Xifaxan

(Rifaximin)

ApprovedSmall molecule

Rifaximin is an antibiotic used to treat traveler's diarrhea caused by bacteria, and it's also used to reduce the risk of hepatic encephalopathy (a serious liver disease complication) in patients with advanced liver disease.[2] Xifaxan is currently approved and in use across 27 indications[4].[1]

Xifaxan is one of 444 small molecule programs targeting Cirrhosis. It is currently in Approved.

Indications

144

Total Trials

Active Trials

443

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

CirrhosisTerminated

Tropical SprueActive, not recruiting

Type 2 Diabetes MellitusActive, not recruiting

Bacterial DiseaseUnknown

HyperammonemiaUnknown

Diverticular DiseaseActive, not recruiting

Hepatic FailureUnknown

Non-Alcoholic Fatty Liver DiseaseActive, not recruiting

Acute DiarrheaActive, not recruiting

Celiac DiseaseActive, not recruiting

CirrhosisApproved

Terminated

Tropical SpruePreclinical

Active, not recruiting

Type 2 Diabetes MellitusPreclinical

Active, not recruiting

Bacterial DiseasePreclinical

Unknown

HyperammonemiaPreclinical

Unknown

Diverticular DiseasePreclinical

Active, not recruiting

Hepatic FailurePreclinical

Unknown

Non-Alcoholic Fatty Liver DiseasePreclinical

Active, not recruiting

Acute DiarrheaApproved

Active, not recruiting

Celiac DiseasePreclinical

Active, not recruiting

Showing 10 of 25 indications

Competition

Competitive Landscape

242 competitors in Efficacy and Safety

#DrugCompanyPhaseTrials

Xifaxan

SSalix

Approved

3 2

BESREMI

PPharmaEssentia

Phase 3

2 3

DWP16001

Daewoong Pharmaceutical Co. LTD.

Phase 3

1 4

Avalglucosidase Alfa

Sanofi

Phase 3

1 5

Tpoxx

SSIGA Technologies

Phase 3

1 6

VAY736

Novartis

Phase 3

2 7

Hemay005

GGanzhou Hemay Pharmaceutical Co., Ltd

Phase 3

2 8

CBL-514

CCaliway Biopharmaceuticals Co., Ltd.

Phase 3

3 9

KN057

SSuzhou Alphamab Co., Ltd.

Phase 3

2 10

KSI-101

KKodiak Sciences Inc

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Post-ApprovalNot yet recruiting

Platelet Reactivity

NCT07203846

N/ARecruiting

Encephalopathy

NCT06483737

Q3 2027

ApprovedRecruiting

Pouchitis

NCT06312683

Post-ApprovalNot yet recruiting

Growth

NCT07426705

ApprovedRecruiting

Diarrhea

NCT07285785

Post-ApprovalRecruiting

Cirrhosis

NCT06538077

Clinical

Trials by Indication[1]

Encephalopathy21 trials

Efficacy and Safety of E.Coli Nissle 1917 in Patients With Mild (Stage 1-2) or Minimal Hepatic Encephalopathy

Completed·—·N/A·NCT04787276·42 enrolled

High Volume Plasmapheresis for Refractory Hepatic Encephalopathy in Liver Intensive Care Unit.

Withdrawn·IInstitute of Liver and Biliary Sciences, India·N/A·NCT03115697

MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy)

Completed·MMallinckrodt·Phase 2·NCT03712280·50 enrolled

Show 18 more trials

Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy

Recruiting·TTanta University·Phase 3·NCT04161053·60 enrolled

RICE Trial: Rifaximin In Chronic Hepatic Encephalopathy - A Randomized, Controlled Trial

Terminated·UUniversity of Miami·Phase 3·NCT00364689·13 enrolled

Randomised Controlled Trial of Mechanistic Effects of Rifaximin in Cirrhosis and Chronic Hepatic Encephalopathy

Completed·KKing's College Hospital NHS Trust·Phase 4·NCT02019784·38 enrolled

Microbial Resistance of Rifaximin in Hepatic Encephalopathy

Completed·NNational Hepatology & Tropical Medicine Research Institute·Phase 4·NCT04736836·100 enrolled

The Role of Bacterial Overgrowth and Delayed Intestinal Transit in Hepatic Encephalopathy

Unknown status·WWeill Medical College of Cornell University·Phase 2·NCT00281502·50 enrolled

Safety and Tolerability Study of Rifaximin in Participants With a History of Hepatic Encephalopathy

Completed·BBausch Health Americas, Inc.·Phase 3·NCT00686920·322 enrolled

Effycacy of Rifaximin on Reverse Minimal Hepatic Encephalopathy and Elimation Small Intestinal Bacterial

Terminated·CCoordinación de Investigación en Salud, Mexico·N/A·NCT02439307·11 enrolled

Study of Rifaximin in Minimal Hepatic Encephalopathy

Completed·HHunter Holmes Mcguire Veteran Affairs Medical Center·Phase 1/2·NCT01069133·20 enrolled

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

Withdrawn·MMetroHealth Medical Center·Phase 3·NCT04244877

A 6-month Efficacy, Safety, and Tolerability Study of Rifaximin In Preventing Hepatic Encephalopathy

Completed·BBausch Health Americas, Inc.·Phase 3·NCT00298038·299 enrolled

Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy

Terminated·BBausch Health Americas, Inc.·Phase 4·NCT01846663·6 enrolled

The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy

Completed·BBausch Health Americas, Inc.·Phase 4·NCT01842581·222 enrolled

Rifaximin in Minimal Hepatic Encephalopathy

Completed·HHunter Holmes Mcguire Veteran Affairs Medical Center·N/A·NCT00533910·42 enrolled

Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy

Completed·SShanghai Changzheng Hospital·Phase 4·NCT03077217·40 enrolled

Transcranial Doppler Ultrasound and Minimal Hepatic Encephalopathy

Completed·FFondazione Policlinico Universitario Agostino Gemelli IRCCS··NCT04077125·100 enrolled

Rifaximin vs Placebo for the Prevention of Encephalopathy in Patients Treated by TIPS

Completed·UUniversity Hospital, Toulouse·Phase 3·NCT02016196·211 enrolled

Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE)

Recruiting·GGeneral Hospital of Shenyang Military Region·N/A·NCT06483737·174 enrolled

Lactulose, L-ornithine L-aspartate, or Rifaximin Versus Placebo for Preventing Hepatic Encephalopathy in Variceal Bleeding

Completed·HHospital General de Mexico·Phase 4·NCT02158182·88 enrolled

Diarrhea11 trials

Single Daily Dose Rifaximin for the Treatment of Travelers' Diarrhea

Withdrawn·TThe University of Texas Health Science Center, Houston·Phase 4·NCT00875875

Prevention of Travelers' Diarrhea in Subjects Traveling Outside the U.S.

Completed·BBausch Health Americas, Inc.·Phase 3·NCT00328380·660 enrolled

Trial Evaluating Chemoprophylaxis Against Travelers' Diarrhea - Prevent TD

Completed·HHenry M. Jackson Foundation for the Advancement of Military Medicine·N/A·NCT02498301·449 enrolled

Show 8 more trials

Single Dose Antibiotic Treatment of Acute Watery Diarrhea, Rifaximin Versus Azithromycin, With Loperamide Adjunct

Recruiting·HHenry M. Jackson Foundation for the Advancement of Military Medicine·Phase 4·NCT05677282·150 enrolled

Efficacy and Safety of Adjunctive Use of Rifaximin In Preventing Radiotherapy-induced Diarrhea in Cancer Patients

Not yet recruiting·MMansoura University·Phase 1/2·NCT06783153·80 enrolled

A Study Comparing Two Rifaximin Tablets in Patients With Travelers' Diarrhea.

