Clostridioides difficile infection (CDI, C. diff infection) is a bacterial intestinal infection that can cause severe diarrhea and life-threatening colitis, often following antibiotic exposure and healthcare contact.
Acurx Pharmaceuticals is advancing ibezapolstat to international Phase 3 clinical trials for C. difficile infection following final regulatory guidance from FDA and EMA. The company launched a new clinical trial program for recurrent CDI and presented structural biology research demonstrating ibezapolstat's mechanism of action. Acurx reported year-end 2025 cash of $7.6 million.
Acurx Pharmaceuticals announced a new clinical trial program for ibezapolstat in patients with recurrent C. difficile infection, building on Phase 2 results showing 96% clinical cure rates with no recurrence while sparing the gut microbiome.
Acurx Pharmaceuticals will discuss full year and fourth quarter 2025 financial results on March 13, 2026, and provide updates on ibezapolstat, its lead antibiotic candidate preparing for international Phase 3 trials for C. difficile infection.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06702345 |
Clostridioides Difficile Controlled Human Infection Model |
NOT_YET_RECRUITING | NA |
| NCT02770326 |
Safety of Stool Transplant for Patients With Difficult to Treat C. Difficile Infection |
COMPLETED | NA |
| NCT01472978 |
Prospective Study of Clostridium Difficile in Children Undergoing Colonoscopy |
WITHDRAWN | NA |
