Is Blujepa Right for You? Latest FDA Treatment For UUTI in 2025

Blujepa (gepotidacin) FDA approval was granted on March 25, 2025, to GSK GlaxoSmithKline. Its launch date is expected to be the second half of 2025.

What Is The Use Of Blujepa?

Blujepa (Gepotidacin) is a new antibiotic tablet for the treatment of simple urinary tract infections (uUTI) in women and girls aged 12 years and over.

A simple urinary tract infection (uUTI) is a bacterial infection that affects only the lower urinary tract and is indicated for women who are otherwise healthy and do not have other medical conditions such as diabetes, urinary complications, pregnancy or immunocompromised status.

Blujepa is a new type of antibiotic, known as a triazaphenylethane antibiotic, that works in a different way than other antibiotics and has a lower likelihood of developing antibiotic resistance.

Blujepa works by targeting and blocking two essential enzymes required for bacterial DNA replication, DNA gyrase (topoisomerase II) and topoisomerase IV. Blujepa is bactericidal, meaning it kills bacteria, not just inhibits their growth.

How Does Blujepa Work?

Blujepa’s mechanism of action is to block two bacterial type II topoisomerases, bacterial topoisomerase II (DNA rotamase) and topoisomerase IV, which are necessary for bacterial replication.

By blocking these two enzymes, it inhibits bacterial DNA replication and kills the bacteria.

Gepotidacin is an inhibitor of the bacterial type II topoisomerase enzyme of triazapenem.

Efficacy & Clinical Trial

Blujepa had positive results in the Phase III EAGLE-2 (NCT04020341) and EAGLE-3 (NCT04187144) clinical trials.

The EAGLE3 clinical trial demonstrated that Gepotidacin was superior to furadantoin in the treatment of uUTIs in women 12 years of age and older:

58.5% of Gepotidacin patients had treatment success compared to 43.6% of patients taking furotoxin (adjusted difference of 14.6%)

The EAGLE-2 clinical trial demonstrated that it is not inferior to furotoxin:

50.6% of patients treated with Gepotidacin had treatment success compared to 47.0% of patients treated with furotoxin (adjusted difference of 4.3%)

Treatment success was defined as a combination of clinical success (complete resolution of symptoms) and microbiologic success (reduction of competent urinary tract pathogens to <103 CFU/mL) without the use of other systemic antimicrobials.

The EAGLE-2 and EAGLE-3 trials compared the therapeutic efficacy of Gepotidacin1500 mg twice daily for 5 days with the therapeutic efficacy of furaztoxin 100 mg twice daily for 5 days of oral treatment in female patients 12 years of age and older who weighed 40 kilograms or more and who had a confirmed diagnosis of uUTI.

Dosage And Administration

💊The recommended dose of Gepotidacin is 1,500 mg (two 750 mg tablets) taken orally twice daily (approximately 12 hours apart) for 5 days.

💊Take Gepotidacin orally twice a day (approximately 12 hours apart) for 5 days.

💊Take Gepotidacin tablets with meals to minimize the potential for gastrointestinal intolerance.
Possibility of gastrointestinal intolerance.

Drug Interactions

❗Avoid combining BLUJEPA with strong CYP3A4 inhibitors.

❗Avoid combining it with strong CYP3A4 inducers.

❗Avoid concomitant administration of it with drugs that are extensively metabolized by CYP3A4 and have a narrow therapeutic window.

❗Due to increased digoxin exposure, consider monitoring digoxin serum concentrations, as appropriate, during concomitant administration of it.

Blujepa Side Effects

The most common adverse reactions occurring in ≥1% of patients are:

🔴diarrhea,

🔴nausea,

🔴abdominal pain,

🔴flatulence,

🔴headache,

🔴soft feces,

🔴dizziness,

🔴vomiting,

🔴vulvovaginal candidiasis.

Serious side effects and warnings:

🔴QTc prolongation (Fast, pounding, or uneven heartbeat, Feeling lightheaded, Dizziness, Losing consciousness (pass out), Feeling faint)

🔴Cholinergic effects (Diarrhea, Vomiting, Feeling faint, Trouble saying words clearly, Muscle spasms, Nausea, Increased saliva, Increased sweating, Stomach pain)

🔴Hypersensitivity Reactions (Hives, Feeling faint or dizzy, Rash, Swelling of your lips, tongue, or throat)

🔴Diarrhea cramps, Diarrhea that does not go away, Fever, Watery diarrhea, Bloody bowel motions)

Blujepa Cost

Although the exact price of Blujepa is not yet available, it is expected to be more expensive than standard alternatives. As the launch date approaches, stay tuned to DengYue, a pharmaceutical wholesaler in Hong Kong, for more affordable pricing options.

Gepotidacin is expected to be available in the second half of 2025.

About DengYueMed – HK Drug Wholesale Distributor

As a legally compliant drug import and export company, DengYueMed is certified by the pharmacy & poisons board of Hong Kong — you can verify our qualification on their official website.

Our efforts to improve the affordability of Blujepa medicine aim to ensure that more patients can benefit from this important medication.

HK DengYue provides detailed medicine information, transparent pricing, and responsive support to ensure a smooth and reliable buying experience.

Feel free to reach out anytime to discuss your needs or ask questions about the medicine.

We welcome you to contact us for a consultation.