Back to discover
Drug

Fidaxomicin

Approved · EMA
ClassDNA-directed RNA polymerase inhibitorEmerging researchLate-stage development
Also known as Dificid, Lipiarmicin, Tiacumicin B, Lipiarmycin+2 more

Dificid, Lipiarmicin, Tiacumicin B, Lipiarmycin, Lipiarrmycin, Fidaxomicina.

RxNorm1111103ChEMBLCHEMBL1255800ATCA07AA12UNIIZ5N076G8YQ
2
Research papers
3
Active clinical trials
4
Protein targets
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Initial Vancomycin Taper for the Prevention of Recurrent Clostridioides Difficile Infection 2: A Randomized Controlled Trial

Clinical trial2026-06-24Results expected Q2 2030 · ClinicalTrials.gov

Use of Fidaxomicin Compared to Vancomycin for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease

Clinical trial2025-11-03Results expected Q3 2030 · ClinicalTrials.gov

Multicenter, Randomized, Open-label, Three-arm Study on the Efficacy of Fecal Microbiota Transplantation vs Fidaxomicin vs Vancomycin in the Treatment and Relapse Prophylaxis of Clostridioides Difficile Infection. STOP-CDI Study

Clinical trial2025-08-13Results expected Q1 2027 · ClinicalTrials.gov

A Randomised, Controlled, Open-label Phase III Clinical Trial in Patients With Primary or Recurrent Clostridioides Difficile (CD) Infection, to Evaluate the Efficacy and Safety of Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin.

Clinical trial2025-03-25Results posted · ClinicalTrials.gov

A Phase 3, Multicenter, Investigator-blind, Randomized, Parallel Group Study to Investigate the Safety and Efficacy of Fidaxomicin Oral Suspension or Tablets Taken q12h, and Vancomycin Oral Liquid or Capsules Taken q6h, for 10 Days in Pediatric Subjects With Clostridium Difficile-associated Diarrhea

Clinical trial2024-11-26Results posted · ClinicalTrials.gov

CSP #596 - Optimal Treatment for Recurrent Clostridium Difficile Infection

Clinical trial2024-08-31Terminated · ClinicalTrials.gov

A Comparison of Fidaxomicin and Oral Vancomycin for the Treatment of Clostridium Difficile Infection (CDI) in Hospitalized Patients Receiving Concomitant Antibiotics for the Treatment of Concurrent Systemic Infections

Clinical trial2022-03-25Results posted · ClinicalTrials.gov

Prospective, Open-label Trial to Evaluate Efficacy of 30-day Duration of Fidaxomicin in Patients With Recurrent C. Difficile Infection

Clinical trial2021-08-30Terminated · ClinicalTrials.gov

Serial Fecal Microbiota Transplant (FMT) Plus Fidaxomicin in the Treatment of Severe or Fulminant Clostridium Difficile Infection, With Detailed Characterization in Microbiota, Metabolomics and Host Immune Response

Clinical trial2020-03-10Terminated · ClinicalTrials.gov

Safety and Pharmacokinetic Study of Fidaxomicin in Children With Clostridium difficile-Associated Diarrhea: A Phase 2a Multicenter Clinical Trial.

Research2018-08-01Journal of the Pediatric Infectious Diseases Society

Approval: Dificlir (EMA)

Regulatory2011-12-05EMA

Fidaxomicin versus vancomycin for Clostridium difficile infection.

Research2011-02-01The New England journal of medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Fidaxomicin
Aliases & brands
DificidLipiarmicinTiacumicin BLipiarmycinLipiarrmycinFidaxomicina
RxNorm CUI
1111103
ChEMBL ID
CHEMBL1255800
ATC codes
A07AA12
UNII
Z5N076G8YQ
Primary mechanism
DNA-directed RNA polymerase inhibitor
Regulatory jurisdictions
ema

Pharmacology & targets

4 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

DNA-directed RNA polymerase subunit alpha
rpoA · Q18CI5
INHIBITORDNA-directed RNA polymerase inhibitor
DNA-directed RNA polymerase subunit beta
rpoB · Q18CF1
INHIBITORDNA-directed RNA polymerase inhibitor
DNA-directed RNA polymerase subunit beta'
rpoC · Q18CF3
INHIBITORDNA-directed RNA polymerase inhibitor
DNA-directed RNA polymerase subunit omega
rpoZ · Q182S6
INHIBITORDNA-directed RNA polymerase inhibitor

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2011-12-05
Latest approval
2011-12-05
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2011-12-05Approval
Approval: Dificlir (EMA)
Indication: Dificlir film-coated tablets is indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adult and… Show full indication

Dificlir film-coated tablets is indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adult and paediatric patients with a body weight of at least 12.5 kg. Consideration should be given to official guidelines on the appropriate use of antibacterial agents. Dificlir granules for oral suspension is indicated for the treatment of Clostridioides  difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adults and paediatric patients from birth to < 18 years of age. Consideration should be given to official guidelines on the appropriate use of antibacterial agents.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

24 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
24
registered trials across all phases
LATEST COMPLETION 2023
3
Active studies
3
Recruiting
19
Late-stage (III+)
14
Completed
7
Discontinued
PHASE DISTRIBUTIONn = 24
Phase 12Phase 23Phase 37Phase 411Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Use of Fidaxomicin Compared to Vancomycin for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease

Not yet recruitingPH IVBrigham and Women's Hospitaln=602031

CSP #596 - Optimal Treatment for Recurrent Clostridium Difficile Infection

TerminatedPH IVVA Office of Research and Developmentn=3082024

A Comparison of Fidaxomicin and Oral Vancomycin for the Treatment of Clostridium Difficile Infection (CDI) in Hospitalized Patients Receiving Concomitant Antibiotics for the Treatment of Concurrent Systemic Infections

CompletedPH IVUniversity of Michigann=1442021

Fidaxomicin Versus Standard of Care Therapy in Solid Organ Transplant Recipients With Clostridium Difficile Infection

WithdrawnPH IVUniversity of Colorado, Denver2019

Exploratory Study of Impact of Oral Metronidazole, Vancomycin and Fidaxomicin on the Extent and Quantity of Host Carriage and Environmental Contamination With C. Difficile

CompletedPH IVDuke Universityn=332017

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Randomised, Controlled, Open-label Phase III Clinical Trial in Patients With Primary or Recurrent Clostridioides Difficile (CD) Infection, to Evaluate the Efficacy and Safety of Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin.

CompletedPH IIIMikrobiomik Healthcare Company S.L.n=932023

A Comparison of Fidaxomicin and Oral Vancomycin for the Treatment of Clostridium Difficile Infection (CDI) in Hospitalized Patients Receiving Concomitant Antibiotics for the Treatment of Concurrent Systemic Infections

CompletedPH IVUniversity of Michigann=1442021

Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection

CompletedPH IIIUniversity of Aarhusn=642019

A Phase 3, Multicenter, Investigator-blind, Randomized, Parallel Group Study to Investigate the Safety and Efficacy of Fidaxomicin Oral Suspension or Tablets Taken q12h, and Vancomycin Oral Liquid or Capsules Taken q6h, for 10 Days in Pediatric Subjects With Clostridium Difficile-associated Diarrhea

CompletedPH IIIAstellas Pharma Europe B.V.n=1482018

Exploratory Study of Impact of Oral Metronidazole, Vancomycin and Fidaxomicin on the Extent and Quantity of Host Carriage and Environmental Contamination With C. Difficile

CompletedPH IVDuke Universityn=332017

Open Label Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI)

CompletedPH IVAstellas Pharma Europe Ltd.n=252016

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20112018
Most influential

Fidaxomicin versus vancomycin for Clostridium difficile infection.

The New England journal of medicine · 2011 · 1,120 cites

Safety and Pharmacokinetic Study of Fidaxomicin in Children With Clostridium difficile-Associated Diarrhea: A Phase 2a Multicenter Clinical Trial.

Journal of the Pediatric Infectious Diseases Society · 2018 · 18 cites
Recent papers

Safety and Pharmacokinetic Study of Fidaxomicin in Children With Clostridium difficile-Associated Diarrhea: A Phase 2a Multicenter Clinical Trial.

Journal of the Pediatric Infectious Diseases Society · 2018 · 18 cites

Fidaxomicin versus vancomycin for Clostridium difficile infection.

The New England journal of medicine · 2011 · 1,120 cites
Major research themes1
Clostridioides difficile2
Journals, researchers & institutions
Top journals
  • Journal of the Pediatric Infectious Diseases Society1
  • The New England journal of medicine1
Leading researchers
  • Sears P2
  • Golan Y1
  • Gorbach S1
  • Hoffenberg EJ1
  • Kaplan SL1
  • Kim KS1
  • Kociolek LK1
  • Lentnek A1
Leading institutions
free-text, unnormalised
  • Ann & Robert H. Lurie Children's Hospital of Chicago1
  • Baylor College of Medicine1
  • Indiana University School of Medicine1
  • IWK Health Center1
  • Johns Hopkins University1
  • Kosair Charities Pediatric Clinical Research Unit1

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Vancomycin

Studied across 2 of the same disease areas as Fidaxomicin in the shared literature.

2 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.