FDA Approves Innoviva's NUZOLVENCE, First-in-Class Oral Treatment For Gonorrhea

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(RTTNews) - Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (INVA), announced that the U.S. Food and Drug Administration approved NUZOLVENCE (zoliflodacin) 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 FDA approval was based on results from the largest Phase 3 clinical trial ever conducted for a new treatment against Neisseria gonorrhoeae infection in regions with a high prevalence of gonorrhea across five countries. NUZOLVENCE is one of the first new treatments approved by the FDA for uncomplicated urogenital gonorrhea in nearly two decades, the company said.

Gonorrhea is the second most common sexually transmitted bacterial infection worldwide, with more than 82 million new cases each year.

The company plans to commercialize NUZOLVENCE in the second half of 2026, either in collaboration with a commercialization partner or independently.

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