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sPLA2 Inhibitor

Phase 1

Sepsis | Small molecule | Infectious Disease |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 Enrollment466
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00034476A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients With Severe SepsisPHASE1 COMPLETED 466Oct 1, 2001Oct 1, 2002Jul 19, 200685 United States, Belgium +3
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
sPLA2 InhibitorDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites85

Inclusion Criteria: Patients must * show evidence of acute infection * meet specified time windows * be 18 years of age or older Exclusion Criteria: Patients must not * have low white blood cell count * have undergone certain organ transplants * be HIV positive * be pregnant or breast feeding * h...

Countries:United StatesBelgiumHungaryNetherlandsPoland
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