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Label indication Depakote Sprinkle Capsules are an anti-epileptic drug indicated for: 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 ( 1 ) 1.1 Epilepsy Depakote Sprinkle Capsules are indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients…
Also known as Divalproex Sodium, Depakote, Depakote Sprinkle
Divalproex · 7 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Divalproex Sodium ER Tablets, 500 mg | EXPERIMENTAL | Divalproex Sodium ER Tablets, 500 mg of Dr. Reddy's Laboratories Limited |
| Depakote ER Tablets, 500 mg | ACTIVE_COMPARATOR | Depakote ER Tablets, 500 mg of Abbott Laboratories |
| Divalproex Sodium | EXPERIMENTAL | Divalproex Sodium Coated Particles in Capsules, 125 mg of Dr. Reddy's Laboratories Limited |
| Depakote Sprinkle | ACTIVE_COMPARATOR | Depakote Sprinkle 125 mg capsules of Abbott Laboratories, USA |
| Divalproex Sodium DR Tablets 500 mg | EXPERIMENTAL | Divalproex Sodium DR Tablets 500 mg of Dr. Reddy's Laboratories Limited |
| Depakote DR 500 mg Tablets | ACTIVE_COMPARATOR | Depakote DR 500 mg Tablets of Abbott Laboratories PR Ltd., |
| Name | Type | Description |
|---|---|---|
| Divalproex Sodium | DRUG | Divalproex Sodium ER Tablets, 500 mg |
Inclusion Criteria: The subjects were selected for study participation, if they met the following criteria: 1. Subjects aged between 18 and 45 years (both inclusive). 2. Subjects' weight within normal range according to normal values for Body Mass Index (18.5 to 24.9 kg/m2) with minimum of 50 kg w...
Divalproex is a small molecule drug developed by Dr. Reddy's Laboratories Ltd (ticker RDY). It is also known as divalproex sodium. The program is in Phase 1 development, and the specific therapeutic indication has not been disclosed. Its clinical work to date consists of bioequivalence studies in healthy adult volunteers.
Divalproex targets ALDH5A1, also known as succinate-semialdehyde dehydrogenase. It is classified as an inhibitor of that target. ALDH5A1 is an enzyme involved in the breakdown of the inhibitory neurotransmitter GABA, so inhibiting it affects GABA metabolism.
Divalproex is developed by Dr. Reddy's Laboratories Ltd, an Indian pharmaceutical company whose shares trade under the ticker RDY. Dr. Reddy's is the sponsor of the divalproex sodium bioequivalence studies registered on ClinicalTrials.gov.
Divalproex is in Phase 1 development. All seven registered trials are Phase 1 studies, and all seven are completed, with no active trials currently listed. The studies enrolled a total of 278 participants and were conducted in healthy volunteers in India.
Divalproex has been studied in Phase 1 bioequivalence trials, including NCT01581788 and NCT01581775, which tested 500 mg extended-release tablets under fed and fasting conditions, plus NCT01132196 for 500 mg delayed-release tablets and NCT01132183 for 125 mg sprinkle capsules. All are completed.
Yes. Divalproex and divalproex sodium refer to the same drug substance, and the two names are used interchangeably. The bioequivalence trials registered for this program list the drug as divalproex sodium, while the shorter name divalproex is also used.