Drug Trials Snapshots: BLUJEPA
HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
LIMITATIONS OF THIS SNAPSHOT
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.
Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the BLUJEPA Prescribing Information for all of the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).
Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).
BLUJEPA (gepotidacin)
blu – JEP – ah
GlaxoSmithKline
Approval date: March 25, 2025
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
BLUJEPA is a triazaacenaphthylene bacterial type II topoisomerase inhibitor that 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.
How is this drug used?
BLUJEPA is an oral tablet that is taken as two tablets twice a day for five days.
Who participated in the clinical trials?
The FDA approved BLUJEPA based on evidence from 2 clinical trials that included 3136 adult and adolescent female patients with uUTI. The two trials were conducted at 219 sites in 15 countries. All patients were female. 1730 (55%) patients were from the United States. The average age of patients from the United States was 47 years, with ages ranging from 13 to 91 years. Patients from the United States were White (84.6%), Black or African American (12.4%), or of other races (3.0%).
How were the trials designed?
The benefit (efficacy) and safety of BLUJEPA were evaluated in two clinical trials of 3136 female patients with uUTI. Patients were enrolled in the trials if they met certain criteria and had at least two of the following symptoms: pain or burning while urinating, urinating frequently, needing to urinate urgently, or pain in the lower abdomen. However, despite having symptoms, not all patients had growth of bacteria on culture of their urine sample. In the clinical trials, a diagnosis of uUTI was made in patients who had the symptoms listed above and growth of a bacterium on urine culture (positive culture). In the two trials, adult and adolescent females with uUTI were chosen at random to receive either BLUJEPA or a comparator antibiotic. Neither the patient nor the investigator knew which treatment was given. The benefit of BLUJEPA was measured only in patients who had urinary symptoms and a positive urine culture before treatment (efficacy population) by comparing the percentage of patients treated with BLUJEPA versus the comparator antibiotic who experienced cure of their uUTI-related symptoms and had a negative urine culture after treatment.
How were the trials designed?
TTrial 1 was a randomized, double-blind clinical trial that included 1,531 adult females with uUTI who were randomized. A total of 1,526 patients received either oral BLUJEPA (1500 mg) twice daily for five days with food or oral nitrofurantoin 100 mg twice daily for five days. The efficacy population, which included all patients who had at least one uropathogen isolated at baseline (≥105 CFU/mL), received at least one dose of study drug, and had baseline uropathogen(s) susceptible to nitrofurantoin, consisted of 634 patients.
Trial 2 was a randomized, double-blind clinical trial that included 1,605 adult females with uUTI who were randomized. A total of 1,602 patients received either oral BLUJEPA (1500 mg) twice daily for five days with food or oral nitrofurantoin 100 mg twice daily for five days. The efficacy population, which included all patients who had at least one uropathogen isolated at baseline (≥105 CFU/mL), received at least one dose of study drug, and were infected with uropathogens susceptible to nitrofurantoin, consisted of 567 patients.
For both trials, efficacy was assessed as a composite of clinical cure and microbiological response at the Test of Cure (TOC) Visit (Study Day 10 to 13). Clinical cure was defined as resolution of all signs and symptoms of acute cystitis present at baseline and no new signs and symptoms without the patient receiving other systemic antimicrobials. Microbiological response was defined as having all qualifying uropathogens found at baseline at ≥105 CFU/mL reduced to <103 CFU/mL without the patient receiving other systemic antimicrobials.
DEMOGRAPHICS SNAPSHOT
The demographics and benefit (efficacy) data include the study participants who had both uUTI symptoms and a positive urine culture before treatment, who received at least one dose of BLUJEPA or comparator antibiotic, and who had baseline uropathogen(s) susceptible to nitrofurantoin.
All patients (100%) enrolled in the two clinical trials were female.
Figure 1. Baseline Demographics by Race (Efficacy Population)
Source: Adapted from FDA Review
Figure 2. Baseline Demographics by Age (Efficacy population)
Source: Adapted from FDA Review
Figure 3. Baseline Demographics by Ethnicity (Efficacy Population)
Source: Adapted from FDA Review
Who participated in the trials?
