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Norfloxacin

Phase 2

Hepatopulmonary Syndrome | Small molecule | Other |Unity Biotechnology, Inc.|Last Updated: Dec 7, 2016

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment9
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00362752A Pilot Study of Norfloxacin for Hepatopulmonary SyndromePHASE2 COMPLETED 9Oct 1, 2006Dec 1, 2009Dec 7, 20161 Canada
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Study Endpoints
Primary Endpoints
- Primary endpoint: A-a gradient
4 weeks
Secondary Endpoints
paO2,
4 weeks
exhaled NO
4 weeks
DLCO
4 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
Norfloxacin 400 mg bidEXPERIMENTAL -
Interventions
NameTypeDescription
NorfloxacinDRUG400 mg po bid
PlaceboDRUGPlacebo 400 mg po bid
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Diagnosis of HPS, based on all of the following: evidence of portal hypertension (esophagogastric varices or portal hypertensive gastropathy identified on esophagogastroduodenoscopy, and/or varices seen on computerized tomography (CT) scan or ultrasound, and/or splenomegaly wit...

Countries:Canada
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