REG - GSK PLC - FDA to review gonorrhea indication for gepotidacin

GSKAnnouncement

Mon 07:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20250811:nRSK6939Ua&default-theme=true

RNS Number : 6939U  GSK PLC  11 August 2025

Issued: 11 August 2025, London UK

 

Gepotidacin accepted for priority review by the US FDA for the oral treatment
of uncomplicated urogenital gonorrhoea

 

·   Submission supported by positive phase III data in patients with
uncomplicated urogenital gonorrhoea in EAGLE 1 trial 1  (#_edn1)

·   Significant need for new antibiotics for gonorrhoea, a priority
pathogen for the World Health Organization 2  (#_edn2)

·   If approved, gepotidacin would offer a new oral option to US patients
currently relying on injectable treatments

·   US decision expected in December 2025

 

 

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) has accepted for priority review a supplemental New Drug
Application for gepotidacin as an oral option for the treatment of
uncomplicated urogenital gonorrhoea in patients 12 years of age and older
(weighing ≥45 kg). The US FDA has assigned a Prescription Drug User Fee Act
action date in December 2025. In March 2025, gepotidacin was approved by the
US FDA under the licensing name Blujepa as oral treatment for female adult and
paediatric patients 12 years of age and older (weighing ≥40 kg) with
uncomplicated urinary tract infection (uUTI). 3  (#_edn3)

 

Gonorrhoea is a common, sexually transmitted infection caused by Neisseria
gonorrhoeae, which has been recognised by the World Health Organization as a
priority pathogen(2) and an urgent public health threat by the US Centers for
Disease Control and Prevention (CDC). 4  (#_edn4) 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. There were
more than 600,000 cases of gonorrhoea reported in the United States in 2023
according to the CDC, making it the second most commonly reported sexually
transmitted infection in the country. 5  (#_edn5) There is currently no
vaccine licensed in the US for the prevention of gonorrhoea infection and the
standard of care is injectable treatment which may not be suitable or
available for all patients. 6  (#_edn6)

 

The US application is based on results from the EAGLE-1 phase III trial
recently published in The Lancet, showing that gepotidacin (oral, two doses of
3,000mg) was non-inferior, with 92.6% (187/202, [95% CI 88·0 to 95·8])
success rates at urogenital site when compared to 91.2% (186/204, [95% CI
86.4-94.7]) success rates for intramuscular ceftriaxone (500mg) plus oral
azithromycin (1,000mg) combined therapy, a leading combination treatment
regimen for gonorrhoea. Additionally, there were no failures at the urogenital
site due to bacterial persistence of N. gonorrhoeae in either treatment arm.
The safety and tolerability profile of gepotidacin in the EAGLE-1 trial was
consistent with results seen in previous clinical trials, 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.1

 

This is the second major indication filed in the US for gepotidacin, and
review of regulatory submissions for the uUTI indication is also ongoing in
the UK and Australia.

 

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 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 US Prescribing Information is 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) compared the efficacy
and safety of gepotidacin (oral, two doses of 3,000mg) to intramuscular
ceftriaxone (500mg) plus oral azithromycin (1,000mg) in approximately 600
patients with uncomplicated urogenital gonorrhoea. The data were presented at
ESCMID in April 2024 7  (#_edn7) and published in The Lancet in April 2025.(1)

EAGLE-2 and EAGLE-3 (non-inferiority uUTI trials) compared 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 European Congress of Clinical Microbiology and
Infectious Diseases (ECCMID) in 2023. 8  (#_edn8)

 

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.

 

 GSK enquiries
 Media:               Simon Moore        +44 (0) 20 8047 5502  (London)
                      Simon Steel        +44 (0) 20 8047 5502  (London)
                      Kathleen Quinn     +1 202 603 5003       (Washington DC)
                      Alison Hunt        +1 540 742 3391       (Washington DC)

 Investor Relations:  Constantin Fest    +44 (0) 7831 826525   (London)
                      James Dodwell      +44 (0) 20 8047 2406  (London)
                      Mick Readey        +44 (0) 7990 339653   (London)
                      Steph Mountifield  +44 (0) 7796 707505   (London)
                      Jeff McLaughlin    +1 215 751 7002       (Philadelphia)
                      Frannie DeFranco   +1 215 751 3126       (Philadelphia)

 

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 Q2 Results for 2025.

 

Registered in England & Wales:

No. 3888792

 

Registered Office:

79 New Oxford Street

London

WC1A 1DG

 

References

 1  (#_ednref1) 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; 405:
1608-20; https://doi.org/10.1016/S0140-6736(25)00628-2
(https://doi.org/10.1016/S0140-6736(25)00628-2)

 2  (#_ednref2) 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
(https://www.who.int/publications/i/item/9789240093461) Last accessed: August
2025

 3  (#_ednref3) 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: August 2025

 4  (#_ednref4) CDC. Antibiotic Resistance Threats Report. Available at:
https://www.cdc.gov/antimicrobial-resistance/media/pdfs/covid19-impact-report-508.pdf
(https://www.cdc.gov/antimicrobial-resistance/media/pdfs/covid19-impact-report-508.pdf)
Last accessed: August 2025

 5  (#_ednref5) CDC. National Overview of STIs in 2023. Available at:
https://www.cdc.gov/sti-statistics/annual/summary.html
(https://www.cdc.gov/sti-statistics/annual/summary.html) . Last accessed:
August 2025

 6  (#_ednref6) CDC. STI treatment guideline. Available:
https://www.cdc.gov/std/treatment-guidelines/default.htm
(https://www.cdc.gov/std/treatment-guidelines/default.htm) Last accessed:
August 2025

 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/
(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: August 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/
(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: August 2025.

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCMZGMRGGFGKZM