Gonorrhea is a common sexually transmitted disease (STD) that causes infection in more than 1.5 million people every year in the United States. The infection is caused by Neisseria gonorrhoeae, a type of bacteria that can infect the genitals, rectum, or throat. If gonorrhea is not treated, it can eventually cause serious complications, including infertility.
Gonorrhea can be treated with antibiotic medicines. However, some gonorrhea-causing bacteria have developed resistance to the antibiotics that are usually used to treat gonorrhea. Because of this resistance, older antibiotic treatments may not work as well to treat gonorrhea. In December 2025, the FDA approved a new antibiotic medicine, Nuzolvence (zoliflodacin). This is one of the first new medicines approved to treat gonorrhea in decades.
How Does Nuzolvence Work for Gonorrhea?
Nuzolvence works by stopping certain bacteria from copying and repairing their DNA, which they need in order to grow and survive. It blocks important bacterial enzymes, called topoisomerases, that normally help unwind and reconnect DNA during reproduction. By preventing this process, the bacteria that cause gonorrhea can no longer multiply and eventually die.
How Do I Take It?
Nuzolvence comes in a kit that includes a packet containing enough granules for a single 3-gram dose of the medicine, a mixing container, and instructions for use. You will take one dose of Nuzolvence once. It is only approved for people who weigh at least 77 pounds. If you weigh more than 77 pounds but less than 110 pounds, you should take your dose on an empty stomach, at least one hour before or two hours after eating food. If you weigh 110 pounds or more, you should take your dose with food.
To prepare the dose, add 60 milliliters of water to the provided mixing container, then empty the contents of the packet into the container. Nuzolvence should only be mixed with water and should not be mixed with other liquids or sprinkled on food. Do not take the medicine in its dry form. Close the lid on the mixing container and shake vigorously for at least one full minute. Continue shaking the medicine until all the granules are mixed into the water. The mixture should look cloudy, but there should not be any clumps.
Once fully mixed, drink the entire contents of the mixing container. Then, add another 60 milliliters of water to the container, close the lid, and shake it. After mixing again, drink the entire contents to make sure that you receive the full dose of the medicine. You must drink the entire dose within 15 minutes of mixing it. If you do not, you will need to throw away that dose and prepare a new one.
How Was It Studied for Gonorrhea?
Nuzolvence was studied for the treatment of gonorrhea in a clinical trial where it was compared to treatment with two different medicines taken together: ceftriaxone plus azithromycin. Ceftriaxone is an antibiotic that is injected into your muscle. Azithromycin is an antibiotic that is taken by mouth. Both ceftriaxone and azithromycin are commonly used to treat gonorrhea. But now they may be less effective for treating gonorrhea because of increasing resistance to them.
In the study, all of the medicines were given one time as a single dose. To be eligible for the trial, people had to be at least 12 years old, weigh at least 77 pounds, and have a diagnosis of uncomplicated gonorrhea. People could not be included in the study if they had complications from gonorrhea, such as more severe infections.
The trial included 930 people with gonorrhea. People in the trial had the following characteristics:
- The average age was about 30 years.
- 88% were assigned male at birth, while 12% were assigned female at birth.
- About 55% were Black or African American, 31% were Asian, 12% were White, and 1% or fewer identified as American Indian or Alaska native, Native Hawaiian or other Pacific Islander, White and Asian, or “other” race.
About two-thirds of people in the study received Nuzolvence, and one-third received ceftriaxone plus azithromycin.
How Did the Researchers Test for Effectiveness?
In this trial, the researchers did not set out to prove that Nuzolvence was better than ceftriaxone plus azithromycin. Instead, they wanted to show that it was not meaningfully worse. The researchers compared microbiological cure rates in both groups to see if the participants’ gonorrhea infection was effectively treated. If a culture from the participants’ gonorrhea infection site (the urethra or cervix) did not show the presence of N. gonorrhoeae, they were considered to be microbiologically cured.
The researchers defined “not meaningfully worse” in advance using a noninferiority margin of 12%. This means that Nuzolvence would be considered an acceptable alternative to ceftriaxone plus azithromycin to treat gonorrhea if its cure rate was no more than 12% lower than that of ceftriaxone plus azithromycin.
What Did the Study Find?
When tested about one week after treatment with Nuzolvence or ceftriaxone plus azithromycin, microbiological cure rates were above 90% in both groups. Microbiological cure rates were about 5% lower with Nuzolvence than with ceftriaxone plus azithromycin. Since this was less than the 12% cutoff the researchers had set, they concluded that Nuzolvence is an acceptable alternative treatment to ceftriaxone plus azithromycin in people with gonorrhea.
Your results may differ from those seen in clinical studies.
How Can I Prevent and Manage Side Effects?
The most common side effects seen in people treated with Nuzolvence are headache, dizziness, nausea, and diarrhea.
Make sure to drink plenty of fluids during and after treatment with Nuzolvence. This will help you stay hydrated if you have diarrhea and may also help relieve a headache. Having smaller, more frequent meals may help if you have nausea. It is best to eat bland foods, such as bananas, rice, applesauce, and toast (also called the BRAT diet) until your nausea gets better. If you have dizziness, you should get up slowly when switching from lying down to sitting, or from sitting to standing, to avoid falls.
Nuzolvence can also increase your risk of a more severe antibiotic-associated diarrhea caused by the bacterium Clostridioides difficile (C. diff). If you have frequent watery or bloody diarrhea after treatment with Nuzolvence, contact your health care provider right away.
This is not a complete list of side effects. Tell your health care provider if these or other side effects bother you or do not go away.
What Kinds of Drug Interactions May Happen?
Nuzolvence is broken down by certain enzymes in the body called CYP3A4 enzymes. Taking medicines that induce (increase the activity of) these CYP enzymes can cause too much Nuzolvence to be broken down in the body, causing it to not work as well. So, Nuzolvence should not be taken with certain medicines called moderate or strong CYP3A4 inducers. Ask your health care provider if you are not sure whether you are taking a CYP3A4 inducer. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
What Are Other Unique Considerations to Be Aware Of?
Nuzolvence may cause harm to a fetus. In some studies where Nuzolvence was tested in pregnant animals at doses higher than the regular dose used in humans, it was associated with fetal malformations (birth defects). There is no evidence yet about the use of Nuzolvence in pregnant humans to know if it is associated with birth defects or other problems.
If you can get pregnant, you should have a test to make sure you are not pregnant before taking Nuzolvence. Tell your health care provider right away if you are pregnant, think you might be pregnant, or plan to become pregnant. If you take Nuzolvence while pregnant, you can sign up for a pregnancy safety study by calling the drugmaker at 800-651-3861. This study collects information about the safety of using Nuzolvence during pregnancy.
Based on a study in animals, there may also be a higher risk of pregnancy loss in people who have a male partner who was treated with Nuzolvence. If you can get your partner pregnant, you should use effective birth control for at least three months (90 days) after taking Nuzolvence.
Based on studies in animals, Nuzolvence may cause harm to the testicles, lower sperm count, or harm sperm. It may also make it hard for you to get your partner pregnant. If you have concerns, talk to your health care provider.
