{"id":"divalproex","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[{"effect":"Vomiting","drugRate":"","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"","severity":"common","organSystem":""},{"effect":"Somnolence","drugRate":"","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"","severity":"common","organSystem":""},{"effect":"Insomnia","drugRate":"","severity":"common","organSystem":""},{"effect":"Tremor","drugRate":"","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"","severity":"common","organSystem":""},{"effect":"Alopecia","drugRate":"","severity":"common","organSystem":""},{"effect":"Weight gain","drugRate":"","severity":"common","organSystem":""},{"effect":"Ataxia","drugRate":"","severity":"common","organSystem":""},{"effect":"Confusion","drugRate":"","severity":"common","organSystem":""},{"effect":"Depression","drugRate":"","severity":"common","organSystem":""},{"effect":"Diplopia","drugRate":"","severity":"common","organSystem":""},{"effect":"Dysarthria","drugRate":"","severity":"common","organSystem":""},{"effect":"Hallucinations","drugRate":"","severity":"common","organSystem":""},{"effect":"Vertigo","drugRate":"","severity":"common","organSystem":""},{"effect":"Agitation","drugRate":"","severity":"common","organSystem":""},{"effect":"Paresthesia","drugRate":"","severity":"common","organSystem":""},{"effect":"Anorexia","drugRate":"","severity":"common","organSystem":""},{"effect":"Dyspnea","drugRate":"","severity":"common","organSystem":""}],"contraindications":["Acute pancreatitis","Arginase deficiency","Arginosuccinate Lyase Deficiency","Chronic pancreatitis","Citrullinemia","Congenital hyperammonemia, type I","Depressive disorder","Disease of blood AND/OR blood-forming organ","Disease of liver","Hyperammonemia","Hypoalbuminemia","Hypothermia","Kidney disease","Organic mental disorder","Ornithine Carbamyltransferase Deficiency","Poisoning by sodium valproate","Porphyria","Pregnancy, function","Suicidal thoughts","Thrombocytopenic disorder"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[{"effect":"Hepatotoxicity","drugRate":"","severity":"serious"},{"effect":"Pancreatitis","drugRate":"","severity":"serious"},{"effect":"Thrombocytopenia","drugRate":"","severity":"serious"},{"effect":"Tardive dyskinesia","drugRate":"","severity":"serious"},{"effect":"Catatonic reaction","drugRate":"","severity":"serious"},{"effect":"Discoid lupus erythematosus","drugRate":"","severity":"serious"},{"effect":"Hypertension","drugRate":"","severity":"serious"},{"effect":"Hypotension","drugRate":"","severity":"serious"},{"effect":"Fecal incontinence","drugRate":"","severity":"serious"},{"effect":"Urinary incontinence","drugRate":"","severity":"serious"}]},"trials":[],"_chembl":null,"aliases":["Depakote","Depakote ER","Valproic Acid","Divalproex (Depakote)"],"patents":[],"pricing":[],"offLabel":[],"timeline":[],"_dailymed":{"setId":"4a0fa934-ec8c-460e-86eb-11281728fe85","title":"DIVALPROEX SODIUM CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]"},"ecosystem":[],"mechanism":{"target":"Alcohol dehydrogenase [NADP(+)], Histone deacetylase 1, Histone deacetylase 2"},"_scrapedAt":"2026-03-28T00:28:59.932Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"references":[],"biosimilars":[],"competitors":[],"dataSources":[{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"indications":{"approved":[{"name":"Absence seizure","diseaseId":"absence-seizure","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Bipolar affective disorder, current episode manic","diseaseId":"bipolar-affective-disorder-current-episode-manic","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Epilepsy","diseaseId":"epilepsy","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Epilepsy characterized by intractable complex partial seizures","diseaseId":"epilepsy-characterized-by-intractable-complex-partial-seizures","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Migraine Prevention","diseaseId":"migraine-prevention","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT07487675","phase":"PHASE2","title":"Evaluation of Intravenous Sodium Valproate on Interleukin-6 Levels in Patients With TMJ Disc Displacement","status":"ACTIVE_NOT_RECRUITING","sponsor":"Tanta University","startDate":"2024-09-29","conditions":"Temporomandibular Joint Internal Derangement (ADWR)","enrollment":10},{"nctId":"NCT06929273","phase":"PHASE3","title":"A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)","status":"RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2025-07-18","conditions":"Bipolar Disorder Type I With Mania","enrollment":450},{"nctId":"NCT02068586","phase":"PHASE2","title":"Sunitinib Malate or Valproic Acid in Preventing Metastasis in Patients