Acurx says FDA open to single Phase 3 trial to support ibezapolstat CDI NDA filing
ACXP•Planned studies and potential labeling
The planned IBZ-ASPIRE Phase 3 study could support treatment and reduced recurrence labeling if outcomes are successful.
Start-up began for the open-label IBZ-PATHFINDER Phase 2 study in multiply recurrent cases, with enrollment expected in coming months.
FDA feedback on ibezapolstat Phase 3 plan
Acurx said it received FDA guidance on its ibezapolstat Phase 3 plan for C. difficile infection, including a possible single-trial NDA path.
No clinical results were presented; the update reflects July 13, 2026 Type C meeting minutes released Aug. 3, 2026.
The FDA signaled it may accept one Phase 3 trial for registration if overall evidence is strong, with a second trial possible.
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