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
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January 2026 — 2 developments
A submission for approval of zoliflodacin in South Africa is planned for early 2026.
A submission for approval of zoliflodacin in South Africa is planned for early 2026.
Innoviva Specialty Therapeutics anticipates the launch of NUZOLVENCE® in the US market, making it available to patients.
Innoviva Specialty Therapeutics anticipates the launch of NUZOLVENCE® in the US market, making it available to patients.
December 2025 — 4 developments
Phase 3 trial results for zoliflodacin also demonstrated comparable efficacy for pharyngeal and rectal gonorrhea infections, which are often more challenging to treat.
Phase 3 trial results for zoliflodacin also demonstrated comparable efficacy for pharyngeal and rectal gonorrhea infections, which are often more challenging to treat.
The U.S. FDA approved a second new oral medicine, Blujepa (gepotidacin), to treat uncomplicated urog…
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.
The U.S. FDA approved NUZOLVENCE® (zoliflodacin) for oral suspension as a first-in-class, single-dos…
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.
Results from the multi-country Phase 3 clinical trial were published in The Lancet, confirming zolif…
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.
November 2025 — 1 developments
Zoliflodacin was submitted for priority review in Thailand, with GARDP planning a Managed Access Program (MAP) to facilitate access prior to full approval.
Zoliflodacin was submitted for priority review in Thailand, with GARDP planning a Managed Access Program (MAP) to facilitate access prior to full approval.
June 2025 — 2 developments
The FDA granted zoliflodacin Qualified Infectious Disease Product (QIDP) status, which includes Prio…
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.
The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for zoliflodacin…
The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for zoliflodacin for the treatment of uncomplicated gonorrhea.
April 2024 — 1 developments
Further positive data from the Phase 3 trial, including details on safety and additional microbiological findings, were presented at the ESCMID Global Congress.
Further positive data from the Phase 3 trial, including details on safety and additional microbiological findings, were presented at the ESCMID Global Congress.
November 2023 — 1 developments
Innoviva Specialty Therapeutics and the Global Antibiotic Research & Development Partnership (GARDP)…
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.
November 2018 — 1 developments
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.
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.
November 2014 — 1 developments
Enrollment began for the Phase 2 clinical trial of zoliflodacin, an investigational oral antibiotic, for the treatment of uncomplicated gonorrhea.
Enrollment began for the Phase 2 clinical trial of zoliflodacin, an investigational oral antibiotic, for the treatment of uncomplicated gonorrhea.