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Depakote

(divalproex sodium)

ApprovedSmall molecule

Divalproex sodium is used to treat seizures in epilepsy, prevent migraine headaches, and manage mood swings in bipolar disorder. It works by stabilizing electrical activity in the brain and nerves.[2] Depakote is currently approved and in use across 31 indications[4].[1]

Depakote is one of 657 small molecule programs targeting Bipolar I Disorder. It is currently in Approved.

31

Indications

46

Total Trials

0

Active Trials

656

Competitors

Pipeline

Status by Indication[4][1]

Indication

Bipolar I DisorderActive, not recruiting

Migraine DisorderUnknown

Generalized Non-Motor (absence) SeizureUnknown

Mood DisorderActive, not recruiting

Attention Deficit Hyperactivity DisorderActive, not recruiting

Focal-Onset SeizureActive, not recruiting

Huntington DiseaseActive, not recruiting

Schizoaffective DisorderActive, not recruiting

Alzheimer DiseaseActive, not recruiting

Borderline Personality DisorderActive, not recruiting

Bipolar I DisorderPhase 3

Active, not recruiting

Migraine DisorderPreclinical

Unknown

Generalized Non-Motor (absence) SeizurePreclinical

Unknown

Mood DisorderPhase 2

Active, not recruiting

Attention Deficit Hyperactivity DisorderApproved

Active, not recruiting

Focal-Onset SeizurePhase 3

Active, not recruiting

Huntington DiseasePhase 2

Active, not recruiting

Schizoaffective DisorderApproved

Active, not recruiting

Alzheimer DiseasePhase 2

Active, not recruiting

Borderline Personality DisorderPreclinical

Active, not recruiting

Showing 10 of 29 indications

Competition

Competitive Landscape

583 competitors in Schizophrenia

#DrugCompanyPhaseTrials

Depakote

Resotran

Ozempic

Depakote

Ibrance

Comtan

Orion Corporation, Orion Pharma

Luvox

SSolvay Pharmaceuticals

Catapres

Boehringer Ingelheim

Permax

VValeant Pharmaceuticals

Rapamune

PPrism Pharmaceuticals

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Fasting Conditions8 trials

Divalproex Sodium Delayed-Release Tablets Under Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00834639·24 enrolled

Bioequivalence Study of Divalproex Sodium 125 MG Delayed Release Tablets Under Fasting Conditions

Completed· Novartis logo

Novartis·Phase 1·NCT00864006·28 enrolled

Divalproex Sodium Delayed-Release Tablets Under Non-Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00834990·24 enrolled

Show 5 more trials

Divalproex Sodium 500 mg Extended Release Tablets Under Non-Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00974012·24 enrolled

Divalproex Sodium 500 mg Extended Release Tablets Under Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00974441·48 enrolled

Bioequivalence Study of Dr. Reddy's Divalproex Sodium Capsules (Sprinkle), 125 mg Under Fasting Conditions

Completed·—·Phase 1·NCT01055938·34 enrolled

Bioequivalency Study of Divalproex Sodium DR Tablets, 500 mg of Dr.Reddy's Under Fasting Conditions

Completed·—·Phase 1·NCT01132170·34 enrolled

Bioequivalence Study of Divalproex Sodium ER Tablets 500 mg of Dr. Reddy's Under Fasting Conditions

Completed·—·Phase 1·NCT01581775·54 enrolled

Bipolar Disorder5 trials

Evaluate the Safety of Depakote Extended Release Tablets in the Treatment of Mania Associated With Bipolar Disorder in Children and Adolescents

Completed·AAbbott·Phase 3·NCT00195767·150 enrolled

Study of Depakote ER for the Treatment of Mania in Children Ages 6-12 With Bipolar Disorder

Completed·MMassachusetts General Hospital·Phase 4·NCT00181727·14 enrolled

An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents

Completed·AAbbott·Phase 3·NCT00067262·150 enrolled

Show 2 more trials

An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder

Completed·AAbbott·Phase 3·NCT00060905·370 enrolled

Safety And Efficacy Study Of Depakote ER To Treat Pediatric Bipolar Disorder

Completed·MMedical College of Wisconsin·Phase 4·NCT00199966·30 enrolled

Migraine2 trials

Study Designed to Evaluate the Safety of Prophylactic Depakote ER in the Treatment of Adolescents With Migraine

Completed·AAbbott·Phase 3·NCT00195806·315 enrolled

The Safety and Efficacy of Divalproex Sodium Extended-Release Tablets in Migraine Prophylaxis: A Study in Adolescents

Completed·AAbbott·Phase 3·NCT00195741·300 enrolled

Effectiveness2 trials

A Phase III Open-Label, Multi-Center, Long-Term Extension Study of Depakote ER in Subjects Who Either Completed or Prematurely Discontinued Due to Ineffectiveness From Study M02-488.

Completed·AAbbott·Phase 3·NCT00195754·114 enrolled

Effectiveness of Divalproex Sodium (Depakote) in Treating Children With Temper Outbursts and Severe Mood Swings

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00217932·15 enrolled

Fed2 trials

Bioequivalence Study of Divalproex Sodium ER Tablets, 500 mg Under Fed Conditions

Completed·—·Phase 1·NCT01581788·54 enrolled

Bioequivalence Study of Divalproex Sodium DR Tablets 500 mg of Dr. Reddy's Under Fed Conditions

Completed·—·Phase 1·NCT01132196·34 enrolled

22 more indications

Bipolar I Disorder2 trials

Olanzapine vs. Comparator and Placebo in the Treatment of Patients With Bipolar I Disorder

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00094549·500 enrolled

A Study for the Treatment of Mania Associated With Bipolar I Disorder in Children and Adolescents

Completed·AAbbott·Phase 3·NCT00195780·227 enrolled

Epilepsy2 trials

Characterization of Epilepsy Patients BEEP 2b

Completed·FFood and Drug Administration (FDA)·Phase 1·NCT02707965·21 enrolled

A Study in Stable Epilepsy Patients Comparing Brand and Generic Divalproex Sodium Extended Release Tablets

Unknown status·VVince & Associates Clinical Research, Inc.·Phase 1·NCT01898676·16 enrolled

Seizure2 trials

A Study for Treatment of Partial Seizures in Children

Completed·AAbbott·Phase 3·NCT00102713·50 enrolled

A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children

Terminated·AAbbott·Phase 3·NCT00067431·300 enrolled

Head Injury1 trial

Valproate for Mood Swings and Alcohol Use Following Head Injury

Completed·UUniversity of Colorado, Denver·N/A·NCT01760785·50 enrolled

Children1 trial

A Study of Divalproex Sodium in Children With ASD and Epileptiform EEG

Withdrawn·NNational Institute of Mental Health (NIMH)·Phase 2·NCT01170325

Autism Spectrum Disorder1 trial

Treatment of Children With Autism Spectrum Disorders and Epileptiform EEG With Divalproex Sodium

Withdrawn·—·Phase 2·NCT02094651

Acute Lymphoblastic Leukemia1 trial

Effects of Divalproex Sodium on Food Intake, Energy Expenditure, and Posture Allocation

Completed·PPennington Biomedical Research Center·Phase 4·NCT00287053·57 enrolled

Alcohol Withdrawal1 trial

Gabapentin for Alcohol Withdrawal Syndrome

Completed·MMayo Clinic·Phase 4·NCT03012815·88 enrolled

Adolescent1 trial

Divalproex Sodium (Depakote) for Explosive Tempers in Adolescents and Adults

Completed·NNew York State Psychiatric Institute·Phase 3·NCT00218114·25 enrolled

Autism1 trial

Divalproex Sodium vs. Placebo in Childhood/Adolescent Autism

Completed·MMontefiore Medical Center·Phase 2·NCT00211757·27 enrolled

Pediatric1 trial

Risperidone and Divalproex Sodium With MRI Assessment in Pediatric Bipolar

Completed·UUniversity of Illinois at Chicago·Phase 3·NCT00176202·65 enrolled

Bipolar Depression1 trial

Efficacy of Quetiapine XR Versus Divalproex on Clinical Outcome Quality of Sleep and Quality of Life in Bipolar Depression

Withdrawn·BBo-Hyun Yoon·Phase 4·NCT01587066

Attention Deficit Hyperactivity Disorder1 trial

Medication Strategies for Treating Aggressive Behavior in Youth With Attention Deficit Hyperactivity Disorder

Completed·SStony Brook University·Phase 4·NCT00228046·40 enrolled

Scleroderma1 trial

Divalproex Sodium in the Treatment of the Cutaneous Manifestations of Scleroderma

Withdrawn·YYale University·Phase 1/2·NCT02166229

ART1 trial

Bioequivalence Study of Dr. Reddy's Divalproex Sodium Coated Particles in Capsules, 125 mg, Under Fed Condition

Completed·—·Phase 1·NCT01056627·34 enrolled

Efficacy1 trial

Tolerability and Efficacy of Depakote-extended Release in the Elderly

Completed·VVirginia Commonwealth University·N/A·NCT00318929·14 enrolled

Anxiety1 trial

Placebo Controlled Trial of Depakote ER in Alcohol Dependent Patients With Mood and/or Anxiety Symptoms

Completed·SSeattle Institute for Biomedical and Clinical Research·Phase 2/3·NCT00202514·40 enrolled

Combination Therapy1 trial

Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects During the Maintenance Phase of Bipolar Illness

Terminated·AAbbott·Phase 4·NCT00071253·180 enrolled

Schizoaffective Disorder1 trial

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)?

Completed·NNorthwestern University·Phase 4·NCT00306475·60 enrolled

Schizophrenia1 trial

Depakote ER Plus an Atypical Antipsychotic Vs. an Atypical Antipsychotic Alone in the Treatment of Schizophrenia

Completed·AAbbott·Phase 2·NCT00073164·400 enrolled

Solid Tumor, Adult1 trial

Phase 1/2 Study of Neratinib and Divalproex Sodium (Valproate) in Advanced Solid Tumors, With an Expansion Cohort in Ras-Mutated Cancers

Suspended·VVirginia Commonwealth University·Preclinical·NCT03919292·83 enrolled

Unspecified3 trials

Bioequivalence Study of Divalproex Sodium Capsules(Sprinkle),125 mg of Dr. Reddy's Under Fasting Condition (Apple Sauce)

Completed·—·Phase 1·NCT01132183·34 enrolled

Fasting Study of Divalproex Sodium Extended-Release Tablets 500 mg to Depakote ER® Tablets 500 mg

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00647712·38 enrolled

Food Study of Divalproex Sodium Extended-Release Tablets 500 mg to Depakote ER® Tablets 500 mg

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00648076·40 enrolled

Sources

References

[1]
ClinicalTrials.gov — 46 trial records for divalproex sodium. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Depakote drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — divalproex sodium compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for divalproex sodium. EMBL-EBI & Wellcome Sanger Institute.
[5]
SEC EDGAR — Teva company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Succinate Semialdehyde Dehydrogenase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Teva

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