Terminated· Novartis logo

Novartis·Phase 3·NCT02920242·28 enrolled

A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)

Completed·BBausch Health Americas, Inc.·Phase 3·NCT00269399·237 enrolled

Rifaximin Versus Placebo in the Prevention of Travelers' Diarrhea

Completed·—·Phase 2·NCT00098384·220 enrolled

Study Comparing Rifaximin With Xifaxan 200 mg in Traveler's Diarrhea

Completed·AActavis Inc.·Phase 3·NCT02498418·739 enrolled

Rifaximin for Prevention of Travellers' Diarrhea

Completed·BBausch Health Americas, Inc.·Phase 3·NCT00742469·210 enrolled

A Randomized, Open-Label Study to Assess Pharmacokinetics of Xifaxan® 200 mg in Pediatric Subjects 6 to 11 Years of Age With Acute Diarrhea of Suspected Bacterial Etiology, and the Safety and Efficacy of Xifaxan® 200 mg Plus Oral Rehydration Therapy (ORT) Compared to ORT Alone

Recruiting·BBausch Health Americas, Inc.·Approved·NCT07285785·54 enrolled

Irritable Bowel Syndrome10 trials

Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS)

Completed·BBausch Health Americas, Inc.·Phase 3·NCT00731679·623 enrolled

To Compare the Efficacy of Drugs in Combination for Treating Irritable Bowel Syndrome Associated With Diarrhea

Completed·—·Phase 4·NCT05867550·162 enrolled

Changes in Microbiota and Metabolomic Profile Between Rifaximin Responders and Non-responders In Diarrhoea-Predominant Irritable Bowel Syndrome

Completed·NNational University Hospital, Singapore·Phase 4·NCT03557788·33 enrolled

Show 7 more trials

Gut Microbiota Reconstruction in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea

Unknown status·SShanghai Zhongshan Hospital·Phase 2/3·NCT02651740·10 enrolled

Study to Assess the Efficacy and Safety of Rifaximin Administered BID in the Treatment of Patients With Diarrhea-Associated Irritable Bowel Syndrome

Completed·BBausch Health Americas, Inc.·Phase 2·NCT00269412·525 enrolled

Rifaximin for the Treatment of Irritable Bowel Syndrome

Completed·—·Phase 2·NCT00259155·92 enrolled

Neomycin and Rifaximin Plus Neomycin in Treating Methane Positive Constipation Predominant Irritable Bowel Syndrome

Completed·MMark Pimentel, MD·N/A·NCT00945334·37 enrolled

Hydrogen Breath Test an Instrument to Predict Rifaximin-Response in Irritable Bowel Syndrome Predominant Diarrhea

Completed·UUniversity of Michigan·Phase 4·NCT03729271·148 enrolled

Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS)

Completed·BBausch Health Americas, Inc.·Phase 3·NCT00724126·637 enrolled

The Effects of Rifaximin Therapy in Irritable Bowel Syndrome

Completed·—·N/A·NCT02009618·500 enrolled

Cirrhosis6 trials

Intestinal Decontamination With Rifaximin. The Inflammatory and Circulatory State in Patients With Cirrhosis

Completed·—·Phase 4·NCT01769040·54 enrolled

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

Completed·JJudit Pich·Phase 2/3·NCT03780673·254 enrolled

Pilot Study Of The Effect Of Rifaximin On B-Cell Dysregulation In Cirrhosis

Terminated·—·N/A·NCT01951209·13 enrolled

Show 3 more trials

Simvastatin Plus Rifaximin in Decompensated Cirrhosis

Completed·JJudit Pich·Phase 2·NCT03150459·44 enrolled

BCAA vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of HE

Recruiting·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 4·NCT06538077·336 enrolled

Rifaximin in Cirrhosis: Effects on Endotoxin and Haemostatic Indexes

Terminated·UUniversity of Roma La Sapienza·Phase 4·NCT06630572·20 enrolled

Rifaximin6 trials

Rifaximin for Chronic Immune Activation in People With HIV

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT01866826·46 enrolled

Rifaximin Therapy vs Low FODMAP Diet In IBS

Unknown status·UUniversity of Malaya·Phase 4·NCT04841980·100 enrolled

The Rifaximin Study in CVID

Completed·OOslo University Hospital·Phase 4·NCT01946906·40 enrolled

Show 3 more trials

Rifaximin as a Modulator of Microbial Translocation and Immune Activation

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 2·NCT01466595·73 enrolled

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

Terminated·BBausch Health Americas, Inc.·Phase 4·NCT03818672·5 enrolled

Rifaximin in Patients With Gastroesophageal Variceal Bleeding

Completed·SShanghai Zhongshan Hospital·N/A·NCT02991612·80 enrolled

57 more indications

Growth5 trials

Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex

Unknown status·—·Phase 1·NCT00956150·210 enrolled

Effect of Multispecies Probiotic Supplementation on the Efficacy of Rifaximin α Therapy in Patients With Small Intestinal Bacterial Overgrowth (SIBO): a Randomized Placebo-controlled Trial

