Blujepa (gepotidacin) / GSK - LARVOL DELTA

Clinical symptom improvement and resolution following uUTI treatment with gepotidacin: a post-hoc subgroup analysis (ESCMID Global 2026) - No abstract available

Clinical • Retrospective data • Nephrology

Daily improvement of activity impairment in patients with uncomplicated urinary tract infection treated with gepotidacin (ESCMID Global 2026) - No abstract available

Clinical • Infectious Disease • Nephrology

Activity impairment improvement with gepotidacin in patients with uncomplicated urinary tract infections: results from the phase III EAGLE-2 and EAGLE-3 trials (ESCMID Global 2026) - No abstract available

Clinical • P3 data • Infectious Disease • Nephrology

Antibacterial interactions of gepotidacin plus standard of care antimicrobials used to treat childhood acute severe bloody diarrhoea in low- and medium-income countries (LMICs) (ESCMID Global 2026) - No abstract available

Clinical

Stepwise evolution and clonal enrichment of gepotidacin resistance in Neisseria gonorrhoeae. (PubMed, Antimicrob Agents Chemother) - "We also found that the strain with preexisting GyrA D95A and ParC D86N more readily acquired A92T and developed high-level resistance under gepotidacin exposure. Our study highlights key mutational patterns and clonal backgrounds that promote gepotidacin resistance, emphasizing the need for optimized dosing strategies as well as targeted molecular surveillance to preserve its effectiveness."

Journal • Infectious Disease

Novel drugs approved by the EMA, the FDA and the MHRA in 2025: A year in review. (PubMed, Br J Pharmacol) - "Among the FIC drugs, it is worth mentioning the Nav1.8 channel inhibitor suzetrigine, the first non-opioid approved to palliate acute pain; the first positive allosteric modulator of transient receptor potential melastatin 8 (TRPM8), acoltremon, that increases basal tear production in dry eye disease, a globally common disorder; lerodalcibep, a 'third generation' adnectin inhibitor of the protease Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) to treat elevated LDL-c; and zoliflodacin and gepotidacin, both innovatively targeting bacterial topoisomerases to treat uncomplicated urinary tract infections. These approaches include: the combination of two FIC drugs, the RAF/MEK clamp avutometinib paired with the FAK/Pyk2 inhibitor defactinib, to block more efficiently the RAS-RAF-MEK-ERK/FAK oncogenic pathway in low-grade serous ovarian cancer; fitusiran, the first RNAi therapy for haemophilia, targeting for the first time the production of the natural..."

European regulatory • FDA event • Journal • Review • Bronchiectasis • Dry Eye Disease • Hematological Disorders • Hemophilia • Infectious Disease • Nephrology • Oncology • Ophthalmology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pain • Pulmonary Disease • Rare Diseases • Respiratory Diseases • Solid Tumor • NAV1 • TRPM8

Two new drugs for gonorrhea. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Infectious Disease

BLUJEPA (gepotidacin). (PubMed, Clin Ther) - No abstract available

Journal

Bacterial DNA topoisomerase IV and DNA gyrase inhibitors: history of the quinolones, their clinical usage and potential alternatives for the future. (PubMed, J Antimicrob Chemother) - "Fluoroquinolones such as levofloxacin and ciprofloxacin remain important and effective therapeutic options today due to their broad-spectrum antibacterial activity, chemical stability and high bioavailability. The clinical development of new non-quinolone bacterial topoisomerase inhibitors (for example, zoliflodacin, gepotidacin and fobrepodacin) offers a promising solution to these issues and has the potential to play a crucial role in combating the growing problem of antimicrobial resistance. This review article will discuss the evolution of quinolone and fluoroquinolone antibacterial agents as key topoisomerase inhibitors, examine their current clinical applications and challenges to future development, and explore the potential of new topoisomerase inhibitors."

