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Fidaxomicin tablets
Fidaxomicin is a macrocyclic antibiotic that inhibits bacterial RNA polymerase, selectively killing Clostridioides difficile while minimizing effects on normal gut flora.
Fidaxomicin is a macrocyclic antibiotic that inhibits bacterial RNA polymerase, selectively killing Clostridioides difficile while minimizing effects on normal gut flora. Used for Clostridioides difficile infection (CDI), including initial episode and recurrent infection.
At a glance
| Generic name | Fidaxomicin tablets |
|---|---|
| Also known as | Dificlir, Dificid |
| Sponsor | Astellas Pharma Europe B.V. |
| Drug class | Macrocyclic antibiotic |
| Target | Bacterial RNA polymerase (C. difficile) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Fidaxomicin binds to bacterial RNA polymerase and inhibits transcription in C. difficile, leading to bacterial cell death. Its narrow spectrum of activity and minimal systemic absorption make it particularly effective for treating C. difficile infection while preserving the beneficial microbiome, reducing recurrence rates compared to broader-spectrum antibiotics.
Approved indications
- Clostridioides difficile infection (CDI), including initial episode and recurrent infection
Common side effects
- Nausea
- Vomiting
- Abdominal pain
- Diarrhea
- Pruritus
Key clinical trials
- A Study to Investigate the Safety and Efficacy of Fidaxomicin (Oral Suspension or Tablets) and Vancomycin (Oral Liquid or Capsules) in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD) (PHASE3)
- Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI) (PHASE4)
- A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population (PHASE4)
- Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD) (PHASE2)
- Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001) (PHASE3)
- A Study of Ridinilazole (SMT19969) Compared With Fidaxomicin for the Treatment of Clostridium Difficile Infection (CDI) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Fidaxomicin tablets CI brief — competitive landscape report
- Fidaxomicin tablets updates RSS · CI watch RSS
- Astellas Pharma Europe B.V. portfolio CI