Not yet recruiting·PPaństwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji·Phase 4·NCT07426705·100 enrolled

Efficacy of Rifaximin in Patients With Small Intestinal Bacterial Overgrowth Presenting With Abdominal Bloating.

Recruiting·XXiuli Zuo·N/A·NCT06772064·115 enrolled

Show 2 more trials

Study of Clinical Features and Efficacy of Small Intestinal Bacterial Overgrowth in Patients With Abdominal Distension

Not yet recruiting·PPeking Union Medical College Hospital·Phase 1/2·NCT06518850·30 enrolled

Treating Bacterial Overgrowth in Parkinson's Disease

Completed·UUniversity of Cincinnati·Phase 2/3·NCT02470780·4 enrolled

Peritonitis5 trials

Two Strategies of Primary Prophylaxis of Spontaneous Bacterial Peritonitis in Severe Cirrhotic Patients With Ascites

Completed·—·Phase 3·NCT03069131·160 enrolled

Primary Prophylaxis for Spontaneous Bacterial Peritonitis

Terminated·—·Phase 2/3·NCT04775329·2 enrolled

Rifaximin Versus Norfloxacin in Spontaneous Bacterial Peritonitis

Unknown status·OOspedali Riuniti di Foggia·Phase 3·NCT04159870·322 enrolled

Show 2 more trials

Rifaximin for the Secondary Prevention of Spontaneous Bacterial Peritonitis Recurrence in Cirrhotic Patients

Withdrawn·SSeoul National University Hospital·Phase 3·NCT02011841

Comparative Study of Rifaximin Versus Norfloxacin in the Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

Unknown status·SSherief Abd-Elsalam·Phase 3·NCT02120196·100 enrolled

Crohn's Disease4 trials

Effectiveness of Rifaximin Combined With Thiopurine on Preventing Postoperative Recurrence in Crohn's Disease

Unknown status·SSixth Affiliated Hospital, Sun Yat-sen University·Phase 3·NCT03185611·120 enrolled

A Multicentre Study on Rifaximin in Post-operative Endoscopic Crohn's Disease Recurrence Prevention

Terminated·AAlfasigma S.p.A.·Phase 2·NCT03537157·43 enrolled

Induction of Clinical Response Using Rifaximin in Crohn's Disease

Completed·SScott Lee·Phase 2·NCT00603616·36 enrolled

Show 1 more trial

Effectiveness of Rifaximin on Preventing Postoperative Recurrence in Crohn's Disease

Unknown status·SSixth Affiliated Hospital, Sun Yat-sen University·Phase 3·NCT03185624·80 enrolled

Rosacea3 trials

Safety, Efficacy and Pharmacokinetics of Rifaximin in Patients With Moderate-to-severe Papulopustular Rosacea

Completed·AAlfasigma S.p.A.·Phase 2·NCT05150587·216 enrolled

Rifaximin Treatment of Papulopustular Rosacea

Withdrawn·UUniversity of California, San Francisco·Phase 2·NCT01359228

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

Unknown status·AAlfasigma S.p.A.·Phase 2·NCT03864978·236 enrolled

Dyspepsia3 trials

Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia

Completed·—·N/A·NCT00956397·55 enrolled

Rifaximin for Functional Dyspepsia

Completed·TThe University of Hong Kong·Phase 2/3·NCT01643083·95 enrolled

Multi-dimensional Clinical and Pathophysiological Profiles of Patients With Functional Dyspepsia and Effect of Gut Microbiota Manipulation Using Rifaximin for Its Treatment

Unknown status·SSanjay Gandhi Postgraduate Institute of Medical Sciences·Phase 2·NCT04302402·132 enrolled

