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Sivelestat

Phase 1

Respiratory Distress Syndrome, Adult | Small molecule | Other |Eli Lilly and Company|Last Updated: Jul 19, 2006

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 Enrollment600
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00036062A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung InjuryPHASE1 COMPLETED 600Aug 1, 2001Dec 1, 2002Jul 19, 2006110 United States, Australia +4
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
SivelestatDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites110

Inclusion Criteria * show evidence of acute lung injury * be on mechanical ventilation Exclusion Criteria * have undergone certain organ transplants * have severe underlying medical problems * be unlikely to survive * be pregnant or breast-feeding

Countries:United StatesAustraliaBelgiumCanadaNew ZealandSpain
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