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Sodium valproate extended-release tablets
Sodium valproate extended-release tablets is a Small molecule drug developed by Xue-chun Lu. It is currently in Phase 1 development. Also known as: sirolimus tablets, calcitriol capsules.
Sodium valproate extended-release tablets are used to study the prevention of migraines in adolescents. They are also studied in other conditions such as bipolar disorder, schizophrenia, and hemophilia, but the specific use in these conditions is not specified.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Sodium valproate extended-release tablets |
|---|---|
| Also known as | sirolimus tablets, calcitriol capsules |
| Sponsor | Xue-chun Lu |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Does The Addition Of Divalproex Sodium ER To An Atypical Antipsychotic Drug (APD) Improve Cognition And Psychopathology In Outpatients With Schizophrenia (SCH) Or Schizoaffective Disorder (SAD)? (PHASE4)
- Effect of Adding Lamotrigine to Sodium Valproate in Childhood Epilepsy: Clinicolabratory Study (PHASE4)
- Combination Regimen With Sodium Valproate for Severe Hemophilia: a Single-arm, Phase 1, Pilot Trial. (PHASE1, PHASE2)
- Bioavailability and Food Effect of Sodium Valproate Minitablets in Healthy Subjects. (PHASE1)
- Bioequivalence Study of Sodium Valproate and Valproic Acid Tablets (PHASE4)
- Tolerability and Efficacy of Depakote-extended Release in the Elderly (NA)
- Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy (PHASE3)
- A Study in Stable Epilepsy Patients Comparing Brand and Generic Divalproex Sodium Extended Release Tablets (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:
- Sodium valproate extended-release tablets CI brief — competitive landscape report
- Sodium valproate extended-release tablets updates RSS · CI watch RSS
- Xue-chun Lu portfolio CI
Frequently asked questions about Sodium valproate extended-release tablets
What is Sodium valproate extended-release tablets?
Who makes Sodium valproate extended-release tablets?
Is Sodium valproate extended-release tablets also known as anything else?
What development phase is Sodium valproate extended-release tablets in?
Related
- Manufacturer: Xue-chun Lu — full pipeline
- Also known as: sirolimus tablets, calcitriol capsules
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing