Taigexyn (nemonoxacin) / TaiGen, R-Pharm - LARVOL DELTA

Comparative Analysis of Nemonoxacin and Other Anti-methicillin Resistant Staphylococcus Aureus (Anti-MRSA) Antimicrobial Therapy in Patients With Complicated Skin and Soft Tissue Infections (cSSTI): a Retrospective Chart Review Study (clinicaltrials.gov) - P=N/A | N=144 | Active, not recruiting | Sponsor: National Taiwan University Hospital

New trial • Infectious Disease

In-vitro antimicrobial activity of new antimicrobial agents against Streptococcus pneumoniae and potential resistance mechanisms: a multicenter study. (PubMed, BMC Microbiol) - "S. pneumoniae in China exhibits high genetic diversity and significant antibiotic resistance, underscoring the need for continuous surveillance and updated vaccines. New antibiotics remain effective against multidrug-resistant strains, offering potential treatment options in clinical settings."

Clinical • Journal • Preclinical • Infectious Disease • Pneumococcal Infections • Pneumonia

Clinical utility of oral Nemonoxacin 500 mg once daily for the treatment of acute lower urinary tract infections: a prospective open-label, multicenter study. (PubMed, BMC Infect Dis) - P=N/A | "Nemonoxacin capsules 500 mg once daily is effective, safe, and well-tolerated for treatment of mild-to-moderate acute lower UTIs in adult outpatients."

Clinical • Journal • Dermatology • Infectious Disease • Nephrology • Pain • Pruritus

Physiologically Based Pharmacokinetic Modeling for Nemonoxacin in Predicting the Respiratory System Pharmacokinetic Profile: Based on Comprehensive Preclinical and Clinical Data (ESCMID Global 2025) - No abstract available

Clinical data • PK/PD data • Preclinical

Comparative In vitro antibacterial activity of nemonoxacin and other fluoroquinolones in correlation with resistant mechanisms in contemporary methicillin-resistant Staphylococcus aureus blood isolates in Taiwan. (PubMed, Ann Clin Microbiol Antimicrob) - "Our study confirmed ST8/USA300 MRSA has disseminated in Taiwan. Using a tCBP defined by a higher parenteral daily dosage, nemonoxacin retained potency against moxifloxacin non-susceptible isolates. Patterns of AAS in QRDRs among different lineages may contribute to difference of nemonoxacin susceptibility."

Clinical • Journal • Preclinical • Infectious Disease

Determination of Nemonoxacin in Small Volumes of Rat Plasma and Bile by a Novel HPLC-Fluorescence Assay and Its Application to Disposition and Biliary Excretion Kinetics. (PubMed, Drug Des Devel Ther) - "A validated method was developed and found to be specific, precise and accurate. The applicability of this proposed method was substantiated in pharmacokinetic studies in rats."

Journal • Preclinical • Infectious Disease • Pneumonia • Respiratory Diseases

Potential effectiveness of parenteral nemonoxacin in the treatment of Clostridioides difficile infections: in vitro, ex vivo, and mouse studies. (PubMed, Front Microbiol) - "However, the standard agent for treating CDIs is limited to oral fidaxomicin or vancomycin...For clinical isolates and laboratory strains, lower MICs of nemonoxacin against C. difficile than levofloxacin and ciprofloxacin were observed, even in those harboring point mutations in the quinolone-resistance determining region...Similarly, no significant differences were found between mice receiving combination therapy of intraperitoneal nemonoxacin plus oral vancomycin and those treated with intraperitoneal nemonoxacin or oral vancomycin alone. The potential role of nemonoxacin, which can be administered parenterally, for treating CDIs was evidenced through the in vitro, ex vivo, and mouse models."

Journal • Preclinical • Infectious Disease

A multicentre, randomised, double-blind, double-dummy, parallel-controlled, phase 3 clinical trial assessing the efficacy and safety of intravenous nemonoxacin malate versus levofloxacin for community-acquired pneumonia in adult patients. (PubMed, Int J Antimicrob Agents) - P3 | "Nemonoxacin 500 mg IV once daily for 7-14 days is effective and safe and noninferior to levofloxacin for treating CAP in adult patients."

Clinical • Journal • P3 data • Infectious Disease • Pneumonia • Respiratory Diseases

Together or Apart? Revealing the Impact of Dietary Interventions on Bioavailability of Quinolones: A Systematic Review with Meta-analyses. (PubMed, Clin Pharmacokinet) - "Several factors may influence interactions, including the physicochemical characteristics of quinolones, the type of intervention, drug formulation, and the patient's health status. We assessed the quality of evidence as low due to the poor actuality of included studies, their methodological diversity, and uneven data availability for individual drugs."

Review

Identifying the Best Initial Oral Antibiotics for Adults with Community-Acquired Pneumonia: A Network Meta-Analysis. (PubMed, J Gen Intern Med) - "We observed trends toward a better clinical response and lower mortality for quinolones as empiric antibiotics for CAP, but found no conclusive evidence of any antibiotic being clearly more effective than another. More trials are needed to inform guideline recommendations on the most effective antibiotic regimens for outpatients with mild to moderate CAP."

Retrospective data • Review • Infectious Disease • Pneumonia • Respiratory Diseases

Schematic-portfolio of potent anti-microbial scaffolds targeting DNA gyrase: Unlocking ways to overcome resistance. (PubMed, Int J Biol Macromol) - "The fluoroquinolones like levofloxacin and moxifloxacin have been listed in class A drugs for treating MDR. Gatifloxacin and ciprofloxacin also proved its efficacy against MDR TB and MDR enteric fever in adults, whereas nemonoxacin can induce anti-MDR activity of other antibiotics already suggested by studies...In addition to fluoroquinolone, the natural compounds novobiocin and simocyclinone could also inhibit the gyrase, impressively which has been designed with the gyrase structure for better understanding. Herein, ongoing clinical development of some novel drugs possessing triazaacenaphthylenes, spiropyrimidinetriones, and oxazolidinone-quinolone hybrids have been highlighted which could further assist the future generation antibiotic development corroborating gyrase as a potential target against MDR pathogens."

Journal • Review

In vitro pharmacodynamics of nemonoxacin and other antimicrobial agents against Mycoplasma pneumoniae. (PubMed, Microbiol Spectr) - "The time-kill assays and pharmacodynamic analysis showed that nemonoxacin has significant mycoplasmacidal activity against MRMP and MSMP. This study paves the road to establish appropriate dosing protocols of a new antimicrobial drug for children infected with M. pneumoniae."

Journal • PK/PD data • Preclinical • Infectious Disease • Pneumonia

Nemonoxacin achieved a better symptomatic improvement and a prolonged interval to next exacerbation than moxifloxacin for outpatients with acute exacerbations of chronic obstructive pulmonary disease. (PubMed, Sci Rep) - "Despite no significant difference in the incidence of exacerbations between two groups, patients treated with nemonoxacin had a significantly prolonged time to next moderate/severe exacerbation than those with moxifloxacin (p < 0.05). Nemonoxacin achieved a better symptomatic improvement and a prolonged interval to next moderate/severe exacerbation for AECOPD outpatients."

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Safety and Efficacy of Nemonoxacin vs Levofloxacin in Patients With Community-Acquired Pneumonia: A Systematic Review and Meta-Analysis of Randomized Control Trials. (PubMed, Cureus) - "Furthermore, the adverse effects associated with nemonoxacin are generally mild. Therefore, both the 500 mg and 750 mg dosages of nemonoxacin can be recommended as appropriate antibiotic therapy regimens for the treatment of CAP."

Clinical • Journal • Retrospective data • Review • Gastrointestinal Disorder • Infectious Disease • Pneumonia • Respiratory Diseases

Overview of Side-Effects of Antibacterial Fluoroquinolones: New Drugs versus Old Drugs, a Step Forward in the Safety Profile? (PubMed, Pharmaceutics) - "The FDA and EMA approved delafloxacin. Additionally, lascufloxacin, levonadifloxacin, nemonoxacin, sitafloxacin, and zabofloxacin were approved in their origin countries...The main AEs of the FQs class were addressed, highlighting the existing data for the recently approved ones. In addition, the general management of AEs when they occur and the rational use and caution of modern FQs were outlined."

Adverse events • Journal • Review • Infectious Disease

Integrative population pharmacokinetic/pharmacodynamic analysis of nemonoxacin capsule in Chinese patients with community-acquired pneumonia. (PubMed, Front Pharmacol) - " Integrative PK/PD analysis justifies the reliable clinical and microbiological efficacy of nemonoxacin 500 mg q24 h in treating CAP caused by S. pneumoniae, S. aureus, and K. pneumoniae, irrespective of patient sex, mild renal impairment, empty stomach or not. However, nemonoxacin 750 mg q24 h would provide better efficacy than 500 mg q24 h for the CAP caused by H. parainfluenzae in terms of CFR."

Journal • PK/PD data • Infectious Disease • Influenza • Pneumococcal Infections • Pneumonia • Renal Disease • Respiratory Diseases

Real-Time Impedance-Based Monitoring of the Growth and Inhibition of Osteomyelitis Biofilm Pathogen Staphylococcus aureus Treated with Novel Bisphosphonate-Fluoroquinolone Antimicrobial Conjugates. (PubMed, Int J Mol Sci) - "We tested early and newer generation quinolone antibiotics (ciprofloxacin, moxifloxacin, sitafloxacin, and nemonoxacin) and several bisphosphonate-conjugated versions of these antibiotics (bisphosphonate-carbamate-sitafloxacin (BCS), bisphosphonate-carbamate-nemonoxacin (BCN), etidronate-carbamate-ciprofloxacin (ECC), and etidronate-carbamate-moxifloxacin (ECX)) and found that they were able to inhibit Staphylococcus aureus biofilms in a dose-dependent manner. They also retained the antimicrobial activity of the parent antibiotic in the presence or absence of hydroxyapatite, albeit at lower levels due to the nature of their chemical modification. These findings will aid in the optimization and testing of this novel class of drugs for future applications to pharmacotherapy in osteomyelitis."

Journal • Infectious Disease • Inflammation • Musculoskeletal Diseases • Orthopedics

Safety of oral nemonoxacin: A systematic review of clinical trials and postmarketing surveillance. (PubMed, Front Pharmacol) - "The Phase II/III studies showed that the commonly reported drug-related AEs were similar for oral 500 mg nemonoxacin and levofloxacin treatments, which mainly included increased alanine aminotransferase levels (4.4% vs. 2.5%), neutropenia (2.5% vs. 4.4%), nausea (2.5% vs. 1.6%), and leukopenia (2.3% vs. 3.2%). Pharmacokinetic data suggested that dose adjustment was not necessary in elderly patients, which was confirmed by a Phase IV study in an elderly population, in patients with renal impairment with CLcr ≥50 ml/min, and in those with mild-to-moderate hepatic impairment. Clinical trial data of approximately 1,450 patients and postmarketing data of >257,420 patients suggest that nemonoxacin is generally well tolerated and can be a suitable alternative to fluoroquinolones for patients with CAP."

Journal • P4 data • Review • Hematological Disorders • Hepatology • Infectious Disease • Leukopenia • Neutropenia • Pneumonia • Renal Disease • Respiratory Diseases

Activities of Eravacycline, Tedizolid, Norvancomycin, Nemonoxacin, Ceftaroline, and Comparators against 1,871 Staphylococcus and 1,068 Enterococcus Species Isolates from China: Updated Report of the CHINET Study 2019. (PubMed, Microbiol Spectr) - "and Enterococcus spp. for their future development and application in clinical practice."

