Drugs / Valproate
last change May 2026 re-read 8 days ago

Valproate

Small molecule targets GSK3B, SMN2 via inhibition / activation

Developed for
epilepsy · bipolar disorder · schizophrenia · attention deficit-hyperactivity disorder · cardiac arrest · epilepsy with generalized tonic-clonic seizures · substance withdrawal syndrome · Wolfram syndrome
+50 more · alcohol dependence · alcohol withdrawal · alopecia areata · Alzheimer disease · ametropic amblyopia · amyotrophic lateral sclerosis · asthma · autism · B-cell chronic lymphocytic leukemia · brain hypoxia - ischemia · cervical cancer · childhood ependymoma · cluster headache syndrome · cocaine dependence · colorectal cancer · delirium · diffuse large B-cell lymphoma · focal epilepsy · glioblastoma · glycogen storage disease V · headache disorder · hemophilia · intracerebral hemorrhage · malignant mesothelioma · manic bipolar affective disorder · mental disorder · metastatic malignant neoplasm in the brain · migraine disorder · multiple organ dysfunction syndrome · myelodysplastic syndrome · neuralgia · neuropathy, painful · opiate dependence · ovarian cancer · post-traumatic epilepsy · pulmonary arterial hypertension · refractory malignant neoplasm · Rubinstein-Taybi syndrome · sensorineural hearing loss disorder · strabismus · temporomandibular joint disorder · toxoplasmosis · traumatic brain injury · bipolar depression · bipolar I disorder · childhood absence epilepsy · COVID-19 · spinal muscular atrophy · subarachnoid hemorrhage · viral pneumonia
Investigated by
National Institute of Mental Health (NIMH) · National Institute of Cancerology · Sanofi · Abbott · AstraZeneca · Lund University Hospital
+89 more · M.D. Anderson Cancer Center · National Council of Science and Technology, Mexico · Psicofarma, S.A. De C.V. · University Hospital, Bordeaux · University of Birmingham · Washington University School of Medicine · Alzheimer's Disease Cooperative Study (ADCS) · Assistance Publique - Hôpitaux de Paris · Australasian Gastro-Intestinal Trials Group · Azienda Ospedaliera San Gerardo di Monza · Belgium Health Care Knowledge Centre · Beth Israel Medical Center · BioPharma Services Inc. · Blood Cancer UK · Boston Children's Hospital · CAMC Health System · Cancer Prevention Research Institute of Texas · Centers for Disease Control and Prevention · Central South University · Centre Leon Berard · Centre d'Etude des Cellules Souches · Centre of Chinese Medicine, Georgia · Cerebral Therapeutics LLC · Cereno Scientific AB · Chinese University of Hong Kong · Desitin Arzneimittel GmbH · Dudley Group NHS Foundation Trust · Emory University · Erasme University Hospital · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · European Lung Cancer Working Party · Federal University of Rio Grande do Sul · Fondation Syndrome de Rubinstein-Taybi · Frequency Therapeutics · Genethon · Guiyun Xu · Harborview Injury Prevention and Research Center · Harmony Biosciences Management, Inc. · Hoffmann-La Roche · Hospital Militar del General Luis Felipe Brieba Aran · Hospital de Clinicas de Porto Alegre · Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Joseph Blader · Kasr El Aini Hospital · King's College Hospital NHS Trust · Mansoura University · Mario Negri Institute for Pharmacological Research · Ministry of Health, Italy · Ministry of Health, Uganda · National Institute of Neurological Disorders and Stroke (NINDS) · National Institute on Aging (NIA) · National Institute on Drug Abuse (NIDA) · Neuroscience Trials Australia · Northwell Health · Norwegian University of Science and Technology · Olivia Newton-John Cancer Research Institute · Princess Beatrix Muscle Foundation · Prof. Janet Dunn · Rea Rehabilitation Centre, Georgia · Samsung Medical Center · Sanofi-Synthelabo · Shanghai Mental Health Center · Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University · Sorlandet Hospital HF · Stanley Medical Research Institute · Tanta University · The Affiliated Brain Hospital of Guangzhou Medical University · The First Affiliated Hospital of University of South China · The University of Hong Kong · Thomas Jefferson University · UMC Utrecht · University College, London · University Hospital, Rouen · University Hospitals Cleveland Medical Center · all 95 on the full record

