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Rifaximin SSD

Phase 3

Hepatic Encephalopathy | Small molecule | Gastrointestinal |Bausch Health Companies Inc.|Last Updated: Sep 10, 2025

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_CONTROLLEDDMC
Total Trials2
Total Enrollment990
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05297448Evaluation of Rifaximin SSD for Delaying Encephalopathy Decompensation in Patients With CirrhosisPHASE3 ACTIVE NOT_RECRUITING 466Aug 3, 2022Jan 1, 2026Sep 10, 2025188 United States, Australia +15
NCT05071716Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in CirrhosisPHASE3 ACTIVE NOT_RECRUITING 524Apr 7, 2022Sep 1, 2025Jul 24, 2025150 United States, Australia +2
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Study Endpoints
Primary Endpoints
Time to first event of overt hepatic encephalopathy requiring medical intervention in hospital/ER/ED/clinic or death.
72 weeks
Secondary Endpoints
Time to first Conn score ≥ 2 or confirmed OHE requiring medical intervention in hospital/ER/ED/clinic or death
72 weeks
Time to all-cause hospitalization
72 weeks
Time to first event of OHE that requires hospitalization, or all-cause death
72 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Rifaximin SSD-40mg IREXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Rifaximin SSDDRUGRifaximin Solid Soluble Dispersion Immediate Release Twice Daily
PlaceboDRUGPlacebo Twice Daily
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites188

Key Inclusion Criteria: * Diagnosis of liver cirrhosis with medically controlled ascites (\>30 days) not requiring therapeutic paracentesis (could have had paracentesis in the past). * Conn (West Haven Criteria) score of \< 2. * Mini-Mental State Examination (MMSE) score \> 24 at screening. * ≥ 18 ...

Countries:United StatesAustraliaBelgiumBulgariaCanadaFranceGermanyHungaryIndiaItalyMongoliaNew ZealandPolandPuerto RicoSouth KoreaSpainUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05297448primaryCompletionDate: changed
LOWMay 26, 2026NCT05071716primaryCompletionDate: changed
LOWMay 24, 2026NCT05297448studyFirstPostDate: changed
LOWMay 24, 2026NCT05071716studyFirstPostDate: changed