Vancomycin is a glycopeptide antibacterial agent; in this oral VANCOCIN label it is indicated for Clostridioides difficile-associated diarrhea and staphylococcal enterocolitis, with explicit limitation that oral dosing is not effective for other infection types. U.S. initial approval in this oral capsule label is 1986.
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 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 |
|---|---|---|---|
| NCT07490054 |
Intestinal Microbiota Transplantation in Patients With Chronic Heart Failure |
RECRUITING | PHASE1 |
| NCT07435051 |
Prospective, Randomized, Multicenter Clinical Trial of Bisphosphonates Combined With Vancomycin for the Treatment of Cierny-Mader Type I and III Osteomyelitis |
NOT_YET_RECRUITING | PHASE3 |
| NCT07282782 |
A Prospective, Randomized Parallel Group Study of the Efficacy of Vancomycin Administered Through Intraarticular Injection Versus Intraosseous Injection Versus Intravenous Infusion in Patients Undergoing Total Knee Arthroplasty |
RECRUITING | PHASE4 |
| NCT06954129 |
A Pragmatic Clinical Trial Comparing the Risk of Acute Kidney Injury During Treatment With Vancomycin and Piperacillin-Tazobactam vs. Vancomycin and Cefepime in Hospitalized Patients |
RECRUITING | PHASE4 |
| NCT06716749 |
Effectiveness of Adding Morphine to Intraosseous Vancomycin for Pain Control in Total Knee Arthroplasty |
COMPLETED | PHASE2 |
| NCT06702345 |
Clostridioides Difficile Controlled Human Infection Model |
NOT_YET_RECRUITING | NA |
| NCT06582264 |
A Phase 1b Trial to Evaluate the Safety of MB310 in Patients With Active, Mild-to-Moderate Ulcerative Colitis |
COMPLETED | PHASE1 |
| NCT06567808 |
Prevention of Infections in Cardiac Surgery (PICS): a Cluster-randomized Factorial Cross-over Trial |
NOT_YET_RECRUITING | PHASE4 |
| NCT06543940 |
Pharmacokinetics Vancomycin CVVHDF with OXiris Membrane |
RECRUITING | NA |
| NCT06540391 |
A Phase 1b Trial to Evaluate Safety of MB097 in Combination With Pembrolizumab in Melanoma Patients |
ACTIVE_NOT_RECRUITING | PHASE1 |