Journal • Infectious Disease

Potential new fluoroquinolone treatments for suspected bacterial keratitis. (PubMed, BMJ Open Ophthalmol) - "For example, the new generation FQs, avarofloxacin, delafloxacin, finafloxacin, lascufloxacin, nadifloxacin, levonadifloxacin, nemonoxacin and zabofloxacin have good activity against the common ophthalmic pathogens such as Staphylococcus aureus, Pseudomonas aeruginosa, Streptococcus pneumoniae and several of the Enterobacteriaceae However, because there are no published ophthalmic break-point concentrations, the susceptibility of an isolated micro-organism to a topical FQ is extrapolated from systemic break-point data and wild type susceptibility. Notably, we found significant variation in the reported corneal and aqueous FQ concentrations so that reliance on the reported mean concentration may not be appropriate, and the first quartile concentration may be more clinically relevant. The provision of the MIC for the microorganism together with the achieved lower (first) quartile concentration of a FQ in the cornea could inform management decisions such as whether to..."

Journal • Review • Infectious Disease • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology • Pneumococcal Infections • Pneumonia

Economic Evaluation of Nemonoxacin, Moxifloxacin and Levofloxacin in the Treatment of Early Community-Acquired Pneumonia with Possible Pulmonary Tuberculosis. (PubMed, Int J Environ Res Public Health) - "Regarding patients with PTB who were misdiagnosed with CAP, taking nemonoxacin could save $290.76 and $205.51 when compared with moxifloxacin and levofloxacin and resulted in a gain of 2.83 QALDs. Our findings demonstrate that nemonoxacin is the more economical compared with moxifloxacin and levofloxacin, and non-fluoroquinolone antibiotics are cost-saving and utility-increasing compared to fluoroquinolones in the differential diagnosis of PTB, which can help healthcare system in making optimal policies and help clinicians in the medication of patients."

Clinical • HEOR • Journal • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Discovery and Development of Antibacterial Agents: Fortuitous and Designed. (PubMed, Mini Rev Med Chem) - "These include solithromycin, plazomicin, lefamulin, omadacycline, eravacycline, delafloxacin, zabofloxacin, finafloxacin, nemonoxacin, gepotidacin, zoliflodacin, cefiderocol, BAL30072, avycaz, zerbaxa, vabomere, relebactam, tedizolid, cadazolid, sutezolid, triclosan and afabiacin. This article aims to review the investigational and recently approved antibacterials with a focus on their structure, mechanisms of action/resistance, and spectrum of activity. Delving deep, their success or otherwise in various phases of clinical trials is also discussed while attributing the same to various causal factors."

Journal

Nemonoxacin enhances antibacterial activity and anti-resistant mutation ability of vancomycin against methicillin-resistant Staphylococcus aureus in an in vitro dynamic pharmacokinetic/pharmacodynamic model. (PubMed, Antimicrob Agents Chemother) - "Nemonoxacin enhances the bactericidal activity and suppresses resistance enrichment ability of vancomycin against MRSA with a MIC of 2 μg/mL. Our in vitro data support the combination of nemonoxacin and vancomycin for the treatment of MRSA infection with a high MIC."

Journal • PK/PD data • Preclinical • Infectious Disease

Oral Nemonoxacin in Treating Elderly Patients With CAP (clinicaltrials.gov) - P4; N=100; Completed; Sponsor: TaiGen Biotechnology Co., Ltd.

Clinical • New P4 trial • Infectious Disease • Pneumonia

In vitro evaluation of the antibacterial activity of nemonoxacin against Mycobacterium abscessus (PubMed, Zhonghua Jie He He Hu Xi Za Zhi) - "The minimum inhibitory concentrations (MICs) of nemonoxacin and other quinolones commonly used (moxifloxacin, levofloxacin and ciprofloxacin) against M. abscessus in clinic was determined by the micro-broth dilution method...abscessus drugs (clarithromycin, amikacin, imipenem, cefoxitin, tigecycline and linezolid) was assessed in vitro... Nemonoxacin showed moderate in vitro antibacterial activity against M. abscessus, which was better than that of other fluoroquinolones commonly used in clinic at present. Therefore, nemonoxacin may be one of the options for combined treatment of M. abscessus infection."

Journal • Preclinical • Infectious Disease