Efficacy and Safety3 trials

Efficacy and Safety of Rifaximin With NAC in IBS-D

Completed·—·Phase 1/2·NCT04557215·45 enrolled

Efficacy and Safety of Rifaximin in Treating MAFLD

Recruiting·SShanghai Changzheng Hospital·Phase 1·NCT07185932·40 enrolled

The Efficacy and Safety of Rifaximin Treatment

Unknown status·SSun Yat-sen University·Phase 1·NCT05786859·124 enrolled

Hepatitis3 trials

Effects of Rifaximin in Patients With Acute Alcoholic Hepatitis

Unknown status·HHospital Universitari Vall d'Hebron Research Institute·Phase 2·NCT02116556·29 enrolled

Rifaximin Use in Severe Alcoholic Hepatitis

Unknown status·SSaint Vincent's Hospital, Korea·Phase 3·NCT02485106·170 enrolled

Efficacy of Rifaximin on Hepatosteatosis and Steatohepatitis Patients

Completed·—·N/A·NCT02009592·42 enrolled

Gut Microbiota3 trials

Effects of Rifaximin on Gut Microbiota and Emotion

Recruiting·UUniversitaire Ziekenhuizen KU Leuven·Phase 2/3·NCT05587036·60 enrolled

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

Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT04074421·240 enrolled

Modulation of Gut Microbiota by Rifaximin in PD Patients

Unknown status·TTaipei Medical University Shuang Ho Hospital·Phase 1/2·NCT03958708·20 enrolled

Treatment3 trials

Trial of Rifaximin in the Treatment of Tropical Enteropathy

Completed·WWashington University School of Medicine·N/A·NCT00858988·147 enrolled

Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin

Completed·—·Phase 3·NCT00979056·258 enrolled

Efficacy of Rifaximin in Treatment of Cirrhotic Gastroesophageal Variceal Bleeding

Unknown status·SShanghai Zhongshan Hospital·N/A·NCT02964195·308 enrolled

Heart Failure2 trials

GutHeart: Targeting Gut Microbiota to Treat Heart Failure

Unknown status·OOslo University Hospital·Phase 2·NCT02637167·150 enrolled

Rifaximin and Cardiac Function in Patients with Heart Failure with Preserved Ejection Fraction

Recruiting·II.M. Sechenov First Moscow State Medical University·N/A·NCT06652087·40 enrolled

Weight loss2 trials

Weight Loss in Parkinson's Disease and Role of Small Bowel Bacterial Overgrowth

Completed·MMayo Clinic·Phase 3·NCT01662791·49 enrolled

Weight Loss Benefits of Rifaximin in an Intermittent Fasting Diet

Unknown status·UUnknown Sponsor·Phase 4·NCT04674176·30 enrolled

Liver Transplant2 trials

Effect of Perioperative Oral Rifaximin on Early Graft Dysfunction in Adult Living Donor Liver Transplant

Recruiting·IInstitute of Liver and Biliary Sciences, India·N/A·NCT06743464·100 enrolled

Rifaximin to Prevent Recurrent HCV-Related Fibrosis After Liver Transplant

Unknown status·—·Phase 2·NCT01603108·59 enrolled

Diverticular Disease2 trials

Clostridium Butyricum CBM588® vs. Rifaximin for Symptomatic Uncomplicated Diverticular Disease (SUDD): A Real-World Retrospective Study

Completed·—·N/A·NCT06852274·70 enrolled

Evaluation of the Metabolome in Diverticular Disease

Unknown status·—··NCT01831323·40 enrolled

Complication2 trials

Rifaximin Predicts the Complications of Decompensated Cirrhosis

Unknown status·SShanghai Changzheng Hospital·Phase 4·NCT02074280·250 enrolled

Rifaximin Reduces the Complications of Decompensated Cirrhosis: a Randomized Controlled Trial

Unknown status·SShanghai Changzheng Hospital·Phase 4·NCT02190357·200 enrolled

Renal Failure2 trials

A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Renal Failure

Withdrawn·NNYU Langone Health·Phase 3·NCT02086825

Rifaximin Versus Lactulose in Renal Failure

Withdrawn·WWeill Medical College of Cornell University·Phase 4·NCT00748904

Crohn Disease2 trials

Evaluation of Adherent Invasive E. Coli Eradication in Adult Crohn Disease

Terminated·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT02620007·24 enrolled

Evaluating the Therapeutic Efficacy of Rifaximin in Patients With Diabetic Gastroparesis Using Bloating as the Primary Endpoint.

Terminated·MMayo Clinic·Phase 2·NCT04254549·5 enrolled

Monoclonal Gammopathy2 trials

Rifaximin in Patients With Monoclonal Gammopathy

Active, not recruiting·EEmory University·Phase 1·NCT03820817·50 enrolled

Rifaximin Versus No Intervention in Patients With IgG/IgA (Non-IgM) Monoclonal Gammopathy of Undetermined Significance

Recruiting·FFred Hutchinson Cancer Center·Phase 2·NCT07209371·50 enrolled

Dysbiosis1 trial

Feasibility of a New Diagnostic Device to Assess Small Intestinal Dysbiosis in Routine Clinical Setting.

Unknown status·AAtmo Biosciences Pty Ltd·N/A·NCT04910815·150 enrolled

Ulcerative Colitis1 trial

Antibiotics for the Treatment of Ulcerative Colitis

Completed·UUniversity of Dundee·N/A·NCT00355602·40 enrolled

Sickle Cell Disease1 trial

Rifaximin to Modify the Disease Course in Sickle Cell Disease

Unknown status·NNew York Medical College·Phase 2·NCT03719729·20 enrolled

Gastrointestinal1 trial

Metabolic Consequences of Gastrointestinal Surgery

Terminated·—·N/A·NCT02836353·81 enrolled

Portal vein thrombosis1 trial

The Effect of Rifaximin on Portal Vein Thrombosis

Unknown status·SShanghai Zhongshan Hospital·N/A·NCT03631147·96 enrolled

Rectal Cancer1 trial

Rifaximin and Placebo in the Treatment of Bowel Dysfunction After Anterior Resection for Rectal Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 3·NCT01345175·69 enrolled

IBS1 trial

Effect of a Probiotic Formula on Reducing SIBO in IBS Patients

Terminated·AAB Biotics, SA·N/A·NCT04316806·8 enrolled

Prophylaxis1 trial

Efficacy of Rifaximin vs Norfloxacin for Secondary Prophylaxis of SBP (NORRIF Trial)

Unknown status·IInstitute of Liver and Biliary Sciences, India·N/A·NCT06199843·280 enrolled

Acute Graft Versus Host Disease1 trial

Rifaximin for Preventing Acute Graft Versus Host Disease (AGVHD)

Completed·EEmory University·Phase 1·NCT00967096·20 enrolled

Esophageal Varices1 trial

Effect of Administration of Rifaximin on the Portal Pressure of Patients With Liver Cirrhosis and Esophageal Varices

Unknown status·UUniversity of Padova·Phase 3·NCT02508623·60 enrolled

Collagenous Colitis1 trial

Rifaximin-treatment of Collagenous Colitis

Unknown status·—·Phase 3·NCT03658993·50 enrolled

Intestinal Pseudo-Obstruction1 trial

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

Unknown status·YYokohama City University·Phase 2·NCT04118699·12 enrolled

Cystic Fibrosis1 trial

Rifaximin for Treatment of Bloating in Children and Adults With Cystic Fibrosis

Withdrawn·WWake Forest University Health Sciences·Phase 2/3·NCT05408910

Bacterial Vaginosis1 trial

Efficacy and Safety Study of Rifaximin Vaginal Tablets in Bacterial Vaginosis

Terminated·AAlfasigma S.p.A.·Phase 2·NCT02376972·392 enrolled

Colon Surgery1 trial

Gut Decolonisation With Neomycin/Metronidazole or Rifaximin Before Colon Surgery

Not yet recruiting·—·Phase 4·NCT07180615·458 enrolled

Microscopic Colitis1 trial

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

Recruiting·EEugene F Yen, MD·Phase 2·NCT04043897·10 enrolled

Insulin resistance1 trial

Rifaximin Improves Gut Dysbiosis in Insulin Resistance and Type 2 Diabetes

Unknown status·ZZagazig University·N/A·NCT03758144·80 enrolled

Microbiota1 trial

A Longitudinal Study to Identify IBS Phenotypes Using Fecal Microbiota and Hydrogen Breath Testing

