WALTHAM, Mass.– The U.S. Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) for zoliflodacin, a novel oral antibiotic for the treatment of uncomplicated gonorrhea, developers Innoviva Specialty Therapeutics and the Global Antibiotic Research & Development Partnership (GARDP) announced Thursday.
The FDA has set a target decision date of December 15, 2025, under the Prescription Drug User Fee Act (PDUFA). A decision on whether the agency will convene an Advisory Committee to review the application is expected to be disclosed in its Day 74 letter.
If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades. The investigational treatment is a single-dose, orally administered drug belonging to a new class of antibacterials known as spiropyrimidinetriones. It has shown efficacy in combating drug-resistant strains of Neisseria gonorrhoeae, the bacterium responsible for gonorrhea.
Zoliflodacin has already received Qualified Infectious Disease Product (QIDP) status from the FDA, granting it both Priority Review and extended market exclusivity.
The NDA was submitted by Entasis Therapeutics, an Innoviva affiliate and the legal holder of the application. Entasis retains commercialization rights in key global markets including North America, Europe, and Asia-Pacific. GARDP, meanwhile, will manage registration and distribution in over three-quarters of the world’s countries, focusing on expanding access in low- and middle-income nations.
Gonorrhea is the world’s second most common bacterial sexually transmitted infection, with more than 82 million new cases reported annually. The rise of antimicrobial resistance has made treatment increasingly difficult, prompting the World Health Organization to name drug-resistant Neisseria gonorrhoeae a top global public health threat.
Zoliflodacin’s mechanism of action targets bacterial type II topoisomerase, a critical enzyme for bacterial survival and replication. The drug demonstrated non-inferiority in a Phase 3 trial when compared to the current standard treatment of injectable ceftriaxone plus oral azithromycin. No serious adverse events or deaths were reported during the trial.
Zoliflodacin’s oral formulation is also seen as a major advantage in expanding access, particularly in healthcare settings where injectable antibiotics may not be feasible. GARDP emphasized that it will work with governments and partners in approved markets to ensure appropriate, affordable, and sustainable access to the treatment.
If cleared by the FDA, zoliflodacin could mark a major milestone in the fight against antibiotic-resistant STIs.
