For the first time in decades, the US Food and Drug Administration (FDA) has approved new antibiotics to treat gonorrhea, a common sexually transmitted infection that is becoming increasingly difficult to treat. Health experts hope these new drugs will help stop the rise of drug-resistant infections.
On Friday, the FDA announced it had approved zoliflodacin, sold under the brand name Nuzolvence, as a single-dose oral treatment for gonorrhea in the urogenital area. This treatment is for adults and adolescents aged 12 and older who weigh at least 77 pounds. The medication comes as granules that dissolve in water, making it easy to take without a clinic visit.
The nonprofit Global Antibiotic Research and Development Partnership worked with Innoviva Specialty Therapeutics Inc. to develop zoliflodacin.
In a related development, GSK announced that the FDA had approved its drug gepotidacin, sold as Blujepa, as oral tablets to treat urogenital gonorrhea in people 12 and older who weigh at least 99 pounds and have limited or no alternative treatment options. In March, gepotidacin was also approved to treat urinary tract infections in women.
“These approvals mark a significant milestone for treatment options for patients with uncomplicated urogenital gonorrhea,” said Dr. Adam Sherwat, director of the Office of Infectious Diseases at the FDA’s Center for Drug Evaluation and Research.
Gonorrhea has become harder to treat in recent years. The bacteria Neisseria gonorrhoeae, which causes the infection, has developed resistance to many commonly used antibiotics, making some first-line treatments almost useless.
“We’re proud to have delivered the first new class of antibiotics for gonorrhea in over three decades and a new oral option for US patients,” said Dr. Tony Wood, GSK’s chief scientific officer. “The ability of N. gonorrhoeae to develop resistance to currently available options makes it important to expand the range of effective oral treatments.”
Currently, the standard treatment involves an injection of ceftriaxone, which requires a clinic visit. But both zoliflodacin and gepotidacin are taken orally, making treatment much easier and more accessible.
“No needles or clinic visit may be required, which could make treating gonorrhea much more convenient,” said Dr. Manica Balasegaram, executive director of the Global Antibiotic Research and Development Partnership.
Zoliflodacin’s single-dose format is a major advantage. “You can administer this treatment in different healthcare settings, but you don’t need all the facilities to inject an injectable,” Balasegaram said.
He added, “When you’re dealing with emerging drug resistance, it’s important to bring new treatment options onto the table. These are urgently needed drugs for a disease that is becoming out of control.”
The need for better treatment is pressing. In the US, sexually transmitted infections like gonorrhea, chlamydia, and syphilis have surged. Reported cases jumped 90% in 2023 compared with 2004. Over 2.4 million STIs were reported in 2023 alone.
Without treatment, gonorrhea can cause serious health problems. In women, it may lead to pelvic inflammatory disease, which can increase the risk of pregnancy complications and infertility. In men, untreated gonorrhea can rarely lead to infertility. There is currently no licensed vaccine to prevent gonorrhea infections.
The infection is also becoming harder to treat because bacteria are developing resistance. Overuse or misuse of antibiotics—such as not completing a full course—allows bacteria to adapt and survive, making them stronger against existing medications.
Zoliflodacin was designed to remain effective against resistant strains that no longer respond to drugs like ciprofloxacin, ceftriaxone, and azithromycin, said Dr. David Altarac, chief medical officer at Innoviva Specialty Therapeutics.
“Rising resistance has steadily eroded the effectiveness of existing therapies, leaving clinicians with very limited options,” Altarac said. “A novel, oral agent like zoliflodacin strengthens our treatment arsenal and helps slow the spread of this major public health concern worldwide.”
Because zoliflodacin is developed solely for gonorrhea, it is less likely to be overused for other infections, reducing the risk of resistance. “We’ve made that part of the strategy from the outset,” Balasegaram explained.
“Bacteria are smart. They can pass resistant mechanisms between each other. What is exciting is that these two new treatments are coming at a time when we haven’t had new options for decades, even as infections rise and resistance grows,” Balasegaram added.
A major trial published in The Lancet showed that a single oral dose of zoliflodacin worked nearly as well as the current standard treatment, which combines a ceftriaxone injection with oral azithromycin. The study included over 900 patients in Belgium, the Netherlands, South Africa, Thailand, and the United States.
About 90.9% of patients treated with zoliflodacin were cured, compared with 96.2% who received the standard treatment. Side effects in both groups were mostly mild, such as headache or minor white blood cell changes.
“These results suggest zoliflodacin offers efficacy comparable to existing treatments, with the added benefit of a single-dose, oral regimen that may broaden access,” Altarac said.
The cost of zoliflodacin has not yet been announced. Pavel Raifeld, CEO of Innoviva, said the company is committed to making the drug accessible and affordable worldwide.
Separate research published in April in The Lancet showed that gepotidacin was also as effective as the standard treatment, with no new safety concerns. The trial included over 600 patients aged 12 and older in Australia, Germany, Mexico, Spain, the UK, and the US.
Patients in the gepotidacin group were given two oral doses 10–12 hours apart. About 92.6% of patients were cured, compared with 91.2% in the standard treatment group. Gastrointestinal issues were the main side effects, mostly mild or moderate.
The list price for gepotidacin is $1,900 for a 20-tablet bottle. A full course of treatment is eight tablets, and final patient costs may vary depending on insurance coverage.
While the new drugs are a major breakthrough, experts warn that continued research is critical. Strains of gonorrhea may eventually develop resistance to gepotidacin.
“Preclinical and clinical development of additional gonorrhea treatments remains important,” wrote Magnus Unemo of Örebro University and Teodora Wi of the World Health Organization. “Gepotidacin is promising, but challenges to keep gonorrhea treatable will continue.”
The approval of zoliflodacin and gepotidacin marks a historic step forward in public health. These oral antibiotics offer hope for easier, more accessible treatment, and a stronger defense against a global rise in drug-resistant gonorrhea.
As experts warn, careful use and ongoing development are essential. With over 80 million new infections globally each year, the fight against gonorrhea is far from over, but these new drugs give patients and doctors powerful tools to fight back.
