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 also known as divalproex sodium delayed-release tablets, USP, 500 mg. The listed indication for this asset is undisclosed, and it is in Phase 1 development.
DIVALPROEX, USP targets ALDH5A1, also known as succinate-semialdehyde dehydrogenase. It acts as an inhibitor of this enzyme. ALDH5A1 is involved in the degradation of the inhibitory neurotransmitter GABA.
DIVALPROEX, USP is developed by Viatris Inc., which trades under the ticker VTRS. Viatris is the company responsible for this asset.
DIVALPROEX, USP is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any indication based on the available information.
DIVALPROEX, USP has been studied in two completed Phase 1 trials: NCT01184391, a bioequivalence study of divalproex sodium delayed-release tablets, 500 mg, and NCT01183676, a fed bioequivalence study of the same formulation. Both enrolled healthy volunteers in the United States.