zoliflodacin (ETX0914) / Global Antibiotic Research and Development Partnership, Innoviva - LARVOL DELTA

Zoliflodacin Maintains High Rates of Microbiologic Eradication of Urogenital Neisseria gonorrhoeae in Patients Co-infected with Chlamydia trachomatis (IDWeek 2026) - No abstract available

Clinical • Infectious Disease

Novel potential treatment options for infections caused by multi-drug and extensively drug-resistant neisseria gonorrhoeae strains. (PubMed, Expert Rev Anti Infect Ther) - "Zoliflodacin and gepotidacin have the potential to optimize gonorrhea management as oral alternatives to current injectable ceftriaxone...Looking ahead, gonorrhea management will hopefully shift from empirical, syndromic treatment toward etiology-guided and AMR-informed therapy, driven by advances in rapid point-of-care testing and whole-genome sequencing technologies. Continuous phenotypic and genomic surveillance remains essential to detect early AMR signals, transmission of AMR strains, and inform treatment guidelines."

Journal • Review • Infectious Disease

Importance of the gonococcal MtrCDE efflux pump system in decreasing bacterial susceptibility to zoliflodacin: implications for future clinical treatment of gonorrhea. (PubMed, mBio) - "The continued emergence and spread of Neisseria gonorrhoeae strains expressing clinical resistance to ceftriaxone (CRO) have stimulated the discovery of new antibiotics to treat gonococcal infections. This suggests that the future use of this new antibiotic will be challenged by mutations that are already present in clinical strains, as well as by mutations in a ZOL target gene (gyrB). Based on our collective observations and to extend the duration of ZOL in treating gonorrhea, we propose that future work should be devoted to developing adjunctive therapies that diminish its export by the MtrCDE efflux pump system."

Journal • Infectious Disease

Fluoroquinolone resistance-conferring gyrA variants alter the fitness cost and potentiate the resistance of the zoliflodacin resistance mutation gyrBD429N in Neisseria gonorrhoeae. (PubMed, Antimicrob Agents Chemother) - "Neisseria gonorrhoeae is a major public health concern due to its high global prevalence and rapid evolution of antibiotic resistance. The fitness cost of the gyrBD429N mutation varied from modest to severe across gyrA backgrounds, with the largest cost in ciprofloxacin-resistant gyrA91F/95G and gyrA91F/95N backgrounds and comparatively minimal cost in the ciprofloxacin-resistant gyrA91F/95A background. These results demonstrate the capacity for epistatic interactions among resistance-associated gyrA and gyrB mutations, underscoring the need for genomic surveillance to monitor high-risk combinations of resistance determinants as new therapies are deployed."

Journal • Infectious Disease

Antimicrobial resistance in Neisseria gonorrhoeae isolates at the Bangrak STIs Center, Bangkok, Thailand and WGS of antimicrobial-resistant isolates, 2018-23. (PubMed, J Antimicrob Chemother) - "Resistance to ceftriaxone, cefixime, azithromycin, tetracycline and ciprofloxacin was 0.5%, 0.8%, 1.7%, 83.7% and 95.7%, respectively. Resistance to ceftriaxone, cefixime and azithromycin has emerged in gonococcal strains circulating in Bangkok, Thailand, and resistance appears to be increasing. Resistance to these last options for monotherapy or dual therapy emphasize the need for strengthened national culture-based and genomic surveillance to prevent the spread of MDR and XDR strains in Thailand and globally, and implementation of the novel oral treatments, i.e. zoliflodacin and gepotidacin."

Journal • Infectious Disease

In vitro activity of zoliflodacin against Neisseria gonorrhoeae collected in the United States from 2020 to 2022. (PubMed, Antimicrob Agents Chemother) - "All isolates were susceptible to zoliflodacin with MIC50/90 values of 0.12 µg/mL. Zoliflodacin activity was consistent over time and against ceftriaxone-, ciprofloxacin-, and tetracycline-resistant and azithromycin-non-susceptible isolates."

Journal • Preclinical • Infectious Disease

The Drug Update: Recent drug approvals, summer 2026 edition. (PubMed, Nurse Pract) - "This article highlights the following new medications: brensocatib (Brinsupri), elinzanetant (Lynkuet), and zoliflodacin (Nuzolvence). Additionally, this article reviews newly approved indications for existing therapies, including finerenone (Kerendia) for heart failure with a left ventricular ejection fraction of >_ 40% and cyclobenzaprine hydrochloride sublingual tablets (Tonmya) for fibromyalgia."

Journal • Bronchiectasis • Cardiovascular • Congestive Heart Failure • Fibromyalgia • Heart Failure • Musculoskeletal Pain • Pain • Pulmonary Disease • Respiratory Diseases • Rheumatology

Efficacy and Safety of Oral Type II Topoisomerase Inhibitors Versus Ceftriaxone-Based Regimens for the Treatment of Gonorrhoea: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. (PubMed, J Infect Chemother) - "Preliminary evidence from a limited number of randomised controlled trials suggests that oral bacterial topoisomerase II inhibitors may represent promising treatment options for uncomplicated gonorrhoea. However, the current evidence remains limited, and further adequately powered clinical trials and post-approval surveillance are required to confirm their long-term efficacy, safety, and resistance implications."

Journal • Retrospective data • Review • Infectious Disease

In vitro evaluation of the activity of pairwise combinations of zoliflodacin, gepotidacin, and ciprofloxacin against Neisseria gonorrhoeae. (PubMed, bioRxiv) - "While combination therapy could, in principle, delay the emergence and spread of resistance, doing so depends on the absence of antagonism between the co-administered drugs. Using in vitro checkerboard testing, we observed no evidence of antagonism for all pairwise combinations of zoliflodacin, gepotidacin, and ciprofloxacin, including in strains with elevated ciprofloxacin MICs."

Journal • Preclinical • Infectious Disease

Uncomplicated Cure: The New Era of Gonorrhea Therapy With Oral Zoliflodacin. (PubMed, Am J Ther) - "In a phase 3, multinational, open-label, noninferiority RCT, participants were randomly assigned (2:1) to receive a single 3 g oral dose of zoliflodacin or a single dose of 500 mg intramuscular injection of ceftriaxone plus 1 g oral azithromycin. The primary end point for microbiological cure was achieved in 90.9% (460/506) of patients on zoliflodacin compared with 96.2% (229/238) of the comparator, demonstrating noninferiority and good tolerability. Oral zoliflodacin represents a novel option for the treatment of uncomplicated urogenital gonorrhea, including antibiotic-resistant strains, providing an important alternative therapy."

Journal • Infectious Disease • Urology

Zoliflodacin: A novel single-dose oral antibiotic for uncomplicated urogenital gonorrhea. (PubMed, Am J Health Syst Pharm) - "Zoliflodacin is a newly approved antibiotic with a novel mechanism of action that is highly effective for the treatment of uUGG. It is given as a single dose that can be administered orally at the time of diagnosis, thereby avoiding the intramuscular injection necessary with ceftriaxone. It is also effective against gonorrhea strains resistant to other antibiotics."

Journal • Infectious Disease • Pediatrics

Some Newer Antibiotics Active Against Helicobacter pylori and Anaerobic Bacteria and the Potential Benefits of Their Wider Availability in More Countries: A Narrative Review. (PubMed, Antibiotics (Basel)) - "Given the limited number of antibiotics for treating CDI and fidaxomicin nonavailability in many countries, it is necessary to conduct more extensive laboratory and clinical studies of promising antibiotics such as ibezapolstat, delafloxacin, lascufloxacin, omadacycline, eravacycline, ridinilazole, and CRS3123...Research on rifasutenizol for bacterial vaginosis, sarecycline and nadifloxacin for acne vulgaris and amixicile for periodontal diseases needs to be expanded. For H. pylori infection, delafloxacin, sitafloxacin, nemonoxacin, zoliflodacin, and rifasutenizol may improve the suboptimal success of most eradication regimens...Establishing more research groups, careful examination of market issues, and additional approaches, such as nanomaterials, efflux pump inhibitors, phage therapy, and CRISPR-Cas systems, should be beneficial. Notwithstanding the difficulties, there are many opportunities to promote research on and potential use of newer antibiotics which show..."

Journal • Review • Acne Vulgaris • Dental Disorders • Dermatology • Infectious Disease • Periodontitis • Vaginitis

Study to Evaluate the Effect of a Single Oral Dose of Zoliflodacin 3 g on Testicular Function in Healthy Adult Men (clinicaltrials.gov) - P4 | N=200 | Not yet recruiting | Sponsor: Global Antibiotics Research and Development Partnership

New P4 trial

Zoliflodacin for uncomplicated gonorrhea: clinical evidence and implications beyond ceftriaxone plus azithromycin. (PubMed, Ann Med Surg (Lond)) - "Zoliflodacin represents a potentially effective oral alternative to the current ceftriaxone-based regimen for gonorrhea. With routine observation and careful stewardship, these findings may contribute significantly to the expansion of future treatment strategies."

Clinical • Journal • Infectious Disease • Urology

Extensively drug-resistant (XDR) Neisseria gonorrhoeae cured with ceftriaxone 2 g intravenous monotherapy in Croatia, March 2026. (PubMed, Euro Surveill) - "The Neisseria gonorrhoeae HR027 isolate (genomic lineage B, MLST sequence type (ST)9903) exhibited high-level azithromycin, ceftriaxone, cefixime, benzylpenicillin, ciprofloxacin and tetracycline resistance. A single dose of ceftriaxone 2 g administered intravenously cured the infection. HR027 showed zoliflodacin and gepotidacin wild-type minimum inhibitory concentrations."

Journal • Monotherapy • Infectious Disease

Zoliflodacin for Urogenital Gonorrhea Infections. (PubMed, Ann Pharmacother) - "Zoliflodacin is a novel, first-in-class spiropyrimidinetrione antibiotic for the treatment of uncomplicated urogenital gonorrhea that is efficacious and provides a novel option for MDR N. gonorrhoeae."

Journal • Review • Allergy • Colorectal Cancer • Immunology • Infectious Disease • Pediatrics

Synthesis and Clinical Application of Small-Molecule Drugs Approved by FDA in 2025. (PubMed, Med Res Rev) - "According to the FDA's 2025 Novel Drug Approvals list, 46 new drugs received approval, including both new chemical entities such as Ziftomenib, Sevabertinib, Zoliflodacin, and Gepotidacin, as well as new biologics. A significant proportion of the approved products navigated accelerated or priority review pathways, reflecting their potential impact on unmet medical needs. This review provides a comprehensive overview of the synthetic routes and clinical applications of FDA-approved small-molecule drugs in 2025, aiming to inspire future development in drug discovery."

FDA event • Journal • Review • Cardiovascular • Genetic Disorders • Immunology • Infectious Disease • Oncology

Fluoroquinolone resistance-conferring gyrA variants alter the fitness cost and potentiate the resistance of the zoliflodacin resistance mutation gyrB D429N in Neisseria gonorrhoeae. (PubMed, bioRxiv) - "Neisseria gonorrhoeae is a major public health concern due to its high global prevalence and rapid evolution of antibiotic resistance. Fitness cost of the gyrB D429N mutation varied from modest to severe across gyrA backgrounds, with the largest cost in ciprofloxacin resistant gyrA 91F/95G and gyrA 91F/95N backgrounds and comparatively minimal cost in the ciprofloxacin resistant gyrA 91F/95A background. These results demonstrate the capacity for epistatic interactions among resistance-associated gyrA and gyrB mutations, underscoring the need for genomic surveillance to monitor high-risk combinations of resistance determinants as new therapies are deployed."

Journal • Infectious Disease

Zoliflodacin: non-inferior, but not equivalent? - Authors' reply. (PubMed, Lancet) - No abstract available

Journal

The pharyngeal sanctuary: a challenge for zoliflodacin. (PubMed, Lancet) - No abstract available

Journal

Zoliflodacin: non-inferior, but not equivalent? (PubMed, Lancet) - No abstract available

Journal

Zoliflodacin: an oral, first-in-class antibacterial agent for drug-resistant gonorrhea. (PubMed, Trends Pharmacol Sci) - No abstract available

Journal

Antimicrobial resistance crisis in STIs: Gonorrhea and M. genitalium on the brink of untreatability. (PubMed, New Microbes New Infect) - "Data sources included WHO reports, peer-reviewed studies (2010-2024), and phase II/III trials of new drugs like zoliflodacin and gepotidacin...Dual resistance to ceftriaxone/azithromycin is emerging...Third-line options (pristinamycin, sitafloxacin) have limited availability and effectiveness...Investment in new antibiotics and alternative approaches (e.g., doxycycline prophylaxis) is crucial. Global public health efforts are needed to curb resistance and prevent untreatable STIs."

Journal • Review • Infectious Disease

Drugs for sexually transmitted infections. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Infectious Disease

Zoliflodacin: First Approval. (PubMed, Drugs) - "In December 2025, zoliflodacin was approved by the US FDA for the treatment of uUGC due to Neisseria gonorrhoeae in adults and pediatric patients 12 years of age and older weighing at least 35 kg. This article summarizes the milestones in the development of zoliflodacin leading to this first approval for the treatment of uUGC."

Journal • Allergy • Immunology • Infectious Disease • Pediatrics