Emrok O (alalevonadifloxacin) / 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

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

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

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

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

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

Design and synthesis of an oral prodrug alalevonadifloxacin for the treatment of MRSA infection. (PubMed, Bioorg Med Chem Lett) - "Additionally, amino acid esters provided an opportunity to make salt, facilitating improved aqueous solubility. Methanesulfonate salt of L-alanine ester of levonadifloxacin (WCK 2349) was successfully developed and launched as oral prodrug alalevonadifloxacin (EMROK-O)."

Journal • Infectious Disease

Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Oral WCK 2349 (clinicaltrials.gov) - P1; N=36; Completed; Sponsor: Wockhardt

Clinical • New P1 trial