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XBD173

Phase 2

Anxiety Disorders | Small molecule | Psychiatry |Novartis AG|Last Updated: May 20, 2010

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 Trials1
Total Enrollment400
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00108836Efficacy, Safety and Tolerability of XBD173 in Patients With Generalized Anxiety DisorderPHASE2 COMPLETED 400Mar 1, 2005May 1, 2006May 20, 201023 United States, Canada
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Study Endpoints
Primary Endpoints
Mean reduction in anxiety from baseline to week 6
Secondary Endpoints
The difference on day 4 in effect between placebo and the individual doses of XBD173 on reduction in anxiety and depression
Pharmacokinetic assessments at baseline
Pharmacogenetic assessments at baseline
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
XBD173DRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: * Current doctor's diagnosis of generalized anxiety disorder * In need of psychiatric treatment * Willingness to complete all aspects of the study Exclusion Criteria: * Current doctor's diagnosis of major depression * History of schizophrenia or schizoaffective disorders * Dru...

Countries:United StatesCanada
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