What Is Nuzolvence, and Why Does It Matter?
Nuzolvence (zoliflodacin) is a new oral antibiotic approved by the FDA to treat uncomplicated gonorrhea of the urinary and genital tract. It is meant for adults and children 12 or older with a body weight of at least 35 kilograms (about 77 pounds). Nuzolvence is one of the first FDA-approved treatments for gonorrhea in almost 20 years.
Gonorrhea is a common sexually transmitted infection (STI) that affects more than 82 million people worldwide each year. In the United States, it’s the second most reported bacterial STI. Over time, Neisseria gonorrhoeae, the bacteria that causes gonorrhea, has become resistant to many antibiotics, including ceftriaxone, which is part of the current standard treatment. This growing resistance makes it harder to treat the infection and increases the need for new treatment options.
Nuzolvence is the first medicine in a new class of antibiotics called spiropyrimidinetrione bacterial type II topoisomerase inhibitors. This means it works differently from other antibiotics by blocking enzymes that the gonorrhea bacteria need to grow and multiply. It’s taken as a single oral dose, which may be easier than treatments that require multiple doses or injections. This simple dosing could help more people complete their treatment and may help slow the spread of drug-resistant gonorrhea.
Why Was It Approved?
Nuzolvence was approved after a large international study showed that it worked well to treat uncomplicated gonorrhea in the urinary and genital areas.
The study included more than 900 people, including both adults and teens, from five countries. Participants were randomly given either a single oral dose of Nuzolvence or the standard treatment, which includes an injection of ceftriaxone and oral azithromycin. About 91% of people who took Nuzolvence, compared with about 96% of those who received the standard treatment, were cured. These results showed that Nuzolvence was nearly as effective, meeting the criteria for what’s called “noninferiority” in medical studies. This means it worked just as well within an acceptable range.
Nuzolvence was generally well tolerated. The most common side effects reported in the study were headache, dizziness, nausea, and diarrhea. Some people had changes in their blood test results, such as lower white blood cell counts (neutropenia and leukopenia), but these didn’t require treatment. No serious side effects or deaths were reported during the study.
What Do I Need to Know?
Nuzolvence is taken as a one-time oral dose. It comes as granules that you mix with water before taking. Don’t mix it with other drinks or sprinkle it on food. Once mixed, you should drink it within 15 minutes.
How you take Nuzolvence depends on your weight. If you weigh between 35 and 50 kilograms (about 77-110 pounds), take it on an empty stomach (one hour before eating or two hours after eating). If you weigh 50 kilograms or more, take it with food.
Nuzolvence is not recommended during pregnancy because it may harm a fetus. A pregnancy test is usually done before treatment in people who can become pregnant. If you’re a man with a partner who can become pregnant, you should use birth control for at least three months after taking Nuzolvenceand discuss family planning during this time. It is not known whether the medicine passes into breast milk. If you are breastfeeding or plan to breastfeed, talk to your health care provider about how to safely feed your baby after taking Nuzolvence.
Do not take Nuzolvence if you are allergic to it or if you are taking medicines that affect certain liver enzymes that can reduce how well Nuzolvence works. Be sure to tell your health care provider about all prescription and over-the-counter medicines, vitamins, supplements, and herbal remedies you take to avoid possible interactions.
Some people may get diarrhea after taking Nuzolvence. In rare cases, this can be a sign of a more serious infection called Clostridioides difficile-associated diarrhea, which needs medical attention.
Nuzolvence is expected to be available in the second half of 2026.