Innoviva Specialty Therapeutics Publishes Positive Phase 3 Data for Zoliflodacin in Treating Drug-Resistant Gonorrhea
Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., has announced the publication of positive results from a Phase 3 trial of zoliflodacin, a single-dose oral antibiotic for treating uncomplicated urogenital gonorrhea. The study, published in The Lancet, demonstrates that zoliflodacin is non-inferior to the current dual therapy of ceftriaxone and azithromycin. This development is significant as gonorrhea, the second most reported bacterial STI in the U.S., is increasingly resistant to first-line treatments. The trial, led by the Global Antibiotic Research & Development Partnership (GARDP), involved 930 participants across five countries, including the U.S. The U.S. FDA has granted zoliflodacin a Qualified Infectious Disease Product designation, allowing for priority review and extended market exclusivity. 