With High-Risk Uveal Melanoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University","startDate":"2014-11-19","conditions":"Ciliary Body and Choroid Melanoma, Medium/Large Size, Ciliary Body and Choroid Melanoma, Small Size, Iris Melanoma","enrollment":210},{"nctId":"NCT06714448","phase":"","title":"A Study of the Effectiveness of Risk Minimization Measures Related to Depakine® (Sodium Valproate) in Saudi Arabia","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sanofi","startDate":"2025-04-29","conditions":"Epilepsy, Seizures","enrollment":3500},{"nctId":"NCT06729970","phase":"PHASE1","title":"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","status":"COMPLETED","sponsor":"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","startDate":"2024-12-26","conditions":"Healthy Volunteers","enrollment":133},{"nctId":"NCT07140913","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine","status":"RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2025-10-08","conditions":"Mania, Bipolar Disorder","enrollment":424},{"nctId":"NCT06930872","phase":"PHASE1","title":"Drug Interaction Study of ZYN002 Transdermal Gel and Probe Substrates","status":"COMPLETED","sponsor":"Harmony Biosciences Management, Inc.","startDate":"2025-06-06","conditions":"Drug Interaction","enrollment":29},{"nctId":"NCT06993662","phase":"PHASE1","title":"The Combination of Pharmacotherapy and Cognitive Behavioral Psychotherapy Under the Recovery Perspective.","status":"ACTIVE_NOT_RECRUITING","sponsor":"Rakitzi, Stavroula","startDate":"2025-06-02","conditions":"Anxiety, Depression, Obsessive-compulsive Disorder","enrollment":107},{"nctId":"NCT07047651","phase":"PHASE4","title":"Τhe Combination of Pharmacotherapy With RECOVERYTRSGR and RECOVERYTRSBDGR.","status":"RECRUITING","sponsor":"Dr. Stavroula Rakitzi","startDate":"2025-06-04","conditions":"Treatment Resistant Schizophrenia, Treatment Resistant Bipolar Disorder","enrollment":40},{"nctId":"NCT05603104","phase":"PHASE3","title":"Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure","status":"RECRUITING","sponsor":"Dr. Inge Winter","startDate":"2025-04-27","conditions":"Schizophrenia and Related Disorders, Major Depressive Disorder, Bipolar Depression","enrollment":1254},{"nctId":"NCT06714357","phase":"PHASE2","title":"ValproIc Acid to Potentiate Anti-EGFR Treatment Efficacy and Prevent/Revert Resistance in Colorectal Cancer","status":"RECRUITING","sponsor":"National Cancer Institute, Naples","startDate":"2025-03-12","conditions":"Colorectal Cancer Metastatic","enrollment":130},{"nctId":"NCT06433635","phase":"PHASE4","title":"Sequential Multiple Assignment Randomized Trial for Bipolar Depression","status":"ACTIVE_NOT_RECRUITING","sponsor":"Massachusetts General Hospital","startDate":"2024-10-01","conditions":"Bipolar I Disorder, Depression","enrollment":2726},{"nctId":"NCT03196466","phase":"","title":"Population Pharmacokinetics of Antiepileptic in Pediatrics","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2017-06-19","conditions":"Epilepsy","enrollment":753},{"nctId":"NCT05431595","phase":"PHASE2, PHASE3","title":"Managing Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neuroleptic Sparing Strategy","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2022-07-19","conditions":"Delirium, Epileptics, Neuroleptics","enrollment":42},{"nctId":"NCT06081283","phase":"PHASE4","title":"Antiseizure Medication in Seizure Networks at Early Acute Brain Injury","status":"TERMINATED","sponsor":"University of North Carolina, Chapel Hill","startDate":"2023-11-20","conditions":"Brain Injuries, Acute, Brain Injuries, Traumatic, Brain Ischemia","enrollment":5},{"nctId":"NCT07226141","phase":"PHASE1, PHASE2","title":"Valproate for the Treatment of Residual Amblyopia","status":"NOT_YET_RECRUITING","sponsor":"Boston Children's Hospital","startDate":"2026-01-01","conditions":"Amblyopia, Amblyopia Unilateral, Amblyopia, Anisometropic","enrollment":28},{"nctId":"NCT01552434","phase":"PHASE1","title":"Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease","status":"ACTIVE_NOT_RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2012-03-16","conditions":"Advanced Malignant Neoplasm, Castleman Disease, Digestive System Carcinoma","enrollment":155},{"nctId":"NCT05973786","phase":"PHASE3","title":"The Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.","status":"RECRUITING","sponsor":"Dr. Inge Winter","startDate":"2025-02-11","conditions":"Bipolar Depression","enrollment":418},{"nctId":"NCT07166393","phase":"PHASE2, PHASE3","title":"Valproic AcId for Traumatic BRAin INjury Trial","status":"NOT_YET_RECRUITING","sponsor":"Northwestern University","startDate":"2026-05","conditions":"Moderate Traumatic Brain Injury (TBI), Severe Traumatic Brain Injury","enrollment":432},{"nctId":"NCT05694936","phase":"PHASE2","title":"Combining Sodium Valproate With Standard-of-care EGFR (Epidermal Growth Factor Receptor) Monoclonal Antibody Treatment in Patients With Metastatic Colorectal Cancer","status":"RECRUITING","sponsor":"Australasian Gastro-Intestinal Trials Group","startDate":"2023-01-23","conditions":"Metastatic Colorectal Cancer","enrollment":90},{"nctId":"NCT02670161","phase":"PHASE4","title":"Quality Improvement and Practice Based Research in Neurology Using the EMR","status":"ENROLLING_BY_INVITATION","sponsor":"Endeavor Health","startDate":"2016-05","conditions":"Brain Tumors, Epilepsy, Migraine","enrollment":3300},{"nctId":"NCT04274179","phase":"PHASE3","title":"Ketogenic Diet for New-Onset Absence Epilepsy","status":"RECRUITING","sponsor":"Johns Hopkins University","startDate":"2020-08-10","conditions":"Absence Epilepsy, Ketogenic Dieting, Epilepsy, Absence","enrollment":40},{"nctId":"NCT05821556","phase":"PHASE2","title":"Valproic Acid/Simvastatin Plus Gemcitabine/Nab-paclitaxel Based Regimens in Untreated Metastatic Pancreatic Adenocarcinoma Patients","status":"RECRUITING","sponsor":"National Cancer Institute, Naples","startDate":"2023-06-12","conditions":"Adenocarcinoma of the Pancreas","enrollment":240},{"nctId":"NCT05756621","phase":"","title":"Dual Anti-glutamate Therapy in Super-refractory Status Epilepticus After Cardiac Arrest","status":"RECRUITING","sponsor":"University of Milano Bicocca","startDate":"2022-01-15","conditions":"Status Epilepticus, Cardiac Arrest","enrollment":80},{"nctId":"NCT07046676","phase":"PHASE4","title":"Pharmacogenetics-Based Study on Individualized Use of Sodium Valproate","status":"RECRUITING","sponsor":"The First Affiliated Hospital of University of South China","startDate":"2022-12-01","conditions":"Epilepsy","enrollment":312},{"nctId":"NCT03689114","phase":"PHASE4","title":"Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy(STANDLOW)","status":"COMPLETED","sponsor":"Mario Negri Institute for Pharmacological Research","startDate":"2021-05-10","conditions":"Epilepsies, Partial","enrollment":58},{"nctId":"NCT07052136","phase":"NA","title":"Efficacy Comparison Between Levetiracetam and Valproic Acid in Pediatric Patients With Status Epilepticus","status":"COMPLETED","sponsor":"RESnTEC, Institute of Research","startDate":"2024-11-01","conditions":"Status Epilepticus","enrollment":138},{"nctId":"NCT06199557","phase":"PHASE1, PHASE2","title":"A Study to Investigate Treatment of HU and VPA, or 6-MP and VPA in Unfit AML/HR-MDS Patients","status":"RECRUITING","sponsor":"Haukeland University Hospital","startDate":"2024-05-23","conditions":"Acute Myeloid Leukemia, Adult, Myelodysplastic Syndromes, Adult","enrollment":48},{"nctId":"NCT00306475","phase":"PHASE4","title":"Does The Addition Of Divalproex Sodium ER To An Atypical Antipsychotic Drug (APD) Improve Cognition And Psychopathology In Outpatients With Schizophrenia (SCH) Or Schizoaffective Disorder (SAD)?","status":"COMPLETED","sponsor":"Northwestern University","startDate":"2006-03","conditions":"Schizophrenia, Schizoaffective Disorder","enrollment":60},{"nctId":"NCT03357757","phase":"PHASE2","title":"Avelumab With Valproic Acid in Virus-associated Cancer","status":"COMPLETED","sponsor":"AHS Cancer Control Alberta","startDate":"2018-02-07","conditions":"Cancer That is Associated With a Chronic Viral Infection, p16 Positive SCCHN, Squamous Cell Carcinoma of the Cervix","enrollment":39},{"nctId":"NCT07024303","phase":"EARLY_PHASE1","title":"Measurement of Treatment Effects","status":"NOT_YET_RECRUITING","sponsor":"Matthew J O'Brien, PhD, BCBA-D","startDate":"2025-06-15","conditions":"Challenging Behavior, Autism Spectrum Disorder","enrollment":20},{"nctId":"NCT02446652","phase":"PHASE3","title":"Evaluation of TRANSKRIP ® Plus Chemotherapy in Recurrent-Persistent Cervical Cancer","status":"WITHDRAWN","sponsor":"National Institute of Cancerología","startDate":"2015-01-01","conditions":"Cervical Cancer","enrollment":""},{"nctId":"NCT06549426","phase":"NA","title":"Treatment of ELectroencephalographic STatus Epilepticus After Cardiopulmonary Resuscitation-2 (TELSTAR-2)","status":"RECRUITING","sponsor":"University of Twente","startDate":"2025-04-10","conditions":"Coma, Electrographic Status Epilepticus","enrollment":150},{"nctId":"NCT03919292","phase":"PHASE1, PHASE2","title":"Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca","status":"RECRUITING","sponsor":"Virginia Commonwealth University","startDate":"2019-05-01","conditions":"Solid Tumor, Adult","enrollment":83},{"nctId":"NCT00227266","phase":"PHASE2","title":"Valproic Acid and Carnitine in Patients With Spinal