FDA Approves Oral Nuzolvence and Blujepa for Treating Uncomplicated Gonorrhea

MONDAY, Dec. 15, 2025 (HealthDay News) -- The U.S. Food and Drug Administration recently approved two new oral medicines to treat the sexually transmitted infection gonorrhea.The first approval is for Nuzolvence (zoliflodacin) granules that dissolve in water and are intended to treat uncomplicated urogenital gonorrhea in adults and children ages 12 years and older, weighing ≥77 pounds. The approval was based on a trial of 930 patients with uncomplicated urogenital gonorrhea, two-thirds of whom received a single 3-g dose of Nuzolvence dissolved in water and one-third of whom received the standard treatment of ceftriaxone shot plus azithromycin pill. The study showed 91 percent of patients who took Nuzolvence were cured of the bacteria at four to eight days after treatment versus 96 percent of patients who received the standard treatment. The most common side effects included low white blood cell counts, headache, dizziness, nausea, and diarrhea. However, there are important safety precautions in the labeling, as animal studies showed Nuzolvence might cause birth defects, pregnancy loss, or male fertility issues.The second approval is for Blujepa (gepotidacin) oral tablets, which are intended to treat uncomplicated urogenital gonorrhea in adults and children ages 12 years and older, weighing ≥99 pounds. Blujepa was evaluated in 628 patients, with half receiving two 3,000-mg doses of Blujepa taken 10 to 12 hours apart and the other half receiving the standard treatment. Ninety-three percent of patients who took Blujepa had bacterial clearance four to 10 days after treatment versus 91 percent of patients who received standard treatment. While there is limited clinical safety data, the most common side effects included diarrhea, nausea, stomach pain, vomiting, gas, dizziness, soft stools, headache, tiredness, and excessive sweating. Blujepa comes with warnings and precautions, including for QTc prolongation, acetylcholinesterase inhibition, and allergic reactions."The availability of additional treatment options is of particular importance given the global rise in gonococcal drug resistance," Peter Kim, M.D., director of the FDA Center for Drug Evaluation and Research Division of Anti-infectives, said in a statement.Approval of Nuzolvence was granted to Entasis Therapeutics; approval of Blujepa was granted to GSK. More Information.Sign up for our weekly HealthDay newsletter