Completed·UUniversity of Michigan·Phase 4·NCT03219528·74 enrolled

Chronic Kidney Disease1 trial

Rifaximin Therapy in Chronic Kidney Disease

Completed·—·Phase 4·NCT02342639·38 enrolled

Diarrhoea1 trial

Rifaximin for Preventing Relapse of Clostridium Associated Diarrhoea

Completed·UUniversity of Nottingham·Phase 4·NCT01670149·151 enrolled

PET/CT1 trial

A Clinical Study to Limit Physiologic Intestinal FDG Uptake Uptake on PET-CT Scans

Completed·—·N/A·NCT01542541·68 enrolled

Midazolam1 trial

Open-Label Study to Evaluate the Effect of Rifaximin on Midazolam in Normal Healthy Volunteers

Completed·BBausch Health Americas, Inc.·Phase 1·NCT00743912·24 enrolled

Platelet Reactivity1 trial

Modulation of Gut MicroFLORA With Rifaximin to Reduce High Platelet Reactivity in Post-ACS Patients on Ticagrelor

Not yet recruiting·CCollegium Medicum w Bydgoszczy·Phase 4·NCT07203846·50 enrolled

Parkinson's Disease1 trial

Microbiota Intervention to Change the Response of Parkinson's Disease

Suspended·UUniversity of California, San Francisco·Phase 1/2·NCT03575195·86 enrolled

Outcome1 trial

Goal Directed Ammonia Lowering Therapy in Hyperammonemic ACLF Patients With no Overt HE to Reduce Major Adverse Liver Related Outcomes (GOAL Trial)

Not yet recruiting·IInstitute of Liver and Biliary Sciences, India·N/A·NCT06808009·90 enrolled

AIN1 trial

Autologous Transplant Targeted Against Crohn's

Withdrawn·NNorthwestern University·Phase 2·NCT04154735

End-Stage Renal Disease1 trial

Impact of Rifaximin Therapy on Intestinal Byproducts in End-Stage Renal Disease

Withdrawn·—·Phase 1·NCT02738905

Hypersensitivity1 trial

Rifaximin on Visceral Hypersensitivity

Terminated·—·Phase 2·NCT03462966·4 enrolled

Liver Disease1 trial

Impact of an Antibiotic (Rifaximin) on Liver Scarring in HIV-Infected Patients With Liver Disease

Withdrawn·—·Phase 4·NCT01654939

Breast Cancer1 trial

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

Terminated·MMayo Clinic·Phase 2·NCT04249622·20 enrolled

Helicobacter Pylori Infection1 trial

Rifaximin Associated With Classic Triple Therapy for the Eradication of Helicobacter Pylori Infection

Completed·FFundación de Investigación Biomédica - Hospital Universitario de La Princesa·Phase 3·NCT03124199·40 enrolled

Quality of Life1 trial

Quality of Life and Nutritional Improvements in Cirrhotic Patients

Terminated·TTampa General Hospital·Phase 4·NCT01842113·4 enrolled

Combination Therapy1 trial

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

Unknown status·—·Phase 2/3·NCT03962283·78 enrolled

Fatty Liver Disease1 trial

Rifaximin in Fatty Liver Disease

Terminated·IImperial College London·Phase 4·NCT01355575·15 enrolled

Celiac Disease1 trial

Rifaximin for the Treatment of Persistent Symptoms in Patients With Celiac Disease

Completed·—·N/A·NCT01137955·50 enrolled

Hematopoietic Stem Cell Transplantation1 trial

Rifaximin for Infection Prophylaxis in Hematopoietic Stem Cell Transplantation

Completed·EEmory University·Phase 1·NCT03529825·26 enrolled

Small Intestinal Bacterial Overgrowth Syndrome (SIBO)1 trial

Comparison of the Efficacy of Saccharomyces Boulardii and Rifaximin in the Treatment of Abdominal Distension and Diarrhea Related to Small Intestinal Bacterial Overgrowth：a Non-inferiority Randomized Controlled Study

