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bifeprunox, olanzapine

Phase 3

Schizophrenia | Small molecule | Psychiatry |Pfizer, Inc.|Last Updated: Dec 27, 2007

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 Enrollment240
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00366171Open Label Extension Study of BifeprunoxPHASE3 COMPLETED 120 — — Nov 1, 2006Oct 1, 2007Dec 27, 200783 United States
NCT00380224Study Comparing the Affect of Bifeprunox Vs Olanzapine on Weight During the Treatment of Outpatients With Schizophrenia.PHASE3 COMPLETED 120 — — Jul 1, 2006Sep 1, 2007Dec 27, 200767 United States
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Study Endpoints
Primary Endpoints
Change in body weight from baseline/first dose of bifeprunox at each observation.
Change from baseline on body weight at the final evaluation.
Secondary Endpoints
Change from baseline/first dose of bifeprunox for triglyceride levels, Positive and Negative Syndrome Scale (PANSS) score, Clinical Global Impression (CGI)-Score, and waist circumference at each observation.
Change from baseline in triglyceride level; Change from baseline in waist circumference; and Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
BifeprunoxDRUG -
bifeprunox, olanzapineDRUG -
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Eligibility Criteria
Age Range18 Years — 66 Years
SexALL
Healthy VolunteersNo
Study Sites83

Inclusion Criteria: 1. Outpatients who have successfully completed Wyeth study 3168A1-311-US. 2. A signed and dated informed consent form for this study. 3. No major protocol violations in previous study. Exclusion Criteria: 1. Clinically important abnormalities noted in preceding short-term stud...

Countries:United States
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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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