A Comparative Review of Gepotidacin and Zoliflodacin for Treating Neisseria gonorrhoeae Infections

Abstract

Background

Gonorrhea remains a major global public health concern due to increasing antimicrobial resistance, particularly to ceftriaxone and azithromycin. The CDC and World Health Organization have identified Neisseria gonorrhoeae as an urgent threat, prompting the development of novel antibiotics. Gepotidacin and zoliflodacin, which are now approved by the FDA, both have unique mechanisms targeting bacterial topoisomerases. Both agents have been studied in completed phase 3 trials and may offer effective alternatives.

Objective

To describe and compare the clinical efficacy of gepotidacin and zoliflodacin in the treatment of genital N gonorrhoeae infections.

Methods

A systematic search was conducted in June 2025 using university library databases and EBSCO. Inclusion criteria were experimental studies with participants reporting safety or efficacy outcomes. Three studies met the criteria: 2 on gepotidacin and 1 on zoliflodacin. Data were extracted and organized by drug and outcome measure.

Results

In the studies, gepotidacin 3000 mg (2 doses) demonstrated noninferiority to standard care with a 92.6% cure rate, and zoliflodacin 3 g (single dose) showed a 96% cure rate, comparable to ceftriaxone. Both agents had reduced efficacy for pharyngeal infections but performed well in treating urogenital and rectal lesions.

Conclusion

Gepotidacin and zoliflodacin are effective for treating uncomplicated urogenital gonorrhea, with efficacy comparable to standard care. Gepotidacin’s evidence base is currently stronger. Further studies should focus on direct comparisons, diverse populations, and improved treatment of pharyngeal infections.

Introduction

Gonorrhea is the second most commonly reported sexually transmitted disease in the United States.^1,2 The CDC’s most recent surveillance data reported 601,319 cases nationally in 2023, and the most recent World Health Organization (WHO) data reported 82.4 million new cases occurring worldwide in 2020.^2,3 Complications from untreated gonorrhea include infertility, pelvic inflammatory disease, higher risk of HIV transmission and acquisition, congenital gonorrhea transmission, and death.^1,4 Neisseria gonorrhoeae, the pathogen that causes gonorrhea, has become increasingly formidable due to its growing resistance to existing antibiotic therapies, including decreased susceptibility to third-generation cephalosporins.⁵ Due to the limited antibiotic options and the continuous challenges of maintaining effective treatments for gonorrhea management, the CDC and the WHO have identified N gonorrhoeae as an “urgent threat,” placing it on a global priority list, and emphasized the urgent need for developing new drugs with novel mechanisms of action to combat this global public health threat.^5,6

The 2020 CDC Gonorrhea Treatment Recommendations and the 2021 Sexually Transmitted Infections Treatment Guidelines were developed to address individual treatment needs, protect public health, and reduce antimicrobial resistance.^1,4 Globally, a single 500-mg intramuscular dose of ceftriaxone (Rocephin; F. Hoffmann-La Roche), a third-generation extended-spectrum cephalosporin, is used in monotherapy or combination with 1 g of azithromycin as first-line therapy for the treatment of gonorrhea.⁷ The CDC’s US Guideline recommends 1 dose of ceftriaxone 500 mg intramuscularly for patients weighing less than 150 kg, and 1 dose of ceftriaxone 1000 mg intramuscularly for patients weighing 150 kg and more.⁴ This dual treatment regimen was recommended based on limited data that it may enhance treatment efficacy for pharyngeal gonococcal lesions and to empirically treat potential Chlamydia trachomatis genital coinfections.⁷ The dual therapy with ceftriaxone and azithromycin resulted in only marginal increases in minimum inhibitory concentration; however, concerns about the impact of dual therapy for treating uncomplicated genital N gonorrhoeae infections when only 1 agent is effective against the organism may needlessly harm the microbiome.⁴

Over the past 2 decades, there has been a global increase in the emergence of gonococcal strains showing resistance to cephalosporins and azithromycin, both in vitro and clinically.^2,5 Until new drugs become available, pharmacokinetic/pharmacodynamic data for ceftriaxone have been utilized to adjust its dosages. Developing drugs with novel mechanisms is crucial due to gonorrhea’s increasing resistance to existing treatments, and continued research is needed to stay ahead of its evolving resistance and ensure treatment options remain available.

A novel drug candidate must be able to circumvent N gonorrhoeae’s drug resistance mechanisms and prevent the emergence of new resistance mechanisms.⁸ This review draws on previous literature and outlines the mechanism of action and pharmacokinetics, as well as adverse events (AEs) reported in published trials of zoliflodacin and gepotidacin—2 novel drugs that have reached phase 3 clinical trials. Gepotidacin (Blujepa; GSK) is a triazaacenaphthylene, and zoliflodacin (Nuzolvence; Innoviva Specialty Therapeutics) is a spiropyrimidinetrione.⁹ Both agents completed their phase 3 clinical trials in 2024 with results.^10,11 Zoliflodacin targets DNA gyrase and was designed to overcome the resistance mechanisms associated with fluoroquinolone therapy.⁹ DNA gyrase is a type II topoisomerase essential for bacterial DNA replication. It introduces negative supercoils into relaxed chromosomal DNA and relieves the positive supercoiling that accumulates ahead of the replication fork. Gyrase accomplishes this by generating a transient double-strand break, passing a second duplex segment through the break, and religating DNA.¹² Gepotidacin targets topoisomerase IV, another enzyme that unwinds and cleaves DNA, in addition to DNA gyrase.⁹ Topoisomerase IV is superior to DNA gyrase in its ability to untangle knots secondary to positive supercoiling, but is unable to unwind a double helix structure. Topoisomerase IV’s primary function in this context is to unlink daughter DNA after DNA replication and resolve any DNA knots that occurred during the process (Online Figure 1).¹³

Because of the novelty of these drugs, practitioners who have not been following the pipeline since 2018 are likely unaware of them. This unawareness may result in therapeutic delays after approval. The FDA recently approved both agents for therapeutic use, a decision that was likely made from the previous 6-year pharmaceutical pipeline: Raccagni (2023) has summarized the primary outcomes for the phase 2 zoliflodacin and gepotidacin trials, but no systematic search strategy was used, and the summary was limited to the primary outcome.¹⁴ Watkins (2023) reviewed gepotidacin for all uses; however, limited efficacy data regarding its treatment of uncomplicated N gonorrhoeae infections were available at the time of its publication.^15,16

To the authors’ knowledge, no review that summarizes the clinical efficacy outcomes of both agents is available as of the submission date for this article. This review aims to provide pharmacy practitioners with information regarding novel pharmacotherapy to treat genital Neisseria gonorrhoeae given the treatments’ recent arrival to the market.

Methods

This review used a systematic search strategy that represented 2 concept domains: agent (gepotidacin and zoliflodacin) and disease (genital N gonorrhoeae infections).

Two platforms were used in June 2025 to conduct the systematic search: the authors’ university library catalog and EBSCO. Databases used from the library catalog were Gale Academic OneFile, Journals@Ovid, PubMed/MEDLINE, Scopus, and Web of Science. EBSCO included Academic Search Premier, CINAHL, and MasterFILE Premier. The finalized search terms used were “gepotidacin OR zoliflodacin AND gonorrhea” with all terms required in the title field. No additional filters were used, and grey literature was not searched as the authors anticipated few results due to the novelty of the topic. Inclusion criteria for studies were experimental methodology, safety or efficacy outcome, and human participants. Exclusion criteria were preclinical studies and no full text availability; the latter was not encountered in the review. Grey literature was not sought by the authors since the agents of interest were proprietary and in the clinical trial phase, the objective was to describe the clinical efficacy of these agents, and the inclusion criteria required experimental methodology. Content from ClinicalTrials.gov was used to give context to published data for included studies; however, only information regarding clinical efficacy was included.

The articles’ metadata was downloaded using 3 separate “.ris” files and uploaded into Rayyan. Duplicates were manually removed, and title and abstract screening were performed in Rayyan. Full text screening and extraction occurred simultaneously, and results were organized by drug and efficacy outcome measure. Results were then compiled and reported. Additionally, authors searched the ClinicalTrials.gov website and the Lexidrug database for available monographs.

