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 14 indications[4].[1]

Depakote is one of 222 small molecule programs targeting Migraine Disorder. It is currently in Approved.

Indications

Total Trials

Active Trials

221

Competitors

142

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Migraine DisorderUnknown

Generalized Non-Motor (absence) SeizureUnknown

Attention Deficit Hyperactivity DisorderActive, not recruiting

Schizoaffective DisorderCompleted

Borderline Personality DisorderActive, not recruiting

Head InjuryActive, not recruiting

Complex Partial EpilepsyUnknown

EpilepsyUnknown

Major Depressive DisorderUnknown

Solid Tumor, AdultSuspended

Migraine DisorderPreclinical

Unknown

Generalized Non-Motor (absence) SeizurePreclinical

Unknown

Attention Deficit Hyperactivity DisorderApproved

Active, not recruiting

Schizoaffective DisorderApproved

Completed

Borderline Personality DisorderPreclinical

Active, not recruiting

Head InjuryPreclinical

Active, not recruiting

Complex Partial EpilepsyPreclinical

Unknown

EpilepsyPreclinical

Unknown

Major Depressive DisorderPreclinical

Unknown

Solid Tumor, AdultPreclinical

Suspended

Showing 10 of 12 indications

Competition

Competitive Landscape

115 competitors in Major Depressive Disorder

#DrugCompanyPhaseTrials

Depakote

Teva

Approved

46 2

Effexor

WWyeth-Lederle Vaccines

Approved

8 3

Buspar

Duragesic

1 5

Zyprexa

MMODAG GmbH

Approved

1 6

Narcan

SScienture

Approved

—7

Seroquel

EEngelhard Arzneimittel GmbH & Co.KG

Phase 3

12 8

Ketalar

Boehringer Ingelheim

Phase 3

5 9

Clozaril

LLife Extension Foundation Inc.

Phase 3

1 10

Lithobid

SSolvay Pharmaceuticals

Phase 3

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 ER Tablets 500 mg of Dr. Reddy's Under Fasting Conditions

Completed·—·Phase 1·NCT01581775·54 enrolled

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

Completed·—·Phase 1·NCT01055938·34 enrolled

Show 5 more trials

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

Completed·—·Phase 1·NCT01132170·34 enrolled

Divalproex Sodium Delayed-Release Tablets Under Non-Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00834990·24 enrolled

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 Divalproex Sodium 125 MG Delayed Release Tablets Under Fasting Conditions

Completed· Novartis logo

Novartis·Phase 1·NCT00864006·28 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

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

Show 2 more trials

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

Migraine2 trials

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

Completed·AAbbott·Phase 3·NCT00195741·300 enrolled

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

Completed·AAbbott·Phase 3·NCT00195806·315 enrolled

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

Fed2 trials

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

Completed·—·Phase 1·NCT01132196·34 enrolled

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

Completed·—·Phase 1·NCT01581788·54 enrolled

22 more indications

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

Effectiveness2 trials

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

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

Epilepsy2 trials

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

Characterization of Epilepsy Patients BEEP 2b

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

Adolescent1 trial

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

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

Head Injury1 trial

Valproate for Mood Swings and Alcohol Use Following Head Injury

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

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

Efficacy1 trial

Tolerability and Efficacy of Depakote-extended Release in the Elderly

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

Autism1 trial

Divalproex Sodium vs. Placebo in Childhood/Adolescent Autism

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

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·NCT03919292·80 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

Regulatory

FDA Approval Timeline[5]

