As gonorrhea cases worldwide have surged to 82 million, the U.S. Food and Drug Administration (FDA) has newly approved two antibiotics for gonorrhea. Antibiotics to treat the sexually transmitted disease already existed, but a recent rise in drug-resistant superbugs has put health authorities on alert. The newly approved antibiotics are known to be effective against resistant strains and are expected to be a key turning point in overcoming a sexually transmitted disease that can cause severe complications.
The U.S. Food and Drug Administration (FDA) said last week it approved two new antibiotics to treat gonorrhea. Blujepa and Nuzolvence were approved as treatments for urogenital gonorrhea on the 11th and 12th, respectively, local time. Both are oral antibiotics, making them easier to administer than the injectable drugs used in standard therapy. Adam Sherwat, M.D., head of the Division of Infectious Diseases at the FDA's Center for Drug Evaluation and Research (CDER), said, "This approval is an important milestone in the treatment of uncomplicated urogenital gonorrhea."
◇ Proven in clinical trials to be on par with standard therapy
Gonorrhea is a sexually transmitted infection caused by the pathogenic bacterium Neisseria gonorrhea. It mainly causes urethritis or cervicitis. Depending on the mode of sex, gonococcal proctitis and pharyngitis also occur. Pregnant people infected with gonorrhea can cause gonococcal ophthalmia in their babies during childbirth.
Blujepa is an antibiotic with the active ingredient gepotidacin developed by the U.K. drugmaker GSK. Blujepa was first approved in March as a treatment for urinary tract infections. Nuzolvence, which contains zoliflodacin, was developed by the nonprofit Global Antibiotic Research & Development Partnership (GARDP) with the U.S. pharmaceutical company Innoviva.
Alison Luckey, who leads zoliflodacin development at GARDP, released in a paper published on the 11th in the international journal The Lancet that clinical trial results showed zoliflodacin had the same therapeutic effect as existing antibiotics. Adverse events were at similar levels.
The researchers enrolled 930 patients with gonorrhea and randomly assigned two-thirds to receive Nuzolvence and one-third to a standard-of-care group receiving a combination of ceftriaxone injection and oral azithromycin. Six days later, swabs from participants' cervixes or urethras showed that zoliflodacin cleared about 91% of gonorrhea bacteria, while the clearance rate in the group treated with existing antibiotics was 96%. The FDA said the results demonstrated that Nuzolvence's effectiveness was equivalent to standard therapy.
Blujepa likewise showed effects similar to standard therapy in clinical trials. According to the FDA, researchers randomly assigned 628 people with gonorrhea so that half received Blujepa and the others received standard therapy. Measuring bacterial clearance 4 to 10 days after treatment, 93% in the Blujepa group were cured, compared with 91% in the standard-therapy group.
◇ Drug-resistant strains spread as global gonorrhea cases surge
Gonorrhea is on the rise worldwide. In 2023, Europe's gonorrhea infection rate was three times higher than in 2014. The surge in cases is due to the spread of resistant strains that do not respond to existing antibiotics. The World Health Organization (WHO) has designated Neisseria gonorrhea as a "priority pathogen" to guide responses to antibiotic resistance.
Last year, the WHO said that in 12 countries, including Thailand, South Africa and Brazil, about 5% of gonorrhea cases as of 2024 showed resistance to ceftriaxone, the first-line antibiotic, a sixfold increase from 2022. According to the U.S. Centers for Disease Control and Prevention (CDC), ceftriaxone-resistant gonorrhea cases in China tripled over five years.
Manica Balasegaram, executive director of GARDP, said, "This approval will be a critical turning point in treating resistant gonorrhea, which until now has outpaced the speed of antibiotic development."
Most patients who took part in GARDP's Nuzolvence clinical trials were infected with strains that were not resistant to ceftriaxone or azithromycin. But a study released in 2020 in the international journal ACS Infectious Diseases found that zoliflodacin, the active component of Nuzolvence, was effective at eliminating gonorrhea strains resistant to all standard antibiotics. Luckey, who leads Nuzolvence development, said, "It has been more than 30 years since a new drug for gonorrhea was approved, and our options have been shrinking," and added, "These results show that zoliflodacin offers a new approach to gonorrhea."
References
The Lancet (2025), DOI: https://doi.org/10.1016/S0140-6736(25)01953-1
Morbidity & Mortality Weekly Report (2024), DOI: https://doi.org/10.15585/mmwr.mm7312a2
WHO (2024), https://iris.who.int/bitstream/handle/10665/376814/9789240094925-eng.pdf
ACS Infectious Diseases (2020), DOI: https://doi.org/10.1021/acsinfecdis.0c00021