Muscular Atrophy","status":"COMPLETED","sponsor":"University of Utah","startDate":"2005-09","conditions":"Spinal Muscular Atrophy","enrollment":94},{"nctId":"NCT03048084","phase":"PHASE4","title":"Seizure Treatment in Glioma","status":"RECRUITING","sponsor":"Leiden University Medical Center","startDate":"2018-02-01","conditions":"Glioma","enrollment":120},{"nctId":"NCT03671681","phase":"PHASE4","title":"Mindfulness Therapy for Chronic Migraine","status":"COMPLETED","sponsor":"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta","startDate":"2018-11-05","conditions":"Chronic Migraine, Medication Overuse Headache","enrollment":177},{"nctId":"NCT02473250","phase":"PHASE4","title":"Prediction of Clinical Response to SSRI Treatment in Bipolar Disorder Using Serotonin 1A Receptor PET Imaging","status":"COMPLETED","sponsor":"New York State Psychiatric Institute","startDate":"2015-01","conditions":"Bipolar Disorder","enrollment":40},{"nctId":"NCT06729541","phase":"NA","title":"Development and Application of Precision Treatment Strategies for Common Mental Disorders","status":"RECRUITING","sponsor":"Peking University","startDate":"2024-11-11","conditions":"Depression - Major Depressive Disorder, Schizophrenia Disorders, Bipolar Disorder (BD)","enrollment":600},{"nctId":"NCT05263674","phase":"PHASE3","title":"Fast Acute Sedation at Intensive Care vs. High-dose i.v. Anti-seizure Medication for Treatment of Non-convulsive Status Epilepticus (FAST-trial)","status":"RECRUITING","sponsor":"University of Southern Denmark","startDate":"2022-02-07","conditions":"Non-Convulsive Status Epilepticus","enrollment":140},{"nctId":"NCT05722951","phase":"PHASE3","title":"Metformin Efficacy and Safety in Epileptic Patients","status":"COMPLETED","sponsor":"Tanta University","startDate":"2022-10-18","conditions":"Epilepsy","enrollment":60},{"nctId":"NCT06674070","phase":"","title":"SCN2A Polymorphisms Are Associated With Response to Valproic Acid in Paediatric Population(Pakistan)","status":"COMPLETED","sponsor":"Riphah International University","startDate":"2023-12-01","conditions":"Epilepsy","enrollment":200},{"nctId":"NCT00211757","phase":"PHASE2","title":"Divalproex Sodium vs. Placebo in Childhood/Adolescent Autism","status":"COMPLETED","sponsor":"Montefiore Medical Center","startDate":"2002-09","conditions":"Autism","enrollment":27},{"nctId":"NCT00581009","phase":"PHASE1, PHASE2","title":"The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients","status":"COMPLETED","sponsor":"University of California, Irvine","startDate":"2001-05-30","conditions":"Major Depressive Disorder, Bipolar Disorder","enrollment":49},{"nctId":"NCT05224531","phase":"PHASE2","title":"Effect of CS1 in Subjects With Pulmonary Arterial Hypertension","status":"COMPLETED","sponsor":"Cereno Scientific AB","startDate":"2022-05-05","conditions":"Pulmonary Arterial Hypertension","enrollment":25},{"nctId":"NCT05830981","phase":"NA","title":"Valproic Acid Use in Patients With Neurological Disorders","status":"COMPLETED","sponsor":"Damanhour University","startDate":"2015-01-01","conditions":"Neurological Disorders","enrollment":600},{"nctId":"NCT04218981","phase":"NA","title":"Definitive Selection of Neuroimaging Biomarkers for the Diagnosis and Treatment to Common Mental Disorders","status":"COMPLETED","sponsor":"Central South University","startDate":"2020-01-15","conditions":"Common Mental Disorder","enrollment":200},{"nctId":"NCT03717909","phase":"PHASE2","title":"Efficacy and Safety Trial of Sodium Valproate, in Paediatric and Adult Patients With Wolfram Syndrome","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Birmingham","startDate":"2018-12-28","conditions":"Wolfram Syndrome","enrollment":63},{"nctId":"NCT05881928","phase":"PHASE4","title":"Effect of Adding Lamotrigine to Sodium Valproate in Childhood Epilepsy: Clinicolabratory Study","status":"NOT_YET_RECRUITING","sponsor":"Assiut University","startDate":"2024-07-29","conditions":"Epilepsy, Lamotrigine, Sodium Valproate Adverse Reaction","enrollment":50},{"nctId":"NCT01817751","phase":"PHASE2","title":"Sorafenib, Valproic Acid, and Sildenafil in Treating Patients With Recurrent High-Grade Glioma","status":"COMPLETED","sponsor":"Virginia Commonwealth University","startDate":"2013-04-11","conditions":"Glioblastoma, Recurrent Adult Brain Neoplasm, Malignant Glioma","enrollment":47},{"nctId":"NCT06248931","phase":"PHASE3","title":"Valproate Versus Topiramate in Migraine","status":"COMPLETED","sponsor":"Kafrelsheikh University","startDate":"2022-05-01","conditions":"Migraine Disorders","enrollment":600},{"nctId":"NCT06499779","phase":"","title":"Prescription of Valproate and Derivatives in Women of Childbearing Age: Qualitative Study","status":"RECRUITING","sponsor":"University Hospital, Strasbourg, France","startDate":"2024-01-02","conditions":"Psychiatric Disorder","enrollment":50},{"nctId":"NCT06485726","phase":"PHASE4","title":"Valproate Versus Propranolol in Migraine","status":"RECRUITING","sponsor":"Kafrelsheikh University","startDate":"2023-01-23","conditions":"Migraine Disorders","enrollment":600},{"nctId":"NCT00145470","phase":"PHASE3","title":"12 Week Study of the Safety/Efficacy of Asenapine When Added to Lithium/Valproate in the Treatment of Bipolar Disorder (A7501008 / P05844 / MK-8274-017)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2005-06-02","conditions":"Bipolar Disorder","enrollment":326},{"nctId":"NCT04698525","phase":"PHASE3","title":"Comparative Study Between Valproate and Memantine in the Prophylactic Management of Episodic Migraine.","status":"COMPLETED","sponsor":"Universidad Autonoma de San Luis Potosí","startDate":"2019-02-15","conditions":"Migraine Headache","enrollment":33},{"nctId":"NCT06393309","phase":"","title":"Levetiracetam Versus Valproate in Idiopathic Generalized Epilepsy","status":"COMPLETED","sponsor":"Mazandaran University of Medical Sciences","startDate":"2022-09-03","conditions":"Treatment of Idiopathic Generalized Epilepsy","enrollment":169},{"nctId":"NCT02265770","phase":"PHASE2, PHASE3","title":"An International Clinical Program for the Diagnosis and Treatment of Children With Ependymoma","status":"RECRUITING","sponsor":"Centre Leon Berard","startDate":"2015-06-02","conditions":"Childhood Ependymoma","enrollment":536},{"nctId":"NCT04529954","phase":"PHASE1, PHASE2","title":"Anti-Epilepsy Medication Valproate Administered Via ICV Route and Catheters and Pumps for CSF Infusion","status":"TERMINATED","sponsor":"Cerebral Therapeutics LLC","startDate":"2021-01-01","conditions":"Focal Epilepsy","enrollment":20},{"nctId":"NCT02893371","phase":"","title":"Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies","status":"TERMINATED","sponsor":"University of New Mexico","startDate":"2016-09","conditions":"Bipolar Disorder","enrollment":1037352},{"nctId":"NCT05920512","phase":"PHASE1, PHASE2","title":"Combination Regimen With Sodium Valproate for Severe Hemophilia: a Single-arm, Phase 1, Pilot Trial.","status":"UNKNOWN","sponsor":"Xue-chun Lu","startDate":"2022-04-01","conditions":"Hemophilia","enrollment":10},{"nctId":"NCT06020898","phase":"PHASE2","title":"Sodium Valproate in Patients With Acute Ischemic Stroke","status":"UNKNOWN","sponsor":"RenJi Hospital","startDate":"2023-09-01","conditions":"Acute Ischemic Stroke","enrollment":40},{"nctId":"NCT00221429","phase":"PHASE3","title":"Lithium Versus Divalproex for Treating Pediatric Bipolar Disorder","status":"COMPLETED","sponsor":"Children's Hospital Medical Center, Cincinnati","startDate":"2001-03","conditions":"Bipolar Disorder","enrollment":153},{"nctId":"NCT06214130","phase":"PHASE1","title":"Bioavailability of Orfiril Long 500 mg Prolonged-Release Minitablets and Ergenyl Chrono 500 mg Prolonged-Release Tablets","status":"COMPLETED","sponsor":"Desitin Arzneimittel GmbH","startDate":"2023-09-22","conditions":"Multiple Drug Use","enrollment":22},{"nctId":"NCT06211283","phase":"PHASE1","title":"Bioavailability and Food Effect of Sodium Valproate Minitablets in Healthy Subjects.","status":"COMPLETED","sponsor":"Desitin Arzneimittel GmbH","startDate":"2023-09-11","conditions":"Food-drug Interaction","enrollment":28},{"nctId":"NCT04729543","phase":"PHASE1, PHASE2","title":"MAGE-C2 TCR T Cell Trial to Treat Melanoma and Head and Neck Cancer","status":"RECRUITING","sponsor":"Erasmus Medical Center","startDate":"2020-10-20","conditions":"Melanoma, Melanoma, Uveal, Head and Neck Cancer","enrollment":20},{"nctId":"NCT04940572","phase":"PHASE2","title":"Efficacy Study of Daily Administration of VPA in Patients Affected by Wolfram Syndrome","status":"UNKNOWN","sponsor":"Centre d'Etude des Cellules Souches","startDate":"2021-11-26","conditions":"Wolfram Syndrome","enrollment":23},{"nctId":"NCT02624128","phase":"PHASE2","title":"Valproic Acid Plus Cisplatin and Cetuximab in Recurrent and/or Metastatic Squamous Cell Carcinoma of Head and Neck","status":"UNKNOWN","sponsor":"National Cancer Institute, Naples","startDate":"2015-02-23","conditions":"Squamous Cell Carcinoma of the Head and Neck","enrollment":39},{"nctId":"NCT04310176","phase":"PHASE2","title":"Valproic Acid in Combination With Bevacizumab and Oxaliplatin/Fluoropyrimidine Regimens in Patients With Ras-mutated Metastatic Colorectal Cancer","status":"UNKNOWN","sponsor":"National Cancer Institute, Naples","startDate":"2019-05-24","conditions":"Ras-mutated Metastatic Colorectal Cancer","enrollment":200},{"nctId":"NCT03825250","phase":"PHASE1, PHASE2","title":"The Val-CARD Trial","status":"UNKNOWN","sponsor":"University of Leicester","startDate":"2018-11-06","conditions":"Cardiac Valve Disease, Coronary Artery Disease, Organ Failure, Multiple","enrollment":122},{"nctId":"NCT06089356","phase":"PHASE4","title":"Zolmitriptane as Prophylaxis for Chilhood Migraine","status":"UNKNOWN","sponsor":"Tanta University","startDate":"2023-01-01","conditions":"Migraine","enrollment":90},{"nctId":"NCT05641649","phase":"PHASE4","title":"Bioequivalence Study of Sodium Valproate and Valproic Acid Tablets","status":"UNKNOWN","sponsor":"Kathmandu University","startDate":"2023-08-06","conditions":"Epilepsy","enrollment":16},{"nctId":"NCT04997811","phase":"PHASE2","title":"Repurposed Drugs to Improve Haematological Responses in Myelodysplastic Syndromes","status":"UNKNOWN","sponsor":"Prof. Janet Dunn","startDate":"2021-12-21","conditions":"Myelodysplastic Syndromes (MDS)","enrollment":120},{"nctId":"NCT05481957","phase":"PHASE4","title":"Vortioxetine Adjunctive Treatment in Bipolar Depression","status":"COMPLETED","sponsor":"First Affiliated Hospital of Zhejiang University","startDate":"2022-03-01","conditions":"Bipolar Depression","enrollment":131},{"nctId":"NCT06005155","phase":"","title":"Lithium Versus Anticonvulsants and the Risk of Physical Disorders","status":"COMPLETED","sponsor":"Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital","startDate":"2022-06-01","conditions":"Bipolar Disorder","enrollment":169285},{"nctId":"NCT05017454","phase":"EARLY_PHASE1","title":"Sodium Valproate-loaded Nanospanlastics in Patchy Alopecia Areata in Comparison to Topical Steroids","status":"COMPLETED","sponsor":"Kasr El Aini Hospital","startDate":"2021-05-01","conditions":"Alopecia Areata","enrollment":67},{"nctId":"NCT02600507","phase":"PHASE3","title":"Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression","status":"COMPLETED","sponsor":"Intra-Cellular Therapies, Inc.","startDate":"2016-03-07","conditions":"Bipolar Depression","enrollment":529},{"nctId":"NCT00374075","phase":"PHASE1","title":"Study of Safety and Dosing Effect on SMN Levels of Valproic Acid (VPA) in Patients With Spinal Muscular Atrophy","status":"COMPLETED","sponsor":"University of Utah","startDate":"2003-09","conditions":"Spinal Muscular Atrophy","enrollment":42},{"nctId":"NCT00261443","phase":"PHASE4","title":"A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2005-09","conditions":"Bipolar Disorder","enrollment":1270},{"nctId":"NCT04513314","phase":"PHASE4","title":"Valproate Alone or in Combination With Quetiapine for Severe COVID-19 Pneumonia With Agitated Delirium","status":"WITHDRAWN","sponsor":"University of Miami","startDate":"2023-03-28","conditions":"Covid19, Hyperactive Delirium, Pneumonia, Viral","enrollment":""},{"nctId":"NCT05788822","phase":"NA","title":"MVA to Improve the Pregnancy Outcome in Aged Infertility Women With Assisted Reproductive Technology","status":"UNKNOWN","sponsor":"Nanjing University","startDate":"2022-10-08","conditions":"Infertility, Female, IVF, Reproductive Disorder","enrollment":148},{"nctId":"NCT01898104","phase":"PHASE1, PHASE2","title":"Preoperative Valproic Acid and Radiation Therapy for Rectal Cancer","status":"UNKNOWN","sponsor":"National Cancer Institute, Naples","startDate":"2012-05","conditions":"Colorectal Cancer","enrollment":152},{"nctId":"NCT02899611","phase":"PHASE1, PHASE2","title":"A Dose Ranging Pilot Study for Intracerebroventricular (ICV) Delivery of Valproate in Subjects With Temporal Seizures","status":"COMPLETED","sponsor":"Cerebral Therapeutics LLC","startDate":"2016-08","conditions":"Epilepsy","enrollment":6},{"nctId":"NCT00289952","phase":"PHASE2","title":"Valproic Acid and Its Effects on HIV Latent Reservoirs","status":"COMPLETED","sponsor":"Jean-Pierre Routy","startDate":"2006-06","conditions":"HIV Infections","enrollment":50},{"nctId":"NCT05737511","phase":"PHASE4","title":"Efficacy of Hydroxyzine for Patients With Panic Disorder","status":"NOT_YET_RECRUITING","sponsor":"Sultan Qaboos University","startDate":"2023-12-30","conditions":"Panic Disorder","enrollment":80},{"nctId":"NCT05697614","phase":"PHASE4","title":"The Benefit and Safety of Older Generation Anti-Epileptic Drugs (AEDs) in Drug-Resistant Epilepsy Children","status":"UNKNOWN","sponsor":"Dr Cipto Mangunkusumo General Hospital","startDate":"2023-03-01","conditions":"Drug Resistant Epilepsy","enrollment":100},{"nctId":"NCT02607904","phase":"PHASE2","title":"An Open-label Extension Trial to Investigate Possible Drug-drug Interactions Between Stiripentol or Valproate and Cannabidiol in Patients With Epilepsy","status":"COMPLETED","sponsor":"Jazz