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temozolomide or PCV
temozolomide or PCV is a Small molecule drug developed by Isarna Therapeutics GmbH. It is currently in Phase 2 development. Also known as: Temodar, Temodal, TMZ, lomustine.
Temozolomide is a small molecule DNA inhibitor used to treat various types of gliomas, including glioblastoma, anaplastic astrocytoma, and high-risk WHO Grade II glioma. It is classified as an inhibitor and is used in treatments such as PCV (a chemotherapy regimen) for these conditions.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 or PCV |
|---|---|
| Also known as | Temodar, Temodal, TMZ, lomustine, Cecenu |
| Sponsor | Isarna Therapeutics GmbH |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Comprehensive Analysis of Chemotherapy and Targeted Therapy Outcomes in Recurrent Malignant Gliomas
- 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)
- Disulfiram in Recurrent Glioblastoma (PHASE2, PHASE3)
- Imiquimod and Tumor Lysate Vaccine Immunotherapy in Adults With High Risk or Recurrent Grade II Gliomas (EARLY_PHASE1)
- Feasibility of Lymphocyte Reinfusion in Newly Diagnosed High Grade Gliomas (NA)
- Phase IIb Clinical Trial With TGF-β2 Antisense Compound AP 12009 for Recurrent or Refractory High-grade Glioma (PHASE2)
- Randomized Phase III Study of Sequential Radiochemotherapy of Anaplastic Glioma With PCV or Temozolomide (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 or PCV CI brief — competitive landscape report
- temozolomide or PCV updates RSS · CI watch RSS
- Isarna Therapeutics GmbH portfolio CI
Frequently asked questions about temozolomide or PCV
What is temozolomide or PCV?
Who makes temozolomide or PCV?
Is temozolomide or PCV also known as anything else?
What development phase is temozolomide or PCV in?
Related
- Manufacturer: Isarna Therapeutics GmbH — full pipeline
- Also known as: Temodar, Temodal, TMZ, lomustine, Cecenu
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing