Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Depakote ER is indicated for: Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features ( 1.1 ) Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; FDA label
Also known as Divalproex Sodium
Divalproex · 4 trials · 1 indication
Bioequivalence based on Cmax.
Bioequivalence based on AUC0-t.
Bioequivalence based on AUC0-inf.
| Arm | Type | Description |
|---|---|---|
| Divalproex Sodium | EXPERIMENTAL | 500 mg Extended Release Tablet |
| Depakote® | ACTIVE_COMPARATOR | 500 mg Extended Release Tablet |
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Divalproex Sodium | DRUG | 500 mg ER Tablet |
| Depakote® | DRUG | 500 mg ER Tablet |
Inclusion Criteria * Subjects who have completed the screening process within 28 days prior to Period 1 dosing * Subjects who are healthy adult men and women 18 years of age or older at the time of dosing. * Subjects who have a body mass index (BMI) between 19-30 kg/m2, inclusive, and weigh at leas...
Divalproex is a small molecule drug developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. It is being studied in Phase 1 clinical development. Its therapeutic area is classified as other, and the specific indications under investigation have not been disclosed.
Divalproex targets ALDH5A1 and acts as an inhibitor of that target. ALDH5A1 is the molecular target associated with this small molecule agent. This target class, an inhibitor mechanism, describes how divalproex is designed to interact with ALDH5A1 at the molecular level.
Divalproex is developed by Teva Pharmaceutical Industries Limited, a pharmaceutical company that trades under the ticker symbol TEVA. Teva is the sponsor associated with the clinical development program for this small molecule drug candidate.
Divalproex is in Phase 1 clinical development. It is an investigational agent and is not described as approved. The program includes four completed Phase 1 trials, with no active trials currently listed, and a total enrolled population of 120 participants across those studies.
Divalproex has been studied in four completed Phase 1 trials: NCT00974441 and NCT00974012, which evaluated divalproex sodium 500 mg extended-release tablets under fasting and non-fasting conditions, and NCT00834990 and NCT00834639, which evaluated divalproex sodium delayed-release tablets under non-fasting and fasting conditions. All enrolled healthy volunteers in the United States.
Yes, divalproex is also known as divalproex sodium. The two names refer to the same drug asset, so searches for either term lead to the same compound. Divalproex sodium is the alternative name used for this agent developed by Teva Pharmaceutical Industries Limited.