Depakote

(divalproex)

ApprovedSmall molecule

AbbVie

Depakote is one of 130 small molecule programs targeting Bipolar I Disorder. It is currently in Approved.

Indications

Total Trials

Active Trials

129

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Bipolar I DisorderActive, not recruiting

Post-Traumatic Stress DisorderActive, not recruiting

Intellectual DisabilityActive, not recruiting

Bipolar DisorderActive, not recruiting

Bipolar I DisorderPhase 3

Active, not recruiting

Post-Traumatic Stress DisorderPhase 3

Active, not recruiting

Intellectual DisabilityPreclinical

Active, not recruiting

Bipolar DisorderPhase 3

Active, not recruiting

Competition

Competitive Landscape

192 competitors in Bipolar Disorder

#DrugCompanyPhaseTrials

Depakote

AbbVie

Approved

5 2

Depacon

AbbVie

Phase 3

6 3

Depakote

AbbVie

Phase 3

5 4

Robitussin

Pfizer

Phase 3

2 5

Lexapro

AbbVie

Phase 3

2 6

Paxil

SSebela Pharmaceuticals Development LLC

Phase 3

3 7

Ketalar

Boehringer Ingelheim

Phase 3

2 8

Methylthioninium Chloride

PProvepharm SAS

Phase 3

1 9

Rescue

Merck & Co.

Phase 3

2 10

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Phase 3

—

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

Clinical

Trials by Indication[1]

Bipolar Disorder5 trials

Treatment and Outcome of Early Onset Bipolar Disorder

Completed·NNorthwell Health·Phase 4·NCT00048802·40 enrolled

Sequential Multiple Assignment Treatment for Bipolar Disorder

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 4·NCT01588457·112 enrolled

Combination Therapy for the Treatment of Bipolar Disorders

Terminated·UUniversity Hospitals Cleveland Medical Center·Phase 3·NCT00063362·49 enrolled

Show 2 more trials

Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Alcohol Dependency in Patients With Bipolar Disorder

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00114686·350 enrolled

Lithium and Divalproex for the Treatment of Comorbid Rapid Cycling Bipolar Disorder and Substance Abuse Disorder

Completed·UUniversity Hospitals Cleveland Medical Center·Phase 3·NCT00194129·31 enrolled

Bipolar I Disorder2 trials

Efficacy & Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00107731·710 enrolled

Efficacy and Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00081380·710 enrolled

Post-Traumatic Stress Disorder2 trials

Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder

Terminated·TTuscaloosa Research & Education Advancement Corporation·Phase 4·NCT00203385·20 enrolled

Divalproex Sodium in the Treatment of PTSD (Post-Traumatic Stress Disorder)

Completed·VVA Office of Research and Development·Phase 3·NCT00108576·101 enrolled

Combination Therapy1 trial

Combination Therapy in Dual Diagnosis Bipolar Rapid Cycling

Completed·UUniversity Hospitals Cleveland Medical Center·Phase 3·NCT00221975·98 enrolled

Agitation1 trial

A Comparison of Two Standard Therapies in the Management of Dementia With Agitation

Completed·EEmory University·Phase 4·NCT00208819·50 enrolled

9 more indications

Olanzapine1 trial

A Comparison of Olanzapine in Combination With a Mood Stabilizer vs Mood Stabilizer Alone, in Mixed Bipolar Patients

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00402324·202 enrolled

Children1 trial

Depakote (Divalproex Sodium) for Children With Temper Dysregulation and Severe Mood Swings

Completed·NNew York State Psychiatric Institute·Phase 4·NCT02078596·15 enrolled

Intermittent Explosive Disorder1 trial

A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder

Completed·UUniversity of Chicago·Phase 2·NCT00078754·90 enrolled

Treatment1 trial

Treatment of Bipolar Mania in Older Adults

Completed·WWeill Medical College of Cornell University·Phase 4·NCT00254488·224 enrolled

Drug Therapy1 trial

Treatment of Mania Symptoms With Drug Therapy

Completed·PPalo Alto Veterans Institute for Research·Phase 3·NCT00183443·75 enrolled

Intellectual disability1 trial

Comparison of Immediate vs Gradual Switch to Divalproex in Adults With Intellectual Disability

Completed·UUniversity of Kansas·N/A·NCT00347152·18 enrolled

Completed·LLindner Center of HOPE·Phase 3·NCT00278772·62 enrolled

Regulatory

FDA Approval Timeline[4]

Oct 26, 1984

DEPAKOTE

NDA NDA018723

Sep 12, 1989

DEPAKOTE

NDA NDA019680

Jul 11, 1990

DEPAKOTE CP

NDA NDA019794

May 31, 2002

DEPAKOTE ER

NDA NDA021168

Sources

References

[1]
ClinicalTrials.gov — 20 trial records for divalproex. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — divalproex compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for divalproex. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA021168). U.S. Food & Drug Administration.
[5]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AbbVie

Depakote

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Bipolar Disorder5 trials

Bipolar I Disorder2 trials

Post-Traumatic Stress Disorder2 trials

Combination Therapy1 trial

Agitation1 trial

Olanzapine1 trial

Children1 trial

Intermittent Explosive Disorder1 trial

Treatment1 trial

Drug Therapy1 trial

Intellectual disability1 trial

Alzheimer's Disease1 trial

Huntington's Disease1 trial

Monotherapy1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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