Results

The PRISMA extension for Scoping Reviews was used for methodological guidance.¹⁷ Of the 85 studies screened, 3 met the inclusion criteria and were included in the review (Online Figure 2).¹⁸ Two studies examined clinical efficacy outcomes of gepotidacin, and there was 1 study for zoliflodacin. The small number of studies was expected by the authors, given the preapproval nature of these agents at the time of the search. Although the review’s scope is specific to efficacy outcomes and was not designed to address safety outcomes, there were AEs noted in each study. The phase 2 nature of 1 of the studies included makes safety comparison challenging until postmarketing studies with safety primary outcomes are published and finalized dosing and administration have been established. The only system organ class with greater than 5% AEs in either group consistently across studies was gastrointestinal disorders (27%-67% for gepotidacin; 7%-12% for zoliflodacin).

Gepotidacin Efficacy

Two gepotidacin studies met the criteria (Table 1). EAGLE-1 (NCT04010539) was a multicenter, open-label, parallel cohort noninferiority study (n = 406) conducted over 4 years.¹⁹ Patients were randomly assigned 1:1 to receive gepotidacin 3000 mg by mouth for 2 doses 10 to 12 hours apart (n = 202), or ceftriaxone 500 mg intramuscularly with azithromycin 1 g by mouth (n = 204), each for 1 dose. Patients were eligible if they were 12 years or older, weighed 45 kg or more, and had suspected uncomplicated urogenital N gonorrhoeae infection. Suspected infection required mucopurulent discharge (cervical discharge for females and urethral discharge for males) and/or microbiological confirmation of infection. Enrolled patients were assessed 4 to 8 days post treatment for culture-confirmed microbiological cure.¹⁹

A phase 2 dose-ranging study (Taylor 2018^b; NCT02294682; n = 69) compared oral single doses of gepotidacin 1500 mg (n = 30) or 3000 mg
(n = 39) for dose optimization in the phase 3 trial. Patients were recruited from 11 sites in the US and 1 site in the United Kingdom over 1 year. Patients were eligible if they were 18 years or older with suspected uncomplicated urogenital gonorrhea. Women who were pregnant or breastfeeding were not enrolled. Suspected infection was defined as a patient having purulent urethral or cervical discharge and one of the following: a positive prior culture or nucleic acid amplification test, a Gram stain positive for gram-negative diplococci from urethral specimens, or reported sexual contact with a partner diagnosed with gonorrhea in the previous 14 days.^20,21 Once enrolled, the patients returned for a culture-confirmed cure in a similar manner as with EAGLE-1.^19,20

EAGLE-1 investigators found that gepotidacin (two 3000-mg oral doses) had cure rates similar to those of standard care, meeting the noninferiority target of a difference greater than –10%, with an observed difference of –0.1% (95% CI, –5.6 to 5.5).¹⁹ The study used a modified intention-to-treat analysis that required microbiological confirmation of infection and a microbiological confirmation at follow-up of cure to be included in the analysis. The Taylor 2018^b study did not compare with a placebo or standard care control, as it was a dose-ranging study designed to determine optimal dosing based on efficacy, which informed the dosing for EAGLE-1. Taylor 2018^b found that the gepotidacin 1500-mg single dose and 3000-mg single dose groups had cure rates of 97% (95% CI, 85.1%-100.0%) and 95% (95% CI, 84.7%-100.0%), respectively.²⁰ The study did not use any comparative hypothesis testing between dose groups and used a microbiological per-protocol analysis. A summary of the primary outcomes and findings is available in Table 1.

Zoliflodacin Efficacy

A phase 2 trial (Taylor 2018^a; NCT02257918; n = 141) was conducted over 1 year and compared single oral doses of zoliflodacin 2 g (n = 57) and 3 g (n = 56) with single-dose intramuscular ceftriaxone 500 mg (n = 28) in a 70:70:40 ratio, respectively. Patients were eligible if they were aged 18 to 55 years, not pregnant or breastfeeding, and had suspected uncomplicated urogenital N gonorrhoeae infection based on signs or symptoms of urogenital gonorrhea, untreated urogenital gonorrhea, or reported sexual contact with a partner diagnosed with gonorrhea within the previous 14 days. Patients returned for clinically confirmed cure at day 6 ± 2 posttreatment and returned at day 31 ± 2 posttreatment for AE monitoring.¹⁹

Taylor 2018^a compared zoliflodacin 2 g by mouth for 1 dose, zoliflodacin 3 g by mouth for 1 dose, and intramuscular ceftriaxone 500 mg for 1 dose using a microbiological intention-to-treat analysis (Table 1). The primary outcome was overall cure rates at 31 ± 2 days after the intervention. The study found that the urogenital microbiologic cure rates were similar at 96% (95% CI, 80%-97%) for zoliflodacin 2 g, 96% (95% CI, 83%-99%) for zoliflodacin 3 g, and 100% (95% CI, 81%-100%) for standard care.¹⁹ Of note, cure rates for pharyngeal lesions appeared at less than 50% for zoliflodacin 2 g, 82% for zoliflodacin 3 g, and 100% for standard care; however, a comparative analysis using hypothesis testing was not conducted and a small number of participants (approximately 16%) of the sample who met the microbiological intention-to-treat criteria had pharyngeal lesions (8 for zoliflodacin 2 g, 11 for zoliflodacin 3 g, and
4 for standard care).¹⁹

Comparing Gepotidacin and Zoliflodacin

Although the available data are limited and the authors do not have access to the original study data for analysis, some simple comparisons can be made of the evidence presented for the use of gepotidacin and zoliflodacin for the treatment of N gonorrhoeae genital infections. The authors have made comparisons below based on the provided percentage data. It should be noted that without the original data sets, error cannot be adequately accounted for, which means a true difference between findings in different studies would be speculative until determined empirically.

The patient age, sex, and race demographics for each study are available in Table 2. Taylor 2018^a appeared to have a lower mean age.²² All study populations were predominantly male (range, 89%-95%). EAGLE-1 participants were predominantly White, whereas Taylor 2018^a and Taylor 2018^b enrolled similar ratios of White and Black patients.^19,20,22 Each study published cure rates either in a published article or the ClinicalTrials.gov database (Table 3).^19,20,22 Gepotidacin and zoliflodacin cure rates appear lower in the presence of pharyngeal lesions compared with urogenital or rectal lesions. Rectal cure rates were higher in the gepotidacin group compared with standard care in EAGLE-1 and were similar between groups in Taylor 2018^a and Taylor 2018^b. Cure rates for urogenital lesions appear similar among gepotidacin, zoliflodacin, and standard care.^19,20,22

Discussion

When analyzing these studies’ results, careful consideration was given to the method of analysis, designed study outcomes, sample, and patient demographics. Although the number of studies was low (n = 3) and the data limited, there are some important takeaways from this work that the authors have discussed below. Of note, direct comparisons are not possible given the lack of head-to-head studies and phase 3 zoliflodacin results at the time of search; however, some indirect comparisons are discussed.

Gepotidacin Efficacy

EAGLE-1 had the highest enrollment, had the most rigorous analysis, provided a direct comparison between groups, and had the most diverse study population of the 3 studies, which may make its findings more generally applicable than the other studies. This also reduces sampling biases, random error, and type II error.¹⁹ This is reflected in the narrower confidence intervals of the study’s findings compared with Taylor 2018^a and Taylor 2018^b.^20,22 Findings from EAGLE-1 did show noninferiority of gepotidacin 3000 mg by mouth for 2 doses compared with standard care. The study also analyzed the findings for superiority of gepotidacin to standard care, which was not successful. Cure rate success appeared greater than standard care for rectal lesions and much lower for pharyngeal lesions.¹⁹ Taylor 2018^b also found a lower cure rate with pharyngeal lesions, albeit with just 2 such cases occurring in the sample.²⁰ Some examples of potential causes could be pharmacodynamic/pharmacokinetic factors (ie, minimum inhibitory concentration, dosing, absorption, metabolism, or distribution) and bacterial factors such as differing resistance patterns by lesion.

Zoliflodacin Efficacy

Taylor 2018^a found a zoliflodacin cure rate similar to standard care, given that the 2-g and 3-g zoliflodacin groups were within 5% of standard care. It is important to give this additional context with factors such as the small sample size, unbalanced groups, and approximately ±10% error of the mean cure rates, which make the differences less reliable. For example, zoliflodacin 3 g has a 96% cure rate (95% CI, 83%-99%) compared with the standard care cure rate of 96% (95% CI, 81%-100%). This means that the study could be repeated many times over, and the most extreme (and extremely unlikely) finding that was within 2 SDs of the mean of all findings could be a cure rate of 83% for zoliflodacin 3 g and a standard care cure rate of 100%.²²

