WALTHAM, Mass. — Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (NASDAQ: INVA), said positive results from a pivotal Phase 3 clinical trial evaluating its investigational oral antibiotic zoliflodacin for the treatment of uncomplicated urogenital gonorrhea have been published in The Lancet.
The Phase 3 study showed that single-dose oral zoliflodacin was non-inferior to the current combination therapy of injectable ceftriaxone and oral azithromycin for the treatment of uncomplicated urogenital gonorrhea. The trial was sponsored and led by the Global Antibiotic Research & Development Partnership (GARDP), a not-for-profit organization.
“Gonorrhea continues to be a significant public health concern worldwide, and the growing challenge of antimicrobial resistance only heightens the urgency for new treatment options,” said Dr. Edward (Ned) Hook, MD, Emeritus Professor of Medicine at the University of Alabama at Birmingham and protocol chair of the study. “The findings published today in The Lancet provide important evidence supporting the potential role of zoliflodacin as a novel, single-dose oral therapy for uncomplicated gonorrhea. These results represent a meaningful step forward in addressing the evolving landscape of gonococcal treatment.”
According to the company, more than 82 million new gonorrhea infections occur globally each year, and untreated infections can lead to serious and permanent health consequences. The rise of drug-resistant infections has prompted the World Health Organization to classify antimicrobial resistance as one of the world’s most critical global health threats. Neisseria gonorrhoeae, the bacterium responsible for gonorrhea, has developed resistance to most antibiotic classes previously used for treatment, including cephalosporins such as ceftriaxone, which is currently the only recommended first-line therapy for uncomplicated gonorrhea.
“Our study demonstrated the non-inferior efficacy of zoliflodacin in uncomplicated urogenital gonorrhea compared to a very potent, two-drug regimen,” said study co-author Stephanie N. Taylor, MD, Professor of Medicine, Section of Infectious Diseases, Louisiana State University Health Sciences Center and Medical Director of the LSU STD Research Laboratory. “Microbiological cure rates at extragenital (pharyngeal and rectal) sites were also comparable between the two arms and both exhibited a similar safety profile.”
The study met its prespecified primary endpoint for non-inferiority compared with ceftriaxone plus azithromycin, with a treatment difference of 5.31 percent (95 percent confidence interval: 1.38 percent to 8.65 percent). Zoliflodacin was generally well tolerated, with adverse events comparable between treatment groups, and no serious adverse events were reported.
Zoliflodacin has received Qualified Infectious Disease Product designation from the U.S. Food and Drug Administration, which provides eligibility for priority review and extended market exclusivity. Innoviva Specialty Therapeutics said the FDA accepted its New Drug Application for zoliflodacin in June 2025 and assigned a target action date of December 15, 2025, under the Prescription Drug User Fee Act.
“Currently, there is only one first-line treatment option available for patients with uncomplicated urogenital gonorrhea,” said Patrik Hornak, MD, Associate Program Director of the Infectious Diseases Fellowship Program and Clinical Director of the AIDS Education and Training Center Program at the University of Texas Medical Branch. “As clinicians, we are eagerly awaiting new treatments that can effectively overcome resistance and provide a single oral dosing option. I am encouraged that these data will lead to a new option that supports early intervention, which is especially important for the health of communities at higher risk of infection and transmission of the disease.”
