Approvals in the US for a pair of new oral antibiotics for gonorrhoea represent a significant improvement in efforts to fight the increasingly difficult-to-treat sexually transmitted infection, according to market analysis.
On 12 December, the US Food and Drug Administration (FDA) approved Entasis Therapeutics’ Nuzolvence (zoliflodacin) for the treatment of uncomplicated urogenital gonorrhea in adults and children 12 years and older who weigh at least 77 pounds. The authorisation followed a gonorrhoea licence expansion for GSK’s urinary tract infection (UTI) medication Blujepa (gepotidacin). The approval is for a narrower patient population, in patients who weigh at least 99lb and have limited or no other treatment choices.
The FDA decisions mark the first drugs from new antibiotic classes to be approved for the treatment of gonorrhoea in over three decades.
Fiona Chisholm, associate director of infectious diseases at GlobalData, said: “These approvals represent a significant milestone in a market that has long been characterised by a pressing unmet need for novel therapies.”
GlobalData is the parent company of Pharmaceutical Technology.
Gonorrhoea is one of the most common sexually transmitted infections in the world. Neisseria gonorrhoeae, the bacterium that causes the illness, has continually been evolving resistance to antibiotics relied upon for treatment. Ceftriaxone is the current standard of care (SoC), though treatment failures are becoming more common. In October 2025, the World Health Organization (WHO) said that the rapid increase of antimicrobial-resistant gonorrhoea has reduced the options for treatment.
“The availability of additional treatment options is of particular importance given the global rise in gonococcal drug resistance,” said Peter Kim, director of the FDA’s Center for Drug Evaluation and Research (CDER) Division of Anti-Infectives (DAI).
Results from a Phase III study (NCT03959527) revealed that 91% of patients who took Entasis’ Nuzolvence were cured, compared to 96% of patients who received SoC. This showed that Nuzolvence’s effectiveness was comparable to the standard treatment. A separate study with Blujepa (NCT04010539) showed that 93% of patients who took the tablet were cured, compared to a SoC rate of 91%. Both studies demonstrated the oral therapies’ effectiveness in combating the infection.
Chisholm said: “These therapies provide new orally administered options for patients currently relying on injectable treatments. This offers patients greater convenience and has the potential to reduce the burden of gonorrhoea in hospitals and other healthcare settings such as sexual health clinics.”
Chisholm added that these new entrants “represent an exciting new era” for the gonorrhoea market.
Nuzolvence is dissolved in water in a single dose, whereas Blujepa is administered as two oral tablets, taken approximately 12 hours apart. Though Nuzolvence possesses the easier route of administration and a wider indication, physicians are more familiar with Blujepa, potentially conferring it a market advantage.
Bluejepa is forecast to generate annual sales of $567m for GSK in 2031, according to analysis by GlobalData. There is no current comparable analysis for Nuzolvence. In August 2025, GSK’s 4CMenB became the world’s first gonorrhoea vaccine available to patients, after England launched the jab on the National Health Service (NHS).