Table 1. Baseline Demographics, Efficacy Population
| Demographic | Trial 1 | Trial 2 | ||
| BLUJEPA | Nitrofurantoin | BLUJEPA | Nitrofurantoin | |
| Sex, n (%) | ||||
| Female | 336 (100.0) | 298 (100.0) | 292 (100.0) | 275 (100.0) |
| Age, years | ||||
| Mean (SD) | 52.0 (17.86) | 52.9 (17.25) | 49.3 (18.27) | 51.5 (18.41) |
| 54.0 | 53.5 | 50.0 | 52.0 | |
| Min, Max | 18.0, 88.0 | 17.0, 91.0 | 16.0, 86.0 | 15.0, 91.0 |
| Age categories, n (%) | ||||
| <18 | 0 | 2 (<1) | 1 (<1) | 2 (<1) |
| ≥ 18-50 | 145 (43.2) | 128 (43.0) | 147 (50.3) | 123 (44.7) |
| >50 | 191 (56.8) | 168 (56.4) | 144 (49.3) | 150 (54.5) |
| Race, n (%) | ||||
| American Indian or Alaska Native | 26 (7.7) | 31 (10.4) | 1 (<1) | 0 |
| Asian | 10 (3.0) | 8 (2.7) | 15 (5.1) | 21 (7.6) |
| Black or African American | 10 (3.0) | 10 (3.4) | 28 (9.6) | 19 (6.9) |
| Native Hawaiian or Other Pacific Islander | 1 (<1) | 0 | 0 | 0 |
| White | 283 (84.2) | 247 (82.9) | 247 (84.6) | 233 (84.7) |
| Multiple | 6 (1.8) | 2 (<1) | 0 | 2 (<1) |
| Missing | 0 | 0 | 1 (<1) | 0 |
| Ethnicity, n (%) | ||||
| Hispanic or Latino | 107 (31.8) | 94 (31.5) | 86 (29.5) | 62 (22.5) |
| Not Hispanic or Latino | 229 (68.2) | 204 (68.5) | 206 (70.5) | 213 (77.5) |
Source: Adapted from FDA Review
What are the benefits of this drug?
In Trial 1, among patients who had growth of a bacteria in their urine culture that was sensitive to the comparator antibiotic (nitrofurantoin), 51.8% of patients treated with BLUJEPA achieved overall success compared to 47.0% of patients treated with nitrofurantoin, showing the efficacy of BLUJEPA.
In Trial 2, among patients who had growth of a bacteria in their urine culture that was sensitive to the comparator antibiotic (nitrofurantoin), 58.9% of patients treated with BLUJEPA achieved overall success compared to 44.0% of patients treated with nitrofurantoin, showing the efficacy of BLUJEPA.
What are the benefits of this drug (results of trials used to assess efficacy)?
Table 2 summarizes the efficacy results at the TOC visit in the efficacy population in Trial 1 and Trial 2. BLUJEPA demonstrated efficacy in the efficacy population with uropathogens susceptible to the comparator.
TABLE 2. Composite Response, Clinical Cure, and Microbiological Response Rates at the Test-of-Cure Visit (Efficacy Population)
| Study Endpoint | BLUJEPA n/N (%) | Nitrofurantoin n/N (%) | Treatment Difference (95% CI)a |
| Trial 1 | |||
| Composite response | 174/336 (51.8) | 140/298 (47.0) | 5.3 (-2.4, 13.0) |
| Clinical cure | 224/336 (66.7) | 196/298 (65.8) | 1.5 (-5.8, 8.8) |
| Microbiological response | 244/336 (72.6) | 199/298 (66.8) | 6.0 (-1.2, 13.1) |
| Trial 2 | |||
| Composite response | 172/292 (58.9) | 121/275 (44.0) | 14.4 (6.4, 22.4) |
| Clinical cure | 199/292 (68.2) | 175/275 (63.6) | 4.3 (-3.4, 12.0) |
| Microbiological response | 213/292 (72.9) | 158/275 (57.5) | 15.5 (7.9, 23.1) |
Source: Adapted from BLUJEPA Prescribing Information.
