FDA Approves First New Gonorrhea Antibiotic in 40 Years

The U.S. Food and Drug Administration approved a new oral antibiotic, gepotidacin, on Thursday for treating uncomplicated urogenital gonorrhea in adults and children aged 12 and older who have limited or no alternative treatment options. Developed by GlaxoSmithKline, the drug marks the first new antibiotic approved for gonorrhea in nearly 40 years, addressing a sexually transmitted infection that has become increasingly resistant to existing therapies.

Gonorrhea, caused by the bacterium Neisseria gonorrhoeae, is the second most commonly reported bacterial sexually transmitted infection in the United States, with more than 600,000 cases documented in 2023, according to the Centers for Disease Control and Prevention. Globally, the World Health Organization estimates it affects over 82 million people annually. The infection has a history of rapidly developing resistance to antibiotics, earning the bacterium a reputation for adaptability. Ciprofloxacin, approved in 1987, was once a standard treatment but now works against only about 5 percent of cases worldwide. Since 2020, ceftriaxone injections combined with oral azithromycin have been the CDC's recommended regimen, yet...