FDA approves new gonorrhea antibiotics from GSK and Innoviva

The US FDA has granted a supplemental approval for GSK’s Blujepa (gepotidacin) as an oral treatment for uncomplicated urogenital gonorrhea, expanding its earlier approval for uncomplicated urinary tract infections.3 5

Gepotidacin/ Blujepa is from a new class of antibiotics, making it the first new class approved for gonorrhea treatment in more than three decades, addressing growing resistance to ceftriaxone, the current standard of care.3 5

The FDA has also approved Innoviva Specialty Therapeutics’ zoliflodacin, to be marketed as Nuzolvence, providing a second new oral option for gonorrhea shortly after the Blujepa approval.4 7

Zoliflodacin (Nuzolvence) is a first‑in‑class, single‑dose oral antibiotic for uncomplicated gonorrhea, including infections caused by drug‑resistant Neisseria gonorrhoeae.2 4

In Phase 3 trials, zoliflodacin showed non‑inferior microbiological cure rates at the urogenital site compared with the regimen of intramuscular ceftriaxone plus oral azithromycin, with good tolerability and no serious drug‑related adverse events reported.2 1

The FDA’s approval of zoliflodacin follows its earlier acceptance of Innoviva’s New Drug Application (NDA) in June 2025 and is part of a public–private partnership with the Global Antibiotic Research & Development Partnership (GARDP) to tackle antimicrobial resistance.2 4

Both Blujepa (gepotidacin) and Nuzolvence (zoliflodacin) are oral therapies, offering more convenient alternatives to injectable ceftriaxone and potentially improving access and adherence in gonorrhea treatment.2 3 5

These back‑to‑back approvals provide two novel, first‑in‑class options aimed at countering multidrug‑resistant gonorrhea, at a time when ceftriaxone‑resistant N. gonorrhoeae strains are an increasing public health concern.2 3 5