Similar to findings from EAGLE-1 and Taylor 2018^b, the rectal lesion cure rates held even as the pharyngeal lesion cure rates appeared to sharply fall, and standard care pharyngeal cure rates held.^19,20,22 The patient racial demographics were similar to Taylor 2018^b, with the notable difference that the population was predominantly Black individuals.^20,22 Neither Taylor 2018^b nor Taylor 2018^a has similar racial demographics to the actual prevalence in the US.^20,22

Comparing Clinical Efficacy for Gepotidacin and Zoliflodacin

Both gepotidacin and zoliflodacin have demonstrated similar cure rates to standard care. The standard care varied by study due to a change in the guideline that occurred between thestudies, but the authors are comfortable considering the 2 standards as similar from an efficacy standpoint, given that the CDC’s rationale for removing azithromycin from standard care was that efficacy was similar but the potential for resistance was concerning.¹ That said, the quality of evidence for the sampling and error issues mentioned above makes the gepotidacin findings from EAGLE-1 more impressive than those of Taylor 2018^a. Despite this, the available evidence still suggests that cure rates between the gepotidacin 3000-mg, 2-dose regimen and the zoliflodacin 3-g dose are similar compared with standard care. A direct comparison via hypothesis testing could generate empirical data that accounts for error, which would make this comparison more precise. Although the groups were unbalanced and the number of participants was small, gepotidacin may be superior to standard care in curing rectal N gonorrhoeae infections. Both agents appeared to have much lower clinical efficacy in treating pharyngeal N gonorrhoeae lesions. Ross noted that combining DNA gyrase mutations with another mutation has been associated with an increase in minimum inhibitory concentrations for N gonorrhoeae; however, this mutation was not observed in the study. Treatment failure at pharyngeal and rectal sites may be due to small sample size and Ross advises interpreting the pharyngeal treatment failure with caution.¹⁹

Further, inconsistencies with age and race/ethnicity between reports and the studies in the review are difficult to appreciate since the surveillance data are collected primarily from public health care facilities (eg, sexually transmitted disease clinics, adolescent clinics such as Planned Parenthood, county hospitals and clinics, federally qualified health centers). This may skew the reported ages of patients with gonorrhea toward younger and the racial/ethnic makeup toward marginalized (eg, Black and Hispanic/Latino) ethnic groups.

Limitations

The major limitation of this review is the lack of available studies due to the novelty of the agents of interest. Because of the current stage of development, the drugs have not generated many studies; however, this is the available evidence from which practitioners will have to make clinical decisions until postmarketing surveillance, small institutional studies, and clinical practice guidelines generate additional data or guidance.

Recommendations for Future Research

The authors have suggestions for future research based on the findings from the studies analyzed in this text. Due to the scope of the review, these suggestions have been restricted to clinical outcomes and sexually transmitted N gonorrhoeae infections. The authors recommend the following: Compare clinical efficacy directly to determine both agents’ place in therapy (this may now ethically occur after both have shown similar cure rates to standard care); establish a minimum clinically important difference for cure rates that can be published for further study; enroll more non-White and female patients in future studies—sex stratification is effective for between-group similarity, but more females and non-White patients must be enrolled as a larger percentage of the samples than have been done to date; further investigate bacterial genome or resistance mechanism differences in the N gonorrhoeae lesion sites; consider the impact of a higher dose or a new dosing scheme for pharyngeal lesions for gepotidacin and zoliflodacin; and empirically evaluate the difference between standard care and gepotidacin in rectal lesions.

Conclusion

The comparison of these 2 drugs in the treatment of urogenital gonorrhea infections could be made only from the 3 available studies that had such data. Gepotidacin 3000 mg by mouth for 2 doses 10 to 12 hours apart, and zoliflodacin 3 g by mouth for 1 dose have similar efficacy to standard care for treatment of uncomplicated urogenital N gonorrhoeae infections. Pharyngeal lesion cure rates were lower with both drugs compared with the standard care. Both drugs require additional study; however, the sampling and methods for 1 of the 2 gepotidacin studies were superior to those of the zoliflodacin study. Future studies should focus on direct comparisons between gepotidacin and zoliflodacin, more representative and robust enrollment, and investigating causes of differing cure rates by lesion.

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