New Antibiotic Zoliflodacin Shows Promise Against Drug-Resistant Gonorrhea
Zoliflodacin, a novel oral antibiotic, has successfully completed its clinical development for the treatment of uncomplicated urogenital gonorrhea, including drug-resistant strains. Following positive Phase 2 and Phase 3 trial results, the U.S. FDA granted approval for NUZOLVENCE® (zoliflodacin) in December 2025. The drug is expected to launch in the U.S. market in 2026, offering a much-needed new treatment option amidst rising global antibiotic resistance.
Timeline
Want updates on this thread?
Track this story2026
2 updates
2026
2 updatesA submission for approval of zoliflodacin in South Africa is planned for early 2026.
via pubmed.ncbi.nlm.nih.gov·nih.gov·niaid.nih.gov·urologytimes.com
Innoviva Specialty Therapeutics anticipates the launch of NUZOLVENCE® in the US market, making it available to patients.
via pubmed.ncbi.nlm.nih.gov·nih.gov·niaid.nih.gov·urologytimes.com
2025
7 updates
2025
7 updatesPhase 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
2024
1 update
2024
1 updateFurther 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
2023
1 update
2023
1 updateInnoviva 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
2018
1 update
2018
1 updateResults 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
2014
1 update
2014
1 updateEnrollment 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
Story began · 11 years, 6 mo ago