Acurx gets FDA conditional brand name acceptance for CDI drug

Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) announced that the FDA has conditionally accepted the proposed brand name CIFBEZY for ibezapolstat, its antibiotic candidate for Clostridioides difficile infection (CDI). The U.S. Patent and Trademark Office (USPTO) has also allowed the trademark application for the name.

According to a company statement, the name CIFBEZY was developed through a screening process involving branding experts, prescribers, pharmacists, and linguists, as evaluated by the FDA's Division of Medication Error Prevention and Analysis. A request for final FDA review and approval of the brand name is required at the time of a New Drug Application (NDA) submission.

The USPTO's notice of allowance indicates the trademark passed both the examination process and the opposition period. Commercial use of the brand name remains contingent upon NDA approval.

Acurx said ibezapolstat is preparing to advance into an international Phase 3 registration program targeting both acute CDI treatment and reduction of recurrence. The company previously received FDA guidance from a July 13, 2026 Type C Meeting indicating the agency is open to an NDA based on a single Phase 3 trial. Trial start-up activities for the IBZ-PATHFINDER Phase 2 trial in patients with multiply-recurrent CDI have been initiated, with patient enrollment expected to begin within the next few months.

Ibezapolstat received FDA Qualified Infectious Disease Product designation in 2018 and Fast Track designation in 2019 for CDI treatment. Phase 2 clinical trial data were published in the Lancet in August 2025.

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