Abbreviations: CI = confidence interval.
aTreatment difference (BLUJEPA – nitrofurantoin) calculated using Miettinen and Nurminen Summary Score method adjusting for age group and recurrent/non-recurrent infection status combinations.
Were there any differences in how well the drug worked in clinical trials among sex, race, and age?
- Sex: The trials only enrolled female patients.
- Race: The number of patients of races other than White was small; therefore, differences in how BLUJEPA worked among races could not be determined.
- Age: BLUJEPA worked similarly in patients below and above 50 years of age.
Table 3. Composite Response at the Test-of-Cure Visit by Subgroup, Efficacy Population, Trial 1
| Demographic Parameters | BLUJEPA | Nitrofurantoin | Difference in % (95% CI) |
|---|---|---|---|
| Age Group | |||
| ≤50 | 75/145 (51.7%) | 65/130 (50.0%) | 1.7% (-10.1%, 13.5%) |
| >50 | 99/191 (51.8%) | 75/168 (44.6%) | 7.2% (-3.2%, 17.4%) |
| Race | |||
| White | 144/283 (50.9%) | 115/247 (46.6%) | 4.3% (-4.2%, 12.8%) |
| American Indian or Alaska Native | 15/26 (57.7%) | 14/31 (45.2%) | 12.5% (-13.5%, 36.9%) |
| Black or African American | 7/10 (70.0%) | 6/10 (60.0%) | 10.0% (-31.4%, 48.3%) |
| Asian | 5/10 (50.0%) | 3/8 (37.5%) | 12.5% (-32.7%, 52.5%) |
| Native Hawaiian or Other Pacific Islander | 1/1 (100%) | 0 | NA |
| Multiple | 2/6 (33.3%) | 2/2 (100%) | -66.7% (-91.1%, 16.9%) |
| Ethnicity | |||
| Hispanic or Latino | 45/107 (42.1%) | 39/94 (41.5%) | 0.6% (-13.1%, 14.1%) |
| Not Hispanic or Latino | 129/229 (56.3%) | 101/204 (49.5%) | 6.8% (-2.6%, 16.1%) |
Source: Adapted from FDA Review
Abbreviations: CI, confidence interval
Table 4. Composite Response at the Test-of-Cure Visit by Subgroup, Efficacy Population, Trial 2
| Demographic Parameters | BLUJEPA | Nitrofurantoin | Difference in % (95% CI) |
|---|---|---|---|
| Age Group | |||
| ≤50 | 83/148 (56.1%) | 56/125 (44.8%) | 11.3% (-0.1%, 22.9%) |
| >50 | 89/144 (61.8%) | 65/150 (43.3%) | 18.5% (7.1%, 29.4%) |
| Race | |||
| White | 152/247 (61.5%) | 104/233 (44.6%) | 16.9% (8.0%, 25.6%) |
| Black or African American | 12/28 (42.9%) | 10/19 (52.6%) | -9.8% (-37.1%, 18.9%) |
| Asian | 7/15 (46.7%) | 7/21 (33.3%) | 13.3% (-18.6%, 43.6%) |
| American Indian or Alaska Native | 0/1 (0%) | 0 | NA |
| Multiple | 0 | 0/2 (0%) | NA |
| Missing | 1/1 (100.0%) | 0 | NA |
| Ethnicity | |||
| Hispanic or Latino | 43/86 (50.0%) | 22/62 (35.5%) | 14.5% (-1.8%, 29.8%) |
| Not Hispanic or Latino | 129/206 (62.6%) | 99/213 (46.5%) | 16.1% (6.6%, 25.4%) |
Source: Adapted from FDA Review
Abbreviations: CI, confidence interval
What are the possible side effects?
BLUJEPA may cause serious side effects including QTc prolongation (which can cause a serious heart rhythm problem), cholinergic effects, serious allergic reactions, or severe diarrhea caused by Clostridioides difficile.
