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Fidaxomicin tablets — Competitive Intelligence Brief
phase 3
Macrocyclic antibiotic
Bacterial RNA polymerase (C. difficile)
Infectious Disease
Small molecule
Live · refreshed every 30 min
Target snapshot
Fidaxomicin tablets (Fidaxomicin tablets) — Astellas Pharma Europe B.V.. Fidaxomicin is a macrocyclic antibiotic that inhibits bacterial RNA polymerase, selectively killing Clostridioides difficile while minimizing effects on normal gut flora.
Comparator set (2 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| Fidaxomicin tablets TARGET | Fidaxomicin tablets | Astellas Pharma Europe B.V. | phase 3 | Macrocyclic antibiotic | Bacterial RNA polymerase (C. difficile) | |
| OPT-80 | OPT-80 | Astellas Pharma Inc | phase 3 | Macrocyclic antibiotic | Bacterial RNA polymerase | |
| Fidaxomicin oral suspension | Fidaxomicin oral suspension | Astellas Pharma Europe B.V. | phase 3 | Macrocyclic antibiotic | Bacterial RNA polymerase (C. difficile) |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
Sponsor landscape (Macrocyclic antibiotic class)
- Astellas Pharma Europe B.V. · 2 drugs in this class
- Astellas Pharma Inc · 1 drug in this class
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Cite this brief
Drug Landscape (2026). Fidaxomicin tablets — Competitive Intelligence Brief. https://druglandscape.com/ci/fidaxomicin-tablets. Accessed 2026-05-14.
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