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Depakote DR
Depakote DR (divalproex sodium delayed-release) increases brain GABA levels and inhibits histone deacetylase, stabilizing neuronal membranes and reducing abnormal electrical activity.
Depakote DR (divalproex sodium delayed-release) increases brain GABA levels and inhibits histone deacetylase, stabilizing neuronal membranes and reducing abnormal electrical activity. Used for Epilepsy (seizure disorders), Bipolar disorder (acute mania), Migraine prophylaxis.
At a glance
| Generic name | Depakote DR |
|---|---|
| Sponsor | Massachusetts General Hospital |
| Drug class | Anticonvulsant; mood stabilizer; histone deacetylase inhibitor |
| Target | GABA synthesis/metabolism; histone deacetylase |
| Modality | Small molecule |
| Therapeutic area | Neurology; Psychiatry |
| Phase | FDA-approved |
Mechanism of action
Divalproex sodium is a compound of sodium valproate and valproic acid that enhances inhibitory neurotransmission by increasing GABA synthesis and reducing GABA catabolism. It also inhibits histone deacetylase enzymes, which may contribute to its mood-stabilizing and anticonvulsant effects. The delayed-release formulation allows for once-daily dosing with reduced gastrointestinal side effects.
Approved indications
- Epilepsy (seizure disorders)
- Bipolar disorder (acute mania)
- Migraine prophylaxis
Common side effects
- Tremor
- Nausea
- Somnolence
- Diarrhea
- Alopecia (hair loss)
- Weight gain
- Hepatotoxicity
- Pancreatitis
- Thrombocytopenia
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)
- Bioequivalence Study of Divalproex Sodium Capsules(Sprinkle),125 mg of Dr. Reddy's Under Fasting Condition (Apple Sauce) (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 CI brief — competitive landscape report
- Depakote DR updates RSS · CI watch RSS
- Massachusetts General Hospital portfolio CI