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OPT-80
OPT-80 is a macrocyclic antibiotic that inhibits bacterial protein synthesis by binding to the bacterial ribosome.
OPT-80 is a macrocyclic antibiotic that inhibits bacterial protein synthesis by binding to the bacterial ribosome. Used for Clostridioides difficile infection (CDI).
At a glance
| Generic name | OPT-80 |
|---|---|
| Also known as | fidaxomicin |
| Sponsor | Astellas Pharma Inc |
| Drug class | Macrocyclic antibiotic |
| Target | Bacterial RNA polymerase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
OPT-80 (fidaxomicin) is a non-systemic antibiotic that acts locally in the colon by binding to bacterial RNA polymerase, inhibiting transcription and protein synthesis in Gram-positive bacteria, particularly Clostridioides difficile. It has minimal systemic absorption and is designed to treat infections in the gastrointestinal tract while maintaining a favorable safety profile.
Approved indications
- Clostridioides difficile infection (CDI)
Common side effects
- Nausea
- Vomiting
- Abdominal pain
- Diarrhea
Key clinical trials
- Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI) (PHASE4)
- A Study to Compare Safety and Efficacy of OPT-80(Fidaxomicin) With Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD) (PHASE3)
- 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)
- A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections (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)
- PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (PHASE3)
- Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018) (PHASE3)
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 |