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Temozolomide + Valproic Acid
Temozolomide + Valproic Acid is a alkylating agent and histone deacetylase inhibitor Small molecule drug developed by University of Göttingen. It is currently in Phase 3 development for Glioblastoma.
Temozolomide is an alkylating agent that works by interfering with DNA replication, while Valproic Acid is a histone deacetylase inhibitor that modulates gene expression.
Temozolomide is a DNA inhibitor used in the treatment of various gliomas, including Glioblastoma, DIPG, Brainstem Glioma, Pediatric, Diffuse Spinal Glioma, and Bilateral Thalamic Glioma. Valproic Acid is a small molecule that, when combined with Temozolomide, may be studied in clinical trials for these conditions, although the exact mechanism of this combination is not specified.
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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 + Valproic Acid |
|---|---|
| Sponsor | University of Göttingen |
| Drug class | alkylating agent and histone deacetylase inhibitor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Temozolomide's mechanism of action involves the formation of DNA cross-links, which prevents cancer cells from replicating. Valproic Acid, on the other hand, inhibits histone deacetylases, leading to increased histone acetylation and altered gene expression. This combination may enhance the effectiveness of temozolomide in treating certain types of cancer.
Approved indications
- Glioblastoma
Common side effects
- Nausea
- Vomiting
- Fatigue
- Headache
- Dizziness
Key clinical trials
- International Cooperative Phase III Trial of the HIT-HGG Study Group (HIT-HGG-2013) (PHASE3)
- Prolonged Exposure to Doxorubicin in Patients With Glioblastoma Multiforme and Diffuse Intrinsic Pontine Glioma (PHASE2)
- Phase I Study of Temozolomide, Valproic Acid and Radiation Therapy in Patients With Brain Metastases (PHASE1)
- Valproic Acid With Temozolomide and Radiation Therapy to Treat Brain Tumors (PHASE2)
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 + Valproic Acid CI brief — competitive landscape report
- Temozolomide + Valproic Acid updates RSS · CI watch RSS
- University of Göttingen portfolio CI
Frequently asked questions about Temozolomide + Valproic Acid
What is Temozolomide + Valproic Acid?
How does Temozolomide + Valproic Acid work?
What is Temozolomide + Valproic Acid used for?
Who makes Temozolomide + Valproic Acid?
What drug class is Temozolomide + Valproic Acid in?
What development phase is Temozolomide + Valproic Acid in?
What are the side effects of Temozolomide + Valproic Acid?
Related
- Drug class: All alkylating agent and histone deacetylase inhibitor drugs
- Manufacturer: University of Göttingen — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Glioblastoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing