Gepotidacin for the Treatment of Uncomplicated Urogenital Gonorrhea

Abstract

Objective:

To review the efficacy and safety of gepotidacin for the treatment of uncomplicated urogenital gonorrhea (uUGG).

Data Sources:

A literature search of PubMed and Google Scholar (January 2010 to January 2026) was conducted using the terms gepotidacin and GSK2140944. Additional sources included conference abstracts, the manufacturer’s website, and prescribing information.

Study Selection and Data Extraction:

Relevant English-language studies evaluating the efficacy and safety of gepotidacin for uUGG were included.

Data Synthesis:

Gepotidacin is a first-in-class triazaacenaphthylene antibiotic with a novel mechanism of action and potent activity against Neisseria gonorrhoeae. In the phase 3 EAGLE-1 trial, gepotidacin demonstrated noninferiority to ceftriaxone plus azithromycin for uUGG treatment. It was generally well tolerated, with gastrointestinal adverse effects most commonly reported. Gepotidacin is administered as 3000 mg orally every 12 hours for 2 doses and is approved for adults and pediatric patients aged ≥12 years weighing ≥45 kg with limited or no alternative treatment options. Administration with food is recommended to reduce gastrointestinal adverse effects.

Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs:

Gepotidacin provides a new 2-dose oral option for uUGG treatment. Compared with ceftriaxone, the current drug of choice, oral administration may improve convenience and access. Similar to cefixime and zoliflodacin, its oral formulation may facilitate treatment while potentially reducing microbiome disruption compared with ceftriaxone.

Conclusions:

Gepotidacin is a promising oral antibiotic with a novel mechanism of action and demonstrated efficacy for uUGG treatment.

Keywords

gepotidacin gonorrhea uncomplicated urogenital gonorrhea antimicrobial resistance ceftriaxone

Introduction

Gonorrhea is one of the most common sexually transmitted infections (STIs) both worldwide and in the United States. The Centers for Disease Control and Prevention (CDC) estimated there were approximately 543 409 infections in the United States in 2023.¹ Comparatively, the World Health Organization (WHO) estimated there were approximately 82 million infections worldwide in 2020.² Neisseria gonorrhoeae, the causative organism of gonorrhea, is becoming increasingly resistant to antibiotics, making treatment challenging. In 2019, the CDC classified N. gonorrhoeae as an “urgent threat” in the United States, the highest level of threat recognized, because of increasing antimicrobial resistance and the potential for widespread dissemination.³ Furthermore, the WHO reported that resistance to ceftriaxone, the drug of choice for gonorrhea, increased from 0.8% in 2022 to 5% in 2024.⁴ Cephalosporins became the drugs-of-choice in the United States to treat gonorrhea in 2007, when fluoroquinolone resistance began to emerge in N. gonorrhoeae.⁵ In 2010, the CDC STI treatment guidelines began recommending the combination of a cephalosporin plus either azithromycin or doxycycline, even if the patient did not have concomitant chlamydia infection, in an attempt to temper the emergence of resistance in N. gonorrhoeae.⁶ However, resistance to cefixime and other oral cephalosporins began to emerge, and cefixime has currently been relegated to an alternative treatment.^6,7 Furthermore, azithromycin resistance has increased in N. gonorrhoeae as well as other pathogens, such as Mycoplasma genitalium, Shigella, and Campylobacter species.⁷ Azithromycin has a pronounced half-life, and therapeutic concentrations slowly diminish over time. This may predispose to the emergence of resistance to N. gonorrhoeae, particularly in cases of rectal and pharyngeal infections, which are more difficult to treat and require sustained drug concentrations for a prolonged period.^8,9 Because of increasing azithromycin resistance and concerns about the overall harm to the microbiome with azithromycin overuse, the 2021 CDC STI guidelines recommend only ceftriaxone for treatment of gonorrhea.⁷

Given this increasing antimicrobial resistance with N. gonorrhoeae, improved treatment options are needed to combat this important pathogen. In December 2025, the Food and Drug Administration (FDA) approved gepotidacin for the treatment of uncomplicated urogenital gonorrhea (uUGG) in adult and pediatric patients aged 12 years and older weighing at least 45 kg who either have limited or no other alternative pharmacotherapy options at a dose of 3000 mg orally every 12 hours for 2 doses.¹⁰ Gepotidacin is a new, first-in-class triazaacenaphthylene antibiotic initially approved by the FDA in March 2025 for the treatment of uncomplicated urinary tract infections (uUTIs) in women aged 12 years and older. A detailed review of gepotidacin for uUTIs has been previously published in the journal.¹¹ This article describes the pharmacology, pharmacokinetics and pharmacodynamics, spectrum of activity, efficacy, safety, dosing and administration, and role of gepotidacin for the treatment of uUGG.

Data Sources

A literature search was performed using PubMed (January 2010 to January 2026) and Google Scholar (January 2010 to January 2026) with the search terms gepotidacin and GSK2140944. All English-language articles of studies assessing the efficacy and safety of gepotidacin for the treatment of uUGG were included. Review articles, conference abstracts, references of articles, and the manufacturer’s website were evaluated for relevant data. Articles evaluating the use of gepotidacin for any indication other than uUGG were excluded.

Pharmacology, Pharmacokinetics, and Pharmacodynamics

Gepotidacin exerts its mechanism of action by selectively targeting and inhibiting both topoisomerase IV and DNA gyrase, thereby inhibiting DNA replication. This mechanism induces high levels of gyrase-mediated single-stranded breaks, resulting in potent bactericidal activity. While fluoroquinolones also target topoisomerase, they induce double-stranded DNA breaks. This difference, coupled with a distinct binding site from the fluoroquinolones, gives gepotidacin a novel mechanism of action and strong in vitro activity against pathogens resistant to fluoroquinolones and other antibiotic classes, such as cephalosporins and macrolides. Bacterial resistance to gepotidacin is possible through several potential mechanisms, including alterations of DNA gyrase and/or topoisomerase, plasma-mediated fluoroquinolone resistance genes, and the production of efflux pumps. However, target-specific cross-resistance to other antimicrobial agents has not been detected.^11-13

Gepotidacin undergoes oxidative metabolism primarily via CYP3A4 and is eliminated through both fecal and renal pathways, with 52% recovered in feces (including 30% as unchanged drug) and 31% recovered in urine (including 20% as unchanged drug). For the absorbed fraction of gepotidacin, renal excretion of the unchanged compound represents the main route of elimination. It has a terminal half-life of approximately 9.4 hours. Because of gepotidacin’s CYP3A4 metabolism, concern exists for potential drug-drug interactions. Concomitant use with strong CYP3A4 inhibitors (eg, itraconazole) should be avoided due to increased gepotidacin exposure and risk of adverse events, whereas coadministration with strong CYP3A4 inducers (eg, rifampin) should be avoided due to reduced concentrations and potential loss of efficacy. Drugs extensively metabolized by CYP3A4 that have a narrow therapeutic index (eg, quinidine, cyclosporin) should also be avoided. Coadministration of gepotidacin increases digoxin concentrations, and digoxin levels should be closely monitored if used concomitantly. Because gepotidacin may potentially prolong the QTc interval, it should be avoided in patients with a history of QTc prolongation or those receiving antiarrhythmics or other QTc-prolonging drugs; of note, QTc prolongation has not been observed in clinical trials with gepotidacin. Gepotidacin is a reversible acetylcholinesterase inhibitor, which may contribute to its gastrointestinal adverse effects and can potentiate the effects of succinylcholine-type neuromuscular blockers and other acetylcholinesterase inhibitors (eg, donepezil), warranting close monitoring for increased adverse effects. Conversely, gepotidacin may reduce the efficacy of systemic anticholinergics (eg, benztropine, oxybutynin) and nondepolarizing neuromuscular blocking agents, requiring monitoring for decreased therapeutic effect.¹⁰

Spectrum of Activity

Gepotidacin exhibits strong antibacterial activity against N. gonorrhoeae. A study conducted by Farrell and colleagues found the MIC₉₀ of gepotidacin to be 0.25 µg/mL, and it was shown to be bactericidal and to demonstrate no single-step resistance, indicating promising results.¹⁴ A separate study by Scangarella-Oman and colleagues found similar results, with an MIC₉₀ of 0.5 µg/mL.¹⁵ Gepotidacin also exhibits antibacterial activity against several other pathogens, particularly those associated with uUTIs, such as Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Staphylococcus saprophyticus. Notably, gepotidacin does not appear to be active against other organisms associated with STIs, such as Chlamydia trachomatis or Treponema pallidum.¹⁰

