Zaynich (cefepime/zidebactam) / Wockhardt - LARVOL DELTA

Clinical, Microbiological and Genomic Characterization of OXA-48-Producing Klebsiella pneumoniae ST395 Circulating in a Secondary-Care Hospital in North-Eastern Italy, 2024-2025. (PubMed, Antibiotics (Basel)) - "We identified a multidrug-resistant OXA-48-producing K. pneumoniae ST395 lineage circulating locally, predominantly in colonization contexts. Active screening and genomic surveillance may support infection control and inform the potential role of emerging cefepime-based inhibitor combinations."

Journal • Infectious Disease • Pneumonia

Escherichia coli with penicillin-binding protein 3 insertions: implications for newer β-lactam/β-lactamase inhibitor combinations. (PubMed, Antimicrob Agents Chemother) - "Newer β-lactam/β-lactamase inhibitor combinations (ceftazidime/avibactam, aztreonam/avibactam, and cefepime/taniborbactam) and cefiderocol with affinities for PBP3 show reduced activity against E. coli with YRIN and YRIK insertions...In contrast, agents targeting PBP2, such as cefepime/zidebactam and cefiderocol-xeruborbactam, retain potent in vitro activity and will likely be important for future treatment strategies...There is an urgent need for enhanced global surveillance, along with rapid diagnostic tools capable of identifying PBP3 insertions and associated high-risk clones among carbapenemase-producing E. coli. Future strategies should prioritize agents with activities against multiple essential PBPs to preserve β-lactam efficacy."

Journal • Review

Comparative Evaluation of Cefepime-Zidebactam (Zaynich®) MIC Testing with Gradient Strip (ETEST®) and CLSI Broth Microdilution Methods (IDWeek 2026) - No abstract available

Infectious Disease

Cefepime/Zidebactam: First Approval. (PubMed, Drugs) - "Cefepime/zidebactam is also currently under regulatory review in the EU for use in the treatment of serious infections caused by Gram-negative bacteria. This article summarises the milestones in the development of cefepime/zidebactam leading to this first approval for the treatment of cUTI (including pyelonephritis) in adults."

Journal • Infectious Disease • Nephrology

Wockhardt Gets US FDA Approval for Novel Antibiotic Zaynich (Whalesbook) - "Wockhardt has received US FDA approval for Zaynich, an antibiotic for complicated urinary tract infections."

ANDA • Infectious Disease

Comparative evaluation of the activity of novel β-lactam antibiotics against difficult-to-treat Pseudomonas aeruginosa clinical isolates. (PubMed, JAC Antimicrob Resist) - "Among the 502 isolates, cefepime-zidebactam exhibited the highest in vitro activity (100% susceptibility), followed by cefiderocol-xeruborbactam (98%), cefiderocol (95%), ceftolozane-tazobactam (90%), cefepime-taniborbactam (86%), ceftazidime-avibactam (85%), and imipenem-relebactam (41%). While currently approved β-lactam agents retained activity against many DTR P. aeruginosa isolates, their performance was markedly compromised in the presence of carbapenemases, with the notable exceptions of cefepime-zidebactam and cefiderocol. Investigational β-lactam/β-lactamase inhibitor combinations exhibited consistently robust activity across resistance phenotypes, including carbapenemase-producing isolates, representing promising options for DTR P. aeruginosa infections."

Journal • Infectious Disease

India has achieved a significant milestone in pharmaceutical innovation with the US Food and Drug Administration (FDA) approving Zaynich, a novel antibiotic developed by Mumbai-based drugmaker Wockhardt. (Daijiworld) - "The injectable drug has been approved for the treatment of complicated urinary tract infections (cUTIs), including kidney infections known as pyelonephritis, in the United States."

FDA approval • Infectious Disease

Near pan-β-lactam resistance in NDM-producing Escherichia coli with PBP3 insertions is overcome by dual PBP2/PBP3 inhibition. (PubMed, NPJ Antimicrob Resist) - "The activity of aztreonam/avibactam in time-kill assays correlated with each isolate's MIC, regardless of PBP3 allele. In summary, cefepime/zidebactam synergistically inhibits PBP2 and PBP3 in isolates harboring wild-type PBP3 but predominantly PBP2 in the presence of PBP3i. Aztreonam and zidebactam engage PBP2 and mutant variants of PBP3, causing synergistic eradication of NDM-producing E. coli with PBP3i."

Journal

Calciphylaxis complicated by NDM-1-producing Pseudomonas aeruginosa: first experience with cefepime-zidebactam alongside phage therapy in the USA. (PubMed, Lancet Infect Dis) - "Management required novel therapeutic strategies, including the first use of cefepime-zidebactam in the USA alongside bacteriophage therapy and calciphylaxis-directed treatment. This case highlights the diagnostic complexity of calciphylaxis in atypical populations and shows the potential for innovative therapeutic approaches to achieve favourable outcomes in this rare, potentially fatal condition."

Journal • Review • Acute Myelogenous Leukemia • Calciphylaxis • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • Rare Diseases

Wockhardt Ltd on Thursday said it has received approval from the Central Drugs Standard Control Organisation (CDSCO) for import and marketing of its indigenously discovered and developed antibiotic, Zaynich (Zidebactam/Cefepime) in India. (The Economic Times)

Approval • Infectious Disease

Overview of novel cefepime-based β-Lactam/β-lactamase inhibitor combinations. (PubMed, Expert Rev Anti Infect Ther) - "This review summarizes approved and investigational cefepime-