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American Focus > Blog > Health and Wellness > FDA approves first new gonorrhea drug in decades
Health and Wellness

FDA approves first new gonorrhea drug in decades

Last updated: December 11, 2025 7:05 pm
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FDA approves first new gonorrhea drug in decades
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Gonorrhea, caused by the bacterium Neisseria gonorrhoeae, has been a persistent challenge for healthcare providers due to its ability to develop resistance to antibiotics. With most treatments failing to effectively combat the infection, the approval of GSK’s Blujepa, also known as gepotidacin, by the Food and Drug Administration comes as a significant breakthrough.

Blujepa belongs to a new class of antibiotics, marking the first of its kind to be approved for the treatment of gonorrhea in over three decades. This approval provides a much-needed alternative to the traditional antibiotic ceftriaxone, which is administered through intramuscular injection. The oral administration of Blujepa, although requiring two doses, offers a more convenient option for patients.

The approval specifies the use of Blujepa in adult and pediatric patients aged 12 and above, weighing at least 45 kilograms, who have limited or no alternative treatment options for uncomplicated urogenital gonorrhea. This decision comes at a critical time as gonorrhea remains a prevalent sexually transmitted infection in the United States, posing a significant public health threat.

The development of resistance to antibiotics has been a major concern in the fight against gonorrhea, prompting the World Health Organization to prioritize it as a pathogen of urgent concern. Untreated gonorrhea can lead to serious complications such as infertility and other reproductive health issues, underscoring the importance of effective treatment options.

In addition to Blujepa, another promising antibiotic, Zoliflodacin, is also in the pipeline for the treatment of gonorrhea. Developed through a partnership between Innoviva Specialty Therapeutics and the Global Antibiotic Research and Development Partnership (GARDP), Zoliflodacin is expected to undergo FDA review by December 15.

See also  Insurer Denies Access To Drugs Granted Accelerated Approval By FDA

The approval of Blujepa and the potential arrival of Zoliflodacin offer hope in the battle against antibiotic-resistant gonorrhea. These new treatment options represent a significant milestone in addressing the challenges posed by this persistent infection, providing healthcare providers with much-needed tools to combat the spread of gonorrhea effectively.

TAGGED:ApprovesDecadesDrugFDAgonorrhea
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