FDA approved two unrelated treatments for Uncomplicated Urogenital Gonorrhea (gonorrhea) back-to-back from December 11th to 12th, 2025. FDA granted GSK’s Bluejapa (gepotidacin) a label expansion for the indication on the 11th, while Innoviva’s Nuzolvence (zoliflodacin) received the nod on the 12th. Both treatments are indicated for patients aged 12 years and older who have few or no other treatment choices, although zoliflodacin can be used in patients weighing 77 pounds or more, whereas gepotidacin patients must be at least 99 pounds.
Gepotidacin is a multi-dose oral bactericidal, triazaacenaphthylene antibiotic designed to inhibit bacterial DNA replication. FDA approval was based on data from the EAGLE-1 clinical trial, which evaluated gepotidacin vs. intramuscular ceftriaxone plus azithromycin in patients with gonorrhea. Patients in the gepotidacin group had a microbiological success rate of 92·6% vs. 91.2% in the ceftriaxone plus azithromycin group, demonstrating non-inferiority. Prior to this approval, gepotidacin has also been approved by FDA for uncomplicated urinary tract infections.
“We’re proud to have delivered the first new class of antibiotics for gonorrhoea in over three decades and a new oral option for US patients,” said Tony Wood, Chief Scientific Officer, GSK, in a company press release. “The ability of N. gonorrhoeae to develop resistance to currently available options, including standard of care, makes it important to expand the range of effective oral treatments.”
Zoliflodacin is a single-dose oral antibiotic designed to inhibit spiropyrimidinetrione bacterial type II topoisomerase. The drug is administered via granules that are dissolved in water given to the patient. FDA approval was based on data from the “Zoliflodacin in Uncomplicated Gonorrhoea” clinical trial, which evaluated the treatment vs. intramuscular ceftriaxone plus azithromycin. Patients in the zoliflodacin group had a 91% microbiological cure rate vs. 96% in the ceftriaxone plus azithromycin group, demonstrating a similar level of effectiveness.
“The FDA’s approval of [zoliflodacin] marks a pivotal moment for patients and the broader healthcare community managing gonorrhea infections. For the first time in decades, both patients and their healthcare providers will have a single-dose, oral treatment option for uncomplicated urogenital gonorrhea,” said David Altarac, M.D., Chief Medical Officer, Innoviva Specialty Therapeutics, in a company press release. “This achievement underscores our commitment to advancing innovative therapies for infectious diseases and fighting antimicrobial resistance. It highlights the strength of our development capabilities, as well as our collaboration with GARDP and the global scientific community.”
