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• Posted December 15, 2025

FDA Approves Two New Antibiotics to Treat Drug-Resistant Gonorrhea

Doctors now have new tools to fight gonorrhea, a common sexually transmitted infection that has grown harder to treat over time.

The U.S. Food and Drug Administration (FDA) has approved two new antibiotics: Zoliflodacin and gepotidacin.

This is the first new major treatment for gonorrhea in decades.

On Friday, the FDA cleared zoliflodacin, a one-dose pill, after a large clinical trial showed it was safe and effective. Results from that trial were published Dec. 11 in the journal The Lancet. 

A day earlier, the agency also approved use of gepotidacin, a drug previously approved to treat urinary tract infections in women, to now treat gonorrhea as well.

Gonorrhea affects more than 80 million people worldwide each year, according to the World Health Organization (WHO).

It is caused by the bacterium Neisseria gonorrhoeae, which has developed resistance to nearly every antibiotic out there. The last new gonorrhea drug, ceftriaxone, was approved in the mid-1980s and is still given as an injection.

“Antibiotic resistance is something that keeps all of us up at night so anytime a new antimicrobial comes to market is a cause for celebration,” Dr. Aniruddha Hazra, medical director of the University of Chicago’s Sexual Wellness Clinic, told The New York Times.

In the U.S. alone, nearly 600,000 cases of gonorrhea were reported last year, according to the U.S. Centers for Disease Control and Prevention (CDC). About half of infections cause no symptoms, making it easy for the disease to spread without being detected. 

When symptoms do occur, they can include burning during urination and joint pain. If left untreated, gonorrhea can lead to infertility, blindness in newborns and in rare cases, death.

Earlier this year, WHO warned that drug-resistant gonorrhea is spreading in several regions, including the Western Pacific, Africa and Asia.

Zoliflodacin was developed through a public-private partnership. The nonprofit Global Antibiotic Research and Development Partnership (GARDP) helped bring the drug to the market after another pharmaceutical company chose not to pursue it. 

Innoviva Specialty Therapeutics will sell the drug in higher-income countries, while GARDP will help distribute lower-cost versions elsewhere.

“The beauty of our model is that we have a stake and skin in the game, and we will exercise those rights to ensure our public health objectives are met,” Dr. Manica Balasegaram, GARDP’s executive director, told The Times.

Both new drugs are only approved for gonorrhea infections in genital and urinary tracts, which is intended to maintain their effectiveness.

Dr. Edward Hook III, an expert on sexually transmitted infections, said the drug’s single-pill treatment could be a game changer.

“This is an important opportunity to expand treatment because no one wants to get a shot,” Hook said.

More information

The Mayo Clinic has more on gonorrhea.

SOURCE: The New York Times, Dec. 12, 2025