December 11, 2025 02:19 PM EST PharmaFDA+
GSK’s new antibiotic wins gonorrhea approval
Nicole DeFeudis
Senior Reporter
GSK won a label expansion on Thursday for its oral antibiotic Blujepa to treat uncomplicated urogenital gonorrhea.
The twice-daily pill is approved for adults and children 12 years and older who weigh at least 45 kg and have limited or no other options to treat their disease. GSK said there is a “significant need” for new antibiotics to fight gonorrhea, one of the most prevalent sexually transmitted diseases in the US. Antimicrobial resistance to gonorrhea has grown rapidly in recent years, according to the World Health Organization, limiting treatment options. The current standard of care is an injectable antibiotic.
In a Phase 3 trial in gonorrhea, Blujepa’s efficacy was deemed non-inferior to that of a commonly used combination treatment, injectable ceftriaxone and oral azithromycin. GSK said there were no serious drug-related side effects in either arm, and the most commonly reported reactions were mild-to-moderate gastrointestinal events.
“The ability of N. gonorrhoeae to develop resistance to currently available options, including standard of care, makes it important to expand the range of effective oral treatments,” GSK’s CSO Tony Wood said in a news release.
Antibiotics see little investment from big drugmakers and VCs, in part because of their poor financial returns. But GSK has had recent success — in March, Blujepa won its first approval to treat uncomplicated urinary tract infections in adults and children over age 12. The drug, the first new antibiotic in the triazaacenaphthylene class, was developed with federal funds.
AUTHOR
Nicole DeFeudis
Senior Reporter
nicole@endpointsnews.com
@Nicole_DeFeudis
