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BCX4208

Phase 2

Gout | Small molecule | Musculoskeletal |BioCryst Pharmaceuticals, Inc.|Last Updated: Jan 23, 2012

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment99
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00985127Study to Evaluate the Urate-Lowering Activity and Safety of Oral BCX4208 Administered in Subjects With GoutPHASE2 COMPLETED 99Sep 1, 2009Sep 1, 2010Jan 23, 201224 United States
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Study Endpoints
Primary Endpoints
To determine the effect of different doses of orally administered BCX4208 on serum uric acid (sUA)levels in subjects with gout.
Day 22
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
40 mgEXPERIMENTAL40 mg BCX4208
80 mgEXPERIMENTALBCX4208
120 mgEXPERIMENTALBCX4208
sugar pillPLACEBO_COMPARATOR -
160mgEXPERIMENTALBCX4208
240mgEXPERIMENTALBCX4208
320mgEXPERIMENTALBCX4208
Interventions
NameTypeDescription
placeboDRUGadministered daily for 21 days
BCX4208DRUGAdministered daily for 21 days.
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Eligibility Criteria
Age Range18 Years — 69 Years
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: 1. Age ≥18 to \<70 years 2. Have read and signed the ICF after the nature of the study has been fully explained 3. Screening sUA ≥8.0 mg/dL 4. Diagnosis of gout according to the preliminary criteria of the American Rheumatism Association (1977) 5. Female participants must meet a...

Countries:United States
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Competitive Landscape -Gout 5 trials