Recent Updates
Recently added Catalysts

Drotrecogin alfa

Phase 3

Sepsis | Small molecule | Infectious Disease |Eli Lilly and Company|Last Updated: Sep 18, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials4
Total Enrollment5,010
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00604214Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Septic ShockPHASE3 COMPLETED 1,696 — — Mar 1, 2008Feb 1, 2012Sep 18, 2012150 United States, Australia +16
NCT00190788Extended Therapy of Drotrecogin Alfa (Activated) 4 vs 7 Days InfusionPHASE3 COMPLETED 200 — — Jun 1, 2004May 1, 2007Oct 12, 20072 United States, France
NCT00049764Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe SepsisPHASE3 COMPLETED 474 — — Nov 1, 2002Apr 1, 2005Nov 20, 200749 United States, Australia +9
NCT00568737The Study of Drotrecogin Alfa (Activated) in Adult Patients With Severe Sepsis at a Low Risk of DeathPHASE3 COMPLETED 2,640 — — Nov 1, 2002Feb 1, 2005Dec 6, 200770 Argentina, Australia +10
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
28-Day All-Cause Mortality
Day 28

Expressed as percentage of participants who died from any cause at Day 28 endpoint.

- To assess whether continued administration of Drotrecogin Alfa (Activated)for up to 72 additional hours after 96 hours infusion of commercial DDA results in more rapid resolution of vasopressor-dependent hypotension
That drotrecogin alfa (activated) compared with placebo reduces severe-sepsis-induced organ dysfunction
3 Years
Efficacy
20 months
Secondary Endpoints
28-Day All-Cause Mortality in Participants With Severe Protein C Deficiency
Day 28
Average Cardiovascular Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28
Day 1 through Day 28
Average Respiratory Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28
Day 1 through Day 28
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Drotrecogin alfa (activated)EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
1EXPERIMENTAL24 microgram/kg/hr for 96 hours (+ or - 1 hour)
2PLACEBO_COMPARATOR0.9% sodium chloride
Interventions
NameTypeDescription
Drotrecogin alfa (activated)DRUG24 microgram/kilogram/hour, intravenous, 96 hours (hr)
PlaceboDRUG0.9% sodium chloride, intravenous, 96 hours
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites150

Inclusion Criteria: * Must be 18 years or older * Must have evidence of infection * Must have systemic inflammatory response syndrome (SIRS) * Must have vasopressor-dependent septic shock Exclusion Criteria: * Have received vasopressor therapy (at any dose) for greater than 24 hours prior to the ...

Countries:United StatesAustraliaBelgiumBrazilCanadaCzechiaFinlandFranceGermanyIndiaItalyMexicoNetherlandsNew ZealandPortugalSpainSwitzerlandUnited KingdomChilePolandSlovakiaArgentinaAustriaDenmarkEgypt
Unlock Eligibility Criteria
Competitive Landscape -Sepsis 17 trials
CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN1PHASE2AZD4144
ImmunityBio IncIBRX1PHASE2Nogapendekin alfa inbakicept
Bluejay Diagnostics, Inc.BJDX2 — Undisclosed
CytoSorbents CorporationCTSO1 — Undisclosed
Danaher CorporationDHR3 — Undisclosed
Spectral AI, Inc. Class AMDAI1NAUndisclosed
Unlock Competitive Intelligence