Clinical Trials

Gepotidacin has been studied in a phase 2 trial for the treatment of gonorrhea by Taylor and colleagues. This randomized, multicenter, open-label, dose-ranging study evaluated the efficacy and safety of 2 single oral doses of gepotidacin in 69 men and nonpregnant, nonlactating women aged 18 years and older with uUGG. Participants were stratified by sex and randomized to receive a single dose of 1500 mg (n=30) or 3000 mg (n=39). The microbiologically evaluable (ME) population included 69 (100%) urogenital, 2 (3%) pharyngeal, and 3 (4%) rectal specimens. Microbiological cure was achieved in 66/69 (96%) urogenital infections; the 3 failures involved isolates with a gepotidacin MIC of 1 μg/mL (the highest observed) and a shared resistance-associated mutation. Microbiological cure was observed in 1 out of 2 pharyngeal infections and all 3 rectal infections. No patients in either treatment group discontinued due to adverse events.¹⁶ The promising results from this phase 2 trial led to gepotidacin being further studied in the phase 3 EAGLE-1 trial.

EAGLE-1 was a phase 3, multicenter, randomized, controlled, open-label, noninferiority trial comparing oral gepotidacin with intramuscular (IM) ceftriaxone plus oral azithromycin for uUGG. Participants received either gepotidacin 3000 mg/dose orally in 2 doses given 10 to 12 hours apart or ceftriaxone 500 mg IM plus azithromycin 1 g orally as single doses.¹⁷ This dose of gepotidacin was selected to maximize efficacy and reduce the risk of developing resistance.¹⁸ Eligible participants had suspected urogenital gonococcal infection based on a positive N. gonorrhoeae test within 5 to 7 days before screening without prior treatment and/or characteristic urethral or cervical/vaginal discharge. The primary endpoint was microbiological success, defined as culture-confirmed eradication of N. gonorrhoeae from the urogenital site at the test-of-cure (TOC) visit (days 4-8). The intention-to-treat (ITT) population included all randomized participants. The microbiological ITT (micro-ITT) population comprised ITT participants who received at least 1 dose of study drug and had baseline ceftriaxone-susceptible N. gonorrhoeae. The ME population included micro-ITT participants who received assigned treatment, had evaluable TOC cultures, used no nonstudy antibiotics, and had no major protocol deviations.¹⁷ A summary of the results of the EAGLE-1 trial is shown in Table 1.

Table 1.

Summary of Results of the EAGLE-1 Clinical Trial of Gepotidacin for Uncomplicated Urogenital Gonorrhea.¹⁷

Reference	Design	Population	Antibiotic regimen	Number of patients in the ITT population^a	Patient demographics	Number of patients in the micro-ITT population^b	Microbiological success at TOC (95% CI)Treatment difference (95% CI); P value	Number of patients in the ME population^c	Microbiological success at TOC (95% CI)Treatment difference (95% CI)
EAGLE-1	Phase 3, MC, MN^d, P, R, OL, SB, AC, NI^e	Patients aged ≥12 years, weighing ≥45 kg, with clinical suspicion of a urogenital gonococcal infection and either a mucopurulent discharge, a positive laboratory test for N. gonorrhoeae, or both	GPO 3000 mg PO given 10-12 hrs apart	n=314	Mean age 33.9 yrs; men 89%; MSM 69%; White 74%; B/AA 16%; Asian 4%; AI/AN 3%; NH/PI/MR 4%; Hispanic or Latino 17%; mean BMI 24.50 kg/m²; CrCl ≥90 mL/min 94%; number of STIs in the past 12 mos ≥1 to ≤3 87%; number of gonorrhea infections in the past 12 mos ≥1 to ≤3 93%; HIV-positive 22%; azithromycin-nonsusceptible isolates 8%; ciprofloxacin-resistant isolates 54%; penicillin-resistant isolates 18%; tetracycline-resistant isolates 24%	n=202	92.6% (95% CI, 88.0 to 95.8) -0.1% (95% CI, -5.6 to 5.5); P=0.5072	n=187	100% (95% CI, 98.0 to 100) 0.0% (95% CI, -2.6 to 2.7)
EAGLE-1	Phase 3, MC, MN^d, P, R, OL, SB, AC, NI^e		CRO 500 mg IM single dose + AZM 1 g PO single dose	n=314	Mean age 33.7 yrs; men 89%; MSM 70%; White 77%; B/AA 12%; Asian 5%; AI/AN 3%; NH/PI/MR 2%; Hispanic or Latino 20%; mean BMI 24.38 kg/m²; CrCl ≥90 mL/min 95%; number of STIs in the past 12 mos ≥1 to ≤3 92%; number of gonorrhea infections in the past 12 mos ≥1 to ≤3 97%; HIV-positive 22%; azithromycin-nonsusceptible isolates 10%; ciprofloxacin-resistant isolates 53%; penicillin-resistant isolates 16%; tetracycline-resistant isolates 26%	n=204	91.2% (95% CI, 86.4 to 94.7)	n=186	100% (95% CI, 98.0 to 100)

