Blujepa (gepotidacin) is a new antibiotic recently approved by the FDA for treating bladder infections caused by certain bacteria in women and girls ages 12 and older. Blujepa works differently than other medicines. It blocks bacteria from copying their DNA, which helps to stop the infection from spreading. In clinical trials, Blujepa worked just as well as or better than another medicine that is commonly used to treat bladder infections.
Bladder infections are the most common type of urinary tract infection (UTI). UTIs are very common, affecting more than half women in their lifetime. The most common germ causing UTIs is bacteria.
Health care providers may prescribe antibiotics to treat these infections, sometimes without testing the bacteria to see if it will resist the medicine. These infections may be hard to treat because bacteria in some locations may have developed resistance to certain antibiotics. As antibiotic resistance grows, these infections have become harder to treat.
The FDA approved Blujepa in March 2025. Blujepa’s approval marks the first new oral antibiotic medicine for UTIs in nearly 30 years. Below are common questions and answers about Blujepa for bladder infections.
Is Blujepa Right for Me?
To decide if Blujepa is right for you, your health care provider will look at things like your age, weight, medical history, and the cause of your bladder infection.
Specifically, Blujepa is FDA-approved to treat simple (uncomplicated) bladder infections in females ages 12 and older who weigh at least 40 kilograms and the UTI is caused by certain types of bacteria. Below are more details about Blujepa’s approved use.
- Women and girls (12+). Blujepa is approved for use in adult women and female children ages 12 and older who weigh at least 88 pounds (40 kilograms). Blujepa has not been studied for the treatment of bladder infections in males.
- Uncomplicated UTI. A simple, or uncomplicated, UTI is a bladder infection that is generally easy to treat. It typically happens without any other problems in the kidneys and without other health conditions that could make the infection worse or lead to serious complications. Blujepa has not been studied for the treatment of complicated UTIs.
- Specific bacteria. To help prevent bacteria from becoming resistant to Blujepa and other antibiotics, Blujepa should only be used to treat infections that are known or strongly believed to be caused by bacteria that can be treated with it. Blujepa may be used to treat bladder infections caused by the following types of bacteria.
- Escherichia coli (E. coli)
- Klebsiella pneumoniae
- Citrobacter freundii
- Staphylococcus saprophyticus
- Enterococcus faecalis
Blujepa may not be the right medicine for some bladder infections, depending on which germs are causing the infection.
Before prescribing Blujepa, your health care provider may test your urine to find out the type of bacteria causing the infection. They can also do tests, known as urine culture and sensitivity tests, to check if the bacteria have developed resistance to certain antibiotics. Your health care provider will likely use these test results to choose or adjust your treatment. If test results are not available, local patterns of bacterial resistance can help health care providers decide on the best treatment for your UTI.
How Does Blujepa Work for Bladder Infections? What Drug Class Does It Belong To?
Blujepa contains the active ingredient gepotidacin. It belongs to a group of medicines called antibiotics. Blujepa is the first medicine in a new class of antibiotics known as triazaacenaphthylenes. It is a bactericidal antibiotic, which means the medicine works by killing bacteria.
Blujepa treats bladder infections by blocking enzymes in certain bacteria. These enzymes, called type II topoisomerases, are important for bacteria to copy their DNA and reproduce. By blocking these enzymes, Blujepa essentially stops the bacteria from growing and multiplying, causing them to die.
How Was Blujepa Studied for Bladder Infections? (Study Population, Exclusion Criteria)
The effectiveness of Blujepa was tested in two clinical trials called EAGLE-2 and EAGLE-3. These trials compared two different treatments for bladder infection in more than 3,000 females (people assigned female at birth) total. The studies involved patients from 219 medical centers worldwide, but most of the participants were in the United States.
In the EAGLE-2 and EAGLE-3 studies, the average age of participants was 48-50. About 82%-84% of participants were White, 5.2%-8.9% were Black or African American, 2.9%-7.2% were Asian, 0.2%-0.3% were American Indian or Alaskan Native, 0.1%-0.3% were Native Hawaiian or Pacific Islander, and the remainder identified as more than one race, did not report, or had an unknown race.
Everyone in the studies had at least two symptoms of a bladder infection, such as painful, frequent urination or lower abdominal pain, with test results showing signs of infection, such as pus in the urine.
People were not allowed to enter the studies if they were pregnant or had a complicated urinary tract infection (UTI). A complicated UTI is a more serious bladder infection that can be harder to treat and may involve upper parts of the urinary tract, such as the kidneys.
Less than half (40%-41%) of the people in the studies had a history of bladder infections that kept coming back (recurrent infections).
In both studies, people were randomly assigned to take either Blujepa twice a day for five days or another antibiotic, nitrofurantoin (Macrobid), twice a day for five days. Nitrofurantoin is commonly used to treat bladder infections. No one knew which treatment they were getting.
The main goal of the EAGLE-2 and EAGLE-3 clinical trials was to see if the treatments successfully resolved symptoms and reduced bacteria in the urine at a follow-up assessment.
