Rifaximin

Generic Name: Rifaximin

Brand Names: Xifaxan, Zaxine

Drug Type: Small Molecule

Chemical Formula: C_₄₃H_₅₁N_₃O_₁₁

CAS Number: 80621-81-4

Unique Ingredient Identifier: L36O5T016N

Background: Rifaximin is a semisynthetic, rifamycin-based non-systemic antibiotic, meaning that the drug will not pass the gastrointestinal wall into the circulation as is common for other types of orally administered antibiotics. It has multiple indications and is used in treatment of traveller's diarrhea caused by E. coli; reduction in risk of overt hepatic encephalopathy recurrence; as well as diarrhea-predominant irritable bowel syndrome (IBS-D) in adult women and men. It is marketed under the brand name Xifaxan by Salix Pharmaceuticals.

Indication: Rifaximin has multiple indications by the FDA: for the treatment of patients (≥12 years of age) with traveller's diarrhea caused by noninvasive strains of Escherichia coli; for the reduction of overt hepatic encephalopathy recurrence in patients ≥18 years of age; and in May 2015 it was approved for irritable bowel syndrome with diarrhea (IBS-D) treatment in adult men and women.

Associated Conditions: Bacterial Infections, Clostridium difficile infection recurrence, Hepatic Encephalopathy (HE), Irritable Bowel Syndrome (IBS), Traveler's Diarrhea

Clinical Trials

Rifaximin for the Treatment of Gastrointestinal Toxicities Related to Pertuzumab-Based Therapy in Patients with Stage I-III HER2 Positive Breast Cancer

Phase 2

Active, not recruiting

Conditions: Anatomic Stage I Breast Cancer AJCC V8
Anatomic Stage IA Breast Cancer AJCC V8
Anatomic Stage IB Breast Cancer AJCC V8
Anatomic Stage II Breast Cancer AJCC V8
Anatomic Stage IIA Breast Cancer AJCC V8
Anatomic Stage IIB Breast Cancer AJCC V8
Anatomic Stage III Breast Cancer AJCC V8
Anatomic Stage IIIA Breast Cancer AJCC V8
Anatomic Stage IIIB Breast Cancer AJCC V8
Anatomic Stage IIIC Breast Cancer AJCC V8

Interventions: Other: Best Practice
Other: Questionnaire Administration
Drug: Rifaximin

First Posted Date: 2020-01-31

Last Posted Date: 2024-12-31

Lead Sponsor: Mayo Clinic

Target Recruit Count: 20

Registration Number: NCT04249622

Locations: 🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States

Rifaximin's Effect on Covert Hepatic Encephalopathy With SIBO and Gastrointestinal Dysmotility

Phase 3

Withdrawn

Conditions: Cirrhosis, Liver
Minimal Hepatic Encephalopathy
Small Intestinal Bacterial Overgrowth
Gastrointestinal Motility Disorder

Interventions: Drug: Rifaximin

First Posted Date: 2020-01-28

Last Posted Date: 2023-06-28

Lead Sponsor: MetroHealth Medical Center

Registration Number: NCT04244877

Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy

Phase 3

Recruiting

Conditions: Hepatic Encephalopathy

Interventions: Drug: Nitazoxanide
Drug: Rifaximin

First Posted Date: 2019-11-13

Last Posted Date: 2019-11-13

Lead Sponsor: Tanta University

Target Recruit Count: 60

Registration Number: NCT04161053

Locations: 🇪🇬
Sherief Abd-Elsalam, Tanta, Egypt

Rifaximin Versus Norfloxacin in Spontaneous Bacterial Peritonitis

Phase 3

Conditions: Spontaneous Bacterial Peritonitis

Interventions: Drug: Norfloxacin
Drug: Rifaximin

First Posted Date: 2019-11-12

Last Posted Date: 2021-02-16

Lead Sponsor: Ospedali Riuniti di Foggia

Target Recruit Count: 322

Registration Number: NCT04159870

Locations: 🇮🇹
Ospedali Riuniti Foggia, Foggia, Italy

Autologous Transplant Targeted Against Crohn's

Phase 2

Withdrawn

Conditions: Crohn's Disease

Interventions: Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Mesna
Drug: Alemtuzumab
Drug: G-CSF
Drug: Rifaximin
Drug: Tacrolimus

First Posted Date: 2019-11-06

Last Posted Date: 2019-11-08

Lead Sponsor: Northwestern University

Registration Number: NCT04154735

Locations: 🇺🇸
Northwestern University, Chicago, Illinois, United States

Efficacy and Safety of Rifaximin for Patients With Chronic Intestinal Pseudo-obstruction: a Phase 2 Trial

Phase 2

Conditions: Chronic Intestinal Pseudo-obstruction

Interventions: Drug: Rifaximin oral tablet
Drug: Placebo oral tablet

First Posted Date: 2019-10-08

Last Posted Date: 2021-06-21

Lead Sponsor: Yokohama City University

Target Recruit Count: 12

Registration Number: NCT04118699

Locations: 🇯🇵
Yokohama city university, Yokohama, Kanagawa, Japan

Transcranial Doppler Ultrasound and Minimal Hepatic Encephalopathy

Completed

Conditions: Minimal Hepatic Encephalopathy

Interventions: Drug: Rifaximin

First Posted Date: 2019-09-04

Last Posted Date: 2019-09-04

Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Target Recruit Count: 100

Registration Number: NCT04077125

Locations: 🇮🇹
Fondazione Policlinico Agostino Gemelli IRCCS, Roma, Italy

Effects of Continuous Treatment With Rifaximin and Probiotics on the Gut Microbiota of Patients With IBS-D

Phase 4

Conditions: Gut Microbiota
IBS - Irritable Bowel Syndrome

Interventions: Drug: Probiotic Formula
Drug: Placebo oral tablet
Drug: Rifaximin

First Posted Date: 2019-08-30

Last Posted Date: 2020-07-28

Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Target Recruit Count: 240

Registration Number: NCT04074421

Locations: 🇨🇳
The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China

Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose

Phase 4

Recruiting

Conditions: Hepatic Encephalopathy
Pathological Processes
Cirrhosis, Liver
Portal Hypertension
Liver Diseases

Interventions: Drug: Rifaximin 550 milligram Oral Tablet [XIFAXAN]
Drug: Placebo oral tablet
Drug: Lactulose 667 milligram/milliliter Oral Solution

First Posted Date: 2019-08-29

Last Posted Date: 2025-01-28

Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Target Recruit Count: 238

Registration Number: NCT04073290

Locations: 🇳🇱
University Medical Center Groningen, Groningen, Netherlands
🇳🇱
Leiden University Medical Center, Leiden, Netherlands
🇧🇪
Universitaire Ziekenhuizen Leuven, Leuven, Belgium

and more 3 locations

Efficacy and Safety of Oral Rifaximin in Patients With Active Microscopic Colitis

Phase 2

Recruiting

Conditions: Microscopic Colitis

Interventions: Drug: Rifaximin 550mg

First Posted Date: 2019-08-02

Last Posted Date: 2021-04-15

Lead Sponsor: Eugene F Yen, MD

Target Recruit Count: 10

Registration Number: NCT04043897

Locations: 🇺🇸
NorthShore University HealthSystem, Evanston, Illinois, United States

Drug Development Updates

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