Temozolomide clinical trials
Temozolomide is named as an intervention in 109 current clinical trials in our USA, France, China, Italy, Spain, Canada, Germany, Australia, Netherlands, Switzerland, Israel, Belgium, Denmark, UK, Sweden, Austria, Norway, Japan, South Korea, Czechia, Mexico, Taiwan, Ireland, Brazil, Portugal, Poland and Turkey registers. 64 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Sun Yat-sen University (4). The most-studied condition is Glioblastoma. The EU clinical trials register (CTIS) separately lists 4 authorised or ongoing trials, 1 with a site in Ireland.
Where Temozolomide is approved
All regulators →Of the three regulators tracked here, the first to approve Temozolomide was the EU, on 26 Jan 1999. It is approved in 3 of the 3 regulators tracked here.
- 3 EU orphan designations, most recently for treatment of glioma (22 Aug 2025, positive)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Temozolomide
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Temozolomide works
All drug targets →- Ewing sarcomaPhase 3
- Anaplastic astrocytomaPhase 3
- Astrocytoma (excluding glioblastoma)Phase 3
- Atypical teratoid rhabdoid tumorPhase 3
- CancerPhase 3
- Choroid plexus carcinomaPhase 3
- Choroid plexus neoplasmPhase 3
- Colon carcinomaPhase 3
- Cutaneous melanomaPhase 3
- Diffuse intrinsic pontine gliomaPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL810, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7301, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Temozolomide
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Temozolomide. 2 are current, and 2 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Carmustine implants and temozolomide for the treatment of newly diagnosed high-grade glioma NICE TA121 | Recommended | 27 Jun 2007 | Current |
| Guidance on the use of temozolomide for the treatment of recurrent malignant glioma (brain cancer) NICE TA23 | Recommended | 26 Apr 2001 Updated 3 Mar 2016 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Temozolomide
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 31 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Temodal, Temomedac (generic), Temozolomide Accord (generic), Temozolomide Sun (generic), Temozolomide Teva (generic)EMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Temozolomide
- ATC code
- L01AX03
- ChEMBL
- CHEMBL810
- DrugBank
- DB00853
- PubChem CID
- 5394
- CAS number
- 85622-93-1
- FDA UNII
- YF1K15M17Y
- Wikidata
- Q425088
- Wikipedia
- Temozolomide
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Temozolomide
109 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Temozolomide in the EU trials register (CTIS)
4 trials · 1 in IrelandAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Temozolomide. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
Temozolomide across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
31 single-substance products containing Temozolomide on the HPRA medicines list.
- Temozolomide Clonmel 100mg hard capsulesClonmel Healthcare Ltd · PA0126/188/003 · Marketed
- Temozolomide Clonmel 140mg hard capsulesClonmel Healthcare Ltd · PA0126/188/004 · Marketed
- Temozolomide Clonmel 180 mg hard capsulesClonmel Healthcare Ltd · PA0126/188/005 · Marketed
- Temozolomide Clonmel 20 mg hard capsulesClonmel Healthcare Ltd · PA0126/188/002 · Marketed
- Temozolomide Clonmel 250 mg hard capsulesClonmel Healthcare Ltd · PA0126/188/006 · Marketed
Supply shortages
No entry for Temozolomide in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Temozolomide
126 conditionsAll 126 conditions
| Condition (as registered) | Trials |
|---|---|
| Glioblastoma | 28 |
| Glioblastoma Multiforme | 6 |
| Neuroblastoma | 5 |
| Ewing Sarcoma | 4 |
| Glioblastoma (GBM) | 4 |
| Glioblastoma, IDH-wildtype | 4 |
| Rhabdomyosarcoma | 3 |
| GBM | 3 |
| Glioblastoma Multiforme (GBM) | 3 |
| Recurrent Glioblastoma | 3 |
| Glioma | 3 |
| Solid Tumors | 2 |
| High-Risk Neuroblastoma | 2 |
| Mucosal Melanoma | 2 |
| Relapsed/Refractory Primary Central Nervous System Lymphoma | 2 |
| Glioblastoma Multiforme of Brain | 2 |
| Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype | 2 |
| Melanoma | 2 |
| Anaplastic Astrocytoma | 2 |
| Gliosarcoma | 2 |
| Ganglioneuroblastoma, Nodular | 2 |
| Malignant Neoplasm of Brain | 2 |
| Cancer | 1 |
| Melanoma Stage IV | 1 |
| Breast Cancer | 1 |
| Prostate Cancer | 1 |
| Advanced or Metastatic NRAS-mutant Melanoma | 1 |
| Melanoma, Cutaneous Malignant | 1 |
| Neoplasms | 1 |
| Child | 1 |
| Adolescent | 1 |
| Advanced Solid Malignancies | 1 |
| Colorectal Adenocarcinoma | 1 |
| Newly Diagnosed Glioblastoma | 1 |
| Melanoma (Skin Cancer) | 1 |
| Melanoma Stage IIIB-IV | 1 |
| Cutaneous Melanoma | 1 |
| Unresectable Melanoma | 1 |
| Progressive Pediatric Brain Cancer | 1 |
| Lymphoma | 1 |
| Sarcoma, Ewing | 1 |
| Neoplasm Metastasis | 1 |
| Recurrent Glioblastoma, IDH-Wildtype | 1 |
| Endometrial Neoplasms | 1 |
| Ovarian Neoplasms | 1 |
| Soft Tissue Sarcoma (STS) | 1 |
| Small Cell Lung Cancer | 1 |
| Diffuse Glioma | 1 |
| Astrocytoma, Grade III | 1 |
| Newly Diagnosed Glioblastoma, IDH-wildtype | 1 |
| PD-L1 Positive | 1 |
| Pediatric Solid Tumor | 1 |
| Relapsed/Refractory Glioma | 1 |
| Solid Tumor | 1 |
| Precision Medicine | 1 |
| Rhabdomyosarcoma, Child | 1 |
| Glioma (Any Grade) in the Brain | 1 |
| IDH1-mutant Glioma | 1 |
| IDH2-mutant Glioma | 1 |
| Soft Tissue Sarcoma | 1 |
| Primary Central Nervous System Lymphoma | 1 |
| Primary Central Nervous System Hodgkin Lymphoma | 1 |
| Acral Melanoma | 1 |
| Temozolomide | 1 |
| Apatinib | 1 |
| Low-grade Glioma | 1 |
| Astrocytoma, IDH-Mutant, Grade 3 | 1 |
| Astrocytoma, IDH-Mutant, Grade 4 | 1 |
| Brain and Central Nervous System Tumors | 1 |
| High Grade Glioma | 1 |
| Diffuse Intrinsic Pontine Glioma | 1 |
| Colon Cancer Stage II | 1 |
| Colon Cancer Stage III | 1 |
| Brain Neoplasms, Adult, Malignant | 1 |
| Brain Tumor | 1 |
| Patient With Insufficient Response Chemoimmunotherapy | 1 |
| Malignant Gliomas | 1 |
| Radiotherapy | 1 |
| PARP Inhibitor | 1 |
| Wilms Tumor | 1 |
| Medulloblastoma Recurrent | 1 |
| Ependymoma Recurrent | 1 |
| ATRT Recurrent | 1 |
| Rare CNS Tumor Recurrent | 1 |
| Primary Glioblastoma | 1 |
| CNS Tumor, Adult | 1 |
| CNS Tumor, Childhood | 1 |
| Pediatric Cancer | 1 |
| Pancreatic Cancer | 1 |
| Metastatic Colorectal Cancer | 1 |
| Glioma, Malignant | 1 |
| Neuroendocrine Tumors | 1 |
| Frailty | 1 |
| Chemotherapy Effect | 1 |
| Rectal Cancer | 1 |
| Diffuse Midline Glioma, H3 K27-Altered | 1 |
| Relapsed Neuroblastoma | 1 |
| MGMT-Methylated Glioblastoma | 1 |
| Recurrent Solid Tumor | 1 |
| Recurrent Ewing Sarcoma | 1 |
