EFFICACY & SAFETY

 

BLUJEPA demonstrated efficacy in 2 trials that included a range of female patients with uncomplicated urinary tract infections (uUTIs)1

BLUJEPA achieved noninferiority* to nitrofurantoin (NTF) in both trials and superiority† in EAGLE-31

Primary endpoint: therapeutic response (success/failure) at test-of-cure (TOC) visit (day 10-13) for the microbiological ITT NTF-S (interim analysis [IA] set) population1‡

EAGLE-2 and EAGLE-3 primary endpoint therapeutic success charts

Therapeutic success was defined as both clinical success (ie, total clinical symptom score for uncomplicated UTI of 0) and microbiological success (ie, reduction of qualifying bacterial uropathogens from ≥10⁵ CFU/mL at baseline to <10³ CFU/mL) without additional antibiotic use for uncomplicated UTI.1

  • *

    The Z statistic was used at the interim analysis to determine noninferiority. In both studies, the observed Z statistic exceeded the Z statistic boundary, indicating noninferiority to NTF. Noninferiority—Z statistic: EAGLE-2—observed 3.5554, boundary 2.065; EAGLE-3—observed 5.8838, boundary 2.098.1

  • †

    Having achieved noninferiority, superiority was then tested. Superiority was declared if the observed 1-sided P value was less than the boundary. EAGLE-2: observed P value 0.1445, boundary 0.019; no superiority. EAGLE-3: observed P value 0.0003, boundary 0.018; superiority achieved.1

  • ‡

    The micro ITT NTF-S (IA set): patients who were randomized, received ≥1 dose of study treatment, had 1 or 2 qualifying uropathogens (≥105 CFU/mL) at baseline that were susceptible to NTF, and, at interim analysis, had reached their TOC visit or had not yet reached their TOC visit but were known already to be therapeutic failures. Both trials stopped early for efficacy on the basis of a pre-specified interim analysis.1

  • §

    Treatment difference (BLUJEPA - NTF) calculated using Miettinen-Nurminen Summary Score method adjusted for age group and recurrent/nonrecurrent infection status combinations.1

Therapeutic success combines the symptom relief and uropathogenic eradication that patients need1

EAGLE-2 and EAGLE-3 were designed in accordance with current FDA guidance for uUTI trials, which includes stringent criteria for clinical trial design. The primary endpoint, therapeutic response, could be classified as either success or failure. Efficacy was based on therapeutic success, requiring both symptom resolution (clinical success) and eradication of qualifying uropathogens (microbiological success).1,2

Therapeutic success required both clinical success plus microbiological success graphic

CLINICAL SUCCESS: Complete resolution of all baseline signs and symptoms of acute cystitis (dysuria, urgency, frequency, and lower abdominal pain), no new signs or symptoms, and no additional antibiotic use for uUTI.1

MICROBIOLOGICAL SUCCESS: Eradication of qualifying uropathogens present at baseline (reduction from ≥105 CFU/mL to <103 CFU/mL) without additional antibiotic use for uUTI.1

Treatment was considered therapeutic failure in patients with any combination of microbiological failure, clinical failure, or missing data.1

SEE BLUJEPA CLINICAL TRIAL DESIGN
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94% (590/628) of patients treated with BLUJEPA did not require a second antibiotic through follow-up1‖

Results are descriptive only. No formal hypothesis test.

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91% (520/573) of patients treated with NTF did not require a second antibiotic through follow-up.1‖  

Results are descriptive only. No formal hypothesis test.

  • ‖

    Pooled data (EAGLE-2 and EAGLE-3) assessed at the follow-up visit in the micro ITT NTF-S population (complete data set).1

Evaluation of symptom improvement and safety of BLUJEPA in uUTI treatment: results from a phase 3b, open-label, single-arm, US study3**

 

Assessment of uUTI Clinical Symptom Score (CSS): calculated by rating uUTI symptoms—dysuria, frequency, urgency, and lower abdominal pain—on a 0-3 scale (none to severe) and summing for a total CSS (0-12).3

  • Symptom improvement: ≥1-point decrease from baseline in CSS
  • Symptom resolution: no symptoms (CSS of 0)
Two women looking forward, dressed in green and gray tops, against a vibrant blue background

Primary endpoint:

54.4% of clinically evaluable patients†† (49/90) experienced clinical symptom improvement or resolution at 24 hours after their first BLUJEPA dose3

 

Secondary endpoint:

~80% of clinically evaluable patients†† (71/89) experienced clinical symptom improvement or resolution at 48 hours after their first BLUJEPA dose3

Results are descriptive only. Data are from an open-label study that assessed clinical improvement via telephone visits.3

 

Adverse events (AEs) that occurred in ≥2% of patients were3:

  • Diarrhea (16%)
  • Flatulence (6%)
  • Dizziness (5%)
  • Abdominal pain (4%)
  • Headache (3%)
  • Abdominal discomfort (2%)
  • Nausea (2%)

 

AEs were mild or moderate in 93% (25/27) of patients; 2 patients experienced severe drug-related diarrhea.

