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divalproex

Phase 3

Bipolar I Disorder | Small molecule | Psychiatry |AstraZeneca PLC|Last Updated: Jan 4, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment1,060
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00114686Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Alcohol Dependency in Patients With Bipolar DisorderPHASE3 COMPLETED 350 — — Jan 1, 2006Apr 1, 2007Jan 4, 201338 United States
NCT00107731Efficacy & Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I DisorderPHASE3 COMPLETED 710 — — Apr 1, 2004Oct 1, 2006Mar 25, 2009166 United States, Australia +16
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Study Endpoints
Primary Endpoints
Change in the proportion of heavy drinking days from Baseline to Week 12, as derived from the Timeline Followback (TLFB) scale
Evaluate the efficacy of quetiapine versus placebo when used as adjunct therapy to mood stabilizer in increasing time to recurrence of a mood event.
Secondary Endpoints
Change in the mean number of standardized drinks per day from Baseline to Week 12 & to monthly intervals, as derived from the TLFB scale
Change in manic symptoms as assessed by the change from Baseline to each visit in the Young Mania Rating Scale (YMRS) total score
Evaluate the efficacy of quetiapine versus placebo when used as a adjunct therapy to mod stabilizer in increasing time to recurrence of a manic event
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Quetiapine fumarateDRUG -
lithiumDRUG -
divalproexDRUG -
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Eligibility Criteria
Age Range21 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites38

Inclusion Criteria: * Meets criteria for Bipolar I Disorder with Alcohol dependence * Outpatient Status * Recent history of heavy drinking Exclusion Criteria: * Unstable medical illness * Recent antipsychotic use * Poorly controlled Diabetes Mellitus or Diabetes related illness

Countries:United StatesAustraliaBelgiumBulgariaCzechiaFinlandFranceGermanyHungaryItalyNorwayPolandRussiaSouth AfricaSpainSwedenTurkey (Türkiye)United Kingdom
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Competitive Landscape -Bipolar Disorder 20 trials
CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY4PHASE3KarXT, Lithium, Valproate, Lamotrigine, Xanomeline/Trospium Chloride
AbbVie, Inc.ABBV3PHASE3Cariprazine, ABBV-932, Icalcaprant
Alkermes Public Limited CompanyALKS2PHASE3OLZ/SAM, Olanzapine
Xenon Pharmaceuticals Inc.XENE2PHASE3Azetukalner
Eli Lilly and CompanyLLY1PHASE2Brenipatide
Neurocrine Biosciences, Inc.NBIX1PHASE2NBI-1117568
Rapport Therapeutics, Inc.RAPP1PHASE2RAP-219
Alto Neuroscience, Inc.ANRO1PHASE2ALTO-100
BioXcel Therapeutics, Inc.BTAI1PHASE1BXCL501 80 Micrograms, BXCL501 120 Micrograms, BXCL501 60 Micrograms
LB Pharmaceuticals, Inc.LBRX1PHASE2LB-102
Alzamend Neuro, Inc.ALZN1PHASE1AL001, Lithium carbonate
Unity Health TorontoUBX1NAUndisclosed
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