Bausch Health announced Phase 3 RED-C trial results showing rifaximin SSD was safe but failed to prevent first hepatic encephalopathy episodes in cirrhosis patients.
Written By: Pharmacally Medical News Desk
Bausch Health Companies Inc. has announced results from its global Phase 3 RED-C clinical program evaluating amorphous-rifaximin solid soluble dispersion (SSD) for the primary prevention of hepatic encephalopathy (HE) in adults with liver cirrhosis. Although the investigational therapy was found to be safe and well-tolerated, both pivotal trials did not achieve their primary endpoint.
The RED-C program was designed to assess whether rifaximin SSD could delay the first episode of hepatic encephalopathy in cirrhosis patients who had not previously experienced HE. Despite the unmet medical need in this population, the outcomes from the two studies were not sufficient to support the intended clinical benefit.
Company Response and Next Steps
Bausch Health expressed disappointment with the trial findings, highlighting the lack of approved preventive therapies for patients at risk of developing hepatic encephalopathy.
“We are disappointed in the results, as there is currently no approved treatment for these patients. We are currently reviewing the full dataset to determine potential new development opportunities,” said Thomas J. Appio, Chief Executive Officer of Bausch Health.
The company also thanked the patients, investigators, and research teams involved and reaffirmed its commitment to advancing treatments in hepatology and other therapeutic areas.
About the RED-C Clinical Program
The RED-C program consisted of two global, randomized, double-blind, placebo-controlled Phase 3 trials RED-C-3132 (NCT05297448) and RED-C-3131 (NCT05071716) enrolling more than 1,000 patients across 398 clinical sites in 17 countries. The trials evaluated rifaximin SSD as a preventive treatment intended to delay the first occurrence of hepatic encephalopathy in adults with liver cirrhosis.
Cirrhosis and Hepatic Encephalopathy Burden
Cirrhosis remains a major cause of end-stage liver disease in the United States. According to CDC data, chronic liver disease and cirrhosis rank among the leading causes of death. Disease progression in cirrhosis is often marked by severe complications such as hepatic encephalopathy, jaundice, ascites, or variceal bleeding. HE in particular represents a serious neurological decline that significantly worsens patient outcomes.
References
Bausch Health Provides Update on RED-C Phase 3 Clinical Trials, 23 January 2026, https://ir.bauschhealth.com/news-releases/2026/01-23-2026-124516159
Evaluation of Rifaximin SSD for Delaying Encephalopathy Decompensation in Patients with Cirrhosis (RED-C-3132), ClinicalTrials.gov ID NCT05297448, https://clinicaltrials.gov/study/NCT05297448
Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis (RED-C-3131), ClinicalTrials.gov ID NCT05071716, https://clinicaltrials.gov/study/NCT05071716