Hepatic Encephalopathy

Gastroenterology
10
Pipeline Programs
3
Companies
10
Clinical Trials
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
2
0
5
3
Early DiscoveryClinical DevelopmentMarket

On Market (2)

Approved therapies currently available

U
RIFAXIMINApproved
rifaximin
Unknown Company
oral
Bausch Health
XIFAXANApproved
rifaximin
Bausch Health
oral2010

Competitive Landscape

2 companies ranked by most advanced pipeline stage

Bausch Health
Bausch HealthQUEBEC, Quebec, Canada
9 programs
1
5
1
RifaximinPhase 41 trial
RifaximinPhase 31 trial
RifaximinPhase 31 trial
RifaximinPhase 31 trial
Rifaximin SSDPhase 31 trial
+4 more programs
Active Trials
NCT00533910CompletedEst. May 2010
NCT01846806TerminatedEst. Mar 2016
NCT00281502UnknownEst. Dec 2012
+6 more trials
Amgen
AmgenTHOUSAND OAKS, CA
1 program
1
sodium phenylacetate and sodium benzoate injection 10% / 10%Phase 21 trial
Active Trials
NCT00597909Terminated1Est. Sep 2008

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Bausch HealthRifaximin
Bausch HealthRifaximin SSD
Bausch HealthRifaximin SSD
Bausch HealthRifaximin
Bausch HealthRifaximin
Bausch HealthRifaximin
Amgensodium phenylacetate and sodium benzoate injection 10% / 10%
Bausch HealthRifaximin
Bausch HealthRifaximin
Bausch HealthRifaximin

Clinical Trials (10)

Total enrollment: 1 patients across 10 trials

NCT01842581Bausch HealthRifaximin

The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy

Start: Jan 2013Est. completion: Dec 2014
Phase 4Completed
NCT05297448Bausch HealthRifaximin SSD

Evaluation of Rifaximin SSD for Delaying Encephalopathy Decompensation in Patients With Cirrhosis

Start: Aug 2022Est. completion: Jan 2026
Phase 3Active Not Recruiting
NCT05071716Bausch HealthRifaximin SSD

Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis

Start: Apr 2022Est. completion: Sep 2025
Phase 3Active Not Recruiting
NCT00686920Bausch HealthRifaximin

Safety and Tolerability Study of Rifaximin in Participants With a History of Hepatic Encephalopathy

Start: Mar 2007Est. completion: Dec 2010
Phase 3Completed
NCT00364689Bausch HealthRifaximin

RICE Trial: Rifaximin In Chronic Hepatic Encephalopathy - A Randomized, Controlled Trial

Start: Aug 2006Est. completion: Jul 2008
Phase 3Terminated
NCT00298038Bausch HealthRifaximin

A 6-month Efficacy, Safety, and Tolerability Study of Rifaximin In Preventing Hepatic Encephalopathy

Start: Dec 2005Est. completion: Aug 2008
Phase 3Completed
NCT00597909Amgensodium phenylacetate and sodium benzoate injection 10% / 10%

Efficacy and Safety Study of Ammonul® in Patients With Grade 3 or 4 Hepatic Encephalopathy

Start: Dec 2007Est. completion: Sep 20081 patients
Phase 2Terminated
NCT00281502Bausch HealthRifaximin

The Role of Bacterial Overgrowth and Delayed Intestinal Transit in Hepatic Encephalopathy

Start: Dec 2005Est. completion: Dec 2012
Phase 2Unknown
NCT01846806Bausch HealthRifaximin

The Role of Bacterial Overgrowth and Delayed Intestinal Transit in Hepatic Encephalopathy.

Start: Sep 2012Est. completion: Mar 2016
N/ATerminated
NCT00533910Bausch HealthRifaximin

Rifaximin in Minimal Hepatic Encephalopathy

Start: Oct 2007Est. completion: May 2010
N/ACompleted

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

5 late-stage (Phase 3) programs — potential near-term approvals
3 companies competing in this space

Related Indications

Hepatic Impairment(79)Gastroesophageal Reflux Disease(37)Irritable Bowel Syndrome(29)Gastroesophageal Reflux(27)Liver Transplantation(24)Celiac Disease(23)Hepatic Insufficiency(22)Liver Cirrhosis(22)Gastroesophageal Reflux Disease (GERD)(14)Gastrointestinal Tolerance(12)