FDA approves two oral therapies to treat gonorrhea

13 December 2025

The US Food and Drug Administration (FDA) on Friday announced it has approved two new oral medicines to treat a common sexually transmitted infection called gonorrhea.

The FDA approved Entasis Therapeutics’, a subsidiary of Innoviva Specialty Therapeutics’ (Nasdaq: INVA), Nuzolvence (zoliflodacin) granules that dissolve in water. This medicine can treat uncomplicated urogenital gonorrhea in adults and children 12 years and older who weigh at least 77 pounds.

The FDA also approved UK pharma major GSK’s (LSE: GSK) Blujepa (gepotidacin) oral tablets for the same condition in patients 12 years and older who weigh at least 99 pounds. This medicine is for patients who have few or no other treatment choices because of limited clinical safety data. Blujepa was first approved in March 2025 to treat urinary tract infections.

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