DEPAKOTE ER (divalproex sodium)
Depakote ER (divalproex sodium) is an extended-release medication indicated for the acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features. It is also approved as monotherapy and adjunctive therapy for complex partial seizures and simple or complex absence seizures in adults and pediatric patients 10 years of age and older. Furthermore, the drug is indicated for the prophylaxis of migraine headaches. Healthcare providers are advised to continually reevaluate the long-term risks and benefits when using the drug for extended periods in bipolar patients.
How DEPAKOTE ER Works
Divalproex sodium functions by dissociating into the valproate ion within the gastrointestinal tract. Although the exact mechanisms of its therapeutic effects have not been definitively established, its activity in treating epilepsy is believed to be linked to neurotransmitter levels. It is suggested that valproate exerts its effects by increasing the concentrations of gamma-aminobutyric acid (GABA) in the brain.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2000-08-04
- Routes
- Oral, ORAL
- Dosage Forms
- Tablet, Extended Release, TABLET, EXTENDED RELEASE
DEPAKOTE ER Approval History
What DEPAKOTE ER Treats
4 indicationsDEPAKOTE ER is approved for 4 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Bipolar Disorder
- Complex Partial Seizures
- Absence Seizures
- Migraine
DEPAKOTE ER Boxed Warning
LIFE THREATENING ADVERSE REACTIONS Hepatotoxicity General Population: Hepatic failure resulting in fatalities has occurred in patients receiving valproate and its derivatives. These incidents usually have occurred during the first six months of treatment. Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting. In patients with epilepsy, a loss of seizure control may also occur. Patients should be monitore...
WARNING: LIFE THREATENING ADVERSE REACTIONS Hepatotoxicity General Population: Hepatic failure resulting in fatalities has occurred in patients receiving valproate and its derivatives. These incidents usually have occurred during the first six months of treatment. Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting. In patients with epilepsy, a loss of seizure control may also occur. Patients should be monitored closely for appearance of these symptoms. Serum liver tests should be performed prior to therapy and at frequent intervals thereafter, especially during the first six months [see Warnings and Precautions ( 5.1 )] . Children under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity, especially those on multiple anticonvulsants, those with congenital metabolic disorders, those with severe seizure disorders accompanied by mental retardation, and those with organic brain disease. When Depakote ER is used in this patient group, it should be used with extreme caution and as a sole agent. The benefits of therapy should be weighed against the risks. The incidence of fatal hepatotoxicity decreases considerably in progressively older patient groups. Patients with Mitochondrial Disease: There is an increased risk of valproate-induced acute liver failure and resultant deaths in patients with hereditary neurometabolic syndromes caused by DNA mutations of the mitochondrial DNA Polymerase γ (POLG) gene (e.g. , Alpers Huttenlocher Syndrome). Depakote ER is contraindicated in patients known to have mitochondrial disorders caused by POLG mutations and children under two years of age who are clinically suspected of having a mitochondrial disorder [see Contraindications ( 4 )] . In patients over two years of age who are clinically suspected of having a hereditary mitochondrial disease, Depakote ER should only be used after other anticonvulsants
DEPAKOTE ER Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03919292 | MCC-17-13821 | Ph 1, Ph 2 | recruiting | Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca |
| NCT03012815 results posted | 16-008712 | Ph 4 | completed | Gabapentin for Alcohol Withdrawal Syndrome |
| NCT01170325 | 100157 10-M-0157 | Ph 2 | withdrawn | A Study of Divalproex Sodium in Children With ASD and Epileptiform EEG |
| NCT02094651 | P00005744 | Ph 2 | withdrawn | Treatment of Children With Autism Spectrum Disorders and Epileptiform EEG With Divalproex Sodium |
| NCT02166229 | 1404013775 | Ph 1, Ph 2 | withdrawn | Divalproex Sodium in the Treatment of the Cutaneous Manifestations of Scleroderma |
| NCT01587066 | D1443L00059 | Ph 4 | withdrawn | Efficacy of Quetiapine XR Versus Divalproex on Clinical Outcome Quality of Sleep and Quality of Life in Bipolar Depression |
| NCT01581775 | 10-VIN-122 | Ph 1 | completed | Bioequivalence Study of Divalproex Sodium ER Tablets 500 mg of Dr. Reddy's Under Fasting Conditions |
| NCT01581788 | 10-vin-123 | Ph 1 | completed | Bioequivalence Study of Divalproex Sodium ER Tablets, 500 mg Under Fed Conditions |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DEPAKOTE ER FDA Label Details
Indications & Usage
FDA Label (PDF)DEPAKOTE ER is indicated for the treatment of Bipolar Disorder; Complex Partial Seizures; Absence Seizures; Migraine.
WARNING: LIFE THREATENING ADVERSE REACTIONS Hepatotoxicity General Population: Hepatic failure resulting in fatalities has occurred in patients receiving valproate and its derivatives. These incidents usually have occurred during the first six months of treatment. Serious or fatal hepatotoxicity may...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment