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Temozolomide (TMZ)
Temozolomide (TMZ) is a Alkylating agent Small molecule drug developed by Institut de Recherches Internationales Servier. It is currently in Phase 3 development for Glioblastoma multiforme (newly diagnosed and recurrent), Anaplastic astrocytoma (recurrent), Melanoma (metastatic). Also known as: Temodar, CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831.
Temozolomide is an alkylating agent that methylates DNA at the O6 position of guanine, causing DNA strand breaks and cell death.
Temozolomide is a small molecule DNA inhibitor used to treat conditions such as glioblastoma, malignant glioma, and brain and central nervous system tumors. It is typically administered in conjunction with radiotherapy as part of the treatment regimen for these conditions.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Temozolomide (TMZ) |
|---|---|
| Also known as | Temodar, CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831 |
| Sponsor | Institut de Recherches Internationales Servier |
| Drug class | Alkylating agent |
| Target | DNA (O6-guanine methylation) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
TMZ is a prodrug that is converted to its active form, MTIC (3-methyl-(triazen-1-yl)imidazole-4-carboxamide), which methylates DNA and triggers apoptosis in rapidly dividing cells. It crosses the blood-brain barrier effectively, making it particularly useful for brain tumors. The drug is cell-cycle nonspecific and causes cumulative DNA damage leading to cancer cell death.
Approved indications
- Glioblastoma multiforme (newly diagnosed and recurrent)
- Anaplastic astrocytoma (recurrent)
- Melanoma (metastatic)
Common side effects
- Myelosuppression (thrombocytopenia, neutropenia)
- Nausea and vomiting
- Fatigue
- Headache
- Constipation
- Anemia
- Opportunistic infections (PCP)
Key clinical trials
- Vorinostat and Temozolomide in Treating Patients With Malignant Gliomas (PHASE1)
- Hyperpolarized Carbon-13 (13C) Pyruvate Imaging in Patients With Glioblastoma (PHASE1)
- Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma (PHASE3)
- Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment (PHASE1, PHASE2)
- Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme (PHASE2, PHASE3)
- Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness (PHASE1, PHASE2)
- Veliparib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Malignant Glioma Without H3 K27M or BRAFV600 Mutations (PHASE2)
- Telaglenastat With Radiation Therapy and Temozolomide in Treating Patients With IDH-Mutated Diffuse Astrocytoma or Anaplastic Astrocytoma (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Temozolomide (TMZ) CI brief — competitive landscape report
- Temozolomide (TMZ) updates RSS · CI watch RSS
- Institut de Recherches Internationales Servier portfolio CI
Frequently asked questions about Temozolomide (TMZ)
What is Temozolomide (TMZ)?
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Is Temozolomide (TMZ) also known as anything else?
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Related
- Drug class: All Alkylating agent drugs
- Target: All drugs targeting DNA (O6-guanine methylation)
- Manufacturer: Institut de Recherches Internationales Servier — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Glioblastoma multiforme (newly diagnosed and recurrent)
- Indication: Drugs for Anaplastic astrocytoma (recurrent)
- Indication: Drugs for Melanoma (metastatic)
- Also known as: Temodar, CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing