Overview
- Zoliflodacin (Nuzolvence) and gepotidacin (Blujepa) won FDA approval for uncomplicated urogenital gonorrhea in patients 12 years and older, with weight thresholds of at least 77 lb and 99 lb, respectively.
- Phase III data showed high efficacy: about 91% cure for zoliflodacin versus 96% with standard therapy, and about 93% for gepotidacin versus 91% with standard therapy.
- Use is limited to urogenital infections, and labeling includes key safety cautions such as potential reproductive risks for zoliflodacin and QTc prolongation, acetylcholinesterase inhibition, and allergic reactions for gepotidacin.
- The new agents are oral regimens—single-dose zoliflodacin and two doses of gepotidacin 10–12 hours apart—providing alternatives to the long‑standing injectable standard, ceftriaxone.
- Zoliflodacin was advanced through a GARDP–Innoviva partnership, with Innoviva managing high-income markets and GARDP pursuing registration and access in many other countries, as experts evaluate stewardship strategies including combination or randomized use to slow resistance.