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Sivelestat

Phase 1

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

Sivelestat development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since May 2002

Sivelestat target and mechanism

Molecular targetELANE
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment600

FDA Designations

No designations recorded

Sivelestat clinical trials

Sivelestat · 1 trial · 2 indications

Phase 1 1
NCT00036062A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung InjuryRespiratory Distress Syndrome, Adult
COMPLETED600 Analytics
PHASE1COMPLETED
A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury
Respiratory Distress Syndrome, AdultUnlock trial analytics

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
SivelestatDRUG -
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Eligibility Criteria

Age Range18 Years to 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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Frequently asked questions about Sivelestat

What is Sivelestat used for?

Sivelestat is being studied for the treatment of Adult Respiratory Distress Syndrome, also referred to as acute lung injury. It is an investigational small molecule developed by Eli Lilly and Company and has not been approved for commercial use. Clinical evaluation has focused on hospitalized adult patients with this respiratory condition.

What does Sivelestat target?

Sivelestat targets ELANE, also known as neutrophil elastase, and acts as an inhibitor of this enzyme. By inhibiting ELANE activity, the drug is designed to reduce enzyme-driven tissue damage in the lungs. This mechanism is the basis for its investigation in acute lung injury and Adult Respiratory Distress Syndrome.

Who makes Sivelestat?

Sivelestat is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. The company is the sponsor of the clinical program evaluating the drug in respiratory distress syndrome and acute lung injury.

What phase is Sivelestat in?

Sivelestat is in Phase 1 clinical development for Adult Respiratory Distress Syndrome. It is an investigational small molecule and is not FDA approved. The program has completed one trial to date, and no trials are currently active.

What clinical trials is Sivelestat in?

Sivelestat has been evaluated in one completed clinical trial, NCT00036062, titled a Phase II study to determine the efficacy and safety of Sivelestat in subjects with acute lung injury. The randomized, double-blind study enrolled 600 adults across the United States, Australia, Belgium, Canada, New Zealand, and Spain.