Miqnaf (nafithromycin) / Wockhardt - LARVOL DELTA

Nafithromycin in CABP: promise and precaution-authors' reply. (PubMed, Lancet Reg Health Southeast Asia) - No abstract available

Journal

Nafithromycin in CABP: promise and precaution. (PubMed, Lancet Reg Health Southeast Asia) - No abstract available

Journal

Efficacy and safety of a 3-day once-daily regimen of oral nafithromycin in comparison to oral moxifloxacin for the treatment of community-acquired bacterial pneumonia in adults: a phase III, randomized, double-blind controlled trial. (PubMed, Lancet Reg Health Southeast Asia) - "A 3-day regimen of oral nafithromycin was non-inferior to a 7-day regimen of oral moxifloxacin for the treatment of CABP. Co-funded by Wockhardt and BIRAC, Department of Biotechnology, Government of India."

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

Novel Macrolide Antibiotic Nafithromycin for Tackling Emerging Resistance in Respiratory Pathogens Encountered in India. (PubMed, Curr Microbiol) - "No significant AEs were encountered. In this comprehensive review, the adverse effects of other antibiotics are examined, along with the benefits of nafithromycin over other medications, its development, mechanism of action, structure-activity relationships, clinical efficacy, drug delivery strategies via various routes to overcome antimicrobial resistance, strategies to combat antimicrobial resistance, and future perspectives in addressing the global antimicrobial resistance challenges."

Journal • Review • Acute Lung Injury • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases • CYP3A4

Nafithromycin: advancements in antibiotic therapy against community-acquired pneumonia-resistant pathogens. (PubMed, Monaldi Arch Chest Dis) - "Phase I studies confirmed its safety and tolerability in healthy adults, while Phase II trials showed its efficacy in treating CAP, with a 3-day treatment regimen proving comparable to a seven-day regimen of moxifloxacin. Its unique mechanism of action, high tissue penetration, and broad-spectrum activity position it as a valuable addition to the antimicrobial arsenal. Continued research and clinical trials are essential to further define its role in combating antibiotic resistance and ensuring effective treatment options."

Journal • Infectious Disease • Pneumonia • Respiratory Diseases

Efficacy and safety of oral nafithromycin as a three- and five-day treatment regimen compared with moxifloxacin in adult patients with community-acquired bacterial pneumonia (CABP): a global Phase 2 randomised trial (ESCMID Global 2025) - No abstract available

Clinical • P2 data • Infectious Disease • Pneumonia • Respiratory Diseases

In vivo pharmacokinetic/pharmacodynamic targets of a novel macrolide antibiotic nafithromycin, determined in neutropenic murine lung infection model of Streptococcus pneumoniae (ESCMID Global 2025) - No abstract available

PK/PD data • Preclinical • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Wockhardt’s drug Miqnaf gets CDSCO nod for adult pneumonia treatment (Healthcare Radius) - "Miqnaf (nafithromycin), a novel treatment for community-acquired bacterial pneumonia (CABP) in adults, has been approved by the Central Drugs Standard Control Organization (CDSCO), the Indian drug regulator. Miqnaf is a once-daily, three-day, ultra-short course treatment for CABP, including infections brought on by multi-drug resistant (MDR) pathogens. The approval comes after the CDSCO Subject Expert Committee (SEC) made a positive recommendation for the production and sale of nafithromycin...In the upcoming months, Wockhardt intends to introduce Miqnaf to the Indian market."

Approval • Infectious Disease

In vitro activity of lactone ketolide nafithromycin (WCK 4873) against Streptococcus pneumoniae isolates enriched with macrolide-resistance phenotype collected from mainland China (ECCMID 2024) - No abstract available

Preclinical • Infectious Disease • Pneumococcal Infections • Pneumonia

In vitro activity of lactone ketolide nafithromycin (WCK 4873) against Streptococcus pneumoniae isolates enriched with macrolide-resistance phenotype collected from mainland China. (PubMed, JAC Antimicrob Resist) - "Clinical S. pneumoniae isolates used in this study showed high macrolide and clindamycin resistance (>95% against erythromycin and azithromycin and 80% against clindamycin) for which nafithromycin showed potent activity (MIC; 0.03/0.06 mg/L) with 100% susceptibility at a proposed pharmacokinetics/pharmacodynamics (PK/PD) breakpoint of 0.25 mg/L. Among other classes of antibiotics tested, moxifloxacin also showed good activity while amoxicillin/clavulanate and ceftriaxone showed lower susceptibility. Nafithromycin exhibited therapeutically relevant in vitro antibacterial activity against contemporary highly resistant pneumococci collected from mainland China. This study supports the clinical development of nafithromycin for the management of CABP caused by pneumococci in China."

Journal • Preclinical • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

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

Activity of novel lactone ketolide nafithromycin against multicentric invasive and non-invasive pneumococcal isolates collected in India. (PubMed, JAC Antimicrob Resist) - "A subset of erythromycin-non-susceptible S. pneumoniae (n = 200) was screened for the presence of erm(B) and mef(A/E) genes...Azithromycin (67.6% non-susceptible) and clindamycin (31.8% non-susceptible) showed limited activity...Nafithromycin overcomes erm as well as mef-mediated macrolide resistance mechanisms expressed individually or concurrently in S. pneumoniae. This study supports continued clinical development of nafithromycin for pneumococcal infections including CABP."

