News|Articles|November 20, 2025

WHO warns of global rise in drug-resistant gonorrhea

Author(s)Denise Myshko
Listen
0:00 / 0:00

Key Takeaways

  • Gonorrhea's antibiotic resistance is rising globally, with significant resistance to ceftriaxone, cefixime, and ciprofloxacin. WHO emphasizes integrating surveillance into national STI programs.
  • Zoliflodacin, a novel antimicrobial agent, shows promise in treating gonorrhea, demonstrating non-inferiority to ceftriaxone/azithromycin in phase 3 trials.
SHOW MORE

Promising new medications for resistant gonorrhea, such as zoliflodacin and gepotidacin, are waiting for FDA approval, and they offer hope for effective treatment options.

Gonorrhea is becoming increasingly resistant to antibiotics, according to new data from the World Health Organization (WHO). The WHO’s Enhanced Gonococcal Antimicrobial Surveillance Programme (EGASP) collects data from sites around the world to track antimicrobial resistance.

Gonorrhea is one of the four most common sexually transmitted diseases that cause an infection in the genitals, rectum, and throat. The infection, if untreated, can lead to pelvic inflammatory disease, ectopic pregnancy, and infertility, and it can increase the risk of getting HIV.

The WHO estimates that in 2020, there were 82.4 million new cases among adolescents and adults aged 15 to 49 years worldwide. The infection is treated with antibiotics, but one particular strain, Neisseria gonorrhoeae, is increasingly resistant to current anti-infective treatments.

In 1993, ciprofloxacin, a fluoroquinolone, and two cephalosporins (ceftriaxone and cefixime) were the recommended treatments for gonorrhea, according to the CDC. But in the late 1990s and early 2000s, ciprofloxacin resistance was detected in Hawaii and the West Coast. By 2004, the use of ciprofloxacin was discontinued for men who have sex with men (MSM) because of increasing resistance, and by 2007, the CDC stopped recommending the use of fluoroquinolones to treat gonorrhea.

The new data from the WHO has found that between 2022 and 2024, resistance to ceftriaxone and cefixime rose from 0.8% to 5% and from 1.7% to 11%, respectively, with resistant strains detected in more countries. Resistance to azithromycin remained stable at 4%, while resistance to ciprofloxacin reached 95%.

In 2024, the WHO advanced genomic surveillance, with nearly 3,000 samples sequenced from several countries. The countries — Brazil, Cambodia, India, Indonesia, Malawi, the Philippines, Qatar, South Africa, Sweden, Thailand, Uganda, and Vietnam — reported 3,615 gonorrhea cases in 2024. Cambodia and Viet Nam reported the highest resistance rates.

In the United States, gonorrhea cases in 2024 declined for the third year in a row, down 10% from 2023, and resistance to treatment is considered rare, according to the CDC.

Officials at WHO have said that rising drug resistance is a serious global public health threat. “WHO calls on all countries to address the rising levels of sexually transmitted infections (STIs) and integrate gonorrhea surveillance into national STI programs,” Tereza Kasaeva, M.D., Ph.D., director of the WHO Department for HIV, TB, Hepatitis & STIs, said in a WHO press release.

There is, however, progress in the antimicrobial pipeline. For example, zoliflodacin is an investigational antimicrobial agent for gonorrhea assessed by WHO researchers; their analysis was published in June 2025 in IJID Regions. Zoliflodacin is a first-in-class spiropyrimidinetrione being developed by Innoviva Specialty Therapeutics. It inhibits bacterial DNA gyrase, an essential enzyme for bacterial survival.

This phase 3 trial was sponsored by the Global Antibiotic Research and Development Partnership. It compared zoliflodacin with a combination of ceftriaxone and azithromycin as a treatment for gonorrhea. The drug demonstrated non-inferiority to ceftriaxone/azithromycin with a microbiological cure rate of 90.9% in the microbiological intent-to-treat population.

Innoviva Specialty Therapeutics has submitted a new drug application to the FDA for zoliflodacin for patients 12 years and older. The FDA has granted zoliflodacin a Qualified Infectious Disease Product (QIDP) designation and granted the company’s application priority review and extended market exclusivity.

Another antibiotic awaiting FDA approval to treat patients with gonorrhea is gepotidacin, which was developed by GSK. A decision is expected by Dec. 11, 2025. GSK’s application was based on data from the EAGLE-1 phase 3 trial published in the May 3, 2025, issue of The Lancet. The trial found that gepotidacin was non-inferior to ceftriaxone and azithromycin with a 92.6% success rate. Additionally, there were no failures at the urogenital site due to bacterial persistence of N. gonorrhoeae in either treatment arm.

The safety and tolerability of gepotidacin in trial were consistent with results seen in previous clinical trials, with no serious drug-related adverse events observed in either the gepotidacin or the comparator arm.

In March 2025, gepotidacin was approved by the FDA with the brand name Blujepa as an oral treatment for female adult and pediatric patients 12 years of age and older with uncomplicated urinary tract infections.

Newsletter

Get the latest industry news, event updates, and more from Managed healthcare Executive.


Latest CME