FDA Approves First New Gonorrhea Antibiotics in Decades Amid Rising Drug Resistance

The Food and Drug Administration has approved the first new antibiotics to treat gonorrhea in decades, marking a major advance in the fight against a rapidly evolving sexually transmitted infection that has become increasingly resistant to existing treatments.

The FDA announced Friday that it has approved zoliflodacin, marketed as Nuzolvence, as a single-dose oral treatment for uncomplicated urogenital gonorrhea in adults and adolescents 12 and older who weigh at least 77 pounds. Developed by the Global Antibiotic Research and Development Partnership in collaboration with Innoviva Specialty Therapeutics, zoliflodacin is administered as granules dissolved in water.

A second newly approved drug, gepotidacin — sold under the brand name Blujepa — was authorized by the FDA this week for people 12 and older who weigh at least 99 pounds and have limited or no alternative treatment options. Manufactured by GSK, Blujepa is taken in tablet form and was earlier approved to treat urinary tract infections in women.

Health officials say the timing could not be more critical. Gonorrhea cases have climbed nationwide, and the bacteria responsible, Neisseria gonorrhoeae, has repeatedly adapted to resist commonly used antibiotics. For years, ceftriaxone injections have been the only reliably effective first-line treatment, requiring patients to visit a clinic or doctor’s office.

These new oral medications offer promising alternatives. Zoliflodacin’s single-dose regimen is particularly significant, allowing for treatment in more settings without specialized equipment. Both medicines were designed to remain effective against strains of gonorrhea that no longer respond to older drugs such as ciprofloxacin, azithromycin or even ceftriaxone.

Clinical trials published in The Lancet found zoliflodacin cured about 90.9% of cases, a rate comparable to standard therapy. Another international study found gepotidacin similarly effective, with cure rates exceeding 92%. Side effects for both treatments were generally mild and manageable.

The FDA approvals come as STIs continue to rise across the United States. According to the CDC, reported cases of chlamydia, gonorrhea and syphilis increased 90% from 2004 to 2023, with more than 2.4 million infections recorded in 2023 alone. Left untreated, gonorrhea can cause severe health problems, including infertility and, in rare cases, life-threatening infections.

Experts caution, however, that vigilance remains essential. Gonorrhea has a long history of adapting to new antibiotics, and some scientists warn that drug-resistant strains could eventually compromise these treatments as well. Continued development of new therapies and responsible use of antibiotics remain important tools to ensure gonorrhea stays treatable.

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