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OPT-80

Phase 2

Diarrhea | Small molecule | Gastrointestinal |Merck & Company, Inc.|Last Updated: Mar 27, 2017

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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00097422OPT-80 in Clostridium Difficile-Associated Diarrhea (CDAD)PHASE2 COMPLETED -Nov 1, 2004Apr 1, 2005Mar 27, 20171 United States
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Study Endpoints
Primary Endpoints
Relief of symptoms of CDAD
Secondary Endpoints
Recurrence Rate.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
OPT-80DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients with CDAD Exclusion Criteria: * Patients with severe CDAD

Countries:United States
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