TheraRadar
Data updated: May 26, 2026

XIFAXAN (rifaximin)

Trial Activity: Declining 6 active trials
Infectious Disease Approved 2004-05-25

XIFAXAN is indicated for the treatment of Travelers' Diarrhea; Hepatic Encephalopathy; Irritable Bowel Syndrome with Diarrhea.

Source: FDA Label • SALIX PHARMS • Rifamycin Antibacterial
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How XIFAXAN Works

Rifaximin is a semi-synthetic, non-systemic antibiotic that inhibits bacterial protein synthesis by binding to the beta-subunit of bacterial DNA-dependent RNA polymerase. This prevents transcription and subsequent translation of proteins. Due to its negligible oral absorption, it concentrates in the gastrointestinal tract, where it exerts local antibacterial activity against enteric pathogens and ammonia-producing flora, the latter of which is critical in managing hepatic encephalopathy.

Source: FDA Label

Development Insights

Bausch Health Americas, Inc. conducting 6 trials (10%)
100 indications explored (Broad Platform)
→ hepatic encephalopathy (7 trials)
→ liver cirrhosis (5 trials)
→ minimal hepatic encephalopathy (3 trials)
3
Indications
--
Phase 3 Trials
2
Priority Reviews
22
Years on Market

Details

Status
Prescription
First Approved
2004-05-25
Patent Cliff
2029

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET

Companies

SALIX PHARMS
Active Ingredient: RIFAXIMIN

XIFAXAN Approval History

2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
29 FDA actions from 2004 to 2023 · 1 indication expansions
Oct 2023 SUPPL
Label · Labeling
FDA Letter Label
Oct 2022 SUPPL
Label · Labeling
FDA Letter Label
Nov 2020 SUPPL
Label · Labeling
FDA Letter Label

What XIFAXAN Treats

3 indications

XIFAXAN is approved for 3 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Travelers' Diarrhea
  • Hepatic Encephalopathy
  • Irritable Bowel Syndrome with Diarrhea
Source: FDA Label

XIFAXAN Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

XPHOZAH
ARDELYX INC
2023 1 indic.
LUBIPROSTONE
ASCENT PHARMS
2021 3 indic.
Unlock 8 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to XIFAXAN

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

GENERLAC
LACTULOSE
1 shared
CHARTWELL RX
Shared indications:
Hepatic Encephalopathy
NEOMYCIN SULFATE
NEOMYCIN SULFATE
1 shared
CHARTWELL MOLECULAR
Shared indications:
Hepatic Encephalopathy
VIBERZI
ELUXADOLINE
1 shared
AbbVie
Shared indications:
Irritable Bowel Syndrome with Diarrhea
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Clinical Trial Registry

55 trials
Trial Sponsor ID Phase Status Title
NCT02016196 PRPET RC31/12/0551 Ph 3 completed Rifaximin vs Placebo for the Prevention of Encephalopathy in Patients Treated by TIPS
NCT07209371 RG1125814 NCI-2025-06773, FHIRB0020984 Ph 2 recruiting Rifaximin Versus No Intervention for the Treatment of IgA Monoclonal Gammopathy of Undetermined Significance
NCT03729271 HUM00142925 Ph 4 completed Hydrogen Breath Test an Instrument to Predict Rifaximin-Response in Irritable Bowel Syndrome Predominant Diarrhea
NCT04244877 IRB17-00550 Ph 3 withdrawn Rifaximin's Effect on Covert Hepatic Encephalopathy With SIBO and Gastrointestinal Dysmotility
NCT04254549 19-002908 Ph 2 terminated Rifaximin in Patients With Diabetic Gastroparesis
NCT07203846 FLORA-ACS FLORA-ACS Ph 4 not yet recruiting Modulation of Gut MicroFLORA With Rifaximin to Reduce High Platelet Reactivity in Post-ACS Patients on Ticagrelor
NCT04249622 results posted MC18C3 NCI-2020-00332, MC18C3 Ph 2 terminated Rifaximin for the Treatment of Gastrointestinal Toxicities Related to Pertuzumab-Based Therapy in Patients With Stage I-III HER2 Positive Breast Cancer
NCT03575195 MICRO-PD 17-22841 Ph 1, Ph 2 suspended Microbiota Intervention to Change the Response of Parkinson's Disease
NCT03820817 IRB00106380 NCI-2018-02106, Winship4480-18 Ph 1 active not recruiting Rifaximin in Patients With Monoclonal Gammopathy
NCT03069131 ProPILARifax ProPILA-Rifax Ph 3 completed Two Strategies of Primary Prophylaxis of Spontaneous Bacterial Peritonitis in Severe Cirrhotic Patients With Ascites
NCT05587036 S66407 2021-006814-35 Ph 2, Ph 3 recruiting Effects of Rifaximin on Gut Microbiota and Emotion
NCT06630572 EudraCT 2017-000488-34 Ph 4 terminated Rifaximin in Cirrhosis: Effects on Endotoxin and Haemostatic Indexes
NCT06518850 I-23PJ1228 Ph 1, Ph 2 not yet recruiting Study of Clinical Features and Efficacy of Small Intestinal Bacterial Overgrowth in Patients With Abdominal Distension
NCT01345175 results posted 11-045 Ph 3 completed Rifaximin and Placebo in the Treatment of Bowel Dysfunction After Anterior Resection for Rectal Cancer
NCT05150587 results posted RE-ROS2002-2021 Ph 2 completed Safety, Efficacy and Pharmacokinetics of Rifaximin in Patients With Moderate-to-severe Papulopustular Rosacea
NCT02470780 SIBO-PD results posted 2015-2175 Ph 2, Ph 3 completed Treating Bacterial Overgrowth in Parkinson's Disease
NCT01846663 results posted RFHE4043 Ph 4 terminated Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy
NCT03818672 results posted RFPK4045 Ph 4 terminated Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy and Hepatically Impaired Subjects
NCT02620007 TEOREM P140503 Ph 2 terminated Evaluation of Adherent Invasive E. Coli Eradication in Adult Crohn Disease
NCT03780673 2018-001698-25 LIVERHOPE_EFFICACY Ph 2, Ph 3 completed Efficacy of the Combination of Simvastatin Plus Rifaximin in Patients With Decompensated Cirrhosis to Prevent ACLF Development
NCT04557215 results posted 550 Ph 1, Ph 2 completed Efficacy and Safety of Rifaximin With NAC in IBS-D
NCT04775329 SIBOC SIBOC Ph 2, Ph 3 terminated Primary Prophylaxis for Spontaneous Bacterial Peritonitis
NCT03462966 results posted 49509 Ph 2 terminated Rifaximin on Visceral Hypersensitivity
NCT00748904 0801009635 Ph 4 withdrawn Rifaximin Versus Lactulose in Renal Failure
NCT00603616 32871 32871 Ph 2 completed Induction of Clinical Response Using Rifaximin in Crohn's Disease
NCT02342639 results posted STUDY00001638 Ph 4 completed Rifaximin Therapy in Chronic Kidney Disease
NCT01670149 RAPID 12072 2012-003205-10 Ph 4 completed Rifaximin for Preventing Relapse of Clostridium Associated Diarrhoea
NCT03712280 results posted MNK61062107 Ph 2 completed MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy)
NCT03077217 CZH0010 Ph 4 completed Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy
NCT04736836 CL(1173) Ph 4 completed Microbial Resistance of Rifaximin in Hepatic Encephalopathy
NCT01355575 RiFL results posted 2010-021515-17 2010-021515-17, 10/H0711/58 Ph 4 terminated Rifaximin in Fatty Liver Disease
NCT01866826 results posted 130062 13-I-0062 Ph 1, Ph 2 completed Rifaximin for Chronic Immune Activation in People With HIV
NCT02498418 results posted ACTA/RIFX/2015 Ph 3 completed Study Comparing Rifaximin With Xifaxan 200 mg in Traveler's Diarrhea
NCT00731679 TARGET 1 results posted RFIB3007 Ph 3 completed Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS)
NCT00743912 RFDI1008 Ph 1 completed Open-Label Study to Evaluate the Effect of Rifaximin on Midazolam in Normal Healthy Volunteers
NCT00724126 TARGET 2 results posted RFIB3008 Ph 3 completed Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS)
NCT04161053 Encephalopathy Ph 3 recruiting Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy
NCT04154735 ATTAC DIAD.ATTAC.2018 Ph 2 withdrawn Autologous Transplant Targeted Against Crohn's
NCT01842581 results posted RFHE4044 Ph 4 completed The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy
NCT01466595 results posted ACTG A5286 1U01AI068636 Ph 2 completed Rifaximin as a Modulator of Microbial Translocation and Immune Activation
NCT02158182 DI/14/107/03/028 Ph 4 completed Lactulose, L-ornithine L-aspartate, or Rifaximin Versus Placebo for Preventing Hepatic Encephalopathy in Variceal Bleeding
NCT03124199 R+OCA results posted R+OCA Ph 3 completed Rifaximin Associated With Classic Triple Therapy for the Eradication of Helicobacter Pylori Infection
NCT02011841 Rifaximin_SBP Ph 3 withdrawn Rifaximin for the Secondary Prevention of Spontaneous Bacterial Peritonitis Recurrence in Cirrhotic Patients
NCT01662791 results posted 11-006817 Ph 3 completed Weight Loss in Parkinson's Disease and Role of Small Bowel Bacterial Overgrowth
NCT02086825 11-00665 Ph 3 withdrawn A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Renal Failure
NCT01769040 RifaxNK150612 2012-002890-71 Ph 4 completed Intestinal Decontamination With Rifaximin. The Inflammatory and Circulatory State in Patients With Cirrhosis
NCT01643083 HKU_RD1 Ph 2, Ph 3 completed Rifaximin for Functional Dyspepsia
NCT01654939 GCO 12-0794 HSM# 12-00436 Ph 4 withdrawn Impact of an Antibiotic (Rifaximin) on Liver Scarring in HIV-Infected Patients With Liver Disease
NCT00875875 Rifaximin 600 Ericsson-001 Ph 4 withdrawn Single Daily Dose Rifaximin for the Treatment of Travelers' Diarrhea
NCT01946906 2013/1037 2013-000883-27, 13/09446-7 Ph 4 completed The Rifaximin Study in CVID

Showing 50 of 55 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

XIFAXAN FDA Label Details

Indications & Usage

FDA Label (PDF)

XIFAXAN is indicated for the treatment of Travelers' Diarrhea; Hepatic Encephalopathy; Irritable Bowel Syndrome with Diarrhea.

View full patent landscape →
19 OB patents · 6 families · 172 international docs across 33 countries

XIFAXAN Patents & Exclusivity

Latest Patent: Oct 2029

Patents (19 active)

US8642573 Expires Oct 2, 2029
US8969398 Expires Oct 2, 2029
US7928115 Expires Jul 24, 2029
US8829017 Expires Jul 24, 2029
US9421195 Expires Jul 24, 2029
US8946252 Expires Jul 24, 2029
US10335397 Expires Jul 24, 2029
US9629828 Expires Jul 24, 2029
US10314828 Expires Jul 24, 2029
US10709694 Expires Jul 24, 2029
US10456384 Expires Feb 26, 2029
US10765667 Expires Feb 26, 2029
US11779571 Expires Feb 26, 2029
US11564912 Expires Feb 26, 2029
US8193196 Expires Sep 2, 2027
US8741904 Expires Feb 27, 2026
US10703763 Expires Feb 27, 2026
US8518949 Expires Feb 27, 2026
US9271968 Expires Feb 27, 2026
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for XIFAXAN

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2029
  • • 62 active patents

Trial Analysis

  • • 58 total trials
  • • Stage: Declining

Competitive Landscape

  • • 3 similar drugs
  • • Same target/indication analysis
Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA022554 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment