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Rifaximin SSD

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment990

FDA Designations

No designations recorded

Clinical trial landscape

Rifaximin SSD · 2 trials · 1 indication

Phase 3 2
NCT05297448Evaluation of Rifaximin SSD for Delaying Encephalopathy Decompensation in Patients With CirrhosisHepatic Encephalopathy
ACTIVE NOT_RECRUITING466 Analytics
NCT05071716Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in CirrhosisHepatic Encephalopathy
ACTIVE NOT_RECRUITING524 Analytics
PHASE3ACTIVE NOT_RECRUITING
Evaluation of Rifaximin SSD for Delaying Encephalopathy Decompensation in Patients With Cirrhosis
Hepatic EncephalopathyUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis
Hepatic EncephalopathyUnlock trial analytics

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 to 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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Frequently asked questions about Rifaximin SSD

What is Rifaximin SSD used for in Hepatic Encephalopathy?

Rifaximin SSD is an investigational small molecule being studied for Hepatic Encephalopathy, a complication of cirrhosis. It is being evaluated for its ability to delay encephalopathy decompensation in patients with cirrhosis. The drug is currently in Phase 3 clinical development and is not yet approved by the FDA.

What does Rifaximin SSD target?

Rifaximin SSD is a rifamycin antibiotic that targets the gut microbiome. It works by reducing the production of ammonia and other toxins in the gastrointestinal tract, which are believed to contribute to hepatic encephalopathy. By modulating gut bacteria, it aims to prevent the neurological symptoms associated with this condition.

Who makes Rifaximin SSD?

Rifaximin SSD is being developed by Bausch Health Companies Inc., traded on the New York Stock Exchange under the ticker BHC. The company is conducting Phase 3 clinical trials to evaluate the drug's efficacy and safety in patients with cirrhosis who are at risk for hepatic encephalopathy.

What phase is Rifaximin SSD in?

Rifaximin SSD is in Phase 3 clinical development. It is currently being evaluated in two active, placebo-controlled, double-blind, randomized trials that are not yet recruiting participants. The drug is investigational and has not received FDA approval for any indication.

What clinical trials is Rifaximin SSD in?

Rifaximin SSD is being studied in two Phase 3 clinical trials. NCT05071716 is assessing the drug for delaying encephalopathy decompensation in cirrhosis with 524 participants. NCT05297448 is evaluating the drug for the same purpose in 466 patients. Both trials are active but not recruiting, and are conducted across multiple countries.

Is Rifaximin SSD the same as Rifaximin?

Rifaximin SSD is a soluble solid dispersion formulation of rifaximin, an antibiotic used to treat hepatic encephalopathy. While it contains the same active ingredient, the SSD formulation is designed to improve solubility and absorption. It is being studied as a potential new treatment to delay encephalopathy decompensation in cirrhosis.