Also known as: Clostridioides difficile
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.
CRS3123, an investigational antibiotic for C. difficile infection, demonstrated 97% clinical cure rates and significantly lower recurrence (4% vs 23% for vancomycin) in a Phase 2 trial. The narrow-spectrum drug better preserves gut microbiome health and secondary bile acid synthesis compared to standard vancomycin treatment. These positive results support advancing CRS3123 into Phase 3 development.
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 |
|---|---|---|---|
| NCT07613645 |
Lifestyle and Recurrent Clostridioides Difficile Infection (CDI) |
RECRUITING | NA |
| NCT07401680 |
Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population |
RECRUITING | PHASE1 |
| NCT07285213 |
Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody |
RECRUITING | PHASE2 |
| NCT06979609 |
Secondary Prevention of Clostridioides Difficile Using Vancomycin |
RECRUITING | PHASE2/PHASE3 |
| NCT06306014 |
Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients |
RECRUITING | PHASE1/PHASE2 |
| NCT06237452 |
VE303 for Prevention of Recurrent Clostridioides Difficile Infection |
RECRUITING | PHASE3 |
| NCT05330182 |
LMN-201 for Prevention of C. Difficile Infection Recurrence |
ACTIVE_NOT_RECRUITING | PHASE2/PHASE3 |
| NCT05266807 |
Fecal Microbiota Transplantation in Clostridioides Difficile Infection First Episode and First Recurrence |
RECRUITING | PHASE3 |
