NCT07513285

ACX-362E [Ibezapolstat] for Oral Treatment of Recurrent Clostridioides Difficile Infection

A Phase 2 Interventional, Open-Label, Single-Arm Trial of Oral Ibezapolstat (ACX-362E) for Treatment and Reduction of Recurrent Clostridioides Difficile Infection in Patients With Multiple Recurrent Infections (IBZ-PATHFINDER)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Acurx Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Single-arm trial to evaluate the safety and efficacy of ACX-362E \[ibezapolstat\] in patients with recurrent C. difficile infection (CDI).

Detailed description

Phase 2 multicenter, open-label, single-arm study is designed to evaluate the efficacy, safety, and tolerability of ibezapolstat in the treatment and reduction of recurrence of CDI in an adult patient population that has experienced ≥3 episodes of CDI within the past 12 months. Up to 20 participants will be treated with ibezapolstat 450 mg taken with food every 12 hours for 14 days (28 total doses) and followed for Clinical Cure (Day 16), Sustained Clinical Cure (Day 42), rate of CDI recurrence (Up to Week 24), and Extended Clinical Cure (ECC) (Up to Week 24).

Conditions

• Clostridium Difficile Infection Recurrence

Interventions

Type	Name	Description
DRUG	Ibezapolstat	Ibezapolstat 450 mg po Q12H x14 days

Timeline

• Start date: 2026-08-19
• Primary completion: 2027-09-29
• Completion: 2027-11-24
• First posted: 2026-04-07
• Last updated: 2026-04-07

Regulatory

• FDA-regulated drug study