Abbreviations: AC, active-controlled; AI/AN, American Indian or Alaska Native; AZM, azithromycin; B/AA, Black or African American; BMI, body mass index; CI, confidence interval; CrCl, creatinine clearance; CRO, ceftriaxone; DB, GPO, gepotidacin; hrs, hours; IM, intramuscularly; ITT, intention-to-treat; MC, multicenter; ME, microbiologically evaluable; micro-ITT, microbiological intention-to-treat; MN, multinational; mos, months; MSM, men who have sex with men; NH/PI/MR, Native Hawaiian or other Pacific Islander or mixed race; NI, noninferiority; OL, open-label; P, prospective; PO, orally; R, randomized; SB, sponsor-blinded; STIs, sexually transmitted infections; TOC, test-of-cure; yrs, years.

Included all patients who were randomly assigned to a study treatment.

Included all patients in the ITT population who received ≥1 dose of their study treatment and had confirmed ceftriaxone-susceptible N. gonorrhoeae isolated from the baseline culture of their urogenital specimen.

Included all patients in the micro-ITT population and who (1) received all planned treatment doses as randomly allocated and their actual treatment was the same as the randomly allocated treatment; (2) had a urogenital specimen collected at TOC with available culture results; (3) had not taken any systemic antibiotic other than those included in the study; and ( 4) had no major protocol deviation that prevented evaluation of efficacy.

Included 49 sites in Australia, Germany, Mexico, Spain, the United Kingdom, and the United States.

Margin of noninferiority was set at -10%.

The ITT population included 314 participants per treatment group; the micro-ITT population included 202 gepotidacin and 204 comparator recipients; and the ME population included 187 and 186 participants, respectively. In the micro-ITT population, microbiological success occurred in 92.6% of gepotidacin-treated patients and 91.2% of comparator-treated patients (treatment difference, −0.1%; 95% CI, −5.6 to 5.5; p=0.5072), meeting the noninferiority criterion; superiority was not demonstrated. The reason for all microbiological failures was inclusion in the “unable to determine category,” which included improper specimen submission, specimen not collected, patient did not return for the TOC visit, and use of other systemic antimicrobials. No microbiological failures were attributed to bacterial persistence. In the ME population, microbiological success was 100% in both groups (treatment difference, 0.0%; 95% CI, −2.6 to 2.7).¹⁷

In subgroup analyses of the micro-ITT population, microbiological success among women was 94.1% in both groups (n=17 each; treatment difference, 0.0%; 95% CI, −22.6 to 22.6). Among men who have sex with men, success occurred in 92.4% of gepotidacin recipients (n=144) and 94.5% of comparator recipients (n=146; treatment difference, −2.2%; 95% CI, −8.4 to 3.8). Among men who have sex with women, success occurred in 92.7% and 78.0% of participants, respectively (n=41 per group; treatment difference, 14.6%; 95% CI, −0.8 to 30.7).

