TheraRadar
Data updated: Jun 28, 2026

RIFAXIMIN · ZYDUS PHARMS USA

Generic · see XIFAXAN
Infectious Disease Approved 2004-05-25

RIFAXIMIN is FDA-approved to treat 3 conditions (same as XIFAXAN).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
22
Years on Market

Details

Status
Prescription
First Approved
2004-05-25
Routes
ORAL
Dosage Forms
TABLET

Companies

ZYDUS PHARMS USA Cipla NORWICH Novartis NORWICH PHARMACEUTICALS INC ALKEM LABORATORIES LIMITED Viatris Teva
Active Ingredient: RIFAXIMIN

RIFAXIMIN Approval History

Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
Mar 2026 ORIGINAL
Update
FDA Letter

What RIFAXIMIN Treats

3 indications

RIFAXIMIN is approved for 3 conditions since its original approval in 2026. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Travelers' Diarrhea
  • Hepatic Encephalopathy
  • Irritable Bowel Syndrome with Diarrhea

Same approved indications as XIFAXAN (same active ingredient).

Source: FDA Label
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Clinical Trial Registry

54 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NCT04244877 IRB17-00550 Ph 3 withdrawn Rifaximin's Effect on Covert Hepatic Encephalopathy With SIBO and Gastrointestinal Dysmotility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 results posted 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 completed 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 54 trials

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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

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.

RIFAXIMIN FDA Label Details

Indications & Usage

RIFAXIMIN is FDA-approved to treat 3 conditions — same approved indications as XIFAXAN.

Looking for the branded version?

XIFAXAN

Full clinical data, patents, trials, and competitive landscape for rifaximin.

See XIFAXAN

Data Sources

FDA Approval: ANDA218650 → Trials: ClinicalTrials.gov →

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