US EditionSecond Oral Antibiotic for Gonorrhea Gets FDA Green Light
Zoliflodacin is the first oral gonorrhea drug in decades, approved amid rising resistance affecting over 80 million people annually, expanding treatment beyond injections.
- On Dec. 15, 2025, the U.S. Food and Drug Administration approved two new antibiotics, zoliflodacin and gepotidacin, marking the first major gonorrhea treatments in decades.
- Rising antibiotic resistance and high case counts prompted urgent need as gonorrhea affects more than 80 million people worldwide annually and nearly 600,000 U.S. cases last year.
- On Friday, the FDA cleared zoliflodacin after a large clinical trial showed it was safe and effective, with results published Dec. 11 in The Lancet.
- Doctors now have new tools, but both drugs are approved only for genital and urinary tract infections to preserve effectiveness, while untreated gonorrhea risks infertility, newborn blindness, and rare death.
- The nonprofit Global Antibiotic Research and Development Partnership helped bring the drug to market after another company withdrew, while Innoviva Specialty Therapeutics sells in higher-income countries and GARDP handles lower-cost distribution.
19 Articles
19 Articles
MedPage Today
Anti-Aging, Acupuncture and Health NewsSecond Oral Antibiotic for Gonorrhea Gets FDA Green Light
(MedPage Today) -- The FDA on Friday announced approval of zoliflodacin (Nuzolvence) as an oral treatment for gonorrhea, a day after approving oral gepotidacin (Blujepa) for the same indication. Zoliflodacin is the first of a new class of antibiotics...
The Philadelphia Tribune
WWAY TVFDA approves first new antibiotics to treat gonorrhea in decades, with hope to combat drug resistance
For the first time in decades, the US Food and Drug Administration has signed off on new antibiotics to fight gonorrhea. The approvals come at a critical moment: The sexually transmitted infection is growing harder to treat, and cases continue…
Watauga Democrat
FDA Approves Two New Antibiotics to Treat Drug-Resistant Gonorrhea
Key Takeaways
In November of this year, the World Health Organization (WHO) launched a report warning that gonorrhea is becoming increasingly resistant to antibiotics. And this month, new antibiotics for the treatment of the disease were approved by the Food and Drug Administration (FDA) in the United States: zoliflodacin and gepotidacin. When the mind warned of the danger: rot the bears, procrastinate and other forms of self-sabotage What is the vasovagal sy…
New FDA-Approved Antibiotics Offer Hope Against Drug-Resistant Gonorrhea
For decades, gonorrhea was considered a routine, easily treatable sexually transmitted infection. That assumption no longer holds. Around the world, doctors have been warning that the bacterium causing gonorrhea is becoming resistant to nearly every antibiotic thrown at it. Now, in what experts are calling a rare and significant breakthrough, the US Food and Drug Administration has approved two new antibiotics designed specifically to tackle dru…
After three decades without a new antibiotic to treat gonorrhea – a sexually transmitted infection – the FDA has approved two oral treatments, first in their class, for this sexually transmitted infection (STIs), which affects more than 80 million people around the world each year. It is Nuzolvence (zoliflodacin) from Innoviva and GSK Blujepa that arrive with just 24 hours of difference in a context in which gonorrhea is increasingly resistant t…
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