Zoliflodacin, Gepotidacin Receive FDA Approval for Gonorrhea

The FDA approved 2 new oral medications, zoliflodacin (Nuzolvence) and gepotidacin (Blujepa), for the treatment of uncomplicated urogenital gonorrhea among patients 12 and up, according to a news release.¹

“These approvals mark a significant milestone for treatment options for patients with uncomplicated urogenital gonorrhea,” Adam Sherwat, MD, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research (CDER), said in the news release.

First, gepotidacin was approved on December 11, and zoliflodacin was given approval the day after. Both will be planned to treat uncomplicated urogenital gonorrhea, with zoliflodacin created in granules that dissolve in water for patients, while gepotidacin comes in oral tablets. Finally, concluding the main differences in each drug’s approval, gepotidacin was indicated for patients of at least 99 pounds, and the zoliflodacin formulation for patients 77 pounds or greater.

Following this announcement, patients who have contracted, or are at risk of contracting, gonorrhea can now explore a more superior collection of treatment options. On an even greater scale, this dual approval is underscored by the growing and concerning prominence of patient resistance to drugs developed for treating gonococcal viruses.¹

Add to that, this is the first FDA-approved oral treatment for gonorrhea in almost 40 years;² this 2-drug occurrence from the administration may be a much-needed intervention for the 500,000-plus US patients that reported the disease in 2024.³

The Growing Challenges in Treating Gonorrhea

“The bacterium has steadily evolved to be less susceptible to the antibiotics used for treatment,” Edward W. Hook III, MD, professor of infectious diseases at the University of Alabama at Birmingham Heersink School of Medicine, said in an NBC News article.⁴ “The ongoing progression of antibiotic resistance has now been combined with a lack of alternatives.”

READ MORE: Social and Economic Factors Significantly Influence Supply of OTC Antibiotics

Despite Hook’s insights shared in a report from 2018, concerns surrounding antimicrobial resistance in gonorrhea treatment continue to be prominent in 2026. CDER Director of Anti-Infectives Peter Kim, MD, MS, explained how these approvals and more options for treating gonorrhea are “of particular importance given the global rise in gonococcal drug resistance.”¹

The disease gonorrhea is caused by a bacterium called Neisseria gonorrhoeae (N. gonorrhoeae). The specific type of gonorrhea these drugs were approved for is uncomplicated urogenital gonorrhea, which is a localized infection among either sex causing painful urination, genital discharge, and swelling.

At the time of the NBC News report, the CDC was recommending a multidrug antibiotic intervention of 2 therapies to treat gonorrhea: a ceftriaxone injection and an azithromycin or doxycycline pill.⁴ However, reports also noted that over 65% of global nations reported gonorrhea cases resistant to all antibiotics, forcing research to move swiftly in exploring antibiotic-resistant gonorrhea.

Potential New Horizons in Gonorrhea Treatment

“Gonorrhea is skilled at outsmarting the antibiotics that are used to kill it,” wrote authors of a report published by the CDC.⁵ “For this reason, we must continuously monitor for resistance and encourage the research and development of new drugs for gonorrhea treatment.”

With antimicrobial drug resistance growing increasingly prominent, not just for gonorrhea but for a myriad of infectious diseases, research and surveillance for drugs like zoliflodacin and gepotidacin are necessary. The research particularly used in the approval of each drug included a minimum of 628 patients in the respective trials.

Zoliflodacin was explored in a study of 930 patients with uncomplicated urogenital gonorrhea. Of the study population, 91% of patients on zoliflodacin were cured, while the standard treatment of antibiotics also cured 96% of patients that received it. Gepotidacin demonstrated similar effects among a group of 628 patients, with 93% who used it reporting they were cured, compared with 91% of patients on standard antibiotics.

With each newly approved drug highlighting similar safety and efficacy profiles as antibiotics that treat gonorrhea, there are now 2 viable options for pharmacists to recommend to patients with antimicrobial resistance. As the FDA stated, these medications are only recommended for use if patients have few or no treatment options for their specific condition—eg, antibiotic-resistant gonorrhea.

“The communities in which there is the greatest occurrence of infection are those that traditionally have less access to care, so we have to target our interventions to those communities where the need is greatest,” Frank Palella, professor of infectious diseases at Northwestern Memorial Hospital told NBC News.⁴ “If you’re sexually active, undergo routine STD screening whether you are having symptoms or not. This is the surefire way to get infections treated and to prevent the spread of it.”

READ MORE: Infectious Disease Resource Center

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REFERENCES

1. FDA approves two oral therapies to treat gonorrhea. News Release. FDA. December 12, 2025. Accessed January 6, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-two-oral-therapies-treat-gonorrhea

2. Shepard S. FDA approves first oral treatments for gonorrhea in decades. December 12, 2025. Accessed January 6, 2025. https://kfoxtv.com/news/nation-world/fda-approves-first-oral-treatments-for-gonorrhea-in-decades-florida-news-nuzolvence-and-blujepa-drug-resistant-strains-of-the-infection-world-december-12-2025

3. Sexually transmitted infections surveillance, 2024 (provisional). FDA. September 24, 2025. Accessed January 6, 2025. https://www.cdc.gov/sti-statistics/annual/index.html

4. Charles S. Gonorrhea is nearly impossible to treat, but a new drug offers hope. NBC News. December 2, 2018. Accessed January 6, 2025. https://www.nbcnews.com/health/health-news/gonorrhea-nearly-impossible-treat-new-drug-offers-hope-n938251

5. Drug-resistant gonorrhea. CDC. February 15, 2024. Accessed January 6, 2025. https://www.cdc.gov/gonorrhea/hcp/drug-resistant/index.html