DEPAKOTE (divalproex sodium) · AbbVie
Depakote is an anti-epileptic drug indicated for the treatment of manic episodes associated with bipolar disorder and the prophylaxis of migraine headaches. It is also approved as monotherapy and adjunctive therapy for patients with complex partial seizures and simple or complex absence seizures. Furthermore, the medication is indicated as an adjunctive treatment for patients with multiple seizure types that include absence seizures.
How DEPAKOTE Works
Divalproex sodium is a valproate compound that dissociates into the valproate ion within the gastrointestinal tract. While the exact mechanisms for its therapeutic effects have not been established, its activity in treating epilepsy is suggested to be related to its impact on brain chemistry. Specifically, the drug is believed to work by increasing the concentrations of gamma-aminobutyric acid (GABA) in the brain.
Details
- Status
- Prescription
- First Approved
- 1983-03-10
- Routes
- ORAL
- Dosage Forms
- CAPSULE, DELAYED REL PELLETS, TABLET, DELAYED RELEASE
DEPAKOTE Approval History
What DEPAKOTE Treats
6 indicationsDEPAKOTE is approved for 6 conditions since its original approval in 1983. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Bipolar Disorder
- Manic Episodes
- Complex Partial Seizures
- Simple Absence Seizures
- Complex Absence Seizures
- Migraine Headaches
DEPAKOTE 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 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 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 should only be used after other anticonvulsants have faile
DEPAKOTE Competitive Set
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Indication competitors
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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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AbbVie's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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
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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 FDA Label Details
Indications & Usage
FDA Label (PDF)Depakote is an anti-epileptic drug indicated for: Treatment of manic episodes associated with bipolar disorder Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures Prophylaxis of migraine headaches 1.1 Mania Depakote (divalproex sodium) is a valproate and is indicated for the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical s...
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.