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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
Divalproex · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Divalproex Sodium Extended-Release Tablets 500 mg |
| 2 | ACTIVE_COMPARATOR | Depakote ER® Tablets 500 mg |
| Name | Type | Description |
|---|---|---|
| Divalproex Sodium Extended-Release Tablets 500 mg | DRUG | 500mg, single dose fasting |
| Depakote ER® Tablets 500 mg | DRUG | 500mg, single dose fasting |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male. 3. Weight: At least 60 kg (132 lbs) and within 15% of Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PR...
Divalproex is a small molecule drug developed by Viatris Inc. (ticker: VTRS). It is being studied in Phase 1 clinical development, and its specific therapeutic indications have not been disclosed. The drug is also known as Divalproex Sodium Extended-Release Tablets 500 mg.
Divalproex targets ALDH5A1 and acts as an inhibitor of this enzyme. ALDH5A1 is the molecular target of the drug, placing it in the inhibitor class of small molecule therapeutics.
Divalproex is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the company responsible for the clinical development of this small molecule drug candidate.
Divalproex is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, with no active trials currently ongoing.
Divalproex has been evaluated in two completed Phase 1 trials: NCT00648076, a food-effect study with 40 healthy male volunteers, and NCT00647712, a fasting study with 38 healthy male volunteers. Both were active-controlled, randomized trials conducted in the United States.