Mar 10, 1983

DEPAKOTE

NDA NDA018723

Dec 6, 1985

DEPAKOTE

NDA NDA018723

Dec 23, 1985

DEPAKOTE

NDA NDA018723

Aug 11, 1986

DEPAKOTE

NDA NDA018723

Aug 11, 1986

DEPAKOTE

NDA NDA018723

Nov 24, 1986

DEPAKOTE

NDA NDA018723

Aug 17, 1988

DEPAKOTE

NDA NDA018723

Mar 21, 1989

DEPAKOTE

NDA NDA018723

Aug 16, 1989

DEPAKOTE

NDA NDA018723

Sep 12, 1989

DEPAKOTE

NDA NDA019680

Jan 14, 1993

DEPAKOTE

NDA NDA019680

Mar 18, 1994

DEPAKOTE

NDA NDA018723

Jun 22, 1994

DEPAKOTE

NDA NDA018723

Mar 23, 1995

DEPAKOTE

NDA NDA018723

Mar 23, 1995

DEPAKOTE

NDA NDA019680

Mar 18, 1996

DEPAKOTE

NDA NDA018723

Apr 26, 1996

DEPAKOTE

NDA NDA019680

Jun 20, 1996

DEPAKOTE

NDA NDA019680

Jun 20, 1996

DEPAKOTE

NDA NDA018723

Dec 2, 1996

DEPAKOTE

NDA NDA018723

Dec 2, 1996

DEPAKOTE

NDA NDA019680

Dec 24, 1997

DEPAKOTE

NDA NDA018723

Apr 2, 1998

DEPAKOTE

NDA NDA018723

May 8, 1998

DEPAKOTE

NDA NDA019680

May 8, 1998

DEPAKOTE

NDA NDA018723

Sep 22, 1998

DEPAKOTE

NDA NDA018723

Jun 19, 2000

DEPAKOTE

NDA NDA018723

Jun 19, 2000

DEPAKOTE

NDA NDA019680

Aug 4, 2000

DEPAKOTE ER

NDA NDA021168

Nov 5, 2002

DEPAKOTE

NDA NDA019680

Nov 5, 2002

DEPAKOTE

NDA NDA018723

Dec 9, 2002

DEPAKOTE

NDA NDA018723

Dec 12, 2002

DEPAKOTE

NDA NDA018723

Dec 12, 2002

DEPAKOTE

NDA NDA019680

Dec 12, 2002

DEPAKOTE ER

NDA NDA021168

Dec 20, 2002

DEPAKOTE ER

NDA NDA021168

Apr 20, 2003

DEPAKOTE ER

NDA NDA021168

Aug 14, 2003

DEPAKOTE ER

NDA NDA021168

Dec 6, 2005

DEPAKOTE ER

NDA NDA021168

Jan 11, 2006

DEPAKOTE

NDA NDA018723

Jan 11, 2006

DEPAKOTE ER

NDA NDA021168

Jan 11, 2006

DEPAKOTE

NDA NDA019680

Oct 13, 2006

DEPAKOTE

NDA NDA018723

Oct 13, 2006

DEPAKOTE ER

NDA NDA021168

Oct 13, 2006

DEPAKOTE

NDA NDA019680

Dec 19, 2006

DEPAKOTE

NDA NDA019680

Mar 24, 2008

DEPAKOTE

NDA NDA019680

Mar 24, 2008

DEPAKOTE ER

NDA NDA021168

Apr 23, 2009

DEPAKOTE ER

NDA NDA021168

Apr 23, 2009

DEPAKOTE

NDA NDA019680

Apr 23, 2009

DEPAKOTE

NDA NDA018723

Oct 7, 2011

DEPAKOTE

NDA NDA018723

Oct 7, 2011

DEPAKOTE

NDA NDA018723

Oct 7, 2011

DEPAKOTE ER

NDA NDA021168

Oct 7, 2011

DEPAKOTE

NDA NDA018723

Oct 7, 2011

DEPAKOTE

NDA NDA019680

Oct 7, 2011

DEPAKOTE

NDA NDA019680

Oct 7, 2011

DEPAKOTE

NDA NDA019680

Oct 7, 2011

DEPAKOTE

NDA NDA019680

Oct 7, 2011

DEPAKOTE

NDA NDA018723

Oct 7, 2011

DEPAKOTE

NDA NDA018723

Oct 7, 2011

DEPAKOTE ER

NDA NDA021168

Oct 7, 2011

DEPAKOTE ER

NDA NDA021168

Oct 7, 2011

DEPAKOTE ER

NDA NDA021168

Feb 27, 2013

DEPAKOTE

NDA NDA019680

Feb 27, 2013

DEPAKOTE ER

NDA NDA021168

Feb 27, 2013

DEPAKOTE

NDA NDA018723

Jun 14, 2013

DEPAKOTE

NDA NDA019680

Jun 14, 2013

DEPAKOTE ER

NDA NDA021168

Jun 14, 2013

DEPAKOTE

NDA NDA018723

Jul 31, 2013

DEPAKOTE

NDA NDA018723

Jul 31, 2013

DEPAKOTE ER

NDA NDA021168

Jul 31, 2013

DEPAKOTE

NDA NDA019680

Jun 9, 2014

DEPAKOTE

NDA NDA019680

Jun 9, 2014

DEPAKOTE ER

NDA NDA021168

Jun 9, 2014

DEPAKOTE

NDA NDA018723

Jun 19, 2014

DEPAKOTE

NDA NDA019680

Jun 19, 2014

DEPAKOTE ER

NDA NDA021168

Jun 19, 2014

DEPAKOTE

NDA NDA018723

Jun 20, 2014

DEPAKOTE

NDA NDA019680

Aug 20, 2014

DEPAKOTE ER

NDA NDA021168

Aug 20, 2014

DEPAKOTE

NDA NDA019680

Aug 20, 2014

DEPAKOTE

NDA NDA018723

Nov 20, 2014

DEPAKOTE