Clinical • Journal • CNS Disorders • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

In Vitro Activity of Nafithromycin (WCK 4873) against Chlamydia pneumoniae. (PubMed, Antimicrob Agents Chemother) - "Nafithromycin (13 WCK 4873) is a novel lactone ketolide under clinical development as an orally administrated antibiotic for treatment of community acquired pneumonia (CAP) caused by Streptococcus pneumoniae, Hemophilus influenzae, Moraxella catarrhalis, and methicillin susceptible Staphylococcus aureus.…."

Journal • Preclinical • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Preclinical Safety Evaluation of Nafithromycin (WCK 4873) with emphasis on liver safety in Rat and Dog. (PubMed, Regul Toxicol Pharmacol) - "Due to hydrophilic nature, nafithromycin in addition to hepatic clearance is also eliminated unchanged by kidneys in significant amount, thereby minimizing hepatic burden. Based on the scientifically integrated evidences such as moderate metabolism, weak CYP inhibition, lack of CYP induction, minimal accumulation in liver, nafithromycin showed promising hepatic safety profile suitable for its intended community-based usage."

Journal • Hepatology • Liver Failure • CYP2D6

Investigational and Experimental Drugs for Community-Acquired Pneumonia: the Current Evidence. (PubMed, J Exp Pharmacol) - "Delafloxacin, omadacycline and lefamulin are the most recently approved antibiotics for CAP...New antimicrobials, such as solithromycin and nemonoxacin, are currently being studied in Phase III clinical trials...These include zabofloxacin, aravofloxacin, nafithromycin, TP-271, gepotidacin, radezolid, delpazolid, and CAL02. The preliminary results of these clinical trials allow us to assure that most of these drugs may play a role in the future treatment of CAP."

Journal • Review • Infectious Disease • Pneumonia • Respiratory Diseases

Assessment of the in vitro cytochrome P450 (CYP) inhibition potential of Nafithromycin, a next generation lactone ketolide antibiotic. (PubMed, Xenobiotica) - "To facilitate comparative assessment of drug-drug interaction potential, CYP inhibitory activities of nafithromycin was evaluated in comparison with clarithromycin, telithromycin, cethromycin and solithromycin. k/K ratio of nafithromycin was 3 to 153 fold lower than comparator drugs, further substantiating its lower affinity for CYP3A4/5. In sum, weaker inhibition and lower k/K ratio for CYP3A4/5, points towards nafithromycin's lower propensities towards clinical drug-drug interactions as compared to other macrolides/ketolides antibiotics."

Journal • Preclinical • Infectious Disease • Pneumonia • Respiratory Diseases • CYP1A2 • CYP3A4

Simultaneous determination of novel ketolide antibiotic nafithromycin and its major metabolite in human plasma using liquid chromatography tandem mass spectrometry. (PubMed, Bioanalysis) - "Clarithromycin was used as an internal standard. Method was validated as per US FDA guideline. The proposed method was successfully applied for determination of plasma levels of the NFT and M1 during Phase I clinical studies."

Journal

Pretreatment of nafithromycin attenuates inflammatory response in murine lipopolysaccharide induced acute lung injury. (PubMed, Cytokine) - "Vehicle, nafithromycin (100 mg/kg), azithromycin (600 mg/kg) and dexamethasone (20 mg/kg) were administered orally, 1 h prior to LPS challenge and bronchoalveolar lavage (BAL) fluid was collected thereafter at 18, 24 and 48 h to determine the total cell count, total protein, myeloperoxidase (MPO), tumor necrosis factor (TNF)-α and interleukin (IL)-6. The immunomodulatory effect of nafithromycin at dose of 100 mg/kg was comparable to azithromycin dosed at 600 mg/kg. As a result of immunomodulatory activity, nafithromycin is expected to provide additional clinical benefits by resolving the secondary complications associated with severe pneumonia and thereby improving survival in such patients."

Journal • Preclinical • IL6 • MPO

Safety, tolerability and pharmacokinetics of oral nafithromycin (WCK4873) after single or multiple doses and effects of food on single-dose bioavailability in healthy adult subjects. (PubMed, Antimicrob Agents Chemother) - "Nafithromycin showed moderate accumulation on Day 7 of dosing. The human pharmacokinetic profile, safety and tolerability data support further development of nafithromycin."

Clinical • Journal • PK/PD data

Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin (clinicaltrials.gov) - P1; N=10; Completed; Sponsor: Wockhardt; Active, not recruiting ➔ Completed

Clinical • Trial completion

Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin (clinicaltrials.gov) - P1; N=10; Active, not recruiting; Sponsor: Wockhardt; Not yet recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin (clinicaltrials.gov) - P1; N=10; Not yet recruiting; Sponsor: Wockhardt

Clinical • New P1 trial

Evaluate The Safety, Tolerability and Pharmacokinetics Of Multiple Ascending Oral Doses Of WCK 4873 In Healthy Adult Volunteers (clinicaltrials.gov) - P1; N=30; Completed; Sponsor: Wockhardt

Clinical • New P1 trial