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) DEPACON — 2002-01-24 fda.gov ↗
Approved US (FDA) DEPACON — 1996-12-30 fda.gov ↗

Trials 69 · started per year

today
US approved 1996
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19911992199319941995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT05017454 May 2021 → Jan 2023 alopecia areata Kasr El Aini Hospital Completed No outcome recorded
Phase 0 NCT02144623 Jan 2015 → Feb 2016 B-cell chronic lymphocytic leukemia Lund University Hospital Completed No outcome recorded
Phase 16 trials
Phase 1 NCT06930872 Jun → Oct 2025 — Harmony Biosciences Management, Inc. Completed No outcome recorded
Phase 1 NCT06211283 Sep → Oct 2023 — Desitin Arzneimittel GmbH Completed No outcome recorded
Phase 1 NCT03681158 Oct 2018 → Apr 2019 epilepsy Sanofi Completed No outcome recorded
Phase 1 NCT02648633 May 2016 → Feb 2017 glioblastoma University of Virginia Terminated No outcome recorded
Phase 1 NCT01495104 Oct 2011 → Jan 2012 — Hoffmann-La Roche Completed No outcome recorded
Phase 1 NCT00513162 Jul 2007 → Sep 2012 metastatic malignant neoplasm in the brain M.D. Anderson Cancer Center Completed No outcome recorded
Phase 1/27 trials
Phase 1/2 NCT07226141 Jan 2026 → Sep 2027 expected ametropic amblyopia, strabismus Boston Children's Hospital Not yet recruiting No outcome recorded
Phase 1/2 NCT05920512 Apr 2022 → Apr 2025 hemophilia Xue-chun Lu Unknown No outcome recorded
Phase 1/2 NCT03825250 Nov 2018 → Oct 2024 coronary artery disorder, heart valve disorder, multiple organ dysfunction syndrome University of Leicester Unknown No outcome recorded
Phase 1/2 NCT03616223 Jul → Dec 2018 sensorineural hearing loss disorder Frequency Therapeutics Completed No outcome recorded
Phase 1/2 NCT02899611 Aug 2016 → Jun 2021 epilepsy Cerebral Therapeutics LLC Completed No outcome recorded
Phase 1/2 NCT01622439 Jun 2012 → Mar 2018 diffuse large B-cell lymphoma Lund University Hospital Completed No outcome recorded
Phase 1/2 NCT00240110 Mar 2006 → Mar 2014 bipolar disorder, cocaine dependence University of Miami Completed No outcome recorded
Phase 214 trials
Phase 2 NCT07487675 Sep 2024 → May 2025 overdue temporomandibular joint disorder Tanta University Active not recruiting No outcome recorded
Phase 2 NCT05694936 Jan 2023 → Jan 2026 overdue colorectal cancer Australasian Gastro-Intestinal Trials Group Active not recruiting No outcome recorded
Phase 2 NCT05224531 May 2022 → Aug 2024 pulmonary arterial hypertension Cereno Scientific AB Completed No outcome recorded
Phase 2 NCT04997811 Dec 2021 → Jan 2025 myelodysplastic syndrome Prof. Janet Dunn Unknown No outcome recorded
Phase 2 NCT04940572 Nov 2021 → Nov 2025 Wolfram syndrome Centre d'Etude des Cellules Souches Unknown No outcome recorded
Phase 2 NCT03717909 Dec 2018 → Nov 2024 Wolfram syndrome University of Birmingham Completed No outcome recorded
Phase 2 NCT03025906 Feb 2017 → Oct 2019 epilepsy with generalized tonic-clonic seizures Xuanwu Hospital, Beijing Unknown No outcome recorded
Phase 2 NCT01730313 Feb 2016 → Jul 2017 — Centers for Disease Control and Prevention Withdrawn No outcome recorded
Phase 2 NCT03112889 Jan 2015 → Apr 2017 glycogen storage disease V University College, London Completed No outcome recorded
Phase 2 NCT01619644 Apr 2012 → Sep 2014 Rubinstein-Taybi syndrome University Hospital, Bordeaux Completed No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT05431595 Jul 2022 → Feb 2027 expected delirium, epilepsy M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 2/3 NCT02265770 Jun 2015 → Jun 2028 expected childhood ependymoma Centre Leon Berard Recruiting No outcome recorded
Phase 2/3 NCT00221637 Mar 2002 → Jul 2005 neuralgia, neuropathy, painful University Hospital, Bordeaux Terminated No outcome recorded Stop: Enrollment
Phase 39 trials · 2 missed
Phase 3 NCT00533299 Aug 2007 → Dec 2009 ovarian cancer National Institute of Cancerology Unknown No outcome recorded
Phase 3 NCT00447369 May 2007 → Mar 2008 migraine disorder Hospital Militar del General Luis Felipe Brieba Aran Withdrawn No outcome recorded Stop: Business