NDA NDA018723

Nov 20, 2014

DEPAKOTE ER

NDA NDA021168

Nov 20, 2014

DEPAKOTE

NDA NDA019680

Jan 7, 2015

DEPAKOTE

NDA NDA018723

Jan 7, 2015

DEPAKOTE

NDA NDA019680

Jan 7, 2015

DEPAKOTE ER

NDA NDA021168

Mar 13, 2015

DEPAKOTE

NDA NDA018723

Mar 13, 2015

DEPAKOTE

NDA NDA019680

Mar 13, 2015

DEPAKOTE ER

NDA NDA021168

Mar 20, 2015

DEPAKOTE ER

NDA NDA021168

Sep 23, 2015

DEPAKOTE ER

NDA NDA021168

Sep 23, 2015

DEPAKOTE

NDA NDA018723

Sep 23, 2015

DEPAKOTE

NDA NDA019680

Feb 18, 2016

DEPAKOTE

NDA NDA018723

Feb 18, 2016

DEPAKOTE

NDA NDA019680

Feb 18, 2016

DEPAKOTE ER

NDA NDA021168

May 12, 2016

DEPAKOTE ER

NDA NDA021168

Nov 2, 2016

DEPAKOTE

NDA NDA018723

Nov 2, 2016

DEPAKOTE

NDA NDA019680

Nov 2, 2016

DEPAKOTE ER

NDA NDA021168

Mar 6, 2017

DEPAKOTE ER

NDA NDA021168

Mar 6, 2017

DEPAKOTE

NDA NDA018723

Mar 6, 2017

DEPAKOTE

NDA NDA019680

Oct 5, 2017

DEPAKOTE ER

NDA NDA021168

Oct 5, 2017

DEPAKOTE

NDA NDA019680

Oct 5, 2017

DEPAKOTE

NDA NDA018723

Mar 6, 2018

DEPAKOTE

NDA NDA019680

Mar 6, 2018

DEPAKOTE ER

NDA NDA021168

Mar 6, 2018

DEPAKOTE

NDA NDA018723

Feb 21, 2019

DEPAKOTE

NDA NDA019680

Feb 21, 2019

DEPAKOTE

NDA NDA018723

Feb 21, 2019

DEPAKOTE ER

NDA NDA021168

Nov 22, 2019

DEPAKOTE

NDA NDA019680

Nov 22, 2019

DEPAKOTE

NDA NDA018723

Nov 22, 2019

DEPAKOTE ER

NDA NDA021168

May 19, 2020

DEPAKOTE

NDA NDA018723

May 19, 2020

DEPAKOTE ER

NDA NDA021168

May 19, 2020

DEPAKOTE

NDA NDA019680

Feb 10, 2021

DEPAKOTE

NDA NDA018723

Feb 10, 2021

DEPAKOTE ER

NDA NDA021168

Feb 10, 2021

DEPAKOTE

NDA NDA019680

Nov 30, 2021

DEPAKOTE

NDA NDA019680

Nov 30, 2021

DEPAKOTE

NDA NDA018723

Nov 30, 2021

DEPAKOTE ER

NDA NDA021168

Feb 24, 2023

DEPAKOTE ER

NDA NDA021168

Feb 24, 2023

DEPAKOTE

NDA NDA018723

Feb 24, 2023

DEPAKOTE

NDA NDA019680

Mar 18, 2024

DEPAKOTE ER

NDA NDA021168

Mar 18, 2024

DEPAKOTE

NDA NDA018723

Mar 18, 2024

DEPAKOTE

NDA NDA019680

Jan 23, 2025

DEPAKOTE

NDA NDA018723

Jan 23, 2025

DEPAKOTE ER

NDA NDA021168

Jan 23, 2025

DEPAKOTE

NDA NDA019680

May 1, 2025

DEPAKOTE

NDA NDA018723

May 1, 2025

DEPAKOTE ER

NDA NDA021168

May 1, 2025

DEPAKOTE

NDA NDA019680

Mar 31, 2026

DEPAKOTE

NDA NDA019680

Mar 31, 2026

DEPAKOTE

NDA NDA018723

Mar 31, 2026

DEPAKOTE ER

NDA NDA021168

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]
OpenFDA — FDA approval records (NDA NDA019680). U.S. Food & Drug Administration.
[6]
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

Depakote

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Fasting Conditions8 trials

Bipolar Disorder5 trials

Migraine2 trials

Bipolar I Disorder2 trials

Fed2 trials

Seizure2 trials

Effectiveness2 trials

Epilepsy2 trials

Pediatric1 trial

Bipolar Depression1 trial

Attention Deficit Hyperactivity Disorder1 trial

Adolescent1 trial

Scleroderma1 trial

ART1 trial

Head Injury1 trial

Combination Therapy1 trial

Schizoaffective Disorder1 trial

Schizophrenia1 trial

Anxiety1 trial

Efficacy1 trial

Autism1 trial

Children1 trial

Autism Spectrum Disorder1 trial

Acute Lymphoblastic Leukemia1 trial

Alcohol Withdrawal1 trial

Solid Tumor, Adult1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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