FDA Approves Two Oral Treatments for Uncomplicated Urogenital Gonorrhea

The FDA approved two new oral therapies to treat uncomplicated urogenital gonorrhea: Nuzolvence (zoliflodacin) and Blujepa (gepotidacin).

“The availability of additional treatment options is of particular importance given the global rise in gonococcal drug resistance,” Peter Kim, MD, MS, director of the Center for Drug Evaluation and Research Division of Anti-infectives said in an FDA press release.

In a study of 930 participants—two-thirds of which received a single 3-gram dose of zoliflodacin dissolved in water and the other third of which received a standard treatment of ceftriaxone shot plus azithromycin pill—91% of the zoliflodacin arm and 96% of the standard treatment arm cleared the bacteria 4 to 8 days post-treatment.

The most common adverse events reported with zoliflodacin were decreased white blood cell counts, headache, dizziness, nausea, and diarrhea. Animal studies suggested potential risks of birth defects, pregnancy loss, and male fertility impairment. Because of this, zoliflodacin labeling includes important safety precautions, including contraindications for patients with known hypersensitivity or those taking certain interacting medications.

In another study of 628 participants, half received two 3,000 mg doses of gepotidacin 10 to 12 hours apart while the other half received standard treatment. 93% of the patients on gepotidacin and 91% of the patients on standard treatment achieved bacterial clearance 4 to 10 days post-treatment.

The most reported adverse events with gepotidacin included diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, soft stools, headache, fatigue, and hyperhidrosis. Gepotidacin carries warnings and precautions related to QTc prolongation, acetylcholinesterase inhibition, and potential allergic reactions, as well as effects on cardiac rhythm and certain neurotransmitter pathways.

Reference:
FDA approves two oral therapies to treat gonorrhea. https://www.fda.gov/news-events/press-announcements/fda-approves-two-oral-therapies-treat-gonorrhea. Published December 12, 2025. Accessed January 13, 2025.