Rifaximin

also known as Xifaxan · RFX · Alfa Normix · Extended Intestinal Release (EIR) · L-105 · NDA 22-554 · Rifaximin (Xifaxan) · rifaximin DR · +4 more

Other / unclassified

Developed for: cirrhosis of liver · hepatic encephalopathy · irritable bowel syndrome · Crohn disease · diarrheal disease · small intestinal bacterial overgrowth · infectious peritonitis · Parkinson disease
+60 more
· acute diarrhea · hepatitis C virus infection · HIV infectious disease · Alzheimer disease · diverticulitis · liver disorder · liver failure · obesity disorder · portal hypertension · rosacea · sickle cell disease · acute leukemia · alcoholic hepatitis · bacterial vaginosis · campylobacteriosis · celiac disease · chronic intestinal pseudoobstruction · chronic kidney disease · Clostridium difficile colitis · common variable immunodeficiency · constipation disorder · cystic fibrosis · diabetes mellitus · diastolic heart failure · end stage renal failure · esophageal varices · esophageal varices with bleeding · functional diarrhea · gas bloat syndrome · gastroparesis · Helicobacter pylori infectious disease · immune dysregulation, neurodevelopmental defects, and colitis · intestinal disorder · kidney failure · light chain deposition disease · metabolic dysfunction-associated steatohepatitis · metabolic dysfunction-associated steatotic liver disease · metabolic syndrome X · microscopic colitis · monoclonal gammopathy · monoclonal gammopathy of uncertain significance · NAFLD1 · peritonitis · poisoning · portal vein thrombosis · pouchitis · rectal cancer · small intestine disorder · thrombocytopenia · tropical sprue · ulcerative colitis · vascular dementia · Waldenstrom macroglobulinemia · chronic pain syndrome · collagenous colitis · dyspepsia · hepatopulmonary syndrome · persian gulf syndrome · systolic heart failure · type 2 diabetes mellitus
Investigated by: Bausch Health Americas, Inc. · Alfasigma S.p.A. · Institute of Liver and Biliary Sciences, India · Cedars-Sinai Medical Center · Shanghai Zhongshan Hospital · Emory University
+153 more
· Mayo Clinic · Naval Medical Research Center · Peking Union Medical College Hospital · Shanghai Changzheng Hospital · Uniformed Services University of the Health Sciences · Columbia University · First Affiliated Hospital, Sun Yat-Sen University · Henry M. Jackson Foundation for the Advancement of Military Medicine · Hunter Holmes Mcguire Veteran Affairs Medical Center · Jason Stubbs, MD · Judit Pich · Mark Pimentel, MD · Ministry of Defence, United Kingdom · National Cancer Institute (NCI) · National Institute of Allergy and Infectious Diseases (NIAID) · Post Graduate Institute of Medical Education and Research, Chandigarh · RenJi Hospital · Salix Pharmaceuticals, Inc. a division of Bausch Health US, LLC · Shanghai 10th People's Hospital · Sir Run Run Shaw Hospital · Sixth Affiliated Hospital, Sun Yat-sen University · The University of Texas Health Science Center, Houston · University of California, San Francisco · Weill Medical College of Cornell University · Xijing Hospital · AB Biotics, SA · ASKA Pharmaceutical Co., Ltd. · Actavis Inc. · Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Air Force Military Medical University, China · American Diabetes Association · American Heart Association · Assistance Publique - Hôpitaux de Paris · Azienda Policlinico Umberto I · Bausch Health Ireland Limited · Bayhealth Medical Center · Baylor College of Medicine · Beijing Aerospace General Hospital · Beijing Chao Yang Hospital · Beijing Ditan Hospital · Beijing Friendship Hospital · Beijing Jishuitan Hospital · Beijing Tiantan Hospital · Beijing Tongren Hospital · Beth Israel Deaconess Medical Center · Bezmialem Vakif University · Cambridge University Hospitals NHS Foundation Trust · Centre Hospitalier Universitaire de Besancon · China-Japan Friendship Hospital · Collegium Medicum w Bydgoszczy · Commonwealth Diagnostics International, Inc. · Copenhagen University Hospital, Hvidovre · Cromsource · Danish Cancer Society · David E. Kaplan, MD MSc · Douglas T. Dieterich · Dr. Amjad Khan · DuPont, Hurbert L., MD · Duke University · Eugene F Yen, MD · Fayoum University Hospital · Fred Hutchinson Cancer Center · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · GE Healthcare · Gateway Institute for Brain Research · Germans Trias i Pujol Hospital · Hospital General de Mexico · Hospital Universitari Vall d'Hebron Research Institute · Hospital de Sant Pau · Hospital del Mar · I.M. Sechenov First Moscow State Medical University · Imperial College London · Indian Council of Medical Research · Infectious Diseases Clinical Research Program · all 159 on the full record

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Label expansion	US (FDA)	XIFAXAN	—	2015-05-27	fda.gov ↗
Approved	US (FDA)	XIFAXAN	—	2004-05-25	fda.gov ↗

Trials 140 · started per year

today

US approved 2004

20032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 05 trials
Phase 0	NCT07185932	Aug 2024 → Dec 2027 expected	metabolic dysfunction-associated steatotic liver disease	Shanghai Changzheng Hospital	Recruiting	No outcome recorded
Phase 0	NCT05786859	Mar 2023 → Jul 2025	hepatic encephalopathy, hepatitis B virus infection, liver failure	Sun Yat-sen University	Unknown	No outcome recorded
Phase 0	NCT03529825	Jul 2018 → Oct 2020	—	Emory University	Completed	No outcome recorded
Phase 0	NCT02738905	Jan 2016 → Feb 2019	end stage renal failure	Jason Stubbs, MD	Withdrawn	No outcome recorded
Phase 0	NCT01638429	Apr 2012 → Apr 2014	diabetes mellitus, obesity disorder	Cedars-Sinai Medical Center	Completed	Mixed
Phase 15 trials
Phase 1	NCT04529811	Sep 2020 → May 2021	—	Bausch Health Americas, Inc.	Completed	No outcome recorded
Phase 1	NCT03820817	May 2019 → Nov 2025	Waldenstrom macroglobulinemia, light chain deposition disease, monoclonal gammopathy	Emory University	Completed	No outcome recorded
Phase 1	NCT04730245	Jun 2018 → Mar 2020	Parkinson disease	Torre Médica Santé	Completed	No outcome recorded
Phase 1	NCT00743912	Sep → Oct 2008	—	Bausch Health Americas, Inc.	Completed	No outcome recorded
Phase 1	NCT00967096	Apr 2007 → Apr 2009	cancer	Emory University	Completed	No outcome recorded
Phase 1/28 trials · 1 missed
Phase 1/2	NCT06783153	Jan → Dec 2025 overdue	cervical adenocarcinoma, enterocolitis, poisoning, prostate cancer +2	Mansoura University	Not yet recruiting	No outcome recorded
Phase 1/2	NCT06718686	Dec 2024 → Oct 2027 expected	Alzheimer disease, vascular dementia	Jasmohan Bajaj	Recruiting	No outcome recorded
Phase 1/2	NCT06518850	Aug → Dec 2024 overdue	small intestinal bacterial overgrowth	Peking Union Medical College Hospital	Not yet recruiting	No outcome recorded
Phase 1/2	NCT04557215	Nov 2020 → Aug 2021	irritable bowel syndrome	Cedars-Sinai Medical Center	Completed	No outcome recorded
Phase 1/2	NCT03575195	Jul 2019 → Aug 2026	Parkinson disease	University of California, San Francisco	Suspended	No outcome recorded
Phase 1/2	NCT03958708	May 2019 → May 2020	Parkinson disease	Taipei Medical University Shuang Ho Hospital	Unknown	No outcome recorded
Phase 1/2	NCT01866826	Jan 2013 → Jun 2016	HIV infectious disease	National Cancer Institute (NCI)	Completed	Missed primary
Phase 1/2	NCT01069133	Feb 2010 → May 2012	hepatic encephalopathy	Hunter Holmes Mcguire Veteran Affairs Medical Center	Completed	No outcome recorded
Phase 231 trials · 5 met primary · 3 missed
Phase 2	NCT06727422	Feb → Aug 2026 overdue	functional diarrhea, irritable bowel syndrome	Mark Pimentel, MD	Recruiting	No outcome recorded
Phase 2	NCT07209371	Jan 2026 → May 2028 expected	monoclonal gammopathy of uncertain significance	Fred Hutchinson Cancer Center	Recruiting	No outcome recorded
Phase 2	NCT06058572	Aug 2024 → Aug 2027 expected	acute leukemia	Tata Memorial Centre	Recruiting	No outcome recorded
Phase 2	NCT05098028	Mar 2022 → Sep 2023	sickle cell disease	Bausch Health Americas, Inc.	Completed	No outcome recorded
Phase 2	NCT04249622	Sep 2020 → Dec 2022	HER2 positive breast carcinoma	Mayo Clinic	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT04118699	Dec 2019 → Nov 2021	chronic intestinal pseudoobstruction	Yokohama City University	Unknown	No outcome recorded
Phase 2	NCT04154735	Nov 2019 → Mar 2023	Crohn disease	Northwestern University	Withdrawn	No outcome recorded
Phase 2	NCT04254549	Jun 2019 → Apr 2025	Crohn disease, gastroparesis	Mayo Clinic	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT03856359	Apr 2019 → Nov 2020	Alzheimer disease	Duke University	Completed	No outcome recorded
Phase 2	NCT05621005	Mar 2019 → Jul 2022	infectious peritonitis	Samar Atef Sebaweh Mohammed	Completed	No outcome recorded
Phase 2	NCT03515044	Sep 2018 → Mar 2020	hepatic encephalopathy	Bausch Health Americas, Inc.	Completed	Met primary
Phase 2	NCT03719729	Aug 2018 → Feb 2020	sickle cell disease	New York Medical College	Unknown	No outcome recorded
Phase 2	NCT03462966	Jul 2018 → Nov 2021	irritable bowel syndrome	Cedars-Sinai Medical Center	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT04043897	Jun 2018 → Dec 2021 overdue	microscopic colitis	Eugene F Yen, MD	Recruiting	No outcome recorded
Phase 2	NCT03864978	Jun 2018 → Apr 2020	rosacea	Alfasigma S.p.A.	Unknown	No outcome recorded
Phase 2	NCT03537157	Nov 2017 → Jul 2020	Crohn disease	Alfasigma S.p.A.	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT03150459	Jul 2017 → Mar 2018	cirrhosis of liver	Judit Pich	Completed	No outcome recorded
Phase 2	NCT02555293	Feb 2016 → Nov 2020	liver cancer	RWTH Aachen University	Terminated	Missed primary
Phase 2	NCT02620007	Dec 2015 → Aug 2021	Crohn disease	Assistance Publique - Hôpitaux de Paris	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT02376972	Apr 2015 → Feb 2016	bacterial vaginosis	Alfasigma S.p.A.	Terminated	No outcome recorded
Phase 2	NCT02124512	Mar 2015 → May 2019	metabolic syndrome X, obesity disorder	Philip Kern	Completed	Missed primary
Phase 2	NCT01904409	Jun 2013 → Jun 2015	cirrhosis of liver	Bausch Health Americas, Inc.	Completed	Missed primary
Phase 2	NCT02116556	Apr 2013 → Dec 2016	alcoholic hepatitis	Hospital Universitari Vall d'Hebron Research Institute	Unknown	No outcome recorded
Phase 2	NCT01359228	Apr 2013 → Jun 2014	rosacea	University of California, San Francisco	Withdrawn	No outcome recorded
Phase 2	NCT01603108	Mar 2012 → Dec 2016	hepatitis C virus infection	Columbia University	Unknown	No outcome recorded
Phase 2	NCT01466595	Sep 2011 → Sep 2012	HIV infectious disease	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	Completed	Met primary
Phase 2	NCT00528073	Sep 2007 → Mar 2009	Crohn disease	Alfasigma S.p.A.	Completed	Met primary
Phase 2	NCT00269412	Dec 2005 → Aug 2007	irritable bowel syndrome	Bausch Health Americas, Inc.	Completed	No outcome recorded
Phase 2	NCT00281502	Dec 2005 → Dec 2012	cirrhosis of liver, hepatic encephalopathy, hepatitis C virus infection	Weill Medical College of Cornell University	Unknown	No outcome recorded
Phase 2	NCT00259155	Jul 2003 → Jan 2007	irritable bowel syndrome	Cedars-Sinai Medical Center	Completed	Met primary
Phase 2	NCT00098384	Jun → Sep 2003	diarrheal disease	DuPont, Hurbert L., MD	Completed	Met primary

Phase 2/39 trials · 2 missed
Phase 2/3	NCT05408910	Jul → Sep 2025	cystic fibrosis, small intestine disorder	Wake Forest University Health Sciences	Withdrawn	No outcome recorded
Phase 2/3	NCT05587036	Feb 2023 → Jul 2025 overdue	—	Universitaire Ziekenhuizen KU Leuven	Recruiting	No outcome recorded
Phase 2/3	NCT03780673	Jan 2019 → Dec 2022	cirrhosis of liver	Judit Pich	Completed	Missed primary
Phase 2/3	NCT03469050	Jul 2018 → Dec 2020	diverticulitis	Alfasigma S.p.A.	Terminated	No outcome recorded
Phase 2/3	NCT02793193	Jul 2016 → Jan 2018	—	University Hospital Tuebingen	Completed	No outcome recorded
Phase 2/3	NCT02651740	Apr 2016 → Jul 2023	irritable bowel syndrome	Shanghai Zhongshan Hospital	Unknown	No outcome recorded
Phase 2/3	NCT02470780	Dec 2015 → Aug 2017	Parkinson disease, small intestinal bacterial overgrowth	University of Cincinnati	Completed	No outcome recorded
Phase 2/3	NCT02280044	Oct 2014 → Aug 2016	campylobacteriosis, dysentery	Johns Hopkins Bloomberg School of Public Health	Completed	Missed primary
Phase 2/3	NCT01897051	Jul 2013 → Feb 2017	cirrhosis of liver, portal hypertension	Yonsei University	Unknown	No outcome recorded
Phase 330 trials · 6 met primary · 2 missed
Phase 3	NCT07522255	Apr 2026 → Oct 2027 expected	constipation disorder, gas bloat syndrome, irritable bowel syndrome	Mahidol University	Not yet recruiting	No outcome recorded
Phase 3	NCT05297448	Aug 2022 → Jan 2026 overdue	hepatic encephalopathy	Bausch Health Americas, Inc.	Active not recruiting	No outcome recorded
Phase 3	NCT05071716	Apr 2022 → Sep 2025 overdue	hepatic encephalopathy	Bausch Health Americas, Inc.	Active not recruiting	No outcome recorded
Phase 3	NCT04244877	Sep 2021 → May 2023	cirrhosis of liver, hepatic encephalopathy, intestinal motility disease, small intestinal bacterial overgrowth	MetroHealth Medical Center	Withdrawn	No outcome recorded Stop: Enrollment
Phase 3	NCT04159870	Nov 2019 → Nov 2021	infectious peritonitis	Ospedali Riuniti di Foggia	Unknown	No outcome recorded
Phase 3	NCT03069131	Jun 2018 → Jun 2022	cirrhosis of liver, peritonitis	Centre Hospitalier Universitaire de Besancon	Completed	Missed primary
Phase 3	NCT03185624	Jul 2017 → Jan 2018	Crohn disease	Sixth Affiliated Hospital, Sun Yat-sen University	Unknown	No outcome recorded
Phase 3	NCT03185611	May 2017 → Jan 2018	Crohn disease	Sixth Affiliated Hospital, Sun Yat-sen University	Unknown	No outcome recorded
Phase 3	NCT02920242	Dec 2016 → May 2017	acute diarrhea	Sandoz	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT02498418	Jan 2016 → Feb 2017	diarrheal disease	Actavis Inc.	Completed	No outcome recorded
Phase 3	NCT03695705	Jan → Dec 2016	cirrhosis of liver	Post Graduate Institute of Medical Education and Research, Chandigarh	Completed	No outcome recorded
Phase 3	NCT02086825	Oct 2015 → Dec 2016	hepatic encephalopathy	NYU Langone Health	Withdrawn	No outcome recorded
Phase 3	NCT02508623	Jul 2015 → Jan 2017	cirrhosis of liver, portal hypertension	University of Padova	Unknown	No outcome recorded
Phase 3	NCT02240108	Oct 2014 → Oct 2017	Crohn disease	Bausch Health Americas, Inc.	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT02240121	Aug 2014 → Aug 2017	Crohn disease	Bausch Health Americas, Inc.	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT03124199	Feb 2014 → Mar 2015	Helicobacter pylori infectious disease	Fundación de Investigación Biomédica - Hospital Universitario de La Princesa	Completed	No outcome recorded
Phase 3	NCT02120196	Jan 2014 → Dec 2023	cirrhosis of liver, infectious peritonitis	Tanta University	Unknown	No outcome recorded
Phase 3	NCT02011841	Jan 2014 → Dec 2015	infectious peritonitis	Seoul National University Hospital	Withdrawn	No outcome recorded Stop: Enrollment
Phase 3	NCT02016196	Sep 2013 → Jul 2017	cirrhosis of liver	University Hospital, Toulouse	Completed	Met primary
Phase 3	NCT01662791	Sep 2012 → Jan 2015	Parkinson disease	Mayo Clinic	Completed	Missed primary
Phase 3	NCT01543178	Feb 2012 → Jun 2014	irritable bowel syndrome	Bausch Health Americas, Inc.	Completed	Met primary
Phase 3	NCT01345175	Apr 2011 → Mar 2023	rectal cancer	Memorial Sloan Kettering Cancer Center	Completed	No outcome recorded
Phase 3	NCT00979056	Oct 2009 → Mar 2012	diarrheal disease	University Hospital Tuebingen	Completed	Met primary
Phase 3	NCT00731679	Jul 2008 → Aug 2009	irritable bowel syndrome	Bausch Health Americas, Inc.	Completed	Met primary
Phase 3	NCT00724126	Jul 2008 → Aug 2009	irritable bowel syndrome	Bausch Health Americas, Inc.	Completed	Met primary
Phase 3	NCT00686920	Mar 2007 → Dec 2010	hepatic encephalopathy	Bausch Health Americas, Inc.	Completed	No outcome recorded
Phase 3	NCT00364689	Aug 2006 → Jul 2008	hepatic encephalopathy	University of Miami	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT00298038	Dec 2005 → Aug 2008	hepatic encephalopathy	Bausch Health Americas, Inc.	Completed	Met primary
Phase 3	NCT00269399	Dec 2005 → Dec 2008	Clostridium difficile colitis, diarrheal disease	Bausch Health Americas, Inc.	Completed	No outcome recorded
Phase 3	NCT00328380	Dec 2005 → Dec 2006	diarrheal disease	Bausch Health Americas, Inc.	Completed	No outcome recorded

Phase 425 trials · 2 missed
Phase 4	NCT07180615	Jun 2026 → Jan 2028 expected	—	University of Lucerne	Not yet recruiting	No outcome recorded
Phase 4	NCT07285785	Feb 2026 → Apr 2027 expected	bacterial infectious disease, diarrheal disease, gastroenteritis	Bausch Health Americas, Inc.	Recruiting	No outcome recorded
Phase 4	NCT07203846	Jan → Dec 2026 expected	acute coronary syndrome, immune dysregulation, neurodevelopmental defects, and colitis, myocardial infarction, platelet aggregation, spontaneous	Collegium Medicum w Bydgoszczy	Not yet recruiting	No outcome recorded
Phase 4	NCT06538077	Feb 2025 → Aug 2026 overdue	cirrhosis of liver, hepatic encephalopathy	Post Graduate Institute of Medical Education and Research, Chandigarh	Recruiting	No outcome recorded
Phase 4	NCT07037394	Dec 2024 → Apr 2025	hepatic encephalopathy	Qurratul Ain Jamil	Completed	No outcome recorded
Phase 4	NCT06312683	Jul 2024 → Jul 2026 overdue	pouchitis	University of North Carolina, Chapel Hill	Recruiting	No outcome recorded
Phase 4	NCT05677282	Oct 2022 → Sep 2025 overdue	acute diarrhea	Henry M. Jackson Foundation for the Advancement of Military Medicine	Recruiting	No outcome recorded
Phase 4	NCT06630572	Apr 2021 → Apr 2022	blood coagulation disease, cirrhosis of liver, platelet disorder, undefined	University of Roma La Sapienza	Terminated	No outcome recorded
Phase 4	NCT04674176	Jan 2021 → Jan 2022	—	Bayhealth Medical Center	Unknown	No outcome recorded
Phase 4	NCT03729271	Jan 2020 → Jan 2026	irritable bowel syndrome	University of Michigan	Completed	No outcome recorded
Phase 4	NCT03818672	Jan 2019 → Feb 2020	—	Bausch Health Americas, Inc.	Terminated	No outcome recorded
Phase 4	NCT03557788	May 2018 → Aug 2021	irritable bowel syndrome	National University Hospital, Singapore	Completed	No outcome recorded
Phase 4	NCT07791940	Oct 2015 → Nov 2017	thrombocytopenia	Fayoum University Hospital	Completed	No outcome recorded
Phase 4	NCT02342639	Jun 2015 → Mar 2019	chronic kidney disease	Jason Stubbs, MD	Completed	Missed primary
Phase 4	NCT02190357	Aug 2014 → Aug 2018	cirrhosis of liver	Shanghai Changzheng Hospital	Unknown	Mixed
Phase 4	NCT02158182	Jul 2014 → Jun 2016	hepatic encephalopathy	Hospital General de Mexico	Completed	Mixed
Phase 4	NCT02074280	Oct 2013 → Jun 2014	cirrhosis of liver	Shanghai Changzheng Hospital	Unknown	No outcome recorded
Phase 4	NCT01946906	Oct 2013 → Dec 2014	common variable immunodeficiency	Oslo University Hospital	Completed	No outcome recorded
Phase 4	NCT01846663	Apr 2013 → Feb 2016	hepatic encephalopathy	Bausch Health Americas, Inc.	Terminated	No outcome recorded
Phase 4	NCT01842581	Jan 2013 → Dec 2014	cirrhosis of liver, hepatic encephalopathy	Bausch Health Americas, Inc.	Completed	Missed primary
Phase 4	NCT01769040	Nov 2012 → Jan 2016	cirrhosis of liver	Copenhagen University Hospital, Hvidovre	Completed	No outcome recorded
Phase 4	NCT01654939	Oct 2012 → Sep 2014	HIV infectious disease, hepatitis C virus infection	Douglas T. Dieterich	Withdrawn	No outcome recorded
Phase 4	NCT01355575	May 2011 → Sep 2012	NAFLD1, metabolic dysfunction-associated steatohepatitis	Imperial College London	Terminated	No outcome recorded
Phase 4	NCT00748904	Jun 2008 → Jul 2009	cirrhosis of liver, kidney failure	Weill Medical College of Cornell University	Withdrawn	No outcome recorded
Phase 4	NCT00292344	Jun 2004 → Aug 2005	acute diarrhea	The University of Texas Health Science Center, Houston	Completed	No outcome recorded

