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FST-100

Phase 2

Acute Viral Conjunctivitis | Small molecule | Infectious Disease |Takeda Pharmaceutical Company Limited|Last Updated: Jun 24, 2021

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_CONTROLLED
Total Trials1
Total Enrollment132
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01461954FST-100 in the Treatment of Acute Viral ConjunctivitisPHASE2 COMPLETED 132May 17, 2013Mar 10, 2014Jun 24, 20212 United States, Brazil
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Study Endpoints
Primary Endpoints
Clinical resolution of acute viral conjunctivitis
6-7 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
FST-100EXPERIMENTAL -
FST-100 VehiclePLACEBO_COMPARATOR -
Interventions
NameTypeDescription
FST-100DRUGFST-100
FST-100 VehicleDRUGFST-100 Vehicle
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Have a clinical diagnosis of suspected acute viral conjunctivitis in at least one eye Exclusion Criteria: * Have a known sensitivity to any of the components of FST-100 or FST-100 vehicle

Countries:United StatesBrazil
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