FDA

FDA OKs new oral treatment option for uncomplicated urogenital gonorrhea

December 15, 2025

On December 11, 2025, FDA approved Blujepa (gepotidacin) oral tablets for uncomplicated urogenital gonorrhea in patients 12 years and older who weigh at least 45 kg who have limited or no other treatment options.

Blujepa was first approved in March 2025 to treat urinary tract infections.

Efficacy

In the phase 3 EAGLE-1 trial (NCT04010539), investigators evaluated the efficacy of Blujepa in 628 patients with gonococcal infection. Participants were randomized to receive either two oral doses of Blujepa (3,000 mg each, administered 10–12 hours apart) or the current standard of care: IM ceftriaxone plus PO azithromycin. The primary endpoint was microbiological eradication assessed 4 to 10 days post-treatment. Results demonstrated bacterial clearance in 93% of patients treated with Blujepa and 91% of those receiving standard therapy, establishing Blujepa’s efficacy as comparable to the existing regimen.

Safety

The most common adverse reactions (≥2%) in the EAGLE-1 trial were diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, soft stools, headache, fatigue, and hyperhidrosis. Key warnings and precautions include the potential for QTc interval prolongation, acetylcholinesterase inhibition, and hypersensitivity reactions.

Sources:

FDA Approves Two Oral Therapies to Treat Gonorrhea. [News release]. 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-two-oral-therapies-treat-gonorrhea

Blujepa (gepotidacin) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218230s000lbl.pdf. Accessed December 12, 2025.

Blujepa (gepotidacin) approved by US FDA as oral option for treatment of uncomplicated urogenital gonorrhoea (uGC). [News release]. 2025. https://www.gsk.com/en-gb/media/press-releases/blujepa-gepotidacin-approved-by-us-fda-as-oral-option-for-treatment-of-uncomplicated-urogenital-gonorrhoea-ugc/