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Xifaxan (rifaximin)
Xifaxan (generic name: rifaximin) is a Rifamycin Antibacterial [EPC] drug developed by Bausch Health. It is currently FDA-approved for Diarrhea due to E. Coli, Hepatic encephalopathy, Irritable bowel syndrome with diarrhea.
Xifaxan, also known as rifaximin, is a non-absorbable, broad-spectrum antibiotic that inhibits bacterial DNA-directed RNA polymerase. It is used to treat various non-infectious gastrointestinal diseases, including irritable bowel syndrome, as indicated by its approval for conditions such as Diverticular Disease, Bloating, Functional Bowel Disorder, and Irritable Bowel Syndrome.
At a glance
| Generic name | rifaximin |
|---|---|
| Sponsor | Bausch Health |
| Drug class | Rifamycin Antibacterial [EPC] |
| Target | Nuclear receptor subfamily 1 group I member 2, Bacterial DNA-directed RNA polymerase |
| Therapeutic area | Gastroenterology |
| Phase | FDA-approved |
| Annual revenue | 1500 |
Approved indications
- Diarrhea due to E. Coli
- Hepatic encephalopathy
- Irritable bowel syndrome with diarrhea
Common side effects
- Peripheral edema
- Nausea
- Dizziness
- Fatigue
- Ascites
- Muscle spasms
- Pruritus
- Abdominal pain
- Anemia
- Depression
- Nasopharyngitis
- Abdominal pain upper
Serious adverse events
- Dysentery
- Taste loss
- Weight decrease
- Anorexia
- Nasal passage irritation
Key clinical trials
- Pilot, Single Center, Open, Trial of Rifaximin in Probable Alzheimer's Disease (Phase 2)
- Efficacy and Safety of Rifaximin in Treating Metabolic Associated Fatty Liver Disease: A Pilot Trial (EARLY/Phase 1)
- A Double Blind Randomized Placebo Controlled Study Examining the Effects of a Non-Absorbable (Rifaximin) Antibiotic on the Chronic Immune Activation Observed In HIV-infected Subjects (Phase 1)
- Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess The Efficacy and Safety of Three Different Doses (275, 550 AND 1100 MG) of Rifaximin Administered BID For Either Two or Four W (Phase 2)
- Clinical Study Evaluating the Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy (Phase 3)
- A Phase 1, Single Arm, Open-Label Study to Evaluate the Effect of Rifaximin 550 MG Tablets TID on the Pharmacokinetics of Orally Administered Midazolam in Healthy Male and Female Volunteers (Phase 1)
- High Volume Plasmapheresis for Refractory Hepatic Encephalopathy in Liver Intensive Care Unit-A Randomized Controlled Trial (NA)
- A Randomized Controlled Trial Evaluating Single-dose Rifaximin Versus Azithromycin With Loperamide Adjunct for Treatment of Acute Watery Diarrhea (Phase 4)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 7928115 | 2029-07-24 | Method of Use |
| 8193196 | 2027-09-02 | Compound |
| 8309569 | 2029-07-18 | Method of Use |
| 8741904 | 2026-02-27 | Compound |
| 8829017 | 2029-07-24 | Method of Use |
| 8642573 | 2029-10-02 | Method of Use |
| 9421195 | 2029-07-24 | Method of Use |
| 8969398 | 2029-10-02 | Method of Use |
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 |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Xifaxan CI brief — competitive landscape report
- Xifaxan updates RSS · CI watch RSS
- Bausch Health portfolio CI
Frequently asked questions about Xifaxan
What is Xifaxan?
What is Xifaxan used for?
Who makes Xifaxan?
What is the generic name of Xifaxan?
What drug class is Xifaxan in?
What development phase is Xifaxan in?
What are the side effects of Xifaxan?
What is Xifaxan's annual revenue?
What does Xifaxan target?
Related
- Drug class: All Rifamycin Antibacterial [EPC] drugs
- Target: All drugs targeting Nuclear receptor subfamily 1 group I member 2, Bacterial DNA-directed RNA polymerase
- Manufacturer: Bausch Health — full pipeline
- Therapeutic area: All drugs in Gastroenterology
- Indication: Drugs for Diarrhea due to E. Coli
- Indication: Drugs for Hepatic encephalopathy
- Indication: Drugs for Irritable bowel syndrome with diarrhea
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing