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rifaximin

Trade name: xifaxan

Small moleculeapprovedOrphan Drug FDA

Approved

May 25, 2004

Rifaximin is a structural analog of rifampin and a non-systemic, gastrointestinal site-specific antibiotic. Rifaximin acts by inhibiting bacterial ribonucleic acid (RNA) synthesis and contributes to restore intestinal microflora imbalance. It is FDA approved for the treatment of travelers’ diarrhea, reduction in risk of overt hepatic encephalopathy (HE) recurrence and treatment of irritable bowel syndrome with diarrhea. More common side effects are: black, tarry stools; dizziness or lightheadedness; muscle spasm; rapid breathing; shortness of breath; trouble sleeping. Co-administration of cyclosporine, with XIFAXAN resulted in 83-fold and 124-fold increases in rifaximin mean Cmax in healthy subjects. — NCATS

Clinical trial activity

182 trials · 175 clinical orgs · 9 marketing orgs

Phase 1
23
Phase 2
82
Phase 3
44
Phase 4
34

Earliest trial started Jun 1, 2003 (NCT00098384)

Timeline

1990s

  1. Feb 10, 1998

    Orphan Drug Designation

2000s

  1. Jan 1, 2003

    Earliest Phase 2 Sponsor(trial)

  2. May 25, 2004

    Salix — Earliest FDA Approval

  3. May 25, 2004

    Salix — NDA Organization

  4. Jan 1, 2005

    Earliest Phase 3 Sponsor(trial)

  5. Jan 1, 2007

    Earliest Phase 1 Sponsor(trial)

2020s

  1. Sep 2, 2022

    Norwich Eaton Company — Marketing Organization

  2. Sep 2, 2022

    AbbVie — Marketing Organization

  3. Mar 8, 2024

    Sandoz — Marketing Organization

  4. May 30, 2025

    Zydus Discovery DMCC — Marketing Organization

  5. Dec 8, 2025

    Cipla — Marketing Organization

  6. Jan 7, 2026

    Mylan — Marketing Organization

  7. Mar 19, 2026

    Actavis — Marketing Organization

  8. Mar 20, 2026

    Alkem Labs Ltd — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedMay 25, 2004

Chemistry & pharmacology

Loading structure…

SMILES

CO[C@H]1\C=C\O[C@@]2(C)OC3=C(C2=O)C4=C5N=C6C=C(C)C=CN6C5=C(NC(=O)C(C)=C\C=C\[C@H](C)[C@H](O)[C@@H](C)[C@@H](O)[C@@H](C)[C@H](OC(C)=O)[C@@H]1C)C(O)=C4C(O)=C3C
Mol. weight
785.8785 g/mol
Lipinski Ro5
3 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 4-deoxy-4'-methylpyrido(1',2'-1,2)imidazo(5,4c)rifamycin
  • l 105
  • l-105
  • normix
  • normix
  • redactiv
  • refaximin
  • rifacol
  • rifacol
  • rifamycin l 105
  • rifamycin l 105
  • rifamycin l 105sv
  • rifamycin l 105sv
  • rifaxidin
  • rifaxidin
  • rifaxidin
  • rifaximin
  • rifaximin
  • rifaximin
  • rifaximin
  • rifaximin
  • rifaximin
  • rifaximin
  • rifaximin
  • rifaximin
  • rifaximin
  • rifaximina
  • rifaximina
  • rifaximine
  • rifaximine
  • rifaximine
  • rifaximine
  • rifaximine
  • rifaximine
  • rifaximinum
  • rifaximinum
  • rifaximinun
  • rifaximinun
  • rifaximin (xifaxan)
  • targaxan
  • xifaxan
  • xifaxan
  • xifaxan
  • xifaxan
  • xifaxan
  • xifaxan
  • xifaxanta
  • xifaxanta
  • xifaxsan
  • xifaxsan

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07203846Phase 4Jan 1, 2026Government of Poland, Nicolaus Copernicus University
NCT07285785Phase 4Dec 20, 2025Bausch Health Companies
NCT07209371Phase 2Dec 19, 2025Rising Tide Foundation, University of Washington
NCT06772064N/AApr 15, 2025Shandong University
NCT06727422Phase 2Apr 1, 2025Cedars-Sinai Medical Center
NCT06808009N/AFeb 5, 2025Institute of Liver and Biliary Sciences, India
NCT06783153Phase 1/Phase 2 (Phase 2)Jan 20, 2025Mansoura University
NCT06718686Phase 1/Phase 2 (Phase 2)Dec 31, 2024Bausch Health Companies, Department of Veteran Affairs
NCT06743464N/ADec 31, 2024Institute of Liver and Biliary Sciences, India
NCT07037394Phase 4Dec 2, 2024Islamia University of Bahawalpur
NCT06483737N/AOct 1, 2024People's Liberation Army of China
NCT06652087N/ASep 2, 2024I.M. Sechenov First Moscow State Medical University
NCT06538077N/AAug 31, 2024Indian Council of Medical Research, Postgraduate Institute of Medical Education and Research
NCT07185932Early Phase 1 (Phase 1)Aug 10, 2024Second Military Medical University
NCT06518850Phase 1/Phase 2 (Phase 2)Aug 1, 2024Air Force Military Medical University, China, Capital Medical University, Chinese Academy of Medical Sciences, Government of China, Peking University
NCT06312683Phase 4Jul 1, 2024Bausch Health Companies, University of North Carolina at Chapel Hill
NCT06199843N/AJan 5, 2024Institute of Liver and Biliary Sciences, India
NCT06058572Phase 2Oct 15, 2023Tata Memorial Hospital
NCT05863364N/AAug 18, 2023Huazhong University of Science and Technology
NCT06234046Phase 3May 28, 2023Ain Shams University
Showing 20 of 182 trials
Page 1 / 10

Organizations

Research & Development (175)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Bausch Health CompaniesFor profit412252003
Institute of Liver and Biliary Sciences, IndiaAcademic/Hospital8812010
Department of Veteran AffairsGovernment7632007
Cedars-Sinai Medical CenterAcademic/Hospital6622003
Mayo ClinicAcademic/Hospital5542007
People's Liberation Army of ChinaGovernment5132013
Alfasigma S.p.A.For profit4422017
Fudan UniversityAcademic/Hospital4422016
Second Military Medical UniversityGovernment4422013
Ain Shams UniversityAcademic/Hospital3322014
Alfa WassermannFor profit3222007
Cornell UniversityAcademic/Hospital3332005
Emory UniversityAcademic/Hospital3312007
Huazhong University of Science and TechnologyAcademic/Hospital3122017
Jiao Tong UniversityAcademic/Hospital3022016
Sun Yat-Sen UniversityAcademic/Hospital3322017
Uniformed Services University of the Health SciencesGovernment3222012
University of MichiganAcademic/Hospital3322017
University of Texas at HoustonAcademic/Hospital3322003
University of WashingtonAcademic/Hospital3312008
175 organizations
Page 1 / 9

Marketing (10)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGSep 2, 2022
ActavisFor profitMKTGMar 19, 2026
Alkem Labs LtdFor profitMKTGMar 20, 2026
CiplaFor profitMKTGDec 8, 2025
MylanFor profitMKTGJan 7, 2026
Norwich Eaton CompanyFor profitMKTGSep 2, 2022
Norwich Eaton CompanyFor profitSYNJun 20, 2024
SalixFor profitNDAMay 25, 2004
SandozFor profitMKTGMar 8, 2024
Zydus Discovery DMCCFor profitMKTGMay 30, 2025