The FDA has approved zoliflodacin, a single-dose, spiropyrimidinetrione oral antibiotic for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older, Innoviva announced on Tuesday. The oral antibiotic inhibits type II topoisomerase, a bacterial enzyme crucial to bacterial function and reproduction.
What laid the groundwork for FDA’s zoliflodacin approval
The FDA approval was based on a phase 3 clinical trial that evaluated zoliflodacin against a standard of care regimen in patients with uncomplicated gonorrhea. The microbiological cure rate at the urogenital site was 90.9% for zoliflodacin compared to 96.2% for the SOC. The trial demonstrated non-inferiority in achieving microbiological cure at the urogenital site of infection of a single oral dose of zoliflodacin compared to a treatment regimen of a single intramuscular injection of 500 mg ceftriaxone followed by 1g of oral azithromycin.
The trial also found that zoliflodacin was well-tolerated. No serious adverse effects or deaths were reported.
Studies have shown that zoliflodacin is active against drug-resistant strains of gonorrhea. According to Innoviva, “In vitro studies have demonstrated its activity against multidrug-resistant strains of Neisseria gonorrhoeae, including those resistant to ceftriaxone and azithromycin, with no cross-resistance to other antibiotics.”
The FDA has granted zoliflodacin a Qualified Infectious Disease Product (QIDP) designation.
Results of the phase 3 clinical trial.
Antibiotic-resistant gonorrhea: an emerging threat
There have been reports of antibiotic-resistant gonorrhea in several countries. Since the first report in 2015, there have been 15,253 papers published mentioning ceftriaxone resistance in their title or abstract. 14 cases of ceftriaxone-resistant gonorrhea were reported during the first five months of 2025. Comparatively, only 13 cases were reported in 2024.
Market for gonorrhea treatments
The global market for ceftriaxone, the usual treatment for gonorrhea, was valued at $1.5 billion in 2023. It was expected to grow at a compound annual growth rate of 5–10%, according to a report by Prof Research. Analysts at Transparency Market Research expect the market size to reach $2.2 billion by the end of 2031.
As zoliflodacin has demonstrated activity against ceftriaxone-resistant strains of gonorrhea, as well as being a more convenient oral treatment compared to intramusclar injection, it has the potential to be a strong competitor to ceftriaxone.
About gonorrhea
Gonorrhea is a common bacterial sexually transmitted infection that affects both men and women. Over 82 million new gonorrhoea infections occur globally each year.
Gonorrhea bacteria can infect the urethra, rectum, female reproductive tract, mouth, throat or eyes. Male symptoms include painful urination, pus-like discharge from the tip of the penis and pain or swelling in one testicle. Female symptoms include increased vaginal discharge, painful urination, vaginal bleeding and abdominal or pelvic pain. Gonorrhea can cause infertility in both men and women.
Filed Under: clinical trials, Nephrology/urology, Urology