Among participants with rectal gonorrhea, microbiological success occurred in 100% of gepotidacin recipients (n=26) and 80.0% of comparator recipients (n=15; treatment difference, 20.0%; 95% CI, 5.2 to 45.5), with no failures attributed to bacterial persistence. Conversely, among participants with pharyngeal gonorrhea, success occurred in 77.8% of gepotidacin recipients (n=18) and 94.1% of comparator recipients (n=17; treatment difference, −16.3%; 95% CI, −41.1 to 8.8), with 2 cases of bacterial persistence in the gepotidacin group. Results in both extragenital subgroups were limited by small sample sizes.¹⁷

In participants with phenotypic antibiotic-nonsusceptible or -resistant N. gonorrhoeae, microbiological success at TOC exceeded 85% in both treatment groups, and no post-treatment reductions in antimicrobial susceptibility were observed in the ITT population. The higher gepotidacin dosing regimen used in EAGLE-1 may have mitigated resistance development observed in the phase 2 trial, but it could also compromise patient adherence due to adverse effects. Adverse events and drug-related adverse events were more frequent with gepotidacin than the comparator (74 and 68% versus 33 and 14%, respectively) and were primarily mild-to-moderate gastrointestinal events, with the most common reported being diarrhea and nausea; no treatment-related severe or serious adverse events occurred. These adverse events occurred more frequently in EAGLE-1 than in the EAGLE-2 and EAGLE-3 trials for uUTIs, likely because of the higher dosing regimen of gepotidacin used for uUGG versus uUTIs (3000 mg 10-12 hours apart versus 1500 mg twice daily for 5 days).^17,19 Overall, EAGLE-1 demonstrated that gepotidacin was non-inferior to ceftriaxone plus azithromycin for uUGG in a predominantly White, young, and healthy male population.¹⁷

Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs

Increasing antimicrobial resistance in N. gonorrhoeae has prompted a need for alternative antimicrobial agents. Gepotidacin is a new, first-in-class antimicrobial with strong activity against N. gonorrhoeae and favorable results in clinical trials. The current recommendation for the treatment of gonorrhea in the United States is a single dose of ceftriaxone 500 mg given IM for those weighing less than 150 kg and 1 gram for those weighing 150 kg or more.⁷ While effective for the treatment of gonorrhea, there are concerns of increasing resistance to ceftriaxone.⁴ In addition, there are other concerns about the harm to the overall microbiome, especially because ceftriaxone is commonly used in a variety of disease states in both outpatient and inpatient settings. Previous literature has demonstrated concerns, including increased antimicrobial resistance, with overuse and inappropriate use of ceftriaxone, highlighting the need for additional treatment options for gonorrhea.^20-25 In the EAGLE-1 trial, gepotidacin demonstrated comparable efficacy to the combination of ceftriaxone and azithromycin, the treatment of choice for gonorrhea at the time of the trial, in a predominantly White, young, and healthy male population.¹⁷

Gepotidacin has several potential advantages over ceftriaxone for the treatment of gonorrhea. Ceftriaxone is a parenteral antimicrobial and requires IM administration, whereas gepotidacin is available orally and can thus be administered more easily to patients. This may be particularly helpful for patients who have a fear of needles, cannot tolerate the discomfort of IM injections, or prefer a more convenient telehealth visit. In addition, the use of gepotidacin for gonorrhea may cause less overall harm to the microbiome compared with the more broad-spectrum ceftriaxone. Besides gonorrhea, gepotidacin is only used for the treatment of uUTIs, whereas ceftriaxone is much more widely used in a variety of disease states. The 2021 CDC STI guidelines recommend either single-dose oral cefixime or single-dose IM gentamicin plus single-dose oral azithromycin for the treatment of gonorrhea when ceftriaxone cannot be used.⁷ Gepotidacin may offer several advantages over these alternative regimens. Cefixime, which is also recommended for expedited partner therapy when a partner is unable or unwilling to receive ceftriaxone, achieves lower and less sustained serum concentrations than ceftriaxone, potentially limiting its effectiveness. Therefore, gepotidacin may represent a more effective and feasible option for expedited partner therapy than cefixime or ceftriaxone. Similar to ceftriaxone, gentamicin requires IM administration. Accordingly, gepotidacin may have a potential role as a preferred alternative when ceftriaxone cannot be used.