Phase 3 NCT00136110 Apr 2005 → Feb 2007 amyotrophic lateral sclerosis UMC Utrecht Completed Missed primary
Phase 3 NCT00071721 Oct 2003 → Feb 2009 Alzheimer disease Alzheimer's Disease Cooperative Study (ADCS) Completed Missed primary
Phase 3 NCT00057681 Feb 2003 → Dec 2008 bipolar disorder Washington University School of Medicine Completed Mixed
Phase 3 NCT00254774 Jan 2002 → Mar 2006 bipolar disorder AstraZeneca Completed No outcome recorded
Phase 3 NCT00236717 Sep 1997 → Nov 2000 epilepsy Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Completed No outcome recorded
Phase 3 NCT00004817 Feb 1991 → ? brain injury, post-traumatic epilepsy National Institute of Neurological Disorders and Stroke (NINDS) Completed No outcome recorded
Phase 3 NCT00065884 — autism Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Unknown No outcome recorded
Phase 418 trials · 1 met primary
Phase 4 NCT06081283 Nov 2023 → Dec 2024 brain hypoxia - ischemia, cardiac arrest, intracerebral hemorrhage, traumatic brain injury University of North Carolina, Chapel Hill Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT07046676 Dec 2022 → Dec 2025 overdue epilepsy The First Affiliated Hospital of University of South China Recruiting No outcome recorded
Phase 4 NCT03689114 May 2021 → Jun 2024 focal epilepsy Mario Negri Institute for Pharmacological Research Completed No outcome recorded
Phase 4 NCT03652974 Sep 2018 → Aug 2021 schizophrenia Shanghai Mental Health Center Completed No outcome recorded
Phase 4 NCT03235531 Jul 2017 → Jul 2019 alcohol abuse, alcohol dependence, alcohol withdrawal CAMC Health System Unknown No outcome recorded
Phase 4 NCT01893229 Sep 2013 → Dec 2015 bipolar disorder Guiyun Xu Unknown No outcome recorded
Phase 4 NCT02011750 Apr 2013 → Oct 2017 schizophrenia, toxoplasmosis University of Pittsburgh Completed No outcome recorded
Phase 4 NCT01083784 Mar 2010 → Dec 2012 cardiac arrest Samsung Medical Center Unknown No outcome recorded
Phase 4 NCT00794625 Nov 2008 → Nov 2012 attention deficit-hyperactivity disorder Joseph Blader Unknown Met primary
Phase 4 NCT00807989 Mar 2008 → May 2012 epilepsy Yonsei University Completed No outcome recorded
Phase not applicable10 trials · 2 missed
— NCT06549426 Apr 2025 → Dec 2029 expected epilepsy University of Twente Recruiting No outcome recorded
— NCT04218981 Jan 2020 → Jun 2023 mental disorder Central South University Completed No outcome recorded
— NCT02556320 May 2013 → Aug 2015 drug allergy, epilepsy University Hospital, Rouen Completed No outcome recorded
— NCT01791868 Feb 2013 → Jul 2018 epilepsy with generalized tonic-clonic seizures Assistance Publique - Hôpitaux de Paris Completed Missed primary
— NCT01463111 May 2011 → Apr 2016 bipolar disorder Emory University Completed No outcome recorded
— NCT00570219 Feb 2005 → May 2008 substance withdrawal syndrome University of Helsinki Completed No outcome recorded
— NCT00167934 Dec 2004 → Dec 2008 schizophrenia Washington University School of Medicine Completed No outcome recorded
— NCT00159588 Jan 2004 → Nov 2006 headache disorder Norwegian University of Science and Technology Completed Missed primary
— NCT00203242 Jul 2003 → Sep 2006 cluster headache syndrome Thomas Jefferson University Completed No outcome recorded
— NCT00012558 Sep 1998 → Sep 2005 bipolar disorder National Institute of Mental Health (NIMH) Completed Mixed
Comparator or background therapy38 trials
Phase 1 NCT05181007 Comparator Dec 2021 → Mar 2022 — Haisco Pharmaceutical Group Co., Ltd. Completed No outcome recorded
Phase 1 NCT03903302 Comparator Oct 2017 → Feb 2018 thrombotic disease Cereno Scientific AB Completed No outcome recorded
Phase 2 NCT02625779 Comparator Mar 2016 → Apr 2017 bipolar depression Ewha Womans University Mokdong Hospital Withdrawn No outcome recorded Stop: Enrollment
Phase 2 NCT01543139 Comparator Dec 2015 → Apr 2017 bipolar depression Ewha Womans University Withdrawn No outcome recorded Stop: Enrollment
Phase 2 NCT02920060 Comparator Jan 2015 → Jul 2016 epilepsy with generalized tonic-clonic seizures Banaras Hindu University Completed No outcome recorded

