NDAORALTABLET
Approved
May 2004
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Data completeness
3/8 — Basic
Drug data last refreshed 12h ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XIFAXAN (rifaximin) is an oral rifamycin-class antibacterial approved in 2004 for treatment of traveler's diarrhea and hepatic encephalopathy. It acts locally in the gastrointestinal tract with minimal systemic absorption, making it suitable for GI infections and conditions requiring targeted luminal activity.
Peak3.0 years to LOE
Product is at peak lifecycle stage with 3 years of patent protection remaining; commercial teams should prepare for competitive pressures and potential revenue defense strategies.
Mechanism of Action
Pharmacologic Class:
Rifamycin Antibacterial
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
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.