DIVALPROEX SODIUM
DIVALPROEX SODIUM is indicated for the treatment of Acute manic or mixed episodes associated with bipolar disorder; Complex partial seizures; Simple and complex absence seizures; Multiple seizure types that include absence seizures; Prophylaxis of migraine headaches.
How DIVALPROEX SODIUM Works
Divalproex sodium functions by dissociating into the valproate ion within the gastrointestinal tract. While the exact therapeutic mechanisms have not been definitively established, the drug's activity in treating epilepsy is believed to be related to its effect on brain chemistry. Specifically, it is suggested that valproate works by increasing the concentrations of gamma-aminobutyric acid (GABA), which is an inhibitory neurotransmitter in the brain.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2008-07-29
- Routes
- ORAL
- Dosage Forms
- CAPSULE, DELAYED REL PELLETS, TABLET, EXTENDED RELEASE, TABLET, DELAYED RELEASE
Companies
DIVALPROEX SODIUM Approval History
What DIVALPROEX SODIUM Treats
5 indicationsDIVALPROEX SODIUM is approved for 5 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute manic or mixed episodes associated with bipolar disorder
- Complex partial seizures
- Simple and complex absence seizures
- Multiple seizure types that include absence seizures
- Prophylaxis of migraine headaches
DIVALPROEX SODIUM 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 divalproex sodium extended-release tablets are 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). Divalproex sodium extended-release tablets are 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
DIVALPROEX SODIUM 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.
Drugs Similar to DIVALPROEX SODIUM
3 of 7FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
16 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 |
| NCT04215003 | SCHBCC0N026 | Ph 1, Ph 2 | recruiting | A Clinical Trial of Breast Cancer Neo-adjuvant Therapy Based on Molecular Pathway in FUSCC |
| NCT05351840 | JWP-PVA-101 | Ph 1 | completed | To Evaluate the Pharmacokinetic Interactions and Safety in Healthy Volunteers |
| 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 |
| NCT01424462 | 114107 | Ph 1 | completed | Healthy Volunteer Pilot Study Using 3 Types of Modified Release Formulations of Firategrast to Investigate How Quickly Absorption From the Digestive System Takes Place. |
| NCT01267071 | 114136 | Ph 1 | completed | A Study to Evaluate the Pharmacokinetics and Absolute Bioavailability of GSK962040 Given as an Oral Dose Simultaneously With an Intravenous Microtracer Dose of [14C]-GSK962040 in Healthy Volunteers |
| 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 |
| NCT00639951 | YA-07/01 | Ph 4 | terminated | Study to Evaluate the Efficacy of Two Treatment Schemes With Antivipmyn ® for the Treatment of Snake Bite Envenomation |
| NCT01525511 | FTM1102 | Ph 1 | completed | Pharmacokinetic Study of Primaquine and Dihydroartemisinin-Piperaquine in Healthy Subjects |
| NCT01199627 TXA-CRT | TXA-CRT | Ph 3 | completed | Tranexamic Acid Versus Placebo for the Reduction of Blood Loss in Total Hip Replacement Surgery |
| NCT01218932 PQCQ | FTM1001 | Ph 1 | completed | Pharmacokinetic Study of Primaquine and Chloroquine in Healthy Subjects |
| 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.
DIVALPROEX SODIUM FDA Label Details
Indications & Usage
FDA Label (PDF)DIVALPROEX SODIUM is indicated for the treatment of Acute manic or mixed episodes associated with bipolar disorder; Complex partial seizures; Simple and complex absence seizures; Multiple seizure types that include absence seizures; Prophylaxis of migraine headaches.
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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Full clinical data, patents, trials, and competitive landscape for divalproex sodium.
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