Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DIVALPROEX, USP · 2 trials · 1 indication
Maximum plasma concentration (micrograms/mL)
Area under the concentration time curve from time zero to the last measurable time point. (micrograms x mL/hour)
Area under the concentration time curve from time zero to infinity (micrograms x mL/hour)
| Arm | Type | Description |
|---|---|---|
| Divalproex Sodium | EXPERIMENTAL | DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG - Mylan Pharmaceuticals Inc |
| Depakote Tablets | ACTIVE_COMPARATOR | DEPAKOTE® Tablets, 500 MG Abbott Laboratories |
| Test: Divalproex Sodium | EXPERIMENTAL | DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG |
| Reference: Depakote Tablets | ACTIVE_COMPARATOR | DEPAKOTE® Tablets, 500 MG Abbott Laboratories |
| Name | Type | Description |
|---|---|---|
| DEPAKOTE® Tablets, 500 MG | DRUG | 1 x 500 mg Tablet, under fed conditions |
| DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG | DRUG | 1 x 500 mg Tablet, under fed conditions |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Females not of child bearing potential and males. * No hormonal contraceptives or hormonal replacement therapies are permitted in this study. * Women will not be considered of childbearing potential if one of the following is reported a...
DIVALPROEX, USP is a small molecule drug developed by Viatris Inc. (ticker VTRS). It is being studied in Phase 1 clinical trials in healthy adult volunteers. The drug is also known as divalproex sodium delayed-release tablets, USP, 500 mg.
DIVALPROEX, USP targets ALDH5A1 and acts as an inhibitor of this enzyme. ALDH5A1 is the molecular target of the drug, and its inhibition is the basis for its pharmacological activity in the studied setting.
DIVALPROEX, USP is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the company responsible for the clinical development of this drug candidate.
DIVALPROEX, USP is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 1 trials have been completed, and no active trials are currently listed.
DIVALPROEX, USP has been evaluated in two completed Phase 1 trials: NCT01184391, a bioequivalence study of divalproex sodium delayed-release tablets, 500 mg, with 17 participants, and NCT01183676, a fed bioequivalence study of the same formulation, with 20 participants. Both enrolled healthy adults in the United States.