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Seroquel

Phase 3

Schizophrenia | 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-BlindUNCONTROLLEDBiomarker
Total Trials3
Total Enrollment1,201
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00228462Relapse Prevention, RoW: Study to Evaluate Prevention of Relapse in Patients in Stable Chronic Schizophrenia Receiving Either Seroquel or PlaceboPHASE3 COMPLETED 197 — — Mar 1, 2005Apr 1, 2006Jan 4, 20135 Bulgaria, Poland
NCT00206128Immediate Release (IR) to Sustained Release (SR) Switching Study: Study of Switching From IR Seroquel to SR Seroquel in Outpatients With SchizophreniaPHASE3 COMPLETED 454 — — Nov 1, 2004Feb 1, 2006Jan 4, 201369 United States, Australia +10
NCT00234377Seroquel Switching Study: Feasibility of Switching Any Antipsychotic Treatment to Seroquel in Patients With SchizophreniaPHASE3 COMPLETED 550 — — Nov 1, 2004May 1, 2006Jan 4, 201327 Canada, Finland +2
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Study Endpoints
Primary Endpoints
The primary objective in this study is to demonstrate superior efficacy of quetiapine to placebo by evaluating relapse prevention in long-term use in patients with schizophrenia as measured by the time to first psychiatric relapse up to one year
The proportion of patients who discontinue study treatment due to lack of efficacy or whose positive and negative syndrome scale (PANSS) total score increases 20% or more
from randomisation to any visit
The proportion of patients who have an improved clinical benefit based on assessment of clinical efficacy in combination with assessment of tolerability
Secondary Endpoints
To demonstrate superiority of quetiapine to placebo by evaluating the risk of relapse in long-term use in patients with schizophrenia by evaluating the one-year relapse rate
The change in PANSS total score
from randomization to week 6
The change in PANSS positive, negative and general psychopathology symptoms subscale scores respectively
from randomization to week 6
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Seroquel (quetiapine)DRUG -
Seroquel SRDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Stable schizophrenic patients who have provided written informed consent * Patients 18 to 65 years old who remain clinically stable after switching to a stable dose of Seroquel (quetiapine). Exclusion Criteria: * Patients with risk of suicide, other disorders or substance ab...

Countries:BulgariaPolandUnited StatesAustraliaCanadaEstoniaFinlandGermanyHungaryItalyLatviaLithuaniaSpain
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Competitive Landscape -Schizophrenia 38 trials
CompanyTickerTrialsLead PhaseDrugs
Neurocrine Biosciences, Inc.NBIX5PHASE3NBI-1117568, NBI-1117570
Bristol-Myers Squibb CompanyBMY9PHASE3KarXT, KarX-EC, Xanomeline and Trospium Chloride, xanomeline and trospium chloride therapy, Xanomeline and trospium chloride
Alkermes Public Limited CompanyALKS2PHASE3OLZ/SAM, Olanzapine
LB Pharmaceuticals, Inc.LBRX2PHASE3LB-102
Vanda Pharmaceuticals Inc.VNDA1PHASE3iloperidone
Eli Lilly and CompanyLLY2PHASE2Brenipatide
Reviva Pharmaceuticals Holdings, Inc.RVPH1PHASE3Brilaroxazine
AbbVie, Inc.ABBV1PHASE2Emraclidine
Novartis AG Sponsored ADRNVS1PHASE2GXV813
MapLight Therapeutics, Inc.MPLT2PHASE2ML-007C-MA
Anavex Life Sciences Corp.AVXL1PHASE2ANAVEX3-71
Alto Neuroscience, Inc.ANRO1PHASE2ALTO-101
Minerva Neurosciences IncNERV1PHASE3Roluperidone, risperidone, aripiprazole, olanzapine
BioXcel Therapeutics, Inc.BTAI1PHASE1BXCL501 80 Micrograms, BXCL501 120 Micrograms, BXCL501 60 Micrograms
Unity Health TorontoUBX1NAUndisclosed
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