Common side effects observed during the clinical trials of BLUJEPA for the treatment of adult and adolescent females with uUTI were diarrhea, nausea, abdominal pain, gas, headache, soft stools, dizziness, vomiting, and yeast infections.
Refer to the Medication Guide for more information.
What are the possible side effects (results of trials used to assess safety)?
The safety population includes all patients who received at least one dose of BLUJEPA or comparator. Table 5 summarizes the most common adverse reactions observed in the trials.
Table 5. Adverse Reactions Occurring in ≥1% of Uncomplicated Urinary Tract Infection Patients Treated with BLUJEPA (Trials 1 and 2 Pooled Data, Safety Population)
| Adverse Reaction | BLUJEPA N = 1,570 n (%) | Nitrofurantoin N = 1,558 n (%) |
| Diarrhea | 258 (16) | 51 (3) |
| Nausea | 146 (9) | 64 (4) |
| Abdominal paina | 60 (4) | 34 (2) |
| Flatulence | 43 (3) | 8 (<1) |
| Headache | 38 (2) | 40 (3) |
| Soft feces | 37 (2) | 8 (<1) |
| Dizziness | 29 (2) | 19 (1) |
| Vomiting | 28 (2) | 10 (<1) |
| Vulvovaginal candidiasis | 20 (1) | 18 (1) |
Source: BLUJEPA Prescribing Information
aAbdominal pain includes abdominal pain, abdominal pain upper, abdominal pain lower, abdominal tenderness, abdominal discomfort, and gastrointestinal pain.
Were there any differences in side effects among sex, race and age?
- Sex: The trials only enrolled female participants.
- Race: The occurrence of side effects was similar in White and Black or African American patients. The number of subjects of other races was too small to draw conclusions about other racial differences in side effects.
- Age: The occurrence of side effects was similar in patients younger and older than 65 years of age.
Were there any differences in side effects of the clinical trials among sex, race, and age groups?
Table 6. Adverse Events by Subgroup, Safety Population
| Subgroup | Gepotidacin 1500 mg BID (N=1570) n/Ns (%) | Nitrofurantoin 100mg BID (N=1558) n/Ns (%) |
|---|---|---|
| Sex | ||
| Female | 551/1570 (35.1) | 365/1558 (23.4) |
| Age group, years | ||
| Adolescents (12 to 17) | 4/14 (28.6) | 1/12 (8.3) |
| Adult (18 to 64) | 418/1203 (34.7) | 262/1169 (22.4) |
| ≥65 to 84 | 124/340 (36.5) | 96/361 (26.6) |
| ≥65 | 129/353 (36.5) | 102/377 (27.1) |
| ≥75 | 48/127 (37.8) | 52/148 (35.1) |
| ≥85 | 5/13 (38.5) | 6/16 (37.5) |
| Race | ||
| American Indian or Alaska Native | 17/64 (26.6) | 9/76 (11.8) |
| Asian | 14/74 (18.9) | 10/86 (11.6) |
| Black or African American | 41/113 (36.3) | 29/102 (28.4) |
| Multiple | 4/14 (28.6) | 2/10 (20.0) |
| Native Hawaiian or other Pacific Islander | 2/4 (50.0) | 0/1 (0) |
| White | 473/1300 (36.4) | 315/1283 (24.6) |
| Missing | 0/1 (0) | 0/0 (NA) |
| Ethnicity | ||
| Hispanic or Latino | 194/524 (37.0) | 104/500 (20.8) |
| Not Hispanic or Latino | 357/1046 (34.1) | 261/1058 (24.7) |
| Geographic Location | ||
| United States | 359/861 (41.7) | 235/863 (27.2) |
| Non-United States | 192/709 (27.1) | 130/695 (18.7) |
Source: Adapted from FDA Review
Abbreviations: BID, twice daily; N, number of subjects in treatment arm; n, number of subjects with adverse event; NA, not applicable; Ns, total number of subjects for each specific subgroup and were assigned to that specific arm
GLOSSARY
CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.