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2020-03-10 Cereno Scientific AB Regulatory Cereno Scientific Receives FDA Orphan Drug Designation for the Treatment of Pulmonary Arterial Hypertension cerenoscientific.com ↗
Cereno Scientific today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company’s lead compound CS1, for the treatment of Pulmonary Arterial Hypertension (PAH).
2019-07-29 Cereno Scientific AB Results Article published in an international scientific journal cerenoscientific.com ↗
The article is based on Cereno's first clinical study with its drug candidate CS1, which was concluded last year with positive results regarding safety, pharmacokinetic properties and effect on biomarker (PAI-1).
2019-05-24 Cereno Scientific AB Results Cereno Scientific identifies possibilities for expanding the use of its treatment concept in cardiovascular diseases cerenoscientific.com ↗
A newly published article (Scholtz et al., 2019) from a research group in Germany showed that valproic acid, the active substance in CS1, prevents atrial fibrillation in mice through slowing the progression of fibrosis in the atria.
2016-10-10 Cereno Scientific AB Results Positive data published in Journal of Thrombosis and Haemostasis (JTH) cerenoscientific.com ↗
A paper entitled “Valproic acid selectively increases vascular endothelial tissue-type plasminogen activator production and reduces thrombus formation in the mouse” has been published online ahead of print in JTH.

All press releases naming this drug 14 releases

DateIssuerRelease

Evidence & citations 18 cited values

Every value below carries the sentence it was read from. 112 sources stand behind the page.

FieldValueCited text
Known as valproate “Drugs from ACT groups N03A, N05BA, N05CD, H02A or S01EC will be used including prednisolon,levetiracetam, valproate, carbamazepine, oxcarbazepine, topiramate, felbamate,...” NCT00552526 ↗
69

“Several preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or...” NCT00159588 ↗

“An adequate mood stabilizer treatment with lithium or valproate(defined as a serum concentration of 0.5-1.2 mEq/L or 50-100 microg/ml, respectively).” NCT00857584 ↗

“Part 2 - DDI with valproate (valproic acid [VPA]), a probe substrate for β-oxidation and glucuronidation.” NCT06930872 ↗

“a first parenteral anti-seizure medication (levetiracetam, valproate, or lacosamide)” NCT06549426 ↗

“Valproate (according to response, serum levels, and tolerance) 125-2000mg” NCT01000402 ↗

“carbamazepine, valproate, oxcarbazepine or levetiracetam” NCT03490487 ↗

“Choose lithium or valproate for bipolar disorder group” NCT04218981 ↗

“Ethosuximide, valproate or lamotrigine” NCT04274179 ↗

NCT01342549 ↗

NCT00367874 ↗

Show 59 more sources

Known as DEP “Sodium Valproate (Depakote, DEP) or placebo (PLA) group” NCT02011750 ↗
Known as Depacon ClinicalTrials.gov intervention name — accepted as the source's own label NCT00203242 ↗
Known as Depakine “Depakine (VPA)” NCT04940572 ↗
Known as Depakine chrono “treatment by VPA (Depakine chrono)” NCT04940572 ↗
Known as Depakote “Depakote (valproate)” NCT00552500 ↗
Known as divalproex “This prospective, 12-week open label study evaluated adjunct extended-release valproate semisodium (divalproex) in 20 older adults with schizophrenia.” PMID 17582828 ↗ Feb 2008
Known as divalproex sodium “We attempted to delay or to prevent agitation and psychosis with the use of divalproex sodium (valproate).” PMID 21810649 ↗ Aug 2011
Known as magnesium valproate “Patients received hydralazine at 182 mg for rapid, or 83 mg for slow, acetylators, and magnesium valproate at 40 mg/kg, beginning a week before chemotherapy.” PMID 17761710 ↗ Sep 2007
1

