GSK's First-in-Class Oral Antibiotic Gepotidacin Approved by FDA as First New Treatment for Gonorrhea in Over 30 Years

Local time on December 11, GSK（GSK）Announce that the US FDA has approved the supplemental new drug application for the oral therapy Gepotidacin, intended for the treatment of12 years and above(Weight ≥45 kg)Patients with Simple Gonorrhea of the Urinary and Reproductive Systems. The application has previously received priority review status from the FDA.

According to the press release,This isThe First New Antibiotic Approved for the Treatment of Gonorrhea in Over Thirty Years。

Screenshot source: GSK official website

Gepotidacin isA first-in-class novel oral antibiotic, with unique drug properties and mechanisms of action, its structure belongs to the triazoloacridine class, different from existing quinolone antibiotics. And quinolones only inhibit topoisomerase II.（Top II）or Topoisomerase IV（Top IV）Different,Gepotidacin Selectively and Equally Inhibits Bacterial DNA Gyrase(Subtype of Top II)With Top IV, Bacterial DNA Replication is Blocked through a Dual Action。

On March 25 this year, Gepotidacin(Product name Blujepa)First obtainedFDA Approved for the Treatment of Uncomplicated Urinary Tract Infections（uUTI）Adult female patients（≥40 kg）and adolescent patients aged 12 years and above（≥40 kg）, which is alsoThe First Novel Oral Antibiotic Approved for the Treatment of uUTI in Over 30 Years。

Gepotidacin New Indication This TimeThe approval was based on data from the EAGLE-1 Phase III clinical trial, which（NCT04010539）Is part of the global Phase III integrated clinical trial program for Gepotidacin in adults and adolescents, with results published in The Lancet in April 2025. In this non-inferiority trial involving approximately 600 patients with uncomplicated urogenital gonorrhea, researchers compared Gepotidacin.(Oral administration, two doses, 3000 milligrams each time)) with intramuscular injection of ceftriaxone(500 mg)Combined oral azithromycin(1000 mg)Efficacy and Safety.

Data shows,Gepotidacin Achieves 92.6% Treatment Success Rate in Urogenital Area（187/202，95% CI：88.0-95.8）The success rate of ceftriaxone combined with azithromycin was 91.2%.（186/204，95% CI：86.4-94.7）, confirming that the efficacy of Gepotidacin met the non-inferiority standard. Additionally, no cases of treatment failure in the urogenital area due to persistent Neisseria gonorrhoeae infection were reported in either group.

The safety and tolerability of Gepotidacin were consistent with previous clinical trial results. No drug-related serious adverse events were observed in either the treatment or control groups. The most common adverse reactions were mild to moderate gastrointestinal reactions, with overall good safety and tolerability.

Gonorrhea, a sexually transmitted infection caused by Neisseria gonorrhoeae, has become a significant challenge in the field of public health. According to the U.S. Centers for Disease Control and Prevention（CDC）Data shows that over 600,000 gonorrhea cases were reported in the U.S. in 2023, ranking second in the country's reported sexually transmitted infections.Currently, there is no approved vaccine for the prevention of gonorrhea in the United States, and the standard clinical treatment mainly involves injectable therapy, with an urgent need for oral treatment options in clinical practice.Gepotidacin has been approved, filling this gap and providing patients with a more convenient new treatment option.

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