Rifaximin
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 141 · started per year
Also used as a comparator or background therapy in 54 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07683936 Background | Jun 2026 → Jan 2027 expected | hepatic encephalopathy | Air Force Military Medical University, China | Recruiting | No outcome recorded |
| Phase 12 trials | ||||||
| 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 1/23 trials | ||||||
| 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| Phase 1/2 | NCT05453916 Comparator | Jul 2022 → Jul 2024 | irritable bowel syndrome | Sadat City University | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT02272868 Background | Jan 2015 → Oct 2016 | Crohn disease | Seattle Children's Hospital | Terminated | No outcome recorded |
| Phase 26 trials | ||||||
| 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 2/36 trials | ||||||
| Phase 2/3 | NCT04775329 Comparator | Nov 2020 → Jan 2023 | cirrhosis of liver, small intestinal bacterial overgrowth | Changi General Hospital | Terminated | No outcome recorded |
| 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 38 trials | ||||||
| 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 |
| 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 413 trials | ||||||
| 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 expected | 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 |
| Phase not applicable15 trials | ||||||
| — | 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 |
| — | NCT02439307 Comparator | Feb 2017 → Jul 2021 | cirrhosis of liver, small intestinal bacterial overgrowth | Coordinación de Investigación en Salud, Mexico | Terminated | No outcome recorded |
| — | 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 | No outcome recorded |
| — | 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 |
| — | NCT00577772 Comparator | Nov 2007 → Jul 2010 | small intestinal bacterial overgrowth, stomach disorder | Mayo Clinic | Terminated | 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 |
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 199 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 ↗193“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 ↗ “Prospective Clinical Trial of Rifaximin Therapy for Patients With Primary Sclerosing Cholangitis.” PMID 24914504 ↗ Jan 2017 “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 ↗ “Ciprofloxacin or Rifaximin for 10 days.” NCT04003181 ↗ “rifaximin” NCT03613545 ↗ |
| 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 | Clostridium butyricum TO-A | “Clostridium butyricum TO-A” NCT03613545 ↗ |
| 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 ↗10“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)” NCT01359228 ↗ “Rifaximin (Xifaxan)” NCT07180615 ↗ “Rifaximin (Xifaxan)” NCT07185932 ↗ “Rifaximin (Xifaxan)” NCT00269399 ↗ |
| 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 |