Reported Earlier, Innoviva Specialty Therapeutics Reports Phase 3 Zoliflodacin Results Published In The Lancet With FDA NDA Accepted In June And December 2025 PDUFA Target

Benzinga·12/12/2025 08:25:14

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Phase 3 findings show oral zoliflodacin to be non-inferior to the combination of ceftriaxone and azithromycin for the treatment of uncomplicated urogenital gonorrhea.
Positive study results are a significant milestone in the development of a first-in-class single-dose, oral antibiotic against gonorrhea, including infections caused by drug-resistant Neisseria gonorrhoeae, an urgent public health threat and high-priority pathogen.
Gonorrhea is the second most reported bacterial STI in the United States, with resistance to first-line treatment emerging.