Emrok (levonadifloxacin) / Wockhardt - LARVOL DELTA

In vitro efficacy of levonadifloxacin against methicillin-resistant Staphylococcus aureus (MRSA) including hVISA isolates collected across India. (PubMed, Indian J Med Microbiol) - "The present study demonstrated 100 % susceptibility to levonadifloxacin among the tested isolates of MRSA, highlighting its promising clinical potential for treating infections caused by this organism. Furthermore, the study recorded a concordance of 100 % between disc diffusion and Etest method with BMD, indicating the reliability of these methods."

Journal • Preclinical • Infectious Disease

A Prospective, Observational, Open-Label, Non-comparative, Multi-center Study for the Evaluation of Efficacy and Safety of Levonadifloxacin (Intravenous and Oral) in Patients With Community-Acquired Bacterial Pneumonia. (PubMed, Cureus) - "All events were mild in severity and resolved without sequelae. Conclusions Levonadifloxacin administered by oral and/or IV route showed promising efficacy and safety outcomes in hospitalized patients or patients receiving outpatient therapy for CABP."

Journal • Observational data • Infectious Disease • Influenza • Musculoskeletal Pain • Pain • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Integrated virtual screening and MD simulation study to discover potential inhibitors of mycobacterial electron transfer flavoprotein oxidoreductase. (PubMed, PLoS One) - "This study underscores the efficacy of computational drug repurposing, highlighting bacterial energy metabolism and lipid catabolism as fruitful targets. Further research is necessary to validate the clinical suitability and efficacy of diacerein, levonadifloxacin, and gatifloxacin, potentially enhancing the arsenal against global TB."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Bacterial profile of wound site infections and evaluation of risk factors for sepsis among road traffic accident patients from Apex Trauma Centre, Northern India. (PubMed, Access Microbiol) - "Among the Gram-negative isolates, none of the isolates were resistant to colistin. All S. aureus isolates were susceptible to vancomycin, teicoplanin and levonadifloxacin...Conclusion. It is essential to ascertain the profile of microorganisms isolated from RTA wounds in order to reduce antibiotic resistance and deliver efficient treatment."

Journal • Immunology • Infectious Disease • Inflammation • Pneumonia • Septic Shock • Systemic Inflammatory Response Syndrome

Serum Pharmacokinetics and Bone Penetration of Novel Broad-Spectrum Anti-MRSA Agent Levonadifloxacin in Wistar Rats. (PubMed, Microb Drug Resist) - "Objectives: Levonadifloxacin (IV) and alalevonadifloxacin (oral) are novel broad-spectrum anti-methicillin-resistant Staphylococcus aureus (S. In single-dosage PK studies, the mean B/S ratio in WB, HB, and BM was 0.40, 0.33, and 0.34, respectively; however, in 5 days' repeated dose studies, it increased to 1.01, 1.14, and 0.61, respectively. On the basis of bone PK data in Wistar rat and ever-growing clinical experience in terms of safety and efficacy, levonadifloxacin has the potential to offer a well-differentiated therapy for the treatment of BJIs."

Journal • PK/PD data • Preclinical • Infectious Disease

Susceptibility of clinical isolates of novel pathogen Stenotrophomonas sepilia to novel benzoquinolizine fluoroquinolone levonadifloxacin. (PubMed, JAC Antimicrob Resist) - "Levofloxacin and levonadifloxacin show similar susceptibility rates against S. sepilia, with levonadifloxacin exhibiting lower MICs. Further studies are required to establish clinical utility of levonadifloxacin in managing these infections."

Journal • Infectious Disease

Efficacy and Safety of Oral and IV Levonadifloxacin Therapy in Management of Bacterial Infections: Findings of a Prospective, Observational, Multi-center, Post-marketing Surveillance Study. (PubMed, Cureus) - "Conclusions The excellent safety and efficacy profile of levonadifloxacin, when administered as an oral or intravenous therapy, makes it a desirable treatment modality for the management of various bacterial infections, including those caused by resistant pathogens such as MRSA and quinolone-resistant Staphylococcus aureus (QRSA). Features of levonadifloxacin, such as availability in both IV and oral form, minimal drug-drug interactions, lack of the need to adjust dosages in renal and hepatically impaired patients along with a broad spectrum of coverage, make it a suitable agent that meets several unmet clinical needs of physicians."

Journal • Observational data • P4 data • Febrile Neutropenia • Hematological Disorders • Infectious Disease • Neutropenia • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

In Vitro Assessment of Antimicrobial Activity of Novel Fluoroquinolone, Levonadifloxacin (WCK 771) Against Multi-Drug-Resistant Clinical Isolates from Cancer Patients in India. (PubMed, Microb Drug Resist) - "Interestingly, all fluoroquinolones-resistant Salmonella species and Stenotrophomonas maltophilla exhibited 100% susceptibility to levonadifloxacin (WCK-771). Levonadifloxacin (WCK-771) possesses potent activity against all the MDR Gram-positive pathogens including the coverage of susceptible Enterobacterales and MDR S. maltophilla and Burkholderia cepacia suggesting its potential utility in the management of polymicrobial infections."

Journal • Preclinical • Infectious Disease • Oncology • Pneumonia

Treatment challenges in the management of difficult-to-treat gram-positive infections: A consensus view apropos therapeutic role of novel anti-MRSA antibiotics, levonadifloxacin (IV) and alalevonadifloxacin (oral). (PubMed, Indian J Med Microbiol) - "This consensus supports the therapeutic use of levonadifloxacin and alalevonadifloxacin in the treatment of antibiotic-resistant GPIs, including those caused by MRSA and certain polymicrobial infections, in patients with multiple co-morbidities requiring drug with adequate safety and consistent efficacy."

Gram positive • Journal • Critical care • Febrile Neutropenia • Hematological Disorders • Hepatology • Infectious Disease • Liver Failure • Nephrology • Neutropenia • Pneumonia • Renal Disease • Respiratory Diseases

IN VITRO ACTIVITY OF LEVONADIFLOXACIN AGAINST GRAM POSITIVE PATHOGENS ISOLATED IN PEDIATRIC CANCER PATIENTS (ESPID 2023) - "Vancomycin, teicoplanin, linezolid, daptomycin and levonadifloxacin showed susceptibility of 100% whereas gentamicin showed 76% and clindamycin showed 60% susceptibility. Of the 35130 samples received in the laboratory, urine was the most common specimen followed by wound swabs, blood, bile, drain fluids, sputum, BAL and pus. Of the 35130 samples, 9380 showed growth of pathogens. 73 % of the pathogens were Gram Negative Bacilli and 27% were Gram Positive Cocci growth."

Gram positive • Preclinical • Infectious Disease • Oncology • Pediatrics • Pneumonia • Respiratory Diseases

Clinical isolates of novel species of Stenotrophomonas sepilia are highly susceptible to novel benzoquinolizine quinolone agent levonadifloxacin (ECCMID 2023) - No abstract available

Clinical

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

Meeting the Unmet Need in the Management of MDR Gram-Positive Infections with Oral Bactericidal Agent Levonadifloxacin. (PubMed, Crit Care Res Pract) - "Unlike existing MRSA drugs such as vancomycin and linezolid, which cause unfavorable side effects like nephrotoxicity, bone-marrow toxicity, and muscle toxicity, levonadifloxacin/alalevonadifloxacin has demonstrated superior safety and tolerability features with no serious adverse events. Levonadifloxacin/alalevonadifloxacin could be a useful weapon in the battle against infections caused by resistant microorganisms and could be a preferred antibiotic of choice for empirical therapy in the future."

Gram positive • Journal • Review • Infectious Disease

India-discovered levonadifloxacin & alalevonadifloxacin: A review on susceptibility testing methods, CLSI quality control and breakpoints along with a brief account of their emerging therapeutic profile as a novel standard-of-care. (PubMed, Indian J Med Microbiol) - "Further, the review also covers in vitro and in vivo activities, registrational clinical studies and patient-friendly features of levonadifloxacin/alalevonadifloxacin. Cumulatively, levonadifloxacin has a potential to offer a long awaited new standard-of-care treatment for the resistant Gram-positive bacterial infections."

Journal • Review • 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

Real-World Evidence of Efficacy and Safety of Levonadifloxacin (Oral and IV) in the Management of Acute Bacterial Skin and Skin Structure Infections (ABSSSI): Findings of a Retrospective, Multi-Center Study. (PubMed, Cureus) - "Results One hundred and forty patients received IV levonadifloxacin therapy, 76 patients received oral alalevonadifloxacin, and 11 received IV followed by oral therapy. Conclusions The excellent safety and efficacy profile of levonadifloxacin on oral and/or intravenous therapy, makes it a desirable treatment modality for management of ABSSSI. Unique features of levonadifloxacin such as availability of both IV and oral form, minimal drug-drug interactions, exemption from dosage adjustment in renal and hepatic impaired patients and a broad spectrum of coverage, makes it a suitable agent meeting several unmet clinical needs in contemporary patients."

HEOR • Journal • Real-world evidence • Retrospective data • Infectious Disease

Antimicrobial spectrum of novel antibiotic levonadifloxacin in bacterial isolates in oncology centre in India (ECCMID 2022) - No abstract available

Oncology

Prescription-Event Monitoring Study on Safety and Efficacy of Levonadifloxacin (Oral and I.V.) in Management of Bacterial Infections: Findings of Real-World Observational Study. (PubMed, Int J Appl Basic Med Res) - "Only 11 mild adverse events were reported in 9 patients which included constipation, diarrhea, hyperglycemia, nausea, fatigue, and vomiting. Overall, 96.3% and 97.3% of investigators rated the efficacy and safety of levonadifloxacin as "good to excellent." An excellent safety and efficacy profile of levonadifloxacin was observed in this study making it a suitable treatment option for management of various bacterial infections, including those caused by resistant Gram-positive pathogens such as MRSA and quinolone-resistant S. aureus."

Journal • Observational data • Prescription event monitoring (PEM) • Real-world evidence • Constipation • Diabetes • Fatigue • Febrile Neutropenia • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Infectious Disease • Neutropenia • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Preclinical safety evaluation of levonadifloxacin, a novel anti-MRSA benzoquinolizine fluoroquinolone by intravenous and oral administration. (PubMed, J Appl Toxicol) - "WCK 771/WCK 2349 were found to be non-genotoxic, however they showed weak phototoxicity that was comparable to levofloxacin. WCK 771 showed chondrotoxicity in the Beagle dog pups on repeat dose administration; however the severity level was lower than ofloxacin. Overall, preclinical safety studies helped establish wider safety margin for WCK 771 and WCK 2349 that supports administration of higher therapeutic doses in humans by both IV and oral routes, thereby enabling safe anti-MRSA treatment."

Journal • Preclinical • Cardiovascular • CNS Disorders • Epilepsy • Hematological Disorders

Ensuring Robustness in Quality of Antibiotic Susceptibility Test Discs for Four Novel Antibiotics. (PubMed, Biomed Chromatogr) - "This methodology has several limitations such as it is time consuming, requires trained manpower, wider acceptance criteria of zone of inhibitions causing ambiguity in judging the small variations in the drug concentration etc. To overcome these issues we have developed and validated high performance liquid chromatographic (HPLC) methods for determination of strength of AST discs for in-house researched antibiotics namely Levonadifloxacin/WCK 771, Nafithromycin/WCK 4873, Cefepime-Tazobactam/WCK 4282 and Cefepime-Zidebactam/WCK 5222. The developed methods are efficient in terms of time and can be very well conducted in quality control laboratory during release as well as stability evaluation of AST disc. Application of HPLC methods for determination of strength of AST disc ensure undoubted quality and indirectly better selection of drug to treat bacterial infections in clinics."

Journal • Infectious Disease

Efficient Synthesis of Potential Impurities in Levonadifloxacin (WCK 771). (PubMed, ACS Omega) - "These compounds are not easily commercially available. The synthesis and characterization of these impurities are discussed in detail."

Journal • Infectious Disease

Anti-MRSA quinolones for acute bacterial skin and skin structure infection: a systematic review and meta-analysis of randomized controlled trials. (PubMed, Expert Rev Anti Infect Ther) - "In the study group receiving anti-MRSA quinolone-based treatment, 935, 246, and 83 patients received delafloxacin, levonadifloxacin, and acorafloxacin, respectively. In patients with MRSA-associated ABSSSIs, the clinical cure rate (OR, 1.09; 95% CI, 0.71-1.65; I = 0%) and microbiological response rate (OR, 1.24; 95% CI, 0.48-3.21; I = 0%) of anti-MRSA quinolones were similar to those of other antibiotics. The efficacy of anti-MRSA quinolone-based treatment is comparable to that of other anti-MRSA antibiotics for treating ABSSSIs."

Journal • Retrospective data • Review • Infectious Disease

Structural Characterization of the Millennial Antibacterial (Fluoro)Quinolones-Shaping the Fifth Generation. (PubMed, Pharmaceutics) - "Special attention is given to eight representatives: besifloxacin, delafoxacin, finafloxacin, lascufloxacin, nadifloxacin and levonadifloxacin, nemonoxacin, and zabofloxacin. Antibacterial quinolones class continues to acquire new compounds with antibacterial potential, among other effects. Numerous derivatives, hybrids or conjugates are currently in various stages of research."

Journal • Review

Assessment of Antibacterial Activity of Levonadifloxacin against Contemporary Gram-positive Clinical Isolates Collected from Various Indian Hospitals using Disk-Diffusion Assay. (PubMed, Indian J Med Microbiol) - "The present study showed that levonadifloxacin was highly active against contemporary Gram-positive pathogens and furthermore demonstrated that levonadifloxacin susceptibilities can be reliably determined using the disc-diffusion method."

Clinical • Journal • Infectious Disease

Chemistry, Biological Properties and Analytical Methods of Levonadifloxacin: A Review. (PubMed, Crit Rev Anal Chem) - "To this context, validated analytical methods for routine quality control are essential for quantification of LND as an API alone and together with pharmaceutical formulations. This review suggests therapeutic, pharmacological, and analytical aspects regarding the novel drug LND and particularly focuses on discussing various reported analytical methods present for analytical or bioanalytical estimation of the drug and suggest to develop a simple and validated method which also complies to green chemistry."

Journal • Review • Infectious Disease