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FDA Approves First New Antibiotics to Treat Gonorrhea in Decades
Blujepa, the first new oral antibiotic in decades, shows a 92.6% microbiological success rate in treating urogenital gonorrhea in patients with limited options, FDA said.
- On December 11, 2025, the Food and Drug Administration granted expanded approval for oral gepotidacin to treat uncomplicated urogenital gonorrhea in patients 12 years of age and older weighing at least 45 kg with limited or no alternative options.
- 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, said Tony Wood, PhD, GSK's chief scientific officer.
- Safety analyses revealed that the EAGLE-1 randomized phase III trial showed microbiological success of 92.6% with gepotidacin versus 91.2% with ceftriaxone plus azithromycin among 406 patients, with the gepotidacin arm reporting more adverse events in 622 participants.
- Blujepa's oral pill offers an outpatient alternative to intramuscular ceftriaxone, was developed with Innoviva Specialty Therapeutics and GARDP, and faces near-term competition as zoliflodacin has an FDA decision date of Dec. 15.
- Globally, WHO estimated 82.4 million new adult infections in 2020, and left untreated, gonorrhea can cause infertility; Blujepa had earlier this year gained FDA approval for uncomplicated urinary tract infections in adolescents and women 12 years and older.
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FDA approves first new antibiotics to treat gonorrhea in decades, with hope to combat drug resistance
For the first time in decades, the US Food and Drug Administration has signed off on new antibiotics to fight gonorrhea. The approvals come at a critical moment: The sexually transmitted infection is growing harder to treat, and cases continue to climb nationwide.
·Atlanta, United States
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Anti-Aging, Acupuncture and Health News
Anti-Aging, Acupuncture and Health NewsFDA Approves New Type of Antibiotic for Gonorrhea, First in Decades
Gepotidacin was noninferior to standard care in the phase III EAGLE-1 trial
·New York, United States
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