No patients experienced C. difficile-associated diarrhea.

No serious AEs occurred.3

  • **

    Study included 97 female patients ≥12 years old who had: a body weight ≥40 kg; ≥2 uUTI symptoms (dysuria, frequency, urgency, or lower abdominal pain) with onset <96 hours prior to study entry; and nitrite or pyuria (presence of 3+/large leukocyte esterase) on a urine dipstick test from a pre-treatment clean-catch midstream urine sample. The in-person baseline visit was followed by telephone assessments at specific time points, including at 24 and 48 hours.3

  • ††

    Clinically evaluable patients must have taken 2 doses of BLUJEPA at 24 (±4) hours and at least 80% of planned doses at 48 (±4) hours, without using other systemic antimicrobials before CSS assessment conducted via telephone.3

C. difficile=Clostridioides difficile; uUTI=uncomplicated urinary tract infection.

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The safety of BLUJEPA was assessed in 2 clinical trials.

Learn about the safety profile from the BLUJEPA clinical trials.

SEE SAFETY DATA

Indication & Important Safety Info

Indication

Important Safety Information

Indication

BLUJEPA is indicated for the treatment of female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg) with uncomplicated urinary tract infections (uUTI) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis.

Usage to Reduce Development of Drug-Resistant Bacteria

To reduce the development of drug-resistant bacteria and maintain the effectiveness of BLUJEPA and other antibacterial drugs, BLUJEPA should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.

Important Safety Information

CONTRAINDICATIONS

BLUJEPA is contraindicated in patients with a history of severe hypersensitivity to BLUJEPA.

WARNINGS AND PRECAUTIONS

QTc Prolongation

  • A dose and concentration-dependent prolongation of the QTc interval has been observed with BLUJEPA. Avoid use of BLUJEPA in patients with a history of QTc prolongation or with relevant pre-existing cardiac disease, patients taking antiarrhythmic agents, and in patients receiving drugs that prolong the QT interval. Due to an increase in BLUJEPA exposure, avoid concomitant administration of BLUJEPA with strong CYP3A4 inhibitors, in patients with severe hepatic impairment (Child-Pugh Class C), and in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min).

Acetylcholinesterase Inhibition

  • Dysarthria and other adverse reactions potentially attributed to acetylcholinesterase inhibition have been reported with BLUJEPA, an acetylcholinesterase inhibitor. Increased cholinergic effects can be associated with severe adverse effects, including atrioventricular block, bradycardia, bronchospasm, seizures/convulsions, and vasovagal syncope. Monitor patients with underlying medical conditions that may be exacerbated by acetylcholinesterase inhibition and patients receiving succinylcholine-type neuromuscular blocking agents, systemic anticholinergic medications, or non-depolarizing neuromuscular blocking agents.

Hypersensitivity Reactions

  • Hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving BLUJEPA. If an allergic reaction to BLUJEPA occurs, discontinue the drug and institute appropriate supportive measures.

Clostridioides difficile-Associated Diarrhea

  • Clostridioides difficile infection (CDI) has been reported with nearly all systemic antibacterial agents, including BLUJEPA. Evaluate patients who develop diarrhea.
ADVERSE REACTIONS
  • The most common adverse reactions occurring in ≥1% of patients are diarrhea, nausea, abdominal pain, flatulence, headache, soft feces, dizziness, vomiting, and vulvovaginal candidiasis.
DRUG INTERACTIONS
  • CYP3A4 Inhibitors: Avoid coadministration of BLUJEPA with strong CYP3A4 inhibitors due to increased gepotidacin exposure.
  • CYP3A4 Inducers: Avoid coadministration of BLUJEPA with strong CYP3A4 inducers due to decreased gepotidacin exposure.
  • CYP3A4 Substrates: Avoid coadministration of BLUJEPA with drugs that are extensively metabolized by CYP3A4 and have a narrow therapeutic window.
  • Digoxin: Due to an increase in digoxin exposures, consider monitoring digoxin serum concentration, as appropriate, with concomitant administration of BLUJEPA.
USE IN SPECIFIC POPULATIONS
  • Renal Impairment: Avoid use of BLUJEPA in patients with severe renal impairment with eGFR <30 mL/min, including those receiving dialysis.
  • Hepatic Impairment: Avoid use of BLUJEPA in patients with severe hepatic impairment (Child-Pugh Class C).

Please see accompanying Prescribing Information, including Medication Guide, for BLUJEPA. 

To report SUSPECTED ADVERSE REACTIONS, contact GSK at gsk.public.reportum.com or 1-888-825-5249 or
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References

  1. Wagenlehner F, Perry CR, Hooton TM, 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. Lancet. 2024;403(10428):741-755. doi:10.1016/S0140-6736(23)02196-7

  2. US Department of Health and Human Services. Food and Drug Administration. Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment. Guidance for Industry. Published 2019. Accessed May 27, 2025. https://www.fda.gov/media/129531/download

  3. Data on file, GSK.