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Fidaxomicin oral suspension
Fidaxomicin oral suspension is a Macrocyclic antibiotic Small molecule drug developed by Astellas Pharma Europe B.V.. It is currently in Phase 3 development for Clostridioides difficile infection (CDI), including initial and recurrent episodes. Also known as: Dificid, Dificlir.
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 and recurrent episodes.
At a glance
| Generic name | Fidaxomicin oral suspension |
|---|---|
| Also known as | Dificid, Dificlir |
| 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 (CDI) while preserving beneficial commensal bacteria in the gastrointestinal tract.
Approved indications
- Clostridioides difficile infection (CDI), including initial and recurrent episodes
Common side effects
- Nausea
- Vomiting
- Abdominal pain
- Diarrhea
Key clinical trials
- STOP-CDI: Efficacy of Fecal Microbiota Transplantation vs Fidaxomicin vs Vancomycin in Treating and Preventing Relapse of Clostridioides Difficile Infection (NA)
- 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)
- Bezlotoxumab Versus FMT for Multiple Recurrent CDI (PHASE4)
- Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD) (PHASE2)
- To Determine the Feasibility of a Fidaxomicin Study in Neonates and to Assess C. Difficile (Clostridium Difficile) Involvement in the Pathogenesis
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 oral suspension CI brief — competitive landscape report
- Fidaxomicin oral suspension updates RSS · CI watch RSS
- Astellas Pharma Europe B.V. portfolio CI
Frequently asked questions about Fidaxomicin oral suspension
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Related
- Drug class: All Macrocyclic antibiotic drugs
- Target: All drugs targeting Bacterial RNA polymerase (C. difficile)
- Manufacturer: Astellas Pharma Europe B.V. — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Clostridioides difficile infection (CDI), including initial and recurrent episodes
- Also known as: Dificid, Dificlir
- Compare: Fidaxomicin oral suspension vs similar drugs
- Pricing: Fidaxomicin oral suspension cost, discount & access