Recent Updates
Recently added Catalysts

Bifeprunox

Phase 3

Depression Bipolar | Small molecule | Psychiatry |Pfizer, Inc.|Last Updated: Dec 5, 2007

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment380
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00245973Study Evaluating Bifeprunox in Bipolar DepressionPHASE3 COMPLETED 380 — — Jun 1, 2005Oct 1, 2007Dec 5, 200740 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Secondary measurement scales will be used:
Hamilton Psychiatric Rating Scale for Depression (HAM-D17), at baseline, and weeks 1, 2, 3, 4, 6, and 8
Secondary Endpoints
Clinical Global Impressions Severity of Illness Score (CGI-S),at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
Clinical Global Impressions Improvement Score (CG-I), at weeks 1, 2, 3, 4, 6, and 8
Young-Mania Rating Scale (Y-MRS), at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
BifeprunoxDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites40

Inclusion Criteria: * Men and women 18 to 65 years of age, inclusive. * Diagnosis of Bipolar Disorder and must be experiencing a depressive episode. Exclusion Criteria: * This is a follow on study to protocol 3168A2-304. Only subjects who have participated in the previous study are eligible.

Countries:United States
Unlock Eligibility Criteria