Here’s what to know about Blujepa, the new FDA-approved UTI treatment heading to market this year

Good news for the millions of women who struggle with urinary tract infections (UTIs). The Food and Drug Administration (FDA) has approved a new drug, Blujepa, the first of a new class of oral antibiotics for treating UTIs, to head to market. Drugmaker GSK plans to release the drug in the U.S. in the second half of 2025. Blujepa, the brand name for gepotidacin, is the first oral antibiotic for UTIs to win FDA approval in almost 30 years. It’s approved for women and girls over 12 years old with “uncomplicated UTIs,” which are often caused by bacteria including E. coli. The pill is part of U.K.-based pharmaceutical giant GSK’s pipeline of drugs fighting infectious diseases, and is being hailed as a breakthrough treatment as it comes at a time when bacteria are increasingly becoming resistant to the standard antibiotics. “The approval of Blujepa is a crucial milestone with UTIs among the most common infections in women,” Tony Wood, GSK’s chief scientific officer, said in a statement. According to GSK, 16 million women in the U.S. struggle with UTIs each year, and half of all women experience them in their lifetime, with some 30% of women suffering from recurrent episodes. “For many, UTIs can be a burden that severely impacts daily life,” said Dr. Thomas Hooton, professor of clinical medicine at the University of Miami School of Medicine. “With an increasing number of patients experiencing recurrent infections, there remains a clear need for continued research of antimicrobials to help address ongoing patient challenges and the strain on healthcare systems.” Blujepa’s development was funded in part by the Department of Health and Human Services (HHS) and a number of other federal agencies, and comes at a time when the Trump administration is slashing the budgets and staff at the HHS and other key federal agencies. The HHS oversees 13 agencies, including the Centers for Disease Control and Prevention (CDC), which are tasked with protecting the nation’s health. Under new Health and Human Services Secretary Robert F. Kennedy Jr., hundreds of millions of dollars in grants for research have been cut, which critics say will hamper the country’s ability to make future breakthroughs in the medical field.

Mar 26, 2025 - 19:55

Here’s what to know about Blujepa, the new FDA-approved UTI treatment heading to market this year

Good news for the millions of women who struggle with urinary tract infections (UTIs). The Food and Drug Administration (FDA) has approved a new drug, Blujepa, the first of a new class of oral antibiotics for treating UTIs, to head to market. Drugmaker GSK plans to release the drug in the U.S. in the second half of 2025.

Blujepa, the brand name for gepotidacin, is the first oral antibiotic for UTIs to win FDA approval in almost 30 years. It’s approved for women and girls over 12 years old with “uncomplicated UTIs,” which are often caused by bacteria including E. coli.

The pill is part of U.K.-based pharmaceutical giant GSK’s pipeline of drugs fighting infectious diseases, and is being hailed as a breakthrough treatment as it comes at a time when bacteria are increasingly becoming resistant to the standard antibiotics.

“The approval of Blujepa is a crucial milestone with UTIs among the most common infections in women,” Tony Wood, GSK’s chief scientific officer, said in a statement. According to GSK, 16 million women in the U.S. struggle with UTIs each year, and half of all women experience them in their lifetime, with some 30% of women suffering from recurrent episodes.

“For many, UTIs can be a burden that severely impacts daily life,” said Dr. Thomas Hooton, professor of clinical medicine at the University of Miami School of Medicine. “With an increasing number of patients experiencing recurrent infections, there remains a clear need for continued research of antimicrobials to help address ongoing patient challenges and the strain on healthcare systems.”

Blujepa’s development was funded in part by the Department of Health and Human Services (HHS) and a number of other federal agencies, and comes at a time when the Trump administration is slashing the budgets and staff at the HHS and other key federal agencies.

The HHS oversees 13 agencies, including the Centers for Disease Control and Prevention (CDC), which are tasked with protecting the nation’s health. Under new Health and Human Services Secretary Robert F. Kennedy Jr., hundreds of millions of dollars in grants for research have been cut, which critics say will hamper the country’s ability to make future breakthroughs in the medical field.