Innoviva Receives FDA Approval for Nuzolvence Oral Suspension
Innoviva Specialty Therapeutics, a subsidiary of Innoviva, announced that the U.S. FDA has approved Nuzolvence for oral suspension, a first-in-class, single-dose oral medication for the treatment of uncomplicated urogenital gonorrhea in adults and pediatric patients 12 years and older weighing at least 35 kg. The development of Nuzolvence was part of a private, not-for-profit collaboration with The Global Antibiotic Research and Development Partnership, which sponsored and led the Phase 3 clinical trial that supported FDA approval.
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FDA Greenlights Innoviva's NUZOLVENCE, the First Oral Treatment for Gonorrhea
FDA Approval: Innoviva Specialty Therapeutics received FDA approval for NUZOLVENCE (zoliflodacin), a first-in-class oral medication for treating uncomplicated urogenital gonorrhea in patients aged 12 and older.
Clinical Trial Success: The approval was based on the largest Phase 3 clinical trial for a new gonorrhea treatment, conducted in high-prevalence regions across five countries.
Significance of Treatment: NUZOLVENCE is one of the first new treatments for uncomplicated urogenital gonorrhea approved by the FDA in nearly 20 years, addressing a significant public health issue.
Commercialization Plans: Innoviva plans to commercialize NUZOLVENCE in the second half of 2026, either independently or with a partner.
