NDAORALCAPSULEPriority Review
Approved
Feb 1978
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
DEPAKENE (valproic acid) by AbbVie is tract. Approved for epilepsy, bipolar disorder. First approved in 1978.
Drug data last refreshed 20h ago
Mechanism of Action
tract. The mechanisms by which valproate exerts its therapeutic effects have not been established. It has been suggested that its activity in epilepsy is related to increased brain concentrations of gamma-aminobutyric acid (GABA).
Indications (2)
Clinical Trials (20)
Valproic AcId for Traumatic BRAin INjury Trial
Started May 2026
432 enrolled
Moderate Traumatic Brain Injury (TBI)Severe Traumatic Brain Injury
A Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Pharmacokinetics of KarXT and Effects of KarXT on the Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants
Started Dec 2024
133 enrolled
Healthy Volunteers
Valproic Acid (VPA) for Acute Kidney Injury (AKI) in Liver Transplant Patients
Started Jan 2022
0Acute Kidney InjuryIschemia Reperfusion Injury
Valproic Acid (VPA) for Acute Kidney Injury (AKI) in Trauma Patients
Started Jan 2022
0Acute Kidney InjuryIschemia Reperfusion Injury
Study to Evaluate the Effect of UGT Inhibition by Valproic Acid on the Pharmacokinetics of BIIB074
Started Sep 2017
30 enrolled
Drug Interaction
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.