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Depakote DR Tablets
Depakote DR Tablets is a Anticonvulsant/Mood Stabilizer Small molecule drug developed by Sandoz. It is currently in Phase 1 development.
Increases brain levels of gamma-aminobutyric acid (GABA) and modulates voltage-gated sodium channels to reduce neuronal excitability.
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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 | Depakote DR Tablets |
|---|---|
| Sponsor | Sandoz |
| Drug class | Anticonvulsant/Mood Stabilizer |
| Modality | Small molecule |
| Phase | Phase 1 |
Mechanism of action
Divalproex sodium is converted to valproic acid in the body. It enhances GABAergic neurotransmission by inhibiting GABA degradation and increasing GABA synthesis. It also blocks voltage-dependent sodium channels, reducing repetitive neuronal firing and stabilizing hyperexcitable neuronal membranes.
Approved indications
Common side effects
Key clinical trials
- Bioequivalence Study of Divalproex Sodium 125 MG Delayed Release Tablets Under Fasting Conditions (PHASE1)
- To Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fed Conditions (PHASE1)
- To Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fasting Conditions (PHASE1)
- Bioequivalence Study of Divalproex Sodium ER Tablets 500 mg of Dr. Reddy's Under Fasting Conditions (PHASE1)
- Bioequivalence Study of Divalproex Sodium ER Tablets, 500 mg Under Fed Conditions (PHASE1)
- Bioequivalency Study of Divalproex Sodium DR Tablets, 500 mg of Dr.Reddy's Under Fasting Conditions (PHASE1)
- Bioequivalence Study of Divalproex Sodium DR Tablets 500 mg of Dr. Reddy's Under Fed Conditions (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:
- Depakote DR Tablets CI brief — competitive landscape report
- Depakote DR Tablets updates RSS · CI watch RSS
- Sandoz portfolio CI
Frequently asked questions about Depakote DR Tablets
What is Depakote DR Tablets?
How does Depakote DR Tablets work?
Who makes Depakote DR Tablets?
What drug class is Depakote DR Tablets in?
What development phase is Depakote DR Tablets in?
Related
- Drug class: All Anticonvulsant/Mood Stabilizer drugs
- Manufacturer: Sandoz — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing