NDAORALTABLETPriority Review
Approved
Mar 2010
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
38
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 9m ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XIFAXAN (rifaximin) is a non-systemic oral antibiotic approved in 2010 for treatment of traveler's diarrhea and hepatic encephalopathy. It works by inhibiting bacterial RNA polymerase, reducing pathogenic gut bacteria while minimizing systemic absorption. The drug is positioned as a targeted, non-absorbed therapeutic for gastrointestinal conditions.
$1.1BPart D
LOE ApproachingProduct is approaching loss of exclusivity with significant Part D utilization (384K claims), signaling contraction phase and potential team restructuring at Bausch Health.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (38)
Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea
Started Feb 2026
54 enrolled
DiarrheaGastroenteritisBacterial Infection+1 more
Rifaximin SSD in Dementia Trial
Started Dec 2024
20 enrolled
Dementia Alzheimer TypeDementia Associated With Cerebrovascular Disease
Rifaximin for the Secondary Prevention of Recurrent Pouchitis
Started Jul 2024
16 enrolled
Pouchitis
Evaluating the Effect Of Rifaximin on the Gut Microbiota and Metabolome in SIBO Using CapScan®
Started Feb 2024
34 enrolled
Small Intestinal Bacterial Overgrowth
Evaluation of Rifaximin SSD for Delaying Encephalopathy Decompensation in Patients With Cirrhosis
Started Aug 2022
466 enrolled
Hepatic Encephalopathy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.