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Temozolomide and lomustine
Temozolomide and lomustine is a Alkylating agent (nitrosourea combination) Small molecule drug developed by University Hospital, Bonn. It is currently in Phase 3 development for Glioblastoma multiforme, Recurrent or progressive high-grade glioma. Also known as: Temodal, Temomedac, CeCeNu.
Temozolomide and lomustine are alkylating agents that cross the blood-brain barrier and cause DNA damage to kill cancer cells, particularly effective in brain tumors.
Temozolomide and lomustine (also known as semustine) are small molecule DNA inhibitors used to treat various types of brain and central nervous system tumors, including glioblastoma, astrocytoma, and melanoma. They are classified as inhibitors and have been studied in clinical trials for their efficacy and safety in treating 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 and lomustine |
|---|---|
| Also known as | Temodal, Temomedac, CeCeNu |
| Sponsor | University Hospital, Bonn |
| Drug class | Alkylating agent (nitrosourea combination) |
| Target | DNA (O6-guanine methylation) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Both drugs are nitrosoureas/alkylating agents that methylate DNA at the O6-guanine position, leading to DNA strand breaks and apoptosis. Temozolomide is a prodrug converted to its active form MTIC, while lomustine acts directly. The combination targets rapidly dividing cells and is particularly suited for CNS penetration in glioblastoma and other brain malignancies.
Approved indications
- Glioblastoma multiforme
- Recurrent or progressive high-grade glioma
Common side effects
- Myelosuppression (thrombocytopenia, leukopenia)
- Nausea and vomiting
- Fatigue
- Anemia
- Hepatotoxicity
- Secondary malignancy
Key clinical trials
- Comprehensive Analysis of Chemotherapy and Targeted Therapy Outcomes in Recurrent Malignant Gliomas
- Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine) to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Methylated Glioblastoma (PHASE3)
- A Clinical Study to Improve Brain Function and Quality of Life of Patients With Newly Diagnosed Brain Tumors (Gliomas). (PHASE3)
- Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma (PHASE3)
- Pediatric Trial of Indoximod With Chemotherapy and Radiation for Relapsed Brain Tumors or Newly Diagnosed DIPG (PHASE2)
- Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM (PHASE3)
- A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma (PHASE2, PHASE3)
- VAL-083 Phase 3 Study in Temozolomide-Avastin (Bevacizumab) Recurrent GBM (PHASE3)
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 and lomustine CI brief — competitive landscape report
- Temozolomide and lomustine updates RSS · CI watch RSS
- University Hospital, Bonn portfolio CI
Frequently asked questions about Temozolomide and lomustine
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Related
- Drug class: All Alkylating agent (nitrosourea combination) drugs
- Target: All drugs targeting DNA (O6-guanine methylation)
- Manufacturer: University Hospital, Bonn — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Glioblastoma multiforme
- Indication: Drugs for Recurrent or progressive high-grade glioma
- Also known as: Temodal, Temomedac, CeCeNu
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing