Ibezapolstat is Acurx's lead oral antibiotic candidate for Clostridioides difficile infection (CDI), including recurrent CDI strategies. It is being advanced into international Phase 3 registration trials after Phase 2 results. The drug belongs to a new DNA polymerase IIIC inhibitor class and is still investigational.
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 |
|---|---|---|---|
| NCT07513285 |
ACX-362E [Ibezapolstat] for Oral Treatment of Recurrent Clostridioides Difficile Infection |
NOT_YET_RECRUITING | PHASE2 |
| NCT04247542 |
ACX-362E [Ibezapolstat] for Oral Treatment of Clostridioides Difficile Infection |
COMPLETED | PHASE2 |
