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Valproate plus doxorubicin
Valproate plus doxorubicin is a Small molecule drug developed by European Lung Cancer Working Party. It is currently in Phase 2 development.
Valproate is a small molecule inhibitor of succinate-semialdehyde dehydrogenase, a mitochondrial enzyme. Valproate is being studied in combination with doxorubicin for the treatment of various gliomas, including glioblastoma, DIPG, and brainstem glioma, among others.
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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 | Valproate plus doxorubicin |
|---|---|
| Sponsor | European Lung Cancer Working Party |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Prolonged Exposure to Doxorubicin in Patients With Glioblastoma Multiforme and Diffuse Intrinsic Pontine Glioma (PHASE2)
- Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma (PHASE1, PHASE2)
- Phase I Trial of Valproic Acid and Epirubicin in Solid Tumor Malignancies (PHASE1)
- Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma (PHASE2)
- A Phase II Study of Doxorubicin, Cyclophosphamide and Vindesine With Valproic Acid in Patients With Refractory or Relapsing Small Cell Lung Cancer After Platinum Derivatives and Etoposide (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:
- Valproate plus doxorubicin CI brief — competitive landscape report
- Valproate plus doxorubicin updates RSS · CI watch RSS
- European Lung Cancer Working Party portfolio CI
Frequently asked questions about Valproate plus doxorubicin
What is Valproate plus doxorubicin?
Who makes Valproate plus doxorubicin?
What development phase is Valproate plus doxorubicin in?
Related
- Manufacturer: European Lung Cancer Working Party — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing