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Drug

Valproate

Regulatory activity · MHRA
Emerging researchLate-stage development
Also known as Depacon, Depakene, Depakote, Stavzor+3 more

Depacon, Depakene, Depakote, Stavzor, Valproic Acid, Divalproex Sodium, Valproate Sodium.

RxNorm40254
1
Research papers
3
Active clinical trials
6
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)

Clinical trial2026-07-24Results expected Q2 2028 · ClinicalTrials.gov

Managing Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neuroleptic Sparing Strategy

Clinical trial2025-11-18Results expected Q1 2027 · ClinicalTrials.gov

Valproate for the Treatment of Residual Amblyopia

Clinical trial2025-11-10Results expected Q3 2027 · ClinicalTrials.gov

Efficacy and Tolerability of Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy (STANDLOW). A Multicenter, Randomized, Single-blind, Parallel-group Trial

Clinical trial2025-07-08Results posted · ClinicalTrials.gov

Drug Safety Update: Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): updated safety and educational materials to support patient discussion on reproductive risks

Regulatory2025-06-10MHRA

Drug Safety Update: Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): review by two specialists is required for initiating valproate but not for male patients already taking valproate

Regulatory2025-02-13MHRA

Drug Safety Update: Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): new safety and educational materials to support regulatory measures in men and women under 55 years of age

Regulatory2024-01-22MHRA

Zolmitriptane as Prophylactic Therapy Childhood Migraine

Clinical trial2024-01-01Primary completion · ClinicalTrials.gov

Drug Safety Update: Valproate: dispense full packs of valproate-containing medicines

Regulatory2023-10-31MHRA

Drug Safety Update: Valproate: re-analysis of study on risks in children of men taking valproate

Regulatory2023-08-30MHRA

A Practical, Pilot, Randomized, Controlled Trial of Valproate Alone or in Combination With Quetiapine for Severe COVID-19 Pneumonia With Agitated Delirium

Clinical trial2023-03-28Withdrawn · ClinicalTrials.gov

Adjunct extended-release valproate semisodium in late life schizophrenia.

Research2008-02-01International journal of geriatric psychiatry

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Valproate
Aliases & brands
DepaconDepakeneDepakoteStavzorValproic AcidDivalproex SodiumValproate Sodium
RxNorm CUI
40254
Regulatory jurisdictions
mhra

Regulatory timeline

6 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities
MHRA
Total events
6
mhraMedicines and Healthcare products Regulatory Agency· 6 events
2025-06-10Safety communicationSafety
Drug Safety Update: Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): updated safety and educational materials to support patient discussion on reproductive risks
Evidence ↗
2025-02-13Safety communicationSafety
Drug Safety Update: Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): review by two specialists is required for initiating valproate but not for male patients already taking valproate
Evidence ↗
2024-01-22Safety communicationSafety
Drug Safety Update: Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): new safety and educational materials to support regulatory measures in men and women under 55 years of age
Evidence ↗

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

39 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
39
registered trials across all phases
LATEST COMPLETION 2024
3
Active studies
3
Recruiting
28
Late-stage (III+)
26
Completed
10
Discontinued
PHASE DISTRIBUTIONn = 39
Early Phase 11Phase 14Phase 1 / 24Phase 22Phase 2 / 31Phase 311Phase 411Phase N / A5

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Efficacy and Tolerability of Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy (STANDLOW). A Multicenter, Randomized, Single-blind, Parallel-group Trial

CompletedPH IVMario Negri Institute for Pharmacological Researchn=582024

Zolmitriptane as Prophylactic Therapy Childhood Migraine

Unknown statusPH IVTanta Universityn=902024

A Practical, Pilot, Randomized, Controlled Trial of Valproate Alone or in Combination With Quetiapine for Severe COVID-19 Pneumonia With Agitated Delirium

WithdrawnPH IVUniversity of Miami2023

Prospective Assessment of Valproate on Ethanol Withdrawal

Unknown statusPH IVCAMC Health Systemn=2102020

Comparison Study of Efficacy and Safety of Levetiracetam Versus Valproate in Treatment of Idiopathic Generalized Tonic-clonic Seizures

CompletedPH IVMazandaran University of Medical Sciencesn=1032019

Recent completions

Trials that read out recently, adding to the completed evidence base.

Efficacy and Tolerability of Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy (STANDLOW). A Multicenter, Randomized, Single-blind, Parallel-group Trial

CompletedPH IVMario Negri Institute for Pharmacological Researchn=582024

An Open-label, Two-stage Study Evaluating Drug-drug Interaction Between Ciprofol Injectable Emulsion and Mefanamic Acid or Valproate in Healthy Volunteers

CompletedPH IHaisco Pharmaceutical Group Co., Ltd.n=412022

A Dose Ranging Pilot Study to Assess Intracerebroventricular (ICV) Delivery of Valproate in Subjects With Focal Seizures, With Temporal Lobe Onset With or Without Secondary Generalization

CompletedPH I/IICerebral Therapeutics LLCn=62021

Comparison Study of Efficacy and Safety of Levetiracetam Versus Valproate in Treatment of Idiopathic Generalized Tonic-clonic Seizures

CompletedPH IVMazandaran University of Medical Sciencesn=1032019

Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma

CompletedPH I/IILund University Hospitaln=502018

Pretreatment With Valproate Prior to Immunotherapy Targeting Cluster of Differentiation Antigen 20 in Chronic Lymphocytic Leukemia

CompletedPH ILund University Hospitaln=42017

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Adjunct extended-release valproate semisodium in late life schizophrenia.

International journal of geriatric psychiatry · 2008 · 8 cites
Recent papers

Adjunct extended-release valproate semisodium in late life schizophrenia.

International journal of geriatric psychiatry · 2008 · 8 cites
Journals, researchers & institutions
Top journals
  • International journal of geriatric psychiatry1
Leading researchers
  • Blow FC1
  • Cassidy KA1
  • Coconcea N1
  • Hays RW1
  • Ignacio RV1
  • Meyer WJ1
  • Sajatovic M1
Leading institutions
free-text, unnormalised
  • Case Western Reserve University1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.