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Dificid (FIDAXOMICIN)
Dificid works by inhibiting protein synthesis in bacteria, preventing them from reproducing and causing infection.
Dificid (fidaxomicin) is a macrolide antibacterial drug originally developed by Cubist Pharms and currently owned by Cubist Pharms LLC. It is a small molecule that was FDA-approved in 2011 for the treatment of Clostridium difficile infection and pseudomembranous enterocolitis. Dificid is commercially available, with multiple generic manufacturers. Key safety considerations include the potential for gastrointestinal side effects. The commercial status of Dificid is not off-patent.
At a glance
| Generic name | FIDAXOMICIN |
|---|---|
| Sponsor | Cubist Pharms Llc |
| Drug class | Macrolide Antibacterial [EPC] |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2011 |
| Annual revenue | 410 |
Mechanism of action
Fidaxomicin is an antibacterial drug [see Microbiology (12.4)].
Approved indications
- Clostridium difficile infection
- Pseudomembranous enterocolitis
Common side effects
- Abdominal pain
- Vomiting
- Diarrhea
- Constipation
- Pyrexia
- Gastrointestinal hemorrhage
- Anemia
- Neutropenia
- Nausea
- Abdominal distension
- Abdominal tenderness
- Dyspepsia
Key clinical trials
- Vancomycin Taper to Prevent Recurrent Clostridioides Difficile (PHASE3)
- Optimal Treatment for Recurrent Clostridium Difficile (PHASE4)
- Use of Fidaxomicin Compared to Vancomycin for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease (PHASE4)
- Prevention of Recurrence of Clostridioides Difficile Colitis With Ursodeoxycholic Acid (UCDA) as a Supplement to Standard Therapy (EARLY_PHASE1)
- Fecal Microbiota Transplantation in Clostridioides Difficile Infection First Episode and First Recurrence (PHASE3)
- STOP-CDI: Efficacy of Fecal Microbiota Transplantation vs Fidaxomicin vs Vancomycin in Treating and Preventing Relapse of Clostridioides Difficile Infection (NA)
- Primary or Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin (PHASE3)
- 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)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Dificid CI brief — competitive landscape report
- Dificid updates RSS · CI watch RSS
- Cubist Pharms Llc portfolio CI