GSK today announced positive results from a Phase III trial of gepotidacin, an oral antibiotic with a novel mechanism of action against uncomplicated urogenital gonorrhea in adolescents and adults.

The trial met its primary efficacy endpoint, with gepotidacin (oral, two doses of 3,000 mg) demonstrating non-inferiority to intramuscular ceftriaxone + oral azithromycin, the standard treatment regimen for gonorrhea.

With rising incidence rates and concerns about increasing resistance to existing treatments, gonorrhea is a global public health threat," said Chris Corsico, Senior Vice President of Development at GSK.

According to him, these positive results demonstrate the potential of gepotidacin, both to address growing resistance to treatment and to provide an alternative care option for patients who were unable to take other treatments due to allergies or intolerances.

As a reminder, gonorrhea is a sexually transmitted infection caused by a bacterium called Neisseria gonorrhoeae. There are an estimated 82 million new cases worldwide every year. In the United States, reported rates of gonorrhea increased by 118% between 2009 and 2021.

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