Not yet recruiting·SShandong University·Approved·NCT07815548·222 enrolled

Chronic Liver Disease1 trial

Evaluation of the Role of Rifaximin on Thrombocytopenia in Patients With Hepatitis C-Related Liver Cirrhosis

Completed·FFayoum University Hospital·Approved·NCT07791940·165 enrolled

Pouchitis1 trial

Rifaximin for the Secondary Prevention of Recurrent Pouchitis

Recruiting·UUniversity of North Carolina, Chapel Hill·Approved·NCT06312683·16 enrolled

Unspecified3 trials

Gulf War Digestive Health Study

Completed·UUS Department of Veterans Affairs·N/A·NCT00680836·54 enrolled

Role of Methane in Glycemic Control

Completed·—·Phase 1·NCT01638429·11 enrolled

Immunohistology in USDD and Correlation Between Bacterial Flora and Phlogosis

Completed·—·Phase 4·NCT02068482·61 enrolled

Regulatory

FDA Approval Timeline[5]

May 25, 2004

XIFAXAN

NDA NDA021361

Sources

References

[1]
ClinicalTrials.gov — 144 trial records for Rifaximin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Xifaxan drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Rifaximin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Rifaximin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021361). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Xifaxan. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Salix company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Bacterial DNA-Directed RNA Polymerase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: SSalix

Patent Landscape[6]

Patent Cliff

Sep 2, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10703763Feb 27, 2026

9271968Feb 27, 2026

8741904Feb 27, 2026

8518949Feb 27, 2026

8193196Sep 2, 2027

15 more patents

10456384Feb 26, 2029

10765667Feb 26, 2029

11779571Feb 26, 2029

11564912Feb 26, 2029

8309569Jul 18, 2029

7928115Jul 24, 2029

9629828Jul 24, 2029

10314828Jul 24, 2029

8946252Jul 24, 2029

9421195Jul 24, 2029

10335397Jul 24, 2029

10709694Jul 24, 2029

8829017Jul 24, 2029

8642573Oct 2, 2029

8969398Oct 2, 2029

Xifaxan

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q3 2027

Trials by Indication[1]

Encephalopathy21 trials

Diarrhea11 trials

Irritable Bowel Syndrome10 trials

Cirrhosis6 trials

Rifaximin6 trials

Growth5 trials

Peritonitis5 trials

Crohn's Disease4 trials

Rosacea3 trials

Dyspepsia3 trials

Efficacy and Safety3 trials

Hepatitis3 trials

Gut Microbiota3 trials

Treatment3 trials

Heart Failure2 trials

Weight loss2 trials

Liver Transplant2 trials

Diverticular Disease2 trials

Complication2 trials

Renal Failure2 trials

Crohn Disease2 trials

Monoclonal Gammopathy2 trials

Dysbiosis1 trial

Ulcerative Colitis1 trial

Sickle Cell Disease1 trial

Gastrointestinal1 trial

Portal vein thrombosis1 trial

Rectal Cancer1 trial

IBS1 trial

Prophylaxis1 trial

Acute Graft Versus Host Disease1 trial

Esophageal Varices1 trial

Collagenous Colitis1 trial

Intestinal Pseudo-Obstruction1 trial

Cystic Fibrosis1 trial

Bacterial Vaginosis1 trial

Colon Surgery1 trial

Microscopic Colitis1 trial

Insulin resistance1 trial

Microbiota1 trial

Chronic Kidney Disease1 trial

Diarrhoea1 trial

PET/CT1 trial

Midazolam1 trial

Platelet Reactivity1 trial

Parkinson's Disease1 trial

Outcome1 trial

AIN1 trial

End-Stage Renal Disease1 trial

Hypersensitivity1 trial

Liver Disease1 trial

Breast Cancer1 trial

Helicobacter Pylori Infection1 trial

Quality of Life1 trial

Combination Therapy1 trial

Fatty Liver Disease1 trial

Celiac Disease1 trial

Hematopoietic Stem Cell Transplantation1 trial

Small Intestinal Bacterial Overgrowth Syndrome (SIBO)1 trial

Chronic Liver Disease1 trial

Pouchitis1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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