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open-label rifaximin
Rifaximin works by inhibiting bacterial RNA synthesis, thereby reducing bacterial load in the gut.
Rifaximin works by inhibiting bacterial RNA synthesis, thereby reducing bacterial load in the gut. Used for Hepatic encephalopathy, Irritable bowel syndrome with diarrhea (IBS-D).
At a glance
| Generic name | open-label rifaximin |
|---|---|
| Also known as | rifaximin |
| Sponsor | Bausch Health Americas, Inc. |
| Drug class | Rifamycin antibiotic |
| Target | RNA polymerase |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
Rifaximin is a rifamycin antibiotic that targets bacterial RNA polymerase, leading to a decrease in bacterial RNA synthesis and ultimately reducing the bacterial load in the gut. This mechanism of action is particularly effective against Gram-negative bacteria, which are often implicated in conditions such as hepatic encephalopathy.
Approved indications
- Hepatic encephalopathy
- Irritable bowel syndrome with diarrhea (IBS-D)
Common side effects
- Diarrhea
- Nausea
- Abdominal pain
Key clinical trials
- Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea (PHASE4)
- Pharmacokinetic Study of Single-Dose Modified Release Glipizide in Healthy Volunteers (PHASE1)
- Efficacy and Safety of Rifaximin-α in Treating MASLD (EARLY_PHASE1)
- A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis (PHASE3)
- Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE) (NA)
- Effect of Perioperative Oral Rifaximin on Early Graft Dysfunction in Adult Living Donor Liver Transplant (NA)
- Vegetarian Versus Non Vegetarian Based Diet in the Recurrence of Hepatic Encephalopathy in Patients With Cirrhosis: An Open Label Pilot Study
- Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy and Hepatically Impaired Subjects (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- open-label rifaximin CI brief — competitive landscape report
- open-label rifaximin updates RSS · CI watch RSS
- Bausch Health Americas, Inc. portfolio CI