New Antibiotic Zoliflodacin Shows Promise Against Drug-Resistant Gonorrhea

Phase 3 trial results for zoliflodacin also demonstrated comparable efficacy for pharyngeal and rectal gonorrhea infections, which are often more challenging to treat.

via cidrap.umn.edu

The U.S. FDA approved a second new oral medicine, Blujepa (gepotidacin), to treat uncomplicated urogenital gonorrhea, alongside Nuzolvence (zoliflodacin). Blujepa is approved for patients 12 years and older.

via fda.gov

The U.S. FDA approved NUZOLVENCE® (zoliflodacin) for oral suspension as a first-in-class, single-dose oral antibiotic for the treatment of uncomplicated urogenital gonorrhea in adults and adolescents.

via pubmed.ncbi.nlm.nih.gov·nih.gov·niaid.nih.gov·urologytimes.com

Results from the multi-country Phase 3 clinical trial were published in The Lancet, confirming zoliflodacin's non-inferiority to the current standard combination therapy for uncomplicated urogenital gonorrhea.

via pubmed.ncbi.nlm.nih.gov·nih.gov·niaid.nih.gov·urologytimes.com

Zoliflodacin was submitted for priority review in Thailand, with GARDP planning a Managed Access Program (MAP) to facilitate access prior to full approval.

via pubmed.ncbi.nlm.nih.gov·nih.gov·niaid.nih.gov·urologytimes.com

The FDA granted zoliflodacin Qualified Infectious Disease Product (QIDP) status, which includes Priority Review, and set a Prescription Drug User Fee Act (PDUFA) target action date of December 15, 2025.

via pubmed.ncbi.nlm.nih.gov·nih.gov·niaid.nih.gov·urologytimes.com

The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for zoliflodacin for the treatment of uncomplicated gonorrhea.

via pubmed.ncbi.nlm.nih.gov·nih.gov·niaid.nih.gov·urologytimes.com

Further positive data from the Phase 3 trial, including details on safety and additional microbiological findings, were presented at the ESCMID Global Congress.

via pubmed.ncbi.nlm.nih.gov·nih.gov·niaid.nih.gov·urologytimes.com

Innoviva Specialty Therapeutics and the Global Antibiotic Research & Development Partnership (GARDP) announced that the global Phase 3 clinical trial for zoliflodacin met its primary endpoint, demonstrating non-inferiority to standard treatment.

via pubmed.ncbi.nlm.nih.gov·nih.gov·niaid.nih.gov·urologytimes.com

Results from the Phase 2 trial were published in The New England Journal of Medicine, indicating that zoliflodacin cured 96% of urogenital gonorrhea cases and was well-tolerated.

via pubmed.ncbi.nlm.nih.gov·nih.gov·niaid.nih.gov·urologytimes.com

Enrollment began for the Phase 2 clinical trial of zoliflodacin, an investigational oral antibiotic, for the treatment of uncomplicated gonorrhea.

via pubmed.ncbi.nlm.nih.gov·nih.gov·niaid.nih.gov·urologytimes.com