| Recurrent Hepatoblastoma | 1 |
| Recurrent Malignant Germ Cell Tumor | 1 |
| CNS Embryonal Tumor | 1 |
| CNS, Medulloblastoma | 1 |
| Atypical Teratoid Rhabdoid Tumor | 1 |
| Medulloblastoma, Childhood | 1 |
| Breast Cancer Triple Negative | 1 |
| Childhood Cancer | 1 |
| Childhood Solid Tumor | 1 |
| Childhood Brain Tumor | 1 |
| Recurrent Cancer | 1 |
| Osteosarcoma | 1 |
| Malignant Glioma | 1 |
| High Risk Neuroblastoma | 1 |
| Recurrent Neuroblastoma | 1 |
| Refractory Neuroblastoma | 1 |
| Metastatic Malignant Neoplasm in the Liver | 1 |
| Pancreatic Neuroendocrine Tumor | 1 |
| Stage I Pancreatic Neuroendocrine Tumor AJCC v8 | 1 |
| Stage II Pancreatic Neuroendocrine Tumor AJCC v8 | 1 |
| Gastric Neuroendocrine Carcinoma | 1 |
| Intestinal Neuroendocrine Carcinoma | 1 |
| Pancreatic Neuroendocrine Carcinoma | 1 |
| Pan-tumor | 1 |
| Gastrointestinal Stromal Tumors | 1 |
| Malignant Neoplasm | 1 |
Sponsors
lead sponsor per trial+ 75 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Temozolomide trials
How many clinical trials are testing Temozolomide?
109 current trials in our USA, France, China, Italy, Spain, Canada, Germany, Australia, Netherlands, Switzerland, Israel, Belgium, Denmark, UK, Sweden, Austria, Norway, Japan, South Korea, Czechia, Mexico, Taiwan, Ireland, Brazil, Portugal, Poland and Turkey registers name Temozolomide (also registered as L01A X03) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Temozolomide trials recruiting patients?
Yes. 64 of the 109 trials are recruiting: 16 with sites in USA, 16 with sites in France, 21 with sites in China, 13 with sites in Italy, 13 with sites in Spain, 11 with sites in Canada, 12 with sites in Germany, 11 with sites in Australia, 8 with sites in Netherlands, 8 with sites in Switzerland, 7 with sites in Israel, 7 with sites in Belgium, 7 with sites in Denmark, 6 with sites in UK, 6 with sites in Sweden, 6 with sites in Austria, 6 with sites in Norway, 4 with sites in Japan, 6 with sites in South Korea, 5 with sites in Czechia, 4 with sites in Mexico, 4 with sites in Taiwan, 3 with sites in Ireland, 2 with sites in Brazil, 2 with sites in Portugal, 1 with sites in Poland and 1 with sites in Turkey. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Temozolomide clinical trials?
Sun Yat-sen University (4), Second Affiliated Hospital, Zhejiang University, School of Medicine (4), Eli Lilly and Company (3) and Gustave Roussy, Cancer Campus, Grand Paris (3), among 90 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Temozolomide clinical trials in Ireland?
Yes. 3 trials in our Ireland register (ClinicalTrials.gov), and 1 trial in the EU register (CTIS) list a site in Ireland. Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Temozolomide licensed in Ireland?
Yes. The HPRA medicines list includes 31 single-substance products containing Temozolomide, for example Temozolomide Clonmel 100mg hard capsules (Clonmel Healthcare Ltd). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Temozolomide shortage?
Not in the lists we track: Temozolomide has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Temozolomide works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Temozolomide works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Temozolomide (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.