Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as sodium valproate
valproate · 1 trial · 1 indication
Fractional and cumulative percentage of radioactive dose excreted in urine and feces
key metabolite(s) of sodium valproate will be assessed in plasma, urine and feces.
Maximum plasma or blood concentration observed
Time to reach Cmax (tmax)
Area under the plasma concentration versus time curve calculated from time zero to the real time, tlast (time corresponding to the last concentration above the limit of quantification, Clast (AUClast)
Area under the plasma concentration versus time curve extrapolated to infinity (AUC)
Terminal half-life associated with the terminal slope (λz) (t1/2z) in plasma, blood radioactivity and plasma VPA
Blood to plasma radioactivity ratio calculated at each time point
RCmax is calculated as Cmax(VPA)/Cmax (radioactivity)
RAUC is calculated as AUC(VPA)/AUC (radioactivity)
| Arm | Type | Description |
|---|---|---|
| sodium valproate | EXPERIMENTAL | Single oral dose of sodium valproate containing \[14C\]-sodium VPA |
| Name | Type | Description |
|---|---|---|
| sodium valproate | DRUG | Pharmaceutical form:Powder for oral solution reconstituted with water Route of administration: Oral |
Inclusion criteria : * Female subjects, between 30 and 60 years of age, inclusive. * Body weight between 40.0 and 90.0 kg, inclusive, body mass index between 18.0 and 30.0 kg/m2, inclusive. * Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical...
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 |
Valproate is a small molecule drug developed by Sanofi for epilepsy, a neurological condition. It is also known as sodium valproate. The compound is catalogued in ChEMBL under the identifier CHEMBL433 and is being studied in clinical development rather than marketed under this program.
Valproate targets ALDH5A1 and acts as an inhibitor of that target. ALDH5A1, also called succinic semialdehyde dehydrogenase, is the enzyme this small molecule is designed to inhibit. This target class places valproate among inhibitor compounds directed at ALDH5A1 in the neurology therapeutic area.
Sanofi develops valproate, and the company trades under the ticker SNY. Sanofi is the sponsor associated with the clinical program for this small molecule in epilepsy. The drug is also referred to as sodium valproate.
Valproate is in Phase 1 clinical development for epilepsy. It has not been approved for this program and remains investigational. The available trial activity is early stage, with one completed Phase 1 study and no active trials currently listed for this asset.
Valproate has been studied in the completed Phase 1 trial NCT03681158, titled a study of excretion balance and pharmacokinetics of [14C]-sodium valproate in healthy postmenopausal or permanently sterile female subjects. That trial enrolled 5 participants in the United Kingdom, was uncontrolled, and involved healthy volunteers aged 30 years and older.
Yes, valproate is also known as sodium valproate. The two names refer to the same small molecule developed by Sanofi for epilepsy. Searches for either name point to the same Phase 1 asset and the same completed clinical trial, NCT03681158, in healthy female volunteers.