FDA Provides Regulatory Guidance for Ibezapolstat, Potentially Allowing Single Phase 3 Trial for NDA

Acurx Pharmaceuticals announced that the FDA has provided regulatory guidance for its ibezapolstat clinical development program, including the potential for a single Phase 3 trial to support a New Drug Application (NDA). The FDA also agreed that the trial design could support indications for both the acute treatment and reduction of recurrence of Clostridioides difficile infection (CDI). This guidance could streamline the development pathway for this new antibiotic.