Journal • Review • Infectious Disease

Simulating treatment effects for gonorrhoea using a within-host mathematical model. (PubMed, Infect Dis Model) - "This extended model was used to investigate different treatment regimens for two potential drugs: monotreatment with gepotidacin, and dual treatment with gentamicin and azithromycin. Although previous experimental results on antibiotic killing of intracellular NG are scarce, our findings highlight the need for further studies on this. This will be useful for testing putative new anti-gonorrhoea antibiotics."

Journal • Infectious Disease

The Drug Update: Recent drug approvals, winter 2026 edition. (PubMed, Nurse Pract) - "This article highlights the following new medications and vaccinations: suzetrigine (Journavx); gepotidacin (Blujepa); meningococcal groups A, B, C, W, and Y vaccine (Penmenvy); clesrovimab-cfor (Enflonsia); and acoltremon (Tryptyr). Additionally, this article highlights the recent approval of moderately to severely active Crohn's disease as a new indication for guselkumab (Tremfya)."

Journal • CNS Disorders • Crohn's disease • Dry Eye Disease • Gastroenterology • Immunology • Infectious Disease • Inflammatory Bowel Disease • Meningococcal Infections • Nephrology • Ophthalmology • Pain • Respiratory Diseases • Respiratory Syncytial Virus Infections

2025 New Drug Update (Part 2): Recent Approvals and Clinical Implications. (PubMed, Sr Care Pharm) - "This review synthesizes the latest evidence on recently approved medications including Atzumi™ and Brekiya® (dihydroergotamine mesylate) for migraine headaches, Attruby™ (acoramidis) for transthyretin amyloid cardiomyopathy, and Blujepa® (gepotidacin) for uncomplicated urinary tract infections. Insights are offered into prescribing considerations for these agents in older populations, potential drug-drug interactions, and administration and handling tips. This work will be of significant interest to health care professionals as they evaluate the appropriateness of these new therapeutic options."

Journal • Amyloidosis • Cardiac Amyloidosis • Cardiomyopathy • Cardiovascular • CNS Disorders • Infectious Disease • Migraine • Nephrology • Pain

A Study in Pediatric Participants Aged ≥2 to <12 Years With a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis Antibiotics (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P1 trial • Infectious Disease • Nephrology • Pediatrics

Development of an impedance-based fast antimicrobial susceptibility test for Neisseria gonorrhoeae. (PubMed, J Antimicrob Chemother) - "iFAST® AST results were concordant with the current clinical standards and measured in under 8 h. This method is therefore promising for the development of a rapid and accurate phenotypic N. gonorrhoeae antimicrobial susceptibility test."

Journal • Infectious Disease

Resistance of uropathogens to gepotidacin: a systematic review of in vitro antimicrobial susceptibility studies. (PubMed, Int J Antimicrob Agents) - "Gepotidacin has very good antimicrobial activity against a variety of pathogens that cause uUTIs. Importantly, it retains activity against uropathogen isolates that exhibit resistance to other antibiotics commonly used for UTIs making it a useful addition to a physician's therapeutic arsenal."

Journal • Preclinical • Review • Infectious Disease • Nephrology • Pneumonia

In vitro activity of gepotidacin against a challenging panel of multidrug-resistant Neisseria gonorrhoeae isolates. (PubMed, J Antimicrob Chemother) - "Overall, gepotidacin was active in vitro against this challenging panel of ceftriaxone-resistant gonococcal clinical isolates. Gepotidacin activity does not seem to be affected in this ceftriaxone-resistant set of strains. A structural analysis suggests that the rare GyrA A92P alteration identified in this study does not affect gepotidacin binding."

Journal • Preclinical • Infectious Disease

Safety and efficacy of gepotidacin in urinary tract infection: a GRADE-assessed systematic review and meta-analysis. (PubMed, J Antimicrob Chemother) - "Gepotidacin provides superior composite and microbiological outcomes relative to nitrofurantoin for female uUTI but is associated with increased mild-to-moderate gastrointestinal toxicity. Long-term tolerability and resistance surveillance are recommended."

Clinical • Journal • Retrospective data • Review • Infectious Disease • Nephrology

Gyrase and Topoisomerase IV as Antibacterial Targets for Gepotidacin and Zoliflodacin: Teaching Old Enzymes New Tricks. (PubMed, Int J Mol Sci) - "The first-in-class agents gepotidacin and zoliflodacin, respectively, were approved for human use in 2025, representing the first new antibacterial classes targeting these enzymes in decades. This commentary examines the mechanisms of action of these agents, contrasts their interactions with gyrase and topoisomerase IV relative to fluoroquinolones, and considers their potential to address resistance while preserving the long-term clinical viability of therapy directed against the bacterial type II topoisomerases."

Journal • Review

Comparing Strategies to Introduce Two New Antibiotics for Gonorrhea: A Modeling Study. (PubMed, Clin Infect Dis) - "In a model of US MSM, the equal allocation strategy for introducing new drugs for gonorrhea matched or outperformed the strategy of sequential introduction in terms of resistance prevalence."

Clinical • Journal • Infectious Disease

Gepotidacin (Blujepa) - a new antibiotic for uncomplicated UTI. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Infectious Disease • Nephrology

Early symptom response in patients with uncomplicated urinary tract infection treated with gepotidacin or nitrofurantoin: pooled analysis from two pivotal Phase 3 studies. (PubMed, Clin Infect Dis) - P3 | "Gepotidacin and nitrofurantoin provide meaningful and similar early relief from uUTI symptoms."

Journal • P3 data • Retrospective data • Infectious Disease • Nephrology

Current Advances in Developing New Antimicrobial Agents Against Non-Tuberculous Mycobacterium. (PubMed, Antibiotics (Basel)) - "While most candidates remain preclinical, several agents have advanced clinically in other infections, including gepotidacin (topoisomerase inhibitor; FDA-approved 2025 for urinary tract infection (UTI)), sulbactam-durlobactam (DBO β-lactamase inhibitor; FDA-approved 2023 for Acinetobacter baumannii complex), and contezolid, supporting repurposing opportunities for NTM. Conversely, SPR720 (gyrase B prodrug) was suspended after not meeting its Phase 2 endpoint in 2024, underscoring translational risk. Overall, the NTM pipeline is expanding, with near-term progress most likely from repurposed agents and optimised combinations, alongside earlier-stage candidates that target biofilms or resistance mechanisms. This review aims to provide a critical and up-to-date overview of emerging antimicrobial strategies against NTM, highlighting recent advances, translational challenges, and opportunities to accelerate the development of effective therapeutics."

Journal • Review • Infectious Disease • Nephrology • Nontuberculous Mycobacterial Disease • Respiratory Diseases

Combatting antimicrobial-resistant Neisseria gonorrhoeae: new antibiotics and the pipeline of antigonococcal therapeutics. (PubMed, Curr Opin Infect Dis) - "Recent advances in the development of antibiotics, biologics and small molecules against gonorrhea provide optimism against the stark background of multidrug-resistant gonorrhea. Ongoing surveillance remains critical to evaluate the efficacy of newly introduced treatments."

Journal • Review • Infectious Disease

Activities of the Novel Bacterial Topoisomerase Inhibitor OSUAB-0284 against the Biothreat Pathogen Bacillus anthracis and Its Type II Topoisomerases. (PubMed, ACS Infect Dis) - "Finally, OSUAB-0284 displayed efficacy in a mouse model of inhalation anthrax. These results provide mechanistic underpinnings supporting the use of gepotidacin and OSUAB-0284 against B. anthracis and suggest that they may be potential candidates for the treatment of anthrax."

Journal • Infectious Disease

In vitro activity of gepotidacin against Chlamydia trachomatis. (PubMed, J Antimicrob Chemother) - No abstract available

Journal • Preclinical • Infectious Disease