FDA Approves First-in-Class Oral Antibiotic Nuzolvence for Gonorrhea
The U.S. FDA approved Nuzolvence (zoliflodacin), a single-dose oral treatment for uncomplicated urogenital gonorrhea, based on a non-inferiority Phase 3 trial. Thailand also authorized the drug under the brand Nuzolvance, expanding access in low- and middle-income countries.
The U.S. Food and Drug Administration has approved Nuzolvence (zoliflodacin) for oral suspension, a first-in-class, single-dose oral antibiotic for the treatment of uncomplicated urogenital gonorrhea in adults and adolescents weighing at least 35 kg. The approval, announced on December 12, 2025, marks the first new oral treatment option for gonorrhea in decades.
Six months after the U.S. clearance, Dr. Reddy's Laboratories received approval from the Thai Food and Drug Administration for zoliflodacin under the brand name Nuzolvance, making Thailand the first low- and middle-income country to authorize the drug. Aurigene Pharmaceutical Services, a CDMO subsidiary of Dr. Reddy's, will manufacture and supply Nuzolvance in partnership with the Global Antibiotic Research and Development Partnership (GARDP).
In the pivotal Phase 3 trial, a single 3g oral dose of zoliflodacin demonstrated non-inferiority to a combination of ceftriaxone (500 mg intramuscular) plus azithromycin (1 g oral) in 930 patients at sites in five countries. The drug was generally well tolerated, with adverse events similar to the control group and no serious adverse events reported. Zoliflodacin is a spiropyrimidinetrione topoisomerase inhibitor that is active against drug-resistant strains of Neisseria gonorrhoeae and shows no cross-resistance to established antibiotics.
Gonorrhea is the second most common bacterial sexually transmitted infection globally, with more than 82 million new cases each year. The U.S. Centers for Disease Control and Prevention estimates over 543,000 reported cases annually in the United States alone. Rising antibiotic resistance has made N. gonorrhoeae a high-priority pathogen, with resistance documented to cephalosporins and other standard therapies.
Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., plans to commercialize Nuzolvence in the U.S. in the second half of 2026, either independently or through a commercialization partner. The drug's development was part of a not-for-profit collaboration with GARDP, which sponsored and led the Phase 3 program.
Zoliflodacin is one of two recently approved oral antibiotics for gonorrhea, joining gepotidacin (Blujepa®). Together, they represent the first new treatments for this infection in over 30 years.