Pharmaceuticals","startDate":"2016-12-15","conditions":"Epilepsy","enrollment":30},{"nctId":"NCT02607891","phase":"PHASE2","title":"A Study of Possible Drug-drug Interactions Between Stiripentol or Valproate and Cannabidiol in Patients With Epilepsy","status":"COMPLETED","sponsor":"Jazz Pharmaceuticals","startDate":"2016-11-09","conditions":"Epilepsy","enrollment":35},{"nctId":"NCT03616223","phase":"PHASE1, PHASE2","title":"FX-322 in Sensorineural Hearing Loss","status":"COMPLETED","sponsor":"Frequency Therapeutics","startDate":"2018-07-03","conditions":"Sensorineural Hearing Loss","enrollment":23},{"nctId":"NCT03652974","phase":"PHASE4","title":"Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy","status":"COMPLETED","sponsor":"Shanghai Mental Health Center","startDate":"2018-09-06","conditions":"Schizophrenia","enrollment":145},{"nctId":"NCT05181007","phase":"PHASE1","title":"Drug-drug Interaction Between Ciprofol and Mefanamic Acid or Valproate","status":"COMPLETED","sponsor":"Haisco Pharmaceutical Group Co., Ltd.","startDate":"2021-12-17","conditions":"Drug Drug Interaction","enrollment":41},{"nctId":"NCT03636958","phase":"NA","title":"Efficacy and Safety of Perampanel in Combination in Glioma-refractory Epilepsy","status":"WITHDRAWN","sponsor":"Assistance Publique Hopitaux De Marseille","startDate":"2021-02-15","conditions":"Refractory Epilepsy","enrollment":""},{"nctId":"NCT03243461","phase":"PHASE3","title":"International Cooperative Phase III Trial of the HIT-HGG Study Group (HIT-HGG-2013)","status":"UNKNOWN","sponsor":"University of Göttingen","startDate":"2018-07-17","conditions":"Glioblastoma WHO Grade IV, Diffuse Midline Glioma Histone 3 K27M WHO Grade IV, Anaplastic Astrocytoma WHO Grade III","enrollment":167},{"nctId":"NCT01730313","phase":"PHASE2","title":"Treatment of Nodding Syndrome - A Randomized Blinded Placebo-Controlled Crossover Trial of Oral Pyridoxine and Conventional Anti-Epileptic Therapy, in Northern Uganda - 2012","status":"WITHDRAWN","sponsor":"Centers for Disease Control and Prevention","startDate":"2016-02","conditions":"Nodding Syndrome","enrollment":""},{"nctId":"NCT03681158","phase":"PHASE1","title":"Study of Excretion Balance and Pharmacokinetics of [14C]-Sodium Valproate (3.7 MBq) in Healthy Postmenopausal or Permanently Sterile Female Subjects","status":"COMPLETED","sponsor":"Sanofi","startDate":"2018-10-05","conditions":"Epilepsy","enrollment":5},{"nctId":"NCT02497443","phase":"PHASE1, PHASE2","title":"Safety of Autologous MSC Infusion to Treat Epilepsy","status":"COMPLETED","sponsor":"Ministry of Public Health, Republic of Belarus","startDate":"2011-04","conditions":"Epilepsy","enrollment":60},{"nctId":"NCT00484471","phase":"PHASE4","title":"ABLE: Abilify in Bipolar Disorder for Long-term Effectiveness","status":"COMPLETED","sponsor":"Korea Otsuka International Asia Arab","startDate":"2007-10","conditions":"Bipolar Disorder","enrollment":127},{"nctId":"NCT03012815","phase":"PHASE4","title":"Gabapentin for Alcohol Withdrawal Syndrome","status":"COMPLETED","sponsor":"Mayo Clinic","startDate":"2017-02-01","conditions":"Alcohol Withdrawal Syndrome","enrollment":88},{"nctId":"NCT00159588","phase":"NA","title":"Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly?","status":"COMPLETED","sponsor":"Norwegian University of Science and Technology","startDate":"2004-01","conditions":"Headache","enrollment":64},{"nctId":"NCT02056236","phase":"NA","title":"TELSTAR: Treatment of ELectroencephalographic STatus Epilepticus After Cardiopulmonary Resuscitation","status":"COMPLETED","sponsor":"University of Twente","startDate":"2014-04","conditions":"Cardiac Arrest, Anoxic Encephalopathy, Status Epilepticus","enrollment":172},{"nctId":"NCT03940326","phase":"PHASE4","title":"Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures","status":"COMPLETED","sponsor":"Mazandaran University of Medical Sciences","startDate":"2018-04-01","conditions":"Epilepsy, Idiopathic Generalized","enrollment":103}],"_emaApprovals":[],"_faersSignals":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"formularyStatus":[],"_approvalHistory":[{"date":"20140205","type":"SUPPL","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA078979"},{"date":"20110121","type":"SUPPL","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA078979"},{"date":"20231011","type":"SUPPL","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA078979"},{"date":"20200121","type":"SUPPL","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA078979"},{"date":"20200706","type":"SUPPL","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA078979"},{"date":"20160519","type":"SUPPL","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA078979"},{"date":"20200121","type":"SUPPL","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA078979"},{"date":"20150818","type":"SUPPL","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA078979"},{"date":"20141108","type":"SUPPL","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA078979"},{"date":"20140205","type":"SUPPL","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA078979"},{"date":"20100107","type":"SUPPL","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA078979"},{"date":"20230111","type":"SUPPL","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA078979"},{"date":"20200121","type":"SUPPL","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA078979"},{"date":"20230111","type":"SUPPL","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA078979"},{"date":"20160519","type":"SUPPL","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA078979"},{"date":"20200121","type":"SUPPL","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA078979"},{"date":"20150818","type":"SUPPL","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA078979"},{"date":"20090123","type":"ORIG","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA078979"},{"date":"20200121","type":"SUPPL","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA078979"},{"date":"20150818","type":"SUPPL","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA078979"},{"date":"20141108","type":"SUPPL","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA078979"},{"date":"20140205","type":"SUPPL","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA078979"},{"date":"20230609","type":"SUPPL","sponsor":"UNICHEM","applicationNumber":"ANDA214643"},{"date":"20260128","type":"SUPPL","sponsor":"UNICHEM","applicationNumber":"ANDA214643"},{"date":"20220225","type":"ORIG","sponsor":"UNICHEM","applicationNumber":"ANDA214643"},{"date":"20260128","type":"SUPPL","sponsor":"UNICHEM","applicationNumber":"ANDA214643"},{"date":"20240603","type":"SUPPL","sponsor":"UNICHEM","applicationNumber":"ANDA214643"},{"date":"20240829","type":"SUPPL","sponsor":"ANNORA PHARMA","applicationNumber":"ANDA215527"},{"date":"20230926","type":"ORIG","sponsor":"ANNORA PHARMA","applicationNumber":"ANDA215527"},{"date":"20250415","type":"SUPPL","sponsor":"ANNORA PHARMA","applicationNumber":"ANDA215527"},{"date":"20100910","type":"SUPPL","sponsor":"MYLAN","applicationNumber":"ANDA077567"},{"date":"20200103","type":"SUPPL","sponsor":"MYLAN","applicationNumber":"ANDA077567"},{"date":"20200103","type":"SUPPL","sponsor":"MYLAN","applicationNumber":"ANDA077567"},{"date":"20150922","type":"SUPPL","sponsor":"MYLAN","applicationNumber":"ANDA077567"},{"date":"20150922","type":"SUPPL","sponsor":"MYLAN","applicationNumber":"ANDA077567"},{"date":"20250902","type":"SUPPL","sponsor":"MYLAN","applicationNumber":"ANDA077567"},{"date":"20140913","type":"SUPPL","sponsor":"MYLAN","applicationNumber":"ANDA077567"},{"date":"20250902","type":"SUPPL","sponsor":"MYLAN","applicationNumber":"ANDA077567"},{"date":"20231023","type":"SUPPL","sponsor":"MYLAN","applicationNumber":"ANDA077567"},{"date":"20231023","type":"SUPPL","sponsor":"MYLAN","applicationNumber":"ANDA077567"},{"date":"20200103","type":"SUPPL","sponsor":"MYLAN","applicationNumber":"ANDA077567"},{"date":"20231023","type":"SUPPL","sponsor":"MYLAN","applicationNumber":"ANDA077567"},{"date":"20200103","type":"SUPPL","sponsor":"MYLAN","applicationNumber":"ANDA077567"},{"date":"20200103","type":"SUPPL","sponsor":"MYLAN","applicationNumber":"ANDA077567"},{"date":"20200103","type":"SUPPL","sponsor":"MYLAN","applicationNumber":"ANDA077567"},{"date":"20150922","type":"SUPPL","sponsor":"MYLAN","applicationNumber":"ANDA077567"},{"date":"20140913","type":"SUPPL","sponsor":"MYLAN","applicationNumber":"ANDA077567"},{"date":"20090129","type":"ORIG","sponsor":"MYLAN","applicationNumber":"ANDA077567"},{"date":"20140913","type":"SUPPL","sponsor":"MYLAN","applicationNumber":"ANDA077567"},{"date":"20250902","type":"SUPPL","sponsor":"MYLAN","applicationNumber":"ANDA077567"},{"date":"20231023","type":"SUPPL","sponsor":"MYLAN","applicationNumber":"ANDA077567"},{"date":"20080729","type":"ORIG","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA078755"},{"date":"20141108","type":"SUPPL","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA078755"},{"date":"20110121","type":"SUPPL","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA078755"}],"developmentCodes":[],"ownershipHistory":[],"publicationCount":0,"therapeuticAreas":["Neuroscience"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Divalproex","genericName":"Divalproex","companyName":"University of Chicago","companyId":"university-of-chicago","modality":"Small molecule","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":4,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}