UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of December 2025
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
79 New Oxford Street, London, WC1A 1DG
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
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]
●
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]
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]
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] 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] 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]
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]
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.
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] 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] and
published in The
Lancet in
February 2024.[9]
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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Alison
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Investor
Relations:
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Constantin
Fest
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+44 (0)
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(London)
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James
Dodwell
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+44 (0)
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(London)
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Mick
Readey
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7990 339653
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(London)
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Steph
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+44 (0)
7796 707505
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(London)
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Sam
Piper
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7824 525779
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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Frannie
DeFranco
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751 3126
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(Philadelphia)
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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.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
[i] 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)
[1] 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] 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/ Last
accessed: November 2025
[3] 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] CDC.
National Overview of STIs in 2023. Available at:
https://www.cdc.gov/sti-statistics/annual/. Last accessed: November
2025
[5] CDC.
STI treatment guideline. Available:
https://www.cdc.gov/std/treatment-guidelines/default.htm Last
accessed: November 2025
[6] 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] 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] 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] 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.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GSK plc
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(Registrant)
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Date: December
11, 2025
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By:/s/ VICTORIA
WHYTE
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GSK plc
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