Phase not applicable27 trials · 3 met primary · 1 missed
—	NCT07429760	Aug 2025 → Aug 2026 overdue	colorectal cancer	Shaukat Khanum Memorial Cancer Hospital & Research Centre	Enrolling by invitation	No outcome recorded
—	NCT06772064	Apr → Dec 2025 overdue	small intestinal bacterial overgrowth	Xiuli Zuo	Recruiting	No outcome recorded
—	NCT06808009	Feb 2025 → Feb 2026 overdue	liver failure	Institute of Liver and Biliary Sciences, India	Not yet recruiting	No outcome recorded
—	NCT06743464	Dec 2024 → Dec 2025 overdue	liver disorder	Institute of Liver and Biliary Sciences, India	Recruiting	No outcome recorded
—	NCT06652087	Sep 2024 → Sep 2026 overdue	diastolic heart failure, small intestinal bacterial overgrowth	I.M. Sechenov First Moscow State Medical University	Recruiting	No outcome recorded
—	NCT06199843	Jan → Dec 2024	infectious peritonitis	Institute of Liver and Biliary Sciences, India	Unknown	No outcome recorded
—	NCT05863364	Aug 2023 → Dec 2025	cirrhosis of liver	Xin Zeng	Unknown	No outcome recorded
—	NCT06223685	Apr 2023 → Aug 2024	irritable bowel syndrome, small intestinal bacterial overgrowth	Pomeranian Medical University Szczecin	Completed	No outcome recorded
—	NCT06852274	Mar 2023 → Apr 2024	diverticulitis	Dr. Amjad Khan	Completed	Met primary
—	NCT04316806	Nov 2020 → Sep 2022	irritable bowel syndrome, small intestinal bacterial overgrowth	AB Biotics, SA	Terminated	No outcome recorded
—	NCT03631147	Sep 2018 → Jun 2019	cirrhosis of liver, portal vein thrombosis	Shanghai Zhongshan Hospital	Unknown	No outcome recorded
—	NCT04003181	Sep 2017 → May 2021	colon adenocarcinoma, diarrheal disease	University of Aarhus	Completed	No outcome recorded
—	NCT02836353	Jan 2017 → Mar 2019	dumping syndrome, esophageal disorder, hypoglycemia	Cambridge University Hospitals NHS Foundation Trust	Terminated	No outcome recorded Stop: Enrollment
—	NCT02991612	Nov 2016 → Dec 2017	cirrhosis of liver, esophageal varices with bleeding	Shanghai Zhongshan Hospital	Completed	Met primary
—	NCT01951209	Nov 2016	chronic hepatitis C virus infection, cirrhosis of liver	David E. Kaplan, MD MSc	Terminated	No outcome recorded Stop: Enrollment
—	NCT02964195	Nov 2016 → Oct 2017	cirrhosis of liver, esophageal varices	Shanghai Zhongshan Hospital	Unknown	No outcome recorded
—	NCT02498301	Nov 2015 → Jul 2019	acute diarrhea, bowel dysfunction, reactive arthritis	Henry M. Jackson Foundation for the Advancement of Military Medicine	Completed	No outcome recorded
—	NCT02321371	Oct 2014 → Jan 2016	liver disorder	Institute of Liver and Biliary Sciences, India	Completed	No outcome recorded
—	NCT02009618	Jan → Oct 2013	irritable bowel syndrome	Bezmialem Vakif University	Completed	No outcome recorded
—	NCT01618591	Sep 2012 → Mar 2016	dysentery	Uniformed Services University of the Health Sciences	Terminated	No outcome recorded Stop: Enrollment
—	NCT01542541	Jul 2011 → Oct 2012	intestinal disorder	Beth Israel Deaconess Medical Center	Completed	No outcome recorded
—	NCT01218568	Oct 2010 → Sep 2012	hepatic encephalopathy	Institute of Liver and Biliary Sciences, India	Completed	No outcome recorded
—	NCT00945334	Aug 2009 → Jun 2013	irritable bowel syndrome	Mark Pimentel, MD	Completed	No outcome recorded
—	NCT00533910	Oct 2007 → Apr 2010	hepatic encephalopathy	Hunter Holmes Mcguire Veteran Affairs Medical Center	Completed	Met primary
—	NCT00858988	Sep → Oct 2007	tropical sprue	Washington University School of Medicine	Completed	No outcome recorded
—	NCT01137955	Oct 2006 → Apr 2008	celiac disease	Columbia University	Completed	Missed primary
—	NCT00355602	Jul 2006 → Dec 2008	ulcerative colitis	University of Dundee	Completed	No outcome recorded

Comparator or background therapy54 trials
Phase 0	NCT07683936 Background	Jun 2026 → Jan 2027 expected	hepatic encephalopathy	Air Force Military Medical University, China	Recruiting	No outcome recorded
Phase 1	NCT05159427 Background	Mar 2022 → Mar 2026	—	University of Michigan	Completed	No outcome recorded
Phase 1	NCT00956150 Comparator	Apr 2009 → Mar 2014	persian gulf syndrome	Henry C. Lin, MD	Unknown	No outcome recorded
Phase 1/2	NCT07454408 Background	Mar 2026 → Jun 2028 expected	hepatic encephalopathy	Air Force Military Medical University, China	Not yet recruiting	No outcome recorded
Phase 1/2	NCT05453916 Comparator	Jul 2022 → Jul 2024	irritable bowel syndrome	Sadat City University	Withdrawn	No outcome recorded Stop: Business
Phase 1/2	NCT02272868 Background	Jan 2015 → Oct 2016	Crohn disease	Seattle Children's Hospital	Terminated	No outcome recorded
Phase 2	NCT05502913 Background	Sep 2023 → Jun 2025 overdue	lung cancer	Soroka University Medical Center	Recruiting	No outcome recorded
Phase 2	NCT05150587 Comparator	Oct 2021 → Oct 2022	rosacea	Alfasigma S.p.A.	Completed	No outcome recorded
Phase 2	NCT04302402 Comparator	Mar 2020 → Mar 2021	dyspepsia	Sanjay Gandhi Postgraduate Institute of Medical Sciences	Unknown	No outcome recorded
Phase 2	NCT03712280 Comparator	Dec 2018 → Jul 2020	cirrhosis of liver, hepatic encephalopathy	Mallinckrodt	Completed	No outcome recorded
Phase 2	NCT02637167 Comparator	Mar 2016 → Jun 2019	systolic heart failure	Oslo University Hospital	Unknown	No outcome recorded
Phase 2	NCT00603616 Comparator	Nov 2008 → Nov 2020	Crohn disease	Scott Lee	Completed	No outcome recorded
Phase 2/3	NCT04775329 Comparator	Nov 2020 → Jan 2023	cirrhosis of liver, small intestinal bacterial overgrowth	Changi General Hospital	Terminated	No outcome recorded Stop: Enrollment
Phase 2/3	NCT03962283 Comparator	Aug 2019 → Jun 2022	small intestine disorder	Chinese University of Hong Kong	Unknown	No outcome recorded
Phase 2/3	NCT03613545 Comparator	Aug 2018 → Dec 2028 expected	irritable bowel syndrome	Guangzhou First People's Hospital	Recruiting	No outcome recorded
Phase 2/3	NCT03420144 Comparator	Jan 2018 → Jun 2020	cirrhosis of liver	Post Graduate Institute of Medical Education and Research, Chandigarh	Completed	No outcome recorded
Phase 2/3	NCT03415698 Comparator	Jul 2016 → Jul 2018	cirrhosis of liver	Post Graduate Institute of Medical Education and Research, Chandigarh	Unknown	No outcome recorded
Phase 2/3	NCT01643083 Comparator	Jan 2013 → May 2015	dyspepsia	The University of Hong Kong	Completed	No outcome recorded
Phase 3	NCT06443502 Background	Nov 2024 → Dec 2029 expected	pouchitis	Takeda	Recruiting	No outcome recorded
Phase 3	NCT06234046 Comparator	May → Nov 2023	infectious peritonitis	Ain Shams University	Completed	No outcome recorded
Phase 3	NCT05754996 Background	Mar 2023 → Jul 2025	hepatic encephalopathy	Cairo University	Completed	No outcome recorded
Phase 3	NCT04128462 Background	Nov 2021 → Apr 2025	hepatic encephalopathy	Mallinckrodt	Withdrawn	No outcome recorded Stop: Business
Phase 3	NCT03658993 Comparator	Nov 2018 → Nov 2020	collagenous colitis	Bonderup, Ole K., M.D.	Unknown	No outcome recorded
Phase 3	NCT04161053 Comparator	Nov 2018 → Nov 2028 expected	hepatic encephalopathy	Tanta University	Recruiting	No outcome recorded
Phase 3	NCT02485106 Comparator	Jul 2015 → Dec 2016	alcoholic hepatitis	Saint Vincent's Hospital, Korea	Unknown	No outcome recorded
Phase 3	NCT00742469 Comparator	Jun → Sep 2005	diarrheal disease	Bausch Health Americas, Inc.	Completed	No outcome recorded
Phase 4	NCT07815548 Comparator	Sep 2026 → Nov 2027 expected	small intestinal bacterial overgrowth	Shandong University	Not yet recruiting	No outcome recorded
Phase 4	NCT07426705 Background	Feb 2026 → Jul 2027 expected	irritable bowel syndrome, small intestinal bacterial overgrowth	Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji	Not yet recruiting	No outcome recorded
Phase 4	NCT05867550 Comparator	Jan → Mar 2023	irritable bowel syndrome	Bahria University	Completed	No outcome recorded
Phase 4	NCT04841980 Comparator	Apr 2021 → May 2024	irritable bowel syndrome, small intestinal bacterial overgrowth	University of Malaya	Unknown	No outcome recorded
Phase 4	NCT05083572 Background	Mar 2021 → Nov 2022	immune dysregulation, neurodevelopmental defects, and colitis	Changi General Hospital	Unknown	No outcome recorded
Phase 4	NCT04074421 Comparator	May 2020 → Jun 2022	irritable bowel syndrome	Second Affiliated Hospital, School of Medicine, Zhejiang University	Unknown	No outcome recorded
Phase 4	NCT04073290 Comparator	Jan 2020 → Sep 2026 overdue	cirrhosis of liver, hepatic encephalopathy, portal hypertension	Academic Medical Center - University of Amsterdam	Recruiting	No outcome recorded
Phase 4	NCT03219528 Comparator	Feb 2018 → Feb 2024	irritable bowel syndrome	University of Michigan	Completed	No outcome recorded
Phase 4	NCT03077217 Comparator	May 2017 → May 2020	hepatic encephalopathy	Shanghai Changzheng Hospital	Completed	No outcome recorded
Phase 4	NCT04736836 Comparator	Jan 2015 → Dec 2018	hepatic encephalopathy	National Hepatology & Tropical Medicine Research Institute	Completed	No outcome recorded
Phase 4	NCT01842113 Comparator	Apr 2013 → May 2014	cirrhosis of liver, hepatic encephalopathy, portal hypertension	Tampa General Hospital	Terminated	No outcome recorded
Phase 4	NCT01670149 Comparator	Dec 2012 → Jul 2016	Clostridium difficile colitis	University of Nottingham	Completed	No outcome recorded
Phase 4	NCT02068482 Comparator	Nov 2010 → May 2012	—	Catholic University of the Sacred Heart	Completed	No outcome recorded
Phase 4	NCT00875875 Comparator	Jun 2009	acute diarrhea	The University of Texas Health Science Center, Houston	Withdrawn	No outcome recorded
—	NCT07635394 Background	Apr 2026 overdue	irritable bowel syndrome	Beijing Tiantan Hospital	Recruiting	No outcome recorded
—	NCT06483737 Background	Jun 2025 → Jun 2027 expected	hepatic encephalopathy	General Hospital of Shenyang Military Region	Recruiting	No outcome recorded
—	NCT04910815 Comparator	Jul 2021 → Jun 2024	small intestinal bacterial overgrowth	Atmo Biosciences Pty Ltd	Unknown	No outcome recorded
—	NCT03758144 Comparator	Nov 2018 → Jun 2019	type 2 diabetes mellitus	Zagazig University	Unknown	No outcome recorded
—	NCT03115697 Comparator	Apr 2018 → Apr 2019	hepatic encephalopathy	Institute of Liver and Biliary Sciences, India	Withdrawn	No outcome recorded Stop: Business
—	NCT02439307 Comparator	Feb 2017 → Jul 2021	cirrhosis of liver, small intestinal bacterial overgrowth	Coordinación de Investigación en Salud, Mexico	Terminated	No outcome recorded Stop: Enrollment
—	NCT04787276 Comparator	Jan 2017 → Jan 2020	cirrhosis of liver, hepatic encephalopathy, liver failure	Bogomolets National Medical University	Completed	No outcome recorded
—	NCT02265484 Background	Nov 2013 → Jan 2015	parkinsonian disorder	Institute of Liver and Biliary Sciences, India	Completed	Met primary
—	NCT02009592 Comparator	Jun 2013 → Jan 2014	NAFLD1, metabolic dysfunction-associated steatohepatitis	Bezmialem Vakif University	Completed	No outcome recorded
—	NCT01773538 Comparator	Jan 2013 → Oct 2015	cirrhosis of liver, hepatic encephalopathy	Mette Munk Lauridsen	Completed	No outcome recorded
—	NCT01676597 Comparator	Sep 2012 → Sep 2014	hepatopulmonary syndrome	Institute of Liver and Biliary Sciences, India	Unknown	No outcome recorded
—	NCT00680836 Comparator	Oct 2007 → Oct 2008	irritable bowel syndrome, small intestinal bacterial overgrowth	US Department of Veterans Affairs	Completed	No outcome recorded
—	NCT00956397 Comparator	Aug 2007 → Mar 2012	dyspepsia, small intestinal bacterial overgrowth	Henry C. Lin, MD	Completed	No outcome recorded
—	NCT00619970 Comparator	Feb 2007 → Sep 2008	chronic pain syndrome, small intestinal bacterial overgrowth	Children's Hospital Los Angeles	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 8

Date	Issuer	Release
2026-01-23	Bausch Health Americas, Inc.	Results Bausch Health Provides Update on RED-C Phase 3 Clinical Trials bauschhealth.com ↗ While safe and well-tolerated, both clinical trials did not meet the primary endpoint.
2025-06-03	Zydus Lifesciences Limited	Regulatory Zydus receives tentative approval from USFDA - Rifaximin Tablets, 550 mg zyduslife.com ↗ Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received tentative approval from the United States Food and Drug Administration (USFDA) for Rifaximin Tablets, 550 mg (USRLD: Xifaxan® Tablets, 550 mg).
2025-01-23	Impax Laboratories, LLC	Regulatory Amneal Receives U.S. FDA Approval for Memantine/Donepezil Extended-Release Capsules and Everolimus Tablets for Oral Suspension, and Tentative U.S. FDA Approval for Rifaximin amneal.com ↗
2019-06-18	Norgine	Results New study shows rifaximin significantly reduced the number and length of hospitalisations in patients with overt hepatic encephalopathy (HE) awaiting liver transplantation norgine.com ↗ Norgine B.V. highlighted results of an independent, investigator initiated trial showing significant reductions in the number and length of hospital admissions when rifaximin is used to treat end-stage liver disease patients with overt hepatic encephalopathy (HE).
2019-04-15	Norgine	Results New real world study shows rifaximin-α significantly reduced hospitalisation in patients with overt hepatic encephalopathy (HE) when added to lactulose norgine.com ↗ Norgine B.V. today highlighted results of a real world study showing significant reductions in the number and length of hospitalisations when rifaximin-α is added to lactulose, the SOC treatment for patients with overt hepatic encephalopathy (HE).
2018-10-19	Norgine	Results Norgine to present data for PLENVU® and XIFAXAN® at the United European Gastroenterology Week (UEG) norgine.com ↗ Long term prevention of overt hepatic encephalopathy is possible with lactulose alone but more effective if combined with rifaximin: A systematic review with number needed to treat analyses of randomised controlled trials.
2018-04-12	Norgine	Results RIFAXIMIN-α reduces the incidence of sepsis and all-cause admissions whilst on the liver transplant waiting list and hospital admissions norgine.com ↗
2018-04-12	Norgine	Results New data show that RIFAXIMIN-α reduces systemic inflammation in patients with cirrhosis and chronic hepatic encephalopathy norgine.com ↗ NEW DATA SHOW THAT RIFAXIMIN-α REDUCES SYSTEMIC INFLAMMATION IN PATIENTS WITH CIRRHOSIS AND CHRONIC HEPATIC ENCEPHALOPATHY

All press releases naming this drug 9 releases

Date	Issuer	Release
2026-08-26	Lotus Pharmaceutical	Lotus Pharmaceutical Announces Favorable U.S. Appeals Court Ruling on Norwich’s Application for Generic Rifaximin lotuspharm.com ↗
2026-01-23	Bausch Health Americas, Inc.	Bausch Health Provides Update on RED-C Phase 3 Clinical Trials bauschhealth.com ↗
2025-06-03	Zydus Lifesciences Limited	Zydus receives tentative approval from USFDA - Rifaximin Tablets, 550 mg zyduslife.com ↗
2025-01-23	Impax Laboratories, LLC	Amneal Receives U.S. FDA Approval for Memantine/Donepezil Extended-Release Capsules and Everolimus Tablets for Oral Suspension, and Tentative U.S. FDA Approval for Rifaximin amneal.com ↗
2019-06-18	Norgine	New study shows rifaximin significantly reduced the number and length of hospitalisations in patients with overt hepatic encephalopathy (HE) awaiting liver transplantation norgine.com ↗
2019-04-15	Norgine	New real world study shows rifaximin-α significantly reduced hospitalisation in patients with overt hepatic encephalopathy (HE) when added to lactulose norgine.com ↗
2018-10-19	Norgine	Norgine to present data for PLENVU® and XIFAXAN® at the United European Gastroenterology Week (UEG) norgine.com ↗
2018-04-12	Norgine	RIFAXIMIN-α reduces the incidence of sepsis and all-cause admissions whilst on the liver transplant waiting list and hospital admissions norgine.com ↗
2018-04-12	Norgine	New data show that RIFAXIMIN-α reduces systemic inflammation in patients with cirrhosis and chronic hepatic encephalopathy norgine.com ↗

Evidence & citations 16 cited values

Every value below carries the sentence it was read from. 197 sources stand behind the page.

Field	Value	Cited text
Known as	RIFAXIMIN	“The subjects will undergo pre-treatment to "cleanse" the gut by consuming orally one tablet of antibiotic rifaximin (200mg) daily for 14 days prior to the initiation of Vivomixx course.” NCT05083572 ↗ 194 “In a double-blinded randomized study, 16 healthy volunteers (27.00 ± 1.60 years; 9 males) received either rifaximin (600 mg/day) (a poorly absorbable antibiotic) or placebo for 7 days.” PMID 29713909 ↗ Jul 2018 “Lactulose ± rifaximin as SoC treatment for overt HE should be administered per the clinical judgement of the investigator and usual institutional practice.” NCT04128462 ↗ “Standard Medical Therapy will include nutritional support, rifaximin, lactulose, bowel wash, albumin, diuretics, multivitamins and antibiotics as required” NCT03420144 ↗ “Phase 1, Randomised, Placebo-Controlled, Single-Ascending Dose and Multiple-Dose with 3 novel RIFAXIMIN Formulations.” NCT04529811 ↗ “Nutritional support, rifaximin, lactulose, bowel wash, albumin, diuretics, multivitamins and antibiotics.” NCT03415698 ↗ “Recipients will undergo bowel preconditioning with antibiotics (Rifaximin) following randomization.” NCT05502913 ↗ “Ciprofloxacin, metronidazole, vancomycin, amoxicillin clavulanate or rifaximin.” NCT06443502 ↗ “three doses of rifaximin 400mg at 7am, 3pm and 11pm the day before surgery” NCT07429760 ↗ “10-day course of 550 mg of rifaximin or placebo 3 times per day” PMID 21240023 ↗ Apr 2011 “Rifaximin: 550 mg TID for 14 days (repeatable)” NCT07635394 ↗ Show 184 more sources
Known as	Alfa Normix	“Rifaximin (Alfa Normix®, Alfa Wassermann S.P.A., Italy, registration number LS-001993, 08/31/2010) in standard doses of 200 mg 3 times a day for 7 days” NCT06652087 ↗
Known as	Extended Intestinal Release (EIR)	“The primary objective is to determine the efficacy of rifaximin DR also referred to as Extended Intestinal Release (EIR) tablets vs. placebo for the induction of clinical...” NCT02240108 ↗
Known as	L-105	“rifaximin (L-105)” NCT04118699 ↗
Known as	NDA 22-554	“NDA 22-554” NCT02555293 ↗
Known as	RFX	“This is a single-site, single-arm, open-label, drug-interaction study that examines the effect of rifaximin (RFX), 550 mg 3 times daily (TID; 1650 mg/day), on orally...” NCT00743912 ↗ 1 “Herein, we present results from a randomized, double-blind, placebo (PBO)-controlled trial to assess whether rifaximin (RFX) has a beneficial effect on 12-month survival in...” PMID 40653111 ↗ Jul 2025
Known as	Rifaximin (Xifaxan)	“Rifaximin (Xifaxan)” NCT01951209 ↗
Known as	rifaximin DR	“The primary objective is to determine the efficacy of rifaximin DR also referred to as Extended Intestinal Release (EIR) tablets vs. placebo for the induction of clinical...” NCT02240108 ↗
Known as	Rifaximin EIR	“Rifaximin EIR tablets will be administered per the dose and schedule specified in the arm.” NCT02240108 ↗
Known as	Rifaximin SSD	“Rifaximin SSD 40 mg IR tablet” NCT06718686 ↗
Known as	Rifaximin- α	“Rifaximin- α (referred to as Rifaximin) is a drug that is not easy to be absorbed and only works locally in the gastrointestinal tract.” NCT05786859 ↗
Known as	Xifaxan	“Rifaximin (Xifaxan, Salix Pharmaceuticals, Bridgewater, N.J.) (See Package Insert) is a drug that is approved by the FDA for use in humans for the treatment of Hepatic...” NCT03856359 ↗ 9 “A Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multicenter, Bioequivalence Study With Clinical Endpoint Comparing Rifaximin 200-mg Tablets With Xifaxan®...” NCT02498418 ↗ “A Phase II Study of Rifaximin (Xifaxan) for Patients With Sickle Cell Disease (SCD)” NCT03719729 ↗ “Rifaximin 550 milligram Oral Tablet [XIFAXAN]” NCT04073290 ↗ “XIFAXAN® (Rifaximin)” NCT02555293 ↗ “Rifaximin (Xifaxan)” NCT07180615 ↗ “Rifaximin (Xifaxan)” NCT07815548 ↗ “Rifaximin (Xifaxan)” NCT00269399 ↗ “Rifaximin (Xifaxan)” NCT07185932 ↗ “Rifaximin (XIFAXAN)” NCT01359228 ↗
Known as	Xifaxanta	“Modified Xifaxanta™ (rifaximin film-coated tablet) manufactured by Alfa Wasermann (AW),” NCT01670149 ↗
Action	Inhibit	“inhibits urease-producing bacteria” PMID 37467180 ↗ Jul 2023
Modality	Other / unclassified	“Rifaximin is an antibiotic” NCT02074280 ↗
Route	Oral	“nonabsorbed oral antibiotic (rifaximin)” PMID 17043337 ↗ Oct 2006