On December 12, 2025, the U.S. health regulator went ahead and approved the oral antibiotic by Innoviva for treatment of gonorrhea, which is a common sexually transmitted infection, by way of offering patients an alternative to the injectable drug, which, by the way, was the only recommended treatment till now.
Approval of the drug by the Food and Drug Administration, which is branded as Nuzolvence, goes on to address a growing public health crisis since gonorrhea has gone on to develop resistance to almost all available antibiotics.
As of now, ceftriaxone, which remains Roche’s decades-old injection, still remains the sole treatment that has been recommended by the CDC.
Gonorrhea causes almost 82 million new infections across the world every year and can also lead to serious complications, which includes infertility, if left untreated, as per the WHO.
A unit of Innova named Innoviva Specialty Therapeutics’s Nuzolvence, in partnership with the Global Antibiotic Research & Development Partnership (GARDP), is an oral antibiotic when it comes to the treatment of uncomplicated gonorrhea within patients aged 12 years and older who weigh a minimum of 77 pounds.
The company confirmed that it plans to make Nuzolvence available within the second half of 2026, either through collaboration with a commercialization partner or independently, and is going to share the pricing details at a later date.
According to what the spokesperson for GARDP told Reuters, the price is indeed going to vary from one country to another, and it has not yet been determined. It was further added that it will likely be an order of magnitude cheaper than what was expected to be priced in the U.S.
It is worth noting that Nuzolvence works through blocking a bacterial enzyme that is essential for reproduction, thereby making use of a mechanism that is different from the present antibiotics. The drug is designed to look into strains that are multidrug-resistant, including ceftriaxone.
Notably, in a late-stage trial of 930 patients, Nuzolvence went ahead and met its main goal of proving non-inferior to the standard shot so as to clear infection at genital sites and also demonstrating quite similar results at throat as well as rectal sites when blended with the standard regimen of ceftriaxone along with azithromycin from Pfizer.
Earlier, the health regulator also broadened the use of Blujepa from GSK as an oral treatment of gonorrhea.