“magnesium valproate at an oral dose of 40mg/Kg t.i.d.” NCT00533299 ↗

Known as sodium valproate “Anyone of Valproic acid, sodium valproate, or a mixture of the two (sodium valproate) has a mechanism of action characterized by increasing or improving GABA neurotransmission,...” NCT04698525 ↗
38

“Antiepileptic drugs allowed are therefore: lamotrigine, levetiracetam, lacosamide, sodium valproate, carbamazepine, oxcarbabazepine, slicarbazepine, pregabalin, gabapentin,...” NCT03636958 ↗

“extended-release sodium valproate (VPA-ER) and controlled-release carbamazepine (CBZ-CR) as monotherapy in patients aged ≥ 60 years with newly diagnosed epilepsy.” PMID 27552848 ↗ Aug 2016

“Patient who initiate anti-epileptic drug (sodium valproate, divalproate sodium, valpromide, lamotrigine, carbamazepine, oxcarbazepine, eslicarbazepine acetate)” NCT02556320 ↗

“ICV Valproate is a dilution of the commercially available Epilim product, which is a sterile intravenous (IV) formulation of Sodium Valproate.” NCT02899611 ↗

“Subjects in group C began to receive sodium valproate sustained-release tablets in combination with the original treatment regimen at week 5.” NCT05481957 ↗

“CS1 delayed-release capsules will be supplied with 160 mg active pharmaceutical ingredient (sodium valproate) per capsule.” NCT05224531 ↗

“Initially 10-15 mg of sodium valproate/kg bodyweight per day will be taken in one or two doses during meals.” NCT04940572 ↗

“Intratympanic injection of FX-322 consists of laduviglusib and sodium valproate” NCT03616223 ↗

“Sodium valproate tablet 200mg” NCT00742638 ↗

“Sodium Valproate” NCT02205931 ↗

Show 28 more sources

Known as Valproate Sodium ClinicalTrials.gov intervention name — accepted as the source's own label NCT04698525 ↗
Known as valproic acid “For children with cryptogenic generalized epileptic disorders, the AED sodium valproate (valproic acid) has been found to be often effective, has fewer side effects than many...” NCT01730313 ↗
2

“Valproate (valproic acid), a widely used antiepileptic and mood-stabilizing agent, is also a histone deacetylase (HDAC) inhibitor” NCT07226141 ↗

“Part 2 - DDI with valproate (valproic acid [VPA]), a probe substrate for β-oxidation and glucuronidation.” NCT06930872 ↗

Known as VPA “Buprenorphine (BPN) combined with Valproate (VPA) - will result in fewer withdrawal symptoms during detoxification of opiate-polydrug users than the existing treatment regimen,...” NCT00367874 ↗
4

“Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.” NCT00774306 ↗

“Sodium valproate (VPA) is a first-line prescription drug widely used in the treatment of epilepsy.” NCT07046676 ↗

“ZYN002 (transdermal), VPA (oral)” NCT06930872 ↗

“Depakine (VPA)” NCT04940572 ↗

Known as VPA-ER “extended-release sodium valproate (VPA-ER) and controlled-release carbamazepine (CBZ-CR) as monotherapy in patients aged ≥ 60 years with newly diagnosed epilepsy.” PMID 27552848 ↗ Aug 2016
Action Inhibit “a histone deacetylase inhibitor” PMID 19743466 ↗ Aug 2009
Modality Small molecule “Valproate, a short chain fatty acid histone deacetylase inhibitor has been shown to increase the protein level of SMN2” NCT01671384 ↗
Route Intravenous “On day 1, the experimental group receives a loading dose of valproate sodium intravenously over 1 hour within 24 hours of injury.” NCT00004817 ↗
Target SMN2 “Drugs such as valproic acid, phenylbutyrate, and sodium butyrate that mainly act as histone deacetylase inhibitors can mediate both: they stimulate the SMN2 gene transcription” NCT01671384 ↗