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R092670

Phase 2

Schizophrenia | Small molecule | Psychiatry |Johnson & Johnson|Last Updated: May 24, 2011

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 Trials1
Total Enrollment250
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00074477Safety and Efficacy of an Anti-Psychotic in Patients With SchizophreniaPHASE2 COMPLETED 250 — — Oct 1, 2003Jul 1, 2004May 24, 2011 - —
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Study Endpoints
Primary Endpoints
The change in total PANSS score from the start of the double-blind treatment period to the end of the double-blind treatment period.
Secondary Endpoints
Changes from the start of to the end of the double-blind treatment period in CGI-S and in the PANSS subscales for specific symptoms. Incidence of adverse events, labs and ECGs throughout study.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
R092670DRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients diagnosed with schizophrenia * for at least 1 year before screening * meet PANSS score criteria * must agree to hospitalization for a minimum of 14 days * body mass index (BMI) \<35.0 kilogram (kg)/meter (m)2. Exclusion Criteria: * Patients who are involuntarily com...

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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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