FDA approves Nuzolvence, first oral gonorrhea treatment in decades

The FDA on December 12, 2025 approved zoliflodacin, a first in class spiropyrimidinetrione antibiotic developed by Innoviva Specialty Therapeutics, for treatment of uncomplicated urogenital gonorrhea in patients aged 12 years and older who weigh at least 77 pounds. Marketed as Nuzolvence, the drug is prescribed as a single dose of granules that dissolve in water, providing the first oral alternative for this infection in decades.

Innoviva has presented the agent as active in laboratory studies against Neisseria gonorrhoeae including multidrug resistant strains. The drug was developed through a public private collaboration with the Global Antibiotic Research and Development Partnership, which led the pivotal clinical trial used for regulatory review. The asset traces through a licensing history that included Entasis Therapeutics, an earlier license holder now part of Innoviva Specialty Therapeutics.

Regulatory progress toward approval was public earlier this year when the company announced the FDA had accepted its new drug application on June 10, 2025. Innoviva said the approval follows that submission and positions zoliflodacin as a single dose oral option at a moment public health officials have called urgent. Several outlets noted this approval followed another licensing decision for a gonorrhea therapy within two days, underscoring an unusually active period for treatments in a disease that has seen little therapeutic innovation.

Company leaders framed the approval as a clinical and policy milestone. David Altarac, M.D., Chief Medical Officer at Innoviva Specialty Therapeutics, said the NDA acceptance “marks significant progress toward delivering health care providers with a potential new oral treatment option for uncomplicated gonorrhea, including infections caused by drug‑resistant strains,” and that Innoviva looks forward to working with the FDA and, if approved, is “committed to expediting the availability of zoliflodacin to patients in the U.S.” Pavel Raifeld, Innoviva’s chief executive, called the approval “a pivotal moment for patients and the broader healthcare community managing gonorrhea infections,” and said the company plans to make the drug “accessible and affordable for patients globally, including underserved markets,” while noting pricing will be announced later.

Public health experts welcomed an additional therapeutic option but emphasized that a pill alone will not solve structural gaps that drive sexually transmitted infection spread. Gonorrhea rates have risen in recent years and resistance has eroded the utility of older agents such as ciprofloxacin, ceftriaxone and azithromycin. Clinics that provide sexually transmitted infection services are often underfunded, and many communities face barriers to testing, treatment and partner notification that contribute to ongoing transmission, particularly among young people, people of color and low income populations.

Policy implications include the need for federal and state programs to support rapid, equitable distribution. If priced beyond the reach of safety net clinics or Medicaid programs faces limited uptake where disease burden is highest, health equity advocates warn that gains against resistant infections could be uneven. Innoviva’s public commitment to affordability and global access will be closely watched by public health agencies and advocacy groups as the company moves toward commercial launch.

With its approval, Nuzolvence adds a valuable option to clinicians’ arsenals against an evolving pathogen. The next questions for regulators, providers and communities will be how quickly the drug reaches clinics, how it is incorporated into treatment guidelines, and whether investment in testing and prevention keeps pace with this new clinical tool.