FDA Accepts GSK’s Gepotidacin for Priority Review

If the oral antibiotic gains regulatory approval, patients who are 12 years of age and older in the U.S. suffering from urogenital gonorrhea will have an alternative, non-invasive treatment option.

The FDA has granted a priority review for GSK’s first-in-class triazaacenaphthylene antibiotic, gepotidacin, as an oral option for the treatment of uncomplicated urogenital gonorrhea in patients aged 12 years and older (1). If approved, the treatment will provide U.S. patients with an alternative to the currently available injectable treatments.

Gonorrhea affects both men and women and, if left untreated or treated inadequately, can cause infertility and other sexual and reproductive health complications. The infection is caused by Neisseria gonorrhoeae, which is a World Health Organization recognized priority pathogen and has been identified as an urgent public health threat by the U.S. Centers for Disease Control and Prevention (CDC). Currently, there is no licensed vaccine in the U.S. for the prevention of gonorrhea and the standard of care treatment is an injectable product, which is not suitable for all patients.

Gepotidacin is a bacterial, first-in-class triazaacenapthylene antibiotic that works through a novel mechanism of action, inhibiting bacterial DNA replication by a distinct binding site. As a result of this mechanism of action, the antibiotic provides well-balanced inhibition of two different Type II topoisomerase enzymes and means that there is an expected lower risk of resistance development.

This supplemental New Drug Application has been based on the results from the EAGLE-1 Phase III trial, which demonstrated that gepotidacin, when administered orally in two doses of 3,000 mg, was non-inferior to the leading combination treatment, intramuscular ceftriaxone (500 mg) plus oral azithromycin (1,000 mg). Additionally, the researchers found that there were no failures at the urogenital site for either treatment arm of the study and the safety and tolerability profile of gepotidacin was consistent with other studies.

Gepotidacin, under the licensing name of Blujepa, has already gained FDA approval in March 2025 as a treatment for female adult and pediatric patients (12 years and older) with uncomplicated urinary tract infection (2).

“The approval of Blujepa is a crucial milestone with uUTIs among the most common infections in women,” said Tony Wood, Chief Scientific Officer, GSK, in a company press release (2). “We are proud to have developed Blujepa, the first in a new class of oral antibiotics for uUTIs in nearly three decades, and to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments.”

“For many, uUTIs can be a burden that severely impacts daily life,” added Thomas Hooton, MD, Professor of Clinical Medicine, University of Miami School of Medicine, in the press release (2). “With an increasing number of patients experiencing recurrent infections, there remains a clear need for continued research of antimicrobials to help address ongoing patient challenges and the strain on healthcare systems.”

References

1. GSK. Gepotidacin Accepted for Priority Review by the US FDA for the Oral Treatment of Uncomplicated Urogenital Gonorrhoea. Press Release, Aug. 11, 2025.

2. GSK. Blujepa (Gepotidacin) Approved by US FDA for Treatment of Uncomplicated Urinary Tract Infections (uUTIs) in Female Adults and Paediatric Patients 12 Years of Age and Older. Press Release, March 25, 2025.