Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Divalproex · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Divalproex Sodium 125 MG Delayed Release Tablets Sandoz |
| 2 | ACTIVE_COMPARATOR | Depakote 125 MG DR Tablets Abbott Laboratories USA |
| Name | Type | Description |
|---|---|---|
| Divalproex Sodium | DRUG | - |
| Depakote DR Tablets | DRUG | - |
Inclusion Criteria: * No clinically significant findings on physical examination, medical history or laboratory tests on screening Exclusion Criteria: * Positive test for HIV or Hepatitis B and C * History of sensitivity to valproic acid or related compounds
Divalproex is a small molecule being developed by Novartis AG for the treatment of seizures. It is currently in Phase 1 clinical development as an investigational drug. The drug is being studied for its potential to manage seizure disorders, though it has not yet been approved for this use.
Divalproex is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating seizures.
Divalproex is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing for the treatment of seizures.
Divalproex has one completed clinical trial, NCT00864006, which was a Phase 1 bioequivalence study of Divalproex Sodium 125 MG delayed release tablets under fasting conditions. The trial enrolled 28 healthy male volunteers aged 18 years and older and was active-controlled.
Divalproex is the drug name, and the clinical trial studied Divalproex Sodium 125 MG delayed release tablets. The trial was designed to assess the bioequivalence of this formulation, indicating that Divalproex and divalproex sodium refer to the same active pharmaceutical ingredient.