Zoliflodacin is a novel antimicrobial that received FDA approval for the treatment of uUGG one day after gepotidacin.^26,27 Like gepotidacin, it has a unique mechanism of action and is administered orally as a powder for reconstitution. However, zoliflodacin requires only a single dose for uUGG treatment, which may improve adherence.²⁷ In contrast, some patients may prefer the oral tablet formulation of gepotidacin over the reconstituted liquid formulation of zoliflodacin. The 2 agents have not been evaluated in direct comparative trials, and it remains uncertain whether either offers superior efficacy or tolerability. Nevertheless, both may offer advantages over ceftriaxone due to their oral administration, particularly for expedited partner therapy.

Gepotidacin may not be suitable for all patients with gonorrhea. It was not well-studied in women and was approved on the basis of limited clinical safety data for this indication. Gepotidacin requires 2 doses given 10-12 hours apart for the treatment of gonorrhea. While the initial dose could theoretically be administered at the time of diagnosis, the second dose would likely be self-administered by the patient outside of the healthcare system, which may be problematic for patients with adherence concerns. Each dose requires four 750 mg tablets to reach the recommended 3000 mg, further raising concerns about adherence.¹⁰ If patients do not take the second required dose, there is also the potential for the development of gepotidacin resistance in N. gonorrhoeae. In addition, while well-tolerated overall, gepotidacin causes more gastrointestinal adverse effects compared with ceftriaxone. The potential for drug-drug interactions is also likely greater with gepotidacin compared to that of ceftriaxone. Furthermore, gepotidacin has not been extensively studied for the treatment of gonorrhea infections of the pharynx and rectum, and further studies should be conducted. Finally, because gepotidacin is a newly approved drug and available by brand only, some insurances may not cover the drug as formulary; therefore, cost and access may be a barrier to many patients.

Summary and Conclusions

In summary, gepotidacin is a recently approved, first-in-class triazaacenaphthylene antibiotic with a novel mechanism of action that has been shown to have comparable efficacy with ceftriaxone plus azithromycin for the treatment of uUGG. With increasing resistance to ceftriaxone, and the need for IM administration of ceftriaxone, gepotidacin represents an attractive new oral treatment for uUGG. Further studies are needed to fully assess the safety and efficacy of gepotidacin for the treatment of gonorrhea in a more diverse patient population.

Footnotes

ORCID iDs

Spencer H. Durham

Amanda K. McAllister

Elias B. Chahine

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

References

Centers for Disease Control and Prevention. Sexually transmitted infections surveillance, 2024 (Provisional). Updated September 24, 2025. Accessed November 15, 2025. https://www.cdc.gov/sti-statistics/annual/index.html

World Health Organization. Sexually transmitted infections (STIs). Updated September 10, 2025. Accessed November 15, 2025. https://www.who.int/news-room/fact-sheets/detail/sexually-transmitted-infections-(stis)

CDC. Antibiotic Resistance Threats in the United States, 2019. U.S. Department of Health and Human Services, CDC; 2019.

Enhanced Gonococcal Antimicrobial Surveillance Programme (EGASP): Gonorrhoea Treatment Optimization , 2025 Report. World Health Organization; 2025.

CDC. Update to CDC’s sexually transmitted diseases treatment guidelines, 2006: fluoroquinolones no longer recommended for treatment of gonococcal infections. MMWR Morb Mortal Wkly Rep. 2007;56:332-336.

CDC. Sexually transmitted disease surveillance 2013. US Department of Health and Human Services, CDC; 2014. Accessed March 18, 2026. https://www.cdc.gov/std/stats/archive/Surv2013-Print.pdf

Workowski

Bachmann

Chan

, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021;70:1-187.

Wind

de Vries

Schim van der Loeff

, et al. Decreased azithromycin susceptibility of Neisseria gonorrhoeae isolates in patients recently treated with azithromycin. Clin Infect Dis. 2017;65:37-45. doi:10.1093/cid/cix249

Kong

FYS

Horner

Unemo

Hocking

. Pharmacokinetic considerations regarding the treatment of bacterial sexually transmitted infections with azithromycin: a review. J Antimicrob Chemother. 2019;74:1157-1166. doi:10.1093/jac/dky548

10.

Blujepa. Prescribing Information. Glaxosmithkline; 2025. Accessed December 12, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218230s000lbl.pdf

11.

Durham

Chahine

EB.

Gepotidacin: a novel antibiotic for the treatment of uncomplicated urinary tract infections. Ann Pharmacother. 2026;60(1):66-75. doi:10.1177/10600280251343682

12.

Bax

Chan

Eggleston

, et al. Type IIA topoisomerase inhibition by a new class of antibacterial agents. Nature. 2010;466:935-940. doi:10.1038/nature09197

13.

Biedenbach

Bouchillon

Hackel

, et al. In vitro activity of gepotidacin, a novel triazaacenaphthylene bacterial topoisomerase inhibitor, against a broad spectrum of bacterial pathogens. Antimicrob Agents Chemother. 2016;60(3):1918-1923. doi:10.1128/AAC.02820-15

14.

Farrell

Sader

Rhomberg

Scangarella-Oman

Flamm

RK.

In vitro activity of gepotidacin (GSK2140944) against Neisseria gonorrhoeae. Antimicrob Agents Chemother. 2017;61:e0204716. doi:10.1128/AAC.02047-16

15.

Scangarella-Oman

Hossain

Dixon

, et al. Microbiological analysis from a phase 2 randomized study in adults evaluating single oral doses of gepotidacin in the treatment of uncomplicated urogenital gonorrhea caused by Neisseria gonorrhoeae. Antimicrob Agents Chemother. 2018;62(12):e01221-18. doi:10.1128/AAC.01221-18

16.

Taylor

Morris

Avery

, et al. Gepotidacin for the treatment of uncomplicated urogenital gonorrhea: a phase 2, randomized, dose-ranging, single-oral dose evaluation. Clin Infect Dis. 2018;67(4):504-512. doi:10.1093/cid/ciy145

17.

Ross

JDC

Wilson

Workowski

, et al. Oral gepotidacin for the treatment of uncomplicated urogenital gonorrhoea (EAGLE-1): a phase 3 randomised, open-label, non-inferiority, multicentre study. Lancet. 2025;405(10489):1608-1620. doi:10.1016/S0140-6736(25)00628-2

18.

Scangarella-Oman

Hossain

Perry

, et al. Dose selection for a phase III study evaluating gepotidacin (GSK2140944) in the treatment of uncomplicated urogenital gonorrhoea. Sex Transm Infect. 2023;99(1):64-69. doi:10.1136/sextrans-2022-055518

19.

Wagenlehner

Perry

Hooton

, 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

20.

Sileshi

Tenna

Feyissa

Shibeshi

Evaluation of ceftriaxone utilization in medical and emergency wards of Tikur Anbessa specialized hospital: a prospective cross-sectional study. BMC Pharmacol Toxicol. 2016;17:7. doi:10.1186/s40360-016-0057-x

21.

Phuphuakrat

Kiertiburanakul

Malathum

Factors determining the appropriateness of ceftriaxone usage at the emergency room of a university hospital in Thailand. J Med Assoc Thai. 2013;96(7):773-781.

22.

Xie

Charles

Urbancic

Inappropriate ceftriaxone use in the emergency department of a tertiary hospital in Melbourne, Australia. Emerg Med Australas. 2013;25(1):94-96. doi:10.1111/1742-6723.12037

23.

Tafere

Endeshaw

Demsie

, et al. Inappropriate ceftriaxone utilization and predictor factors in Ethiopia: a systematic review and meta-analysis. Sci Rep. 2024;14(1):25035. doi:10.1038/s41598-024-75728-z

24.

Kutyabami

Munanura

Kalidi

, et al. Evaluation of the clinical use of ceftriaxone among in-patients in selected health facilities in Uganda. Antibiotics. 2021;10(7):779. doi:10.3390/antibiotics10070779

25.

Durham

Wingler

Eiland

LS.

Appropriate use of ceftriaxone in the emergency department of a veteran’s health care system. J Pharm Technol. 2017;33(6):215-218. doi:10.1177/8755122517720293

26.

U.S Food and Drug Administration. FDA approves two oral therapies to treat gonorrhea. December 12, 2025. Accessed March 6, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-two-oral-therapies-treat-gonorrhea

27.

Nuzolvence (zoliflodacin). Prescribing Information. Innoviva Specialty Therapeutics; 2025. Accessed March 6, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219491Orig1s000lbl.pdf