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 June 2026
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 . . . . . . . .
17 June 2026, London UK
Utebzi (tebipenem
pivoxil) approved in the US for adults with complicated urinary
tract infections (cUTIs)
● First and only oral carbapenem antibiotic approved
in the US
● Approval
based on PIVOT-PO trial demonstrating
non-inferiority compared to intravenous
treatment[1]
● More
than 3 million cases of cUTIs are treated annually in the
US[2] with
up to a third of patients impacted by resistant
infections[3]
GSK plc (LSE/NYSE: GSK) and Spero Therapeutics (Nasdaq: SPRO) today
announced that the US Food and Drug Administration (FDA) has
approved Utebzi, an oral antibiotic
for the treatment of complicated urinary tract infections (cUTIs)
including pyelonephritis[i],
caused by certain susceptible pathogens[ii] in
adult patients who have limited or no alternative oral treatment
options. This is the first and only oral carbapenem antibiotic
approved for these patients. This approval is a result of GSK's
development and exclusive global licensing agreement (excluding
select Asian territories) with Spero
Therapeutics.[4]
There are more than 3 million cases of cUTI in the US annually and
treatment failure impacts up to 34% of patients.2,3 Often
caused by multidrug-resistant pathogens,[5] these
infections account
for over
$6 billion per year in healthcare costs.[6] Carbapenems
are the standard treatment for severe or resistant infections, but
until now have only been available through intravenous
administration[7],
increasing hospital resource use and reducing patients' quality of
life.[8] Tebipenem
pivoxil offers the potential for an effective oral alternative
taken outside of a hospital setting.
Tony Wood, Chief Scientific Officer, GSK, said:
"With antibiotic resistance continuing to rise,
patients and healthcare
professionals need
new treatment options. The approval of Utebzi provides the first and only oral carbapenem
antibiotic for appropriate adults with complicated UTIs, a solution
that could help reduce reliance on hospital-based intravenous care
and support efforts to address resistant
infections."
Dr. Bilal Chughtai, Chief of Urology at Plainview Hospital,
Northwell Health and Associate Professor of Urology at the Zucker
School of Medicine at Hofstra/Northwell, said: "For patients with complicated urinary
tract infections (cUTIs) and their caregivers, this approval is a
major milestone as today's standard of care places a serious burden
on them and hospitals. A new effective oral treatment offering an
alternative option to intravenous care has the potential to enable
more treatment in the outpatient settings with the ambition to
improve their experience."
Esther Rajavelu, President and Chief Executive Officer, Spero
Therapeutics added: "The
FDA approval of tebipenem pivoxil marks the culmination of more
than a decade of dedication from our team, partners, and, most
importantly, the patients who placed their trust in this program.
We are proud to reach this important milestone. Through our
partnership with GSK, we look forward to this much-needed oral
treatment option reaching cUTI patients to help reduce the burden
of the disease."
This approval is supported by positive results from the PIVOT-PO
phase III trial, which demonstrated non-inferiority
of tebipenem pivoxil compared to intravenous imipenem-cilastatin in
hospitalised patients with cUTI, including pyelonephritis, based on
the overall response (composite of clinical cure plus
microbiological eradication) at the test of cure visit. Tebipenem
pivoxil (oral, 600 mg) achieved a 58.5% overall success rate
(261/446 participants) compared to 60.2% overall success rate
(291/483 participants) for imipenem-cilastatin (intravenous, 500
mg) (adjusted treatment difference: −1.3%; 95% CI:
−7.5%, 4.8%).
The safety profile of tebipenem pivoxil was generally similar to
that of imipenem-cilastatin and other carbapenem
antibiotics. The
most frequently reported adverse events (in ≥3% of
patients) were diarrhoea
and headache; these events were all mild or moderate and
non-serious.1
Tebipenem pivoxil is anticipated to be made available to US
patients by the end of 2026. With this approval, GSK builds on
recent advances in its growing anti-infectives
portfolio.
This approval confirms the successful and productive collaboration
between GSK and Spero Therapeutics. The
development of tebipenem pivoxil has been supported 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 contract
numbers HHSO100201800015C and
HHSO100201300011C.
About tebipenem pivoxil
Tebipenem pivoxil was developed in collaboration with Spero
Therapeutics4 for
the treatment of cUTIs, including pyelonephritis. In September
2022, GSK entered into an exclusive license agreement with Spero
Therapeutics for the development and commercialisation in all
markets, except certain Asian territories. Under
this agreement, GSK sub-licensed back to Spero Therapeutics the
rights and responsibility to conduct certain development work,
including the PIVOT-PO phase III study. The sponsorship of the New
Drug Application has been transferred to GSK. As part of the
license agreement, tebipenem pivoxil has received Qualified
Infectious Disease Product and Fast Track designations from the US
FDA.
The US Prescribing Information will be available here [https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Utebzi/pdf/UTEBZI-PI-PIL.PDF]
About the PIVOT-PO trial
The PIVOT-PO trial was a global, randomised, double-blind, pivotal,
non-inferiority (NI margin: -10%) phase III trial evaluating the
potential of oral tebipenem pivoxil compared to IV
imipenem-cilastatin, in hospitalised adult patients with
complicated urinary tract infections, including
acute pyelonephritis. Patients were randomised 1:1 to
receive tebipenem
pivoxil (600
mg) orally every six hours, or imipenem-cilastatin (500 mg) IV
every six hours, for a total of seven to ten days. Dose adjustments
were made for patients with reduced renal function. Matching
placebos were used to maintain blinding. The primary efficacy
endpoint was composite response (combined per-patient clinical cure
and microbiological response) at the test-of-cure visit (about 17
days from first dose administration of study drug) in patients with
qualifying pathogens susceptible to imipenem. The trial enrolled a
total of 1,690 patients, with randomisation stratified by age,
baseline diagnosis (cUTI or acute pyelonephritis),
and the presence or absence of urinary tract instrumentation. For
further details on the trial, refer to clinicaltrials.gov
identifier NCT06059846.[9]
About complicated urinary tract infections
(cUTIs)
cUTIs are broadly described as any UTI that carries an increased
risk of morbidity and mortality.5 Definitions
of cUTIs are not currently uniform among international societies
and regulatory agencies. cUTIs encompass a heterogeneous patient
population due to the wide range of host factors, comorbidities and
urological abnormalities associated with cUTIs. Risk factors for
cUTIs include indwelling catheters, ureteric stents, neurogenic
bladder, obstructive uropathy, urinary retention, urinary
diversion, kidney stones, diabetes mellitus, immune deficiency,
urinary tract modification and UTIs in renal transplant
patients.[10],[11],[12],[13]
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 need globally. Our
expertise and capabilities in infectious disease strongly position
us to help prevent and treat disease and potentially mitigate the
challenge of antimicrobial resistance. The approval of tebipenem
pivoxil continues the momentum for our anti-infectives
portfolio.
About Spero Therapeutics
Spero Therapeutics, headquartered in Cambridge, Massachusetts, is a
clinical-stage biopharmaceutical company focused on identifying and
developing novel treatments for rare diseases and diseases with
high unmet need. For more information, visit www.sperotherapeutics.com.
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 2025, and
GSK's Q1 Results for 2026.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References
[i] Pyelonephritis
is a specific type of UTI that has travelled up the urinary tract
to infect one or both kidneys.
[ii] Escherichia
coli, Klebsiella pneumoniae, Enterobacter
cloacae species
complex, Klebsiella
oxytoca,
and Enterococcus
faecalis.
[1] GSK
press release, Positive
PIVOT-PO phase III data show tebipenem HBr's potential as the first
oral carbapenem antibiotic for patients with complicated urinary
tract infections (cUTIs), October 2025.
[2] Carreno
JJ, et al. Longitudinal,
nationwide, cohort study to assess incidence, outcomes, and costs
associated with complicated urinary tract
infection. Open Forum
Infect Dis.
2019;7:ofil446. doi: 10.1093/ofid/ofz446.
[3] Lodise
TP, et al. Retrospective Cohort Study of the 12-Month Epidemiology,
Treatment Patterns, Outcomes, and Health Care Costs Among Adult
Patients With Complicated Urinary Tract
Infections. Open Forum
Infect Dis. 2022 Jun 20;9(7):ofac307.
doi: 10.1093/ofid/ofac307.
[4] GSK
press release, GSK and Spero Therapeutics announce exclusive
licence agreement for tebipenem HBr, a late-stage antibiotic that
may treat complicated urinary tract infections, 22 September
2022.
[5] Sabih
A, Leslie SW. Complicated urinary tract infections
in StatPearls.
2023. StatPearls, Treasure Island, FL, USA.
[6] Lodise
TP, et al. Hospital admission patterns of adult patients with
complicated urinary tract infections who present to the hospital by
disease acuity and comorbid conditions: How many admissions are
potentially avoidable? Am J Infect
Control.
2021;49(12):1528-1534.
[7] Eckburg
PB, et al. Oral tebipenem pivoxil hydrobromide in complicated
urinary tract infection. New England
Journal of Medicine,.2022;386:1327-1338. doi:
10.1056/NEJMoa2105462.
[8] NHS.
Reducing complications with a prolonged hospital stay.
2024. Available
from: https://www.plymouthhospitals.nhs.uk/display-pil/pil-reducing-complications-with-a-prolonged-hospital-stay-6686.
Last accessed: June 2026.
[9] CT.gov.
A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr)
Compared to Intravenous Imipenem-cilastatin in Participants With
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis
(AP) (PIVOT-PO), last updated on 01 July 2025.
[10] Bonkat G, et
al. Keep it Simple: A Proposal for a
New Definition of Uncomplicated and Complicated Urinary Tract
Infections from the EAU Urological Infections Guidelines
Panel. Eur
Urol. 2024;86(3):195-197.
[11] Wagenlehner
FME, et al. Epidemiology, definition and treatment of complicated
urinary tract infections. Nat Rev
Urol.
2020;17(10):586-600.
[12] Gomila
A, et al. Predictive factors for multidrug-resistant gram-negative
bacteria among hospitalised patients with complicated urinary tract
infections. Antimicrob
Resist Infect Control. 2018;7:111.
[13] Altunal
N, et al. Ureteral stent infections: a prospective
study. Braz J Infect
Dis.
2017;21(3):361-364.
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: June
17, 2026
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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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