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Uridine

Phase 2

Bipolar Depression | Small molecule | Psychiatry |Repligen Corporation|Last Updated: Nov 9, 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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00322764Phase II Study to Assess RG2417 in the Treatment of Bipolar I DepressionPHASE2 COMPLETED 80Mar 1, 2006 -Nov 9, 200711 United States
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Study Endpoints
Primary Endpoints
Improvement of MADRS and CGI BP C for RG2417 treatment in comparison to placebo
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
UridineDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: 1. DSM-IV-TR diagnosis of Bipolar I Depression 2. 18 to 65 years of age, inclusive 3. Depressive phase, as measured by MADRS greater than or equal to 20 at Screening and Day1 4. Duration of current depressive episode of at least four weeks by Day 1 5. Competent to give informed ...

Countries:United States
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