The effectiveness of the treatment was evaluated at a follow-up visit, which took place on day 10 to 13 of the study. During this visit, the researchers looked at two specific outcomes.
- Clinical cure: The researchers checked whether the symptoms of the infection, such as painful urination, had improved or completely gone away. The patient was considered to be clinically cured if all the symptoms of the infection were gone and no new symptoms appeared, without taking any other antibiotics.
- Microbiological response: The researchers tested the urine of the participants to see whether the bacteria causing the infection had decreased in number.
Both of these outcomes were considered together to assess whether the treatment worked. The treatment could only be considered successful if a patient showed improvement in both their symptoms and urine bacteria levels. This combined result, which looks at more than one measure to determine overall treatment success, is known as a composite response.
What Are the Main Benefits of Blujepa Based on Studies? (Primary Outcomes)
Effectiveness was measured at a follow-up visit on day 10 to 13 of the studies. The results showed that Blujepa worked just as well as or better than nitrofurantoin (Macrobid) to successfully treat bladder infections.
The tables below summarize the results of the EAGLE-2 and EAGLE-3 clinical trials. More specifically, results are shown as the percentages of people who experienced an overall treatment success, a clinical cure, and a microbiological response.
EAGLE-2 Results | Nitrofurantoin | Blujepa |
Overall treatment success (composite response) | 47% | 51.8% |
Symptoms resolved (clinical cure) | 65.8% | 66.7% |
Urine bacteria reduced (microbiological response) | 66.8% | 72.6% |
EAGLE-3 Results | Nitrofurantoin | Blujepa |
Overall treatment success (composite response) | 44% | 58.9% |
Symptoms resolved (clinical cure) | 63.6% | 68.2% |
Urine bacteria reduced (microbiological response) | 57.5% | 72.9% |
Together, these studies support Blujepa as an effective treatment option for uncomplicated bladder infections caused by certain types of bacteria in women and girls ages 12 and older. Your results may be different from what was seen in studies.
How Fast Does Blujepa Start to Work? How Long Until I See the Full Effects of the Medicine?
Blujepa starts to work soon after you take your first dose. Blujepa is typically prescribed for five days. It may take longer than five days for the medicine to cure the infection. This is because Blujepa continues to work in your body to kill bacteria after you finish taking it.
How Do I Take Blujepa?
Blujepa comes in 750-milligram tablets.
The typical dosage is 1,500 milligrams (two 750-milligram tablets) taken by mouth twice a day for five days. It is recommended to take doses of Blujepa 12 hours apart. Take each dose after a meal to lessen the chance of stomach discomfort.
Even if the symptoms of your bladder infection start to ease early on, it is important to take Blujepa exactly as your health care provider has directed. Do not skip doses or stop the medicine early. If you do, it could make the treatment less effective and increase the chances of the bacteria becoming resistant. This means Blujepa may not work for you in the future, and other antibiotics might also become less effective.
Be sure to follow your prescriber’s directions while taking Blujepa.
What Can I Do to Prevent or Manage Common Side Effects of Blujepa?
The list below includes some details about the common side effects of Blujepa and possible ways to help manage them. This is not a complete list of side effects. Tell your health care provider if these side effects bother you or do not go away. They may let you know about other ways to prevent or manage Blujepa side effects.
Diarrhea. Diarrhea is the most common side effect of Blujepa and often starts within the first two days of treatment. Your bowel movements may be watery or soft. For most people, this side effect is usually mild and goes away within a few days.
- Be sure to take each dose of Blujepa after a meal to help minimize digestive upset.
- To help prevent your body from losing too much fluid, be sure to stay hydrated by drinking plenty of fluids. Check with a health care provider before taking over-the-counter (OTC) medicines for diarrhea.
- Tell your health care provider if diarrhea is severe or does not go away.
Nausea or vomiting. Nausea is a more common side effect of Blujepa, while vomiting is relatively less common. Taking Blujepa after a meal may help lessen these side effects.
Stomach pain or gas. It is common to have pain in your belly (abdomen) while taking Blujepa. As mentioned, timing your dose after you eat can help make this side effect less bothersome.
Headache or dizziness. Some people may have a headache or feel dizzy while taking Blujepa. These effects usually go away on their own. Drinking plenty of water and resting can help. If needed, a health care professional can recommend an OTC pain reliever that is safe for you, such as acetaminophen (Tylenol).
Vaginal yeast infections. The most common symptom is itchiness in and around the vagina, along with possible burning, swelling, and a thick, white discharge. A health care provider can confirm the yeast infection and recommend the best treatment for it. Yeast infections are typically treated with antifungal medicines, which are available OTC and by prescription.
Blujepa may cause serious side effects such as rare heart rhythm problems, severe antibiotic-associated diarrhea (C. difficile), or allergic reactions. Tell your health care provider or get help right away if you have side effects that feel severe or do not go away.
How Can I Get Blujepa?
Blujepa requires a prescription from a health care provider. You cannot buy it over the counter.
