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Millions Of Women Get Painful UTIs That Keep Coming Back. A New Kind Of Antibiotic May Help Break The Cycle
CNN —
The US Food and Drug Administration has approved a new type of antibiotic to treat urinary tract infections. The pill, gepotidacin, will be sold under the brand name Blujepa and is expected to be available in the second half of 2025.
Blujepa is approved to treat females 12 and older with uncomplicated urinary tract infections, or UTIs. About half of all women will experience a UTI at some point in their lives, and about 30% will have a UTI that comes back after treatment, drugmaker GSK said.
Recurrent UTIs have become a bigger problem as the bacteria that cause them have become more resistant to the antibiotics available to treat them.
Blujepa is the first new type of oral antibiotic to treat UTIs to gain approval in more than 20 years. Its development was funded in part by grants from the US government's Biomedical Advanced Research and Development Authority and the Defense Threat Reduction Agency.
Dr. Tony Wood, chief scientific officer of GSK, said in a statement that Blujepa's approval is "a crucial milestone."
"We are proud to have developed Blujepa, the first in a new class of oral antibiotics for [uncomplicated UTIs] in nearly three decades, and to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments," the statement said.
Other antibiotics have recently been approved for UTIs, although they fit into existing drug classes. Pivya, a type of penicillin, was approved in April 2024 to treat uncomplicated UTIs, and Orlynvah was approved in December 2024 to treat uncomplicated UTIs in women who have limited or no other antibiotic treatment options. Blujepa is what's known as a triazaacenaphthylene antibiotic and it's the first of its kind.
UTIs are the cause of roughly 8 million emergency room visits and 100,000 hospitalizations in the US each year, GSK said. They strike women more often than men.
Blujepa works by interfering with two enzymes that bacteria need to copy themselves. Because its mechanism of action is targeted, it may cut down on the possibility that bacteria will become resistant to it, Wood said Monday during a call with reporters.
In clinical trials with more than 3,000 women and teen girls, the drug - a pill taken twice daily - performed as well as or better than nitrofurantoin, the frontline antibiotic which is currently used to treat UTIs.
Its main side effects were diarrhea, which affected 16% of patients in the clinical trial, and nausea, which affected 9% of participants. Most of these events were considered mild.
Symptoms of UTIs include frequent urination that is painful or burns, bloody urine, low stomach cramps and the need to urinate even after having just gone.
Does HIV Cause Urinary Symptoms?
HIV doesn't cause urinary symptoms on its own but may increase your risk of a health condition, such as a urinary tract infection or kidney damage, that can lead to symptoms.
Living with HIV can potentially raise your risk of certain health conditions that can affect your urinary tract. These complications may result from its effects on the immune system or from certain medications used to treat HIV.
These conditions can include:
People who are on stable antiretroviral therapy regimens will have less compromised immune systems. However, they may still have a risk of certain urinary tract complications.
Keep reading to learn more about possible urinary symptoms associated with HIV, how to manage them, and when to get medical attention.
Some people with HIV may have an increased risk of certain infections, including UTIs. This can include people following their ART regimen. Research suggests UTIs are more likely in people with a lower CD4 count and a higher viral load.
UTIs develop when there's too many bacteria or the wrong bacteria in the urinary tract. They typically cause symptoms that can include:
In people with HIV with compromised immune systems, UTIs are typically considered complicated. Complicated UTIs are more serious and may require longer antibiotic treatment. They are more likely to cause additional symptoms, such as:
UTIs are more likely to develop in females, including among people with HIV. This is because females have a shorter urethra. However, when they develop in males, UTIs are more likely to be considered complicated and more serious.
Doctors often treat complicated UTIs with oral antibiotics. However, if a UTI progresses and a person develops symptoms that affect their body systems, they may need intravenous (IV) antibiotics and necessary fluids.
People with HIV may have an increased risk of damage to the kidneys. This may be due to:
Having certain other health conditions in addition to HIV can increase the risk. These can include:
Kidney damage can result in symptoms that can affect urination, including:
Kidney damage can also cause other symptoms that may affect other areas of the body as it gets worse. These can include:
If you have HIV, your regular monitoring appointments likely include tests to monitor your kidney function. If doctors notice signs of kidney damage, they may adjust your medications. It's best to talk with a doctor if you notice changes in your urination or other concerning symptoms, especially if you have HIV.
HIV may increase the risk of certain types of prostatitis, or prostate inflammation, in people with prostates who have HIV. This is likely due to HIV's effects on the immune system.
Prostatitis can result from a bacterial or viral infection and can become chronic, or long lasting.
Prostatitis causes urinary symptoms that can include:
It may also cause additional symptoms, such as:
Treatment for prostatitis can depend on the type of prostatitis you have. It can involve medication, physical therapy, and at-home care.
FDA Approves First New Antibiotic Treatment For UTIs In Decades
Prev NextAlan Brian Nilsen/ABN Photography via GSK
Close up of pipette work at GSK's HIV R&D laboratory in Branford, U.S.
A new antibiotic has been approved to treat urinary tract infections by the Food and Drug Administration for the first time in decades.
It's an oral pill called Blujepa from the London-based biopharma company GSK.
The company announced Tuesday that the FDA has approved its medication to treat uncomplicated UTIs in women and girls ages 12 and up.
It's the most common type of UTI seen in women and more than half are likely to have at least one in their lifetime, GSK said.
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The last time the FDA cleared a new class of antibiotics for these types of UTIs was in 1996, according to GSK.
"New treatments are needed as the number of uUTIs caused by drug-resistant bacteria is increasing which can result in higher treatment failure rates," GSK said in a statement.
The company expects its new medication to be available in the U.S. In the second half of this year.
A UTI occurs when bacteria enter the urethra and infect the urinary tract, according to the Centers for Disease Control and Prevention.
Symptoms typically include burning while urinating, frequent urination, bloody urine, and cramping in the groin area. The CDC said it can escalate to a kidney infection.
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