Approval Probability
TA Base Rate
Adjusted LOA
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divalproex · 3 trials · 3 indications
| Name | Type | Description |
|---|---|---|
| Quetiapine fumarate | DRUG | - |
| lithium | DRUG | - |
| divalproex | DRUG | - |
| Seroquel®, quetiapine fumarate (atypical antipsychotic) | DRUG | - |
| lithium (mood stabilizer) | DRUG | - |
| divalproex (mood stabilizer) | DRUG | - |
Inclusion Criteria: * Meets criteria for Bipolar I Disorder with Alcohol dependence * Outpatient Status * Recent history of heavy drinking Exclusion Criteria: * Unstable medical illness * Recent antipsychotic use * Poorly controlled Diabetes Mellitus or Diabetes related illness
Divalproex is an investigational small molecule being studied for the maintenance treatment of Bipolar I Disorder. It is evaluated in combination with quetiapine fumarate (Seroquel) in Phase 3 clinical trials. The drug is intended for adult patients aged 18 years and older with bipolar disorder.
Divalproex is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting Phase 3 clinical trials to evaluate the drug's efficacy and safety in patients with Bipolar I Disorder.
Divalproex is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. Two Phase 3 trials have been completed, with a total enrollment of 1,060 patients across multiple countries.
Divalproex has been studied in two completed Phase 3 trials: NCT00081380 and NCT00107731, both evaluating its efficacy and safety in the maintenance of Bipolar I Disorder. A third trial, NCT00114686, examined quetiapine fumarate in alcohol dependency among bipolar patients. All trials were randomized and double-blind.
Divalproex is a small molecule developed for the treatment of Bipolar I Disorder. The specific molecular target of divalproex is not disclosed in the available clinical trial information. The trials focus on its use as an adjunct to quetiapine fumarate for maintenance therapy in bipolar disorder patients.