---
title: "FDA Approves GSK’s Blujepa for Uncomplicated Urinary Tract Infections"
description: "The FDA has approved GSK's Blujepa (gepotidacin), a first-in-class oral antibiotic for uncomplicated urinary tract infections (uUTIs) in women and patients over 12. This marks the first new oral antib"
type: "news"
locale: "en"
url: "https://longbridge.com/en/news/233332244.md"
published_at: "2025-03-26T18:18:00.000Z"
---

# FDA Approves GSK’s Blujepa for Uncomplicated Urinary Tract Infections

> The FDA has approved GSK's Blujepa (gepotidacin), a first-in-class oral antibiotic for uncomplicated urinary tract infections (uUTIs) in women and patients over 12. This marks the first new oral antibiotic for uUTIs in nearly 30 years. Clinical trials showed Blujepa's efficacy, with therapeutic success rates of 50.6% and 58.5% compared to nitrofurantoin. The drug is expected to launch commercially in the U.S. in the second half of this year, addressing a significant health issue affecting millions of women annually.

*Image Credit: Adobe Stock Images/Bungon*

The FDA has approved GSK’s Blujepa (gepotidacin), a first-in-class oral antibiotic for the treatment of uncomplicated urinary tract infections (uUTIs) in female adults and patients over 12 years of age. According to the company, Blujepa introduces a novel mechanism of action, marking the first new oral antibiotic for uUTIs in almost 30 years.1

“The approval of Blujepa is a crucial milestone with uUTIs among the most common infections in women,” said Tony Wood, chief scientific officer, GSK, in a press release. “We are proud to have developed Blujepa, the first in a new class of oral antibiotics for uUTIs in nearly three decades, and to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments.”

Approval was based on results from the Phase III randomized, multicenter, double-blind, double-dummy, non-inferiority EAGLE-2 and EAGLE-3 trials, which evaluated the efficacy and safety of Blujepa. In the trials, 1,531 patients in EAGLE-2 and 1,605 patients in EAGLE-3 were randomly assigned in a 1:1 ratio to receive either Blujepa at a dose of 1,500 mg twice daily or nitrofurantoin at a dose of 100 mg twice daily. The primary endpoint of the studies was therapeutic response at test-of-cure (day 10–13) in patients with bacteria susceptible to nitrofurantoin.1,2

EAGLE-2 confirmed that Blujepa was non-inferior to nitrofurantoin, with therapeutic success in 50.6% of patients administered Blujepa compared to 47% in the nitrofurantoin group. In EAGLE-3, Blujepa demonstrated statistical superiority, achieving therapeutic success in 58.5% of patients compared to 43.6% in the nitrofurantoin group.

The most common adverse events (AEs) in patients treated with Blujepa were gastrointestinal, including diarrhea and nausea. Of all gastrointestinal AEs, 69% were mild, 28% were moderate, and 3% were severe. The safety and tolerability profile of Blujepa was consistent with previous clinical trials.

According to GSK, uUTIs affect up to 16 million women in the United States annually, making them the most common bacterial infection in women. Globally, over 50% of women will experience a uUTI during their lifetime, 30% of whom will also experience at least one recurrence.

The commercial launch of Blujepa in the United States is expected in the second half of this year. Development was partially funded by the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority, and the Defense Threat Reduction Agency.1

According to *Medscape*, 25% to 40% of women between 20 and 40 years of age have had at least one UTI during their lifetime. Additionally, UTIs have resulted in over six million visits to physician offices within the past year, with 20% of cases reported in emergency departments. The incidence of UTIs in women tends to increase with age. However, women between 18 and 30 years of age are more likely to develop a UTI if they have also experienced honeymoon cystitis or pregnancy. In postmenopausal women, the rates tend to increase due to bladder or uterine prolapse, which causes incomplete bladder emptying.3

“For many, uUTIs can be a burden that severely impacts daily life,” said Thomas Hooton, MD, professor, clinical medicine, University of Miami School of Medicine, in the press release. “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.”

**References**

1\. Blujepa (gepotidacin) approved by US FDA for treatment of uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients 12 years of age and older. *GSK.* March 25, 2025. Accessed March 26, 2025. https://www.gsk.com/en-gb/media/press-releases/blujepa-gepotidacin-approved-by-us-fda-for-treatment-of-uncomplicated-urinary-tract-infections/

2\. Oral gepotidacin versus nitrofurantoin in patients with uncomplicated urinary tract infection (EAGLE-2 and EAGLE-3): two randomised, controlled, double-blind, double-dummy, phase 3, non-inferiority trials. *ScienceDirect.* Accessed March 26, 2025. https://www.sciencedirect.com/science/article/abs/pii/S0140673623021967#:~:text=EAGLE%2D2%20and%20EAGLE%2D3%20were%20phase%203%2C%20randomised%2C,patients%20were%20enrolled%20at%20219%20centres%20worldwide.&text=The%20trials%20are%20registered%20with%20ClinicalTrials.gov%20%2C,(EAGLE%2D2)%20and%20NCT04187144%20(EAGLE%2D3)%2C%20and%20are%20completed.

3\. Urinary Tract Infection (UTI) and Cystitis (Bladder Infection) in Females. *Medscape.* Accessed March 26, 2025. https://emedicine.medscape.com/article/233101-overview#a5

### Related Stocks

- [GSK.UK - GlaxoSmithKline plc](https://longbridge.com/en/quote/GSK.UK.md)
- [GSK.US - GSK](https://longbridge.com/en/quote/GSK.US.md)

## Related News & Research

| Title | Description | URL |
|-------|-------------|-----|
| 葛蘭素史克獲得歐洲委員會對 Exdensur 的批准 | 葛蘭素史克：葛蘭素史克 - 歐洲委員會批准的 EXDENSUR | [Link](https://longbridge.com/en/news/276102835.md) |
| 葛蘭素史克啓動最多達 4.5 億英鎊的股票回購批次 | 葛蘭素史克啓動高達 4.5 億英鎊的股票回購計劃 | [Link](https://longbridge.com/en/news/276103252.md) |
| 貝倫貝格銀行維持對葛蘭素史克（GSK）的持有評級 | Berenberg Bank 分析師 Kerry Holford 對葛蘭素史克 (GSK) 維持了持有評級，目標價為 20.00 英鎊。Holford 專注於醫療保健行業，推薦股票的平均回報率為 9.7%，成功率為 59.14%。此外，美國 | [Link](https://longbridge.com/en/news/276103203.md) |
| Exdensur 在歐盟獲批用於治療重度哮喘和慢性鼻竇炎伴鼻息肉（CRSwNP） | 葛蘭素史克已獲得歐洲委員會對 Exdensur（depemokimab）的批准，這是一種用於重度哮喘和伴有鼻息肉的慢性鼻竇炎的首個超長效生物製劑。該治療適用於 12 歲及以上的成年人和青少年，適用於那些在高劑量吸入類固醇治療下仍未得到有效控 | [Link](https://longbridge.com/en/news/276226507.md) |
| 葛蘭素史克啓動了第四批股票回購，金額最高可達 4.5 億英鎊，這是其 20 億英鎊回購計劃的一部分 | 英國製藥巨頭葛蘭素史克（GSK plc）宣佈啓動其 20 億英鎊股票回購計劃的第四個階段，計劃回購高達 4.5 億英鎊的股份。這是在完成前三個階段之後的舉措。此次回購是 GSK 將多餘資本返還給股東並提升每股收益的戰略的一部分。股票購買將於 | [Link](https://longbridge.com/en/news/276103384.md) |

---

> **Disclaimer**: This article is for reference only and does not constitute any investment advice.
