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 and Misoprostol Combination Therapy for Healing of Small Bowel Ulcers in Aspirin Users

Phase 2

Conditions: Small Bowel Disease
Rifaximin

Interventions: Drug: Placebo oral tablet
Drug: Rifaximin

First Posted Date: 2019-05-24

Last Posted Date: 2020-07-01

Lead Sponsor: Chinese University of Hong Kong

Target Recruit Count: 78

Registration Number: NCT03962283

Locations: 🇭🇰
Prince of Wales Hospital, Hong Kong, Hong Kong
🇨🇳
Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing, China

Modulation of Gut Microbiota by Rifaximin in PD Patients

Phase 1

Conditions: Parkinson Disease
Inflammation

Interventions: Drug: Rifaximin 550 MG

First Posted Date: 2019-05-22

Last Posted Date: 2019-05-22

Lead Sponsor: Taipei Medical University Shuang Ho Hospital

Target Recruit Count: 20

Registration Number: NCT03958708

Locations: 🇨🇳
Shuang Ho Hospital, New Taipei City, Taiwan

Safety and Efficacy of Rifaximin in Patients With Papulopustular Rosacea and Positive Lactulose Breath Test

Phase 2

Conditions: Papulopustular Rosacea

Interventions: Drug: Rifaximin delayed release 400 mg tablet
Drug: Placebo

First Posted Date: 2019-03-06

Last Posted Date: 2019-03-11

Lead Sponsor: Alfasigma S.p.A.

Target Recruit Count: 236

Registration Number: NCT03864978

Locations: 🇮🇹
Azienda Ospedaliera Universitaria Federico II, Napoli, Italy
🇮🇹
Azienda Ospedaliera Santa Maria, Terni, Italy
🇮🇹
A.O.U. Città della Salute e della Scienza, Torino, Italy

and more 9 locations

Trial of Rifaximin in Probable Alzheimer's Disease

Phase 2

Completed

Conditions: Alzheimer's Disease

Interventions: Drug: Rifaximin 550 milligrams (MG)

First Posted Date: 2019-02-27

Last Posted Date: 2021-12-17

Lead Sponsor: Duke University

Target Recruit Count: 10

Registration Number: NCT03856359

Locations: 🇺🇸
Duke University Medical Center, Durham, North Carolina, United States

Rifaximin in Patients With Monoclonal Gammopathy

Phase 1

Active, not recruiting

Conditions: IgA Monoclonal Gammopathy
IgM Monoclonal Gammopathy
Monoclonal Gammopathy
Waldenstrom Macroglobulinemia
IgG Monoclonal Gammopathy
Light Chain Deposition Disease
Smoldering Waldenstrom Macroglobulinemia
Gammopathy Igg
Gammopathy, Monoclonal

Interventions: Drug: Rifaximin

First Posted Date: 2019-01-29

Last Posted Date: 2025-04-20

Lead Sponsor: Emory University

Target Recruit Count: 50

Registration Number: NCT03820817

Locations: 🇺🇸
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States

Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy and Hepatically Impaired Subjects

Phase 4

Terminated

Conditions: Severe Hepatic Impairment

Interventions: Drug: Rifaximin

First Posted Date: 2019-01-28

Last Posted Date: 2023-11-30

Lead Sponsor: Bausch Health Americas, Inc.

Target Recruit Count: 5

Registration Number: NCT03818672

Locations: 🇺🇸
Valeant Site 01, San Antonio, Texas, United States

Efficacy of the Combination of Simvastatin Plus Rifaximin in Patients With Decompensated Cirrhosis to Prevent ACLF Development

Phase 2

Completed

Conditions: Liver Cirrhoses

Interventions: Drug: Simvastatin
Drug: Placebo of Simvastatin
Drug: Placebo of Rifaximin
Drug: Rifaximin

First Posted Date: 2018-12-19

Last Posted Date: 2023-05-24

Lead Sponsor: Judit Pich

Target Recruit Count: 254

Registration Number: NCT03780673

Locations: 🇫🇷
Beajuon Hospital, Clichy, Paris, France
🇳🇱
Academic Medical Centre, Amsterdam, Netherlands
🇪🇸
Hospital Universitari Vall d'Hebrón, Barcelona, Spain

and more 11 locations