Researchers are testing a new oral medication called zoliflodacin that could offer a simpler way to treat gonorrhea, especially strains that no longer respond well to existing antibiotics. In a late-stage phase 3 clinical trial published in The Lancet, scientists found that a single dose of this pill worked just as well as the current standard treatment used today.
Phase 3 trials are the final and largest testing stage before a drug can be approved. They are designed to confirm how well a treatment works and to closely monitor safety in large groups of people. In this case, the results suggest zoliflodacin may be ready to become a real-world option.
Why Gonorrhea Is Becoming Harder to Treat
Gonorrhea is one of the most widespread sexually transmitted infections in the world, with more than 82 million new cases each year. It is caused by a bacterium that infects the reproductive tract and can also affect the throat and rectum. If left untreated, it can lead to serious health problems, including infertility.
One of the biggest challenges in treating gonorrhea is antibiotic resistance. Over time, bacteria can adapt and survive drugs that once killed them. As a result, doctors have fewer effective treatment options. The current recommended therapy relies on two antibiotics: an injection of ceftriaxone followed by an oral dose of azithromycin. This approach works, but it requires access to injections and careful medical supervision.
How the New Treatment Performed in Trials
The new study included more than 900 participants across five countries (USA, South Africa, Thailand, Belgium, and the Netherlands). Volunteers were randomly assigned to receive either zoliflodacin or the standard two-drug treatment.
The results were encouraging. More than 90 percent of genital infections were cured with the single-dose pill. Researchers also found that the drug was generally well tolerated. Side effects were similar to those already seen with existing gonorrhea treatments, and no serious safety concerns were reported during the trial.
What FDA Review Could Mean Going Forward
Zoliflodacin is now under review by the U.S. Food and Drug Administration (FDA), the agency responsible for evaluating the safety and effectiveness of new medications in the United States. Approval would allow the drug to be prescribed more widely.
According to the study authors, access to a one-dose oral treatment could make a major difference worldwide. It could simplify care, support community-led treatment programs, reduce reliance on injections, and help slow the spread of drug-resistant gonorrhea. If approved, the medication could play an important role in protecting reproductive health for millions of people around the globe.