rectal Cancer1 trial

Neuroendocrine Tumors1 trial

Soft Tissue Sarcoma1 trial

Medulloblastoma1 trial

Leiomyosarcoma1 trial

Malignancies1 trial

Efficacy1 trial

Acute Leukemia1 trial

Lung Cancer1 trial

Malignant Brain Tumors1 trial

Brain Tumors1 trial

Brain Metastases1 trial

Locally Advanced or Metastatic Solid Tumors1 trial

Patients With Advanced Solid Tumors1 trial

Acute Myeloid Leukemia1 trial

Stem Cell Transplantation1 trial

Anaplastic Astrocytoma1 trial

Chemoradiotherapy1 trial

Leukemia1 trial

Bevacizumab1 trial

Safety and Efficacy1 trial

Anaplastic Oligodendroglioma1 trial

Germ Cell Tumor1 trial

Chemotherapy1 trial

Astrocytoma1 trial

Neurocognitive Function1 trial

Central Nervous System Tumor1 trial

Colorectal Cancer1 trial

Avutometinib1 trial

Metastatic Prostate Cancer1 trial

Adult Brainstem Glioma1 trial

Gastric Cancer1 trial

Solid Tumors1 trial

Neoadjuvant Treatment1 trial

Brain Cancer1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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