REG - GSK PLC - Blujepa approved in US for gonorrhoea indication

GSKAnnouncement

11/12/2025 18:00

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RNS Number : 2835L  GSK PLC  11 December 2025

Issued: 11 December 2025, London UK

 

Blujepa (gepotidacin) approved by US FDA as oral option for treatment of
uncomplicated urogenital gonorrhoea (uGC)

 

·   Blujepa is the first in a new antibiotic class for the treatment of
gonorrhoea approved in over three decades i  (#_ftn1)

·   Offers a new oral option for US patients with gonorrhoea currently
relying on injectable treatments

·   Neisseria gonorrhoeae is a priority pathogen for the World Health
Organization with significant need for new treatments 1  (#_edn1)

 

 

 

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) has approved a supplemental New Drug Application for
gepotidacin as an oral option for adult and paediatric patients from 12 years
of age weighing at least 45 kg who have limited or no alternative options for
the treatment of uncomplicated urogenital gonorrhoea caused by susceptible
strains of Neisseria gonorrhoeae (e.g., where standard of care is
contraindicated, or where patients are intolerant or unwilling to use first
line treatment). This milestone follows the US FDA approval of gepotidacin
earlier this year as an oral treatment for female adult and paediatric
patients 12 years of age and older (weighing ≥40 kg) with uncomplicated
urinary tract infection (uUTI). 2  (#_edn2)

 

Gonorrhoea is a common, sexually transmitted infection caused by Neisseria
gonorrhoeae, which has been recognised by the World Health Organization as a
priority pathogen1 and an urgent public health threat by the US Centers for
Disease Control and Prevention (CDC). 3  (#_edn3) It affects both men and
women and if left untreated or inadequately treated, it can lead to
infertility and other sexual and reproductive health complications. In 2023,
there were over 600,000 cases of gonorrhoea reported in the United States
according to the CDC, making it the second most commonly reported sexually
transmitted infection in the country. 4  (#_edn4) There is currently no
licensed vaccine in the US for the prevention of gonorrhoea infections and the
standard treatment relies on an injectable antibiotic. 5  (#_edn5)

 

Tony Wood, Chief Scientific Officer, GSK, said: "We're proud to have delivered
the first new class of antibiotics for gonorrhoea in over three decades and a
new oral option for US patients. The ability of N. gonorrhoeae to develop
resistance to currently available options, including standard of care, makes
it important to expand the range of effective oral treatments".

 

The US application was based on positive results from the EAGLE-1 phase III
trial which demonstrated that gepotidacin was non-inferior to standard of care
combination treatment for gonorrhoea (intramuscular ceftriaxone plus oral
azithromycin). The trial also supported the safety and tolerability profile of
gepotidacin, with no serious drug related adverse events observed in either
the gepotidacin or the comparator arm. The most common reported adverse
reactions were mild to moderate gastrointestinal events. 6  (#_edn6)

 

With this approval, gepotidacin is now available to US patients for the
treatment of uncomplicated urogenital gonorrhoea when appropriate.

 

The development of gepotidacin has been funded in part with federal funds
from the US Department of Health and Human Services, Administration for
Strategic Preparedness and Response, Biomedical Advanced Research and
Development Authority (BARDA), under Other Transaction Agreement number
HHSO100201300011C based on its potential for use against secondary bacterial
infections that may arise following chemical, biological, radiological, and
nuclear (CBRN) incidents and with federal funds awarded by the US Department
of Defense's Threat Reduction Agency under agreement number HDTRA1-07-9-0002.

 

About gepotidacin

Gepotidacin, discovered by GSK scientists, is a bactericidal, first-in-class
triazaacenaphthylene antibiotic that inhibits bacterial DNA replication by a
distinct binding site, a novel mechanism of action, and for most pathogens,
provides well-balanced inhibition of two different Type II topoisomerase
enzymes. This provides activity against Neisseria gonorrhoeae and most target
uropathogens (such as Escherichia coli and Staphylococcus saprophyticus),
including isolates resistant to current antibiotics. Due to this well-balanced
inhibition for most pathogens, a single target-specific mutation may not
significantly impact gepotidacin activity.

 

The updated US Prescribing Information will be available here
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Blujepa/pdf/BLUJEPA-PI-MG.PDF)
.

 

About the EAGLE clinical programme

The EAGLE-1 trial (NCT04010539) is part of a comprehensive global phase III
clinical programme for gepotidacin in adults and adolescents including:

EAGLE-1 (non-inferiority urogenital gonorrhoea trial) enrolled approximately
600 patients with uncomplicated urogenital gonorrhoea to compare the efficacy
and safety of gepotidacin (oral, two doses of 3,000mg) to intramuscular
ceftriaxone (500mg) plus oral azithromycin (1,000mg). The data were presented
at the congress of the European Society of Clinical Microbiology and
Infectious Diseases (ESCMID) in April 2024 7  (#_edn7) and published in The
Lancet in April 2025.6

EAGLE-2 and EAGLE-3 (non-inferiority uUTI trials) enrolled approximately 3000
patients to compare the efficacy and safety of gepotidacin (1,500mg
administered orally twice daily for five days) to nitrofurantoin (100mg
administered orally twice daily for five days). The data were first presented
at the European Congress of Clinical Microbiology and Infectious Diseases
(ECCMID) in 2023 8  (#_edn8) and published in The Lancet in February 2024. 9 
(#_edn9)

 

GSK in infectious diseases

GSK has pioneered innovation in infectious diseases for over 70 years, and the
Company's pipeline of medicines and vaccines is one of the largest and most
diverse in the industry, with a goal of developing preventive and therapeutic
treatments for multiple disease areas or diseases with high unmet needs
globally. Our expertise and capabilities in infectious disease strongly
position us to help prevent disease and mitigate the challenge of
antimicrobial resistance (AMR).

 

About GSK

GSK is a global biopharma company with a purpose to unite science, technology,
and talent to get ahead of disease together. Find out more at gsk.com.

 

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Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made
by GSK, including those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially from those
projected. Such factors include, but are not limited to, those described in
the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2024, and
GSK's Q3 Results for 2025.

 

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 i  (#_ftnref1) The last new class of antibiotics approved for the treatment
of GC was the Fluoroquinolone class-Ciprofloxacin, with US approval in 1987
(CIPROFLOXACIN TABLETS, for oral use Initial U.S. Approval: 1987
(https://fda.report/DailyMed/f2b76ee7-ab1d-4430-e053-2995a90a4be0) )

 1  (#_ednref1) WHO. Bacterial priority pathogens list, 2024: Bacterial
pathogens of public health importance to guide research, development and
strategies to prevent and control antimicrobial resistance. Available at:
https://www.who.int/publications/i/item/9789240093461 Last accessed: November
2025

 2  (#_ednref2) GSK. Blujepa approved by US FDA for treatment of uncomplicated
urinary tract infections. Available at:
https://www.gsk.com/en-gb/media/press-releases/blujepa-gepotidacin-approved-by-us-fda-for-treatment-of-uncomplicated-urinary-tract-infections/
(https://www.gsk.com/en-gb/media/press-releases/blujepa-gepotidacin-approved-by-us-fda-for-treatment-of-uncomplicated-urinary-tract-infections/)
Last accessed: November 2025

 3  (#_ednref3) CDC. Antibiotic Resistance Threats Report. Available at:
https://www.cdc.gov/antimicrobial-resistance/media/pdfs/covid19-impact-report-508.pdf
Last accessed: August 2025

 4  (#_ednref4) CDC. National Overview of STIs in 2023. Available at:
https://www.cdc.gov/sti-statistics/annual/. Last accessed: November 2025

 5  (#_ednref5) CDC. STI treatment guideline. Available:
https://www.cdc.gov/std/treatment-guidelines/default.htm Last accessed:
November 2025

 6  (#_ednref6) Ross J, et al, "Oral gepotidacin for the treatment of
uncomplicated urogenital gonorrhoea (EAGLE-1): a phase 3 randomised,
open-label, non-inferiority, multicentre study" in The Lancet, 2025;
05:1608-20; https://doi.org/10.1016/ S0140-6736(25)00628-2

 7  (#_ednref7) GSK. EAGLE 1 phase III data show potential for gepotidacin as
a new oral treatment option for uncomplicated urogenital gonorrhoea (GC) amid
growing resistance to existing treatments. Available at:
https://www.gsk.com/en-gb/media/press-releases/eagle-1-phase-iii-data-show-potential-for-gepotidacin-as-a-new-oral-treatment-option-for-uncomplicated-gc/
Last accessed: November 2025.

 8  (#_ednref8) GSK. Gepotidacin's positive phase III data shows potential to
be the first in a new class of oral antibiotics for uncomplicated urinary
tract infections in over 20 years. Available at:
https://www.gsk.com/en-gb/media/press-releases/gepotidacin-s-positive-phase-iii-data-shows-potential-to-be-the-first-in-a-new-class-of-oral-antibiotics-for-uncomplicated-urinary-tract-infections/
Last accessed: November 2025.

 9  (#_ednref9) F.Wagenlehner et al, "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" in The Lancet, vol. 403, Issue 10428, 741-755, Feb
2024.

 

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