Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Divalproex DR · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA) |
| 2 | ACTIVE_COMPARATOR | Depakote 500 mg DR Tablets (Abbott Laboratories, USA) |
| Name | Type | Description |
|---|---|---|
| Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA) | DRUG | - |
| Depakote 500 mg DR Tablets (Abbott Laboratories, USA) | DRUG | - |
Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.
Top 9 of 13 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Xenon Pharmaceuticals Inc. | XENE | 4 | PHASE3 | Azetukalner |
| Praxis Precision Medicines, Inc. | PRAX | 5 | PHASE3 | Vormatrigine, Elsunersen |
| Rapport Therapeutics, Inc. | RAPP | 3 | PHASE3 | RAP-219 |
| Supernus Pharmaceuticals, Inc. | SUPN | 4 | PHASE2 | SPN-817, BIS-001ER |
| Biohaven Ltd. | BHVN | 3 | PHASE2 | BHV-7000 |
| Harmony Biosciences Holdings, Inc. | HRMY | 1 | PHASE3 | Clemizole |
| Jazz Pharmaceuticals Public Limited Company | JAZZ | 3 | PHASE1 | CBD-OS, Epidiolex |
| Bright Minds Biosciences Inc. | DRUG | 1 | PHASE2 | BMB-101 |
| uniQure N.V. | QURE | 1 | PHASE1 | AMT-260 |
Divalproex DR is a delayed release tablet formulation of divalproex sodium, a small molecule drug. It is used in epilepsy and is also studied in bipolar disorder. The 500 mg delayed release tablets are marketed by Sandoz Inc. in the USA, and Novartis AG (ticker NVS) is the developer.
Divalproex DR is used for epilepsy. The clinical trials for this 500 mg delayed release tablet formulation enrolled healthy adult male volunteers to compare bioavailability under fasting and fed conditions, and the studied conditions included epilepsy and bipolar disorder.
Divalproex DR targets ALDH5A1, also known as succinate semialdehyde dehydrogenase. It acts as an inhibitor of this enzyme. ALDH5A1 is involved in the gamma aminobutyric acid (GABA) degradation pathway, and inhibition of this target is the described mechanism of action for divalproex sodium.
Novartis AG, which trades under the ticker NVS, is the developer of Divalproex DR. The specific 500 mg delayed release tablet product is made by Sandoz Inc. in the USA, and Sandoz is part of the Novartis group.
Divalproex DR is in Phase 1 development. Both of its recorded trials are Phase 1 bioavailability studies, and both are completed. There are no active trials for this asset, and it is an investigational formulation rather than an approved product in this development program.
Divalproex DR has been studied in two completed Phase 1 trials: NCT00913874, which assessed relative bioavailability of the 500 mg delayed release tablets under fasting conditions, and NCT00913848, which assessed relative bioavailability under fed conditions. Each trial enrolled 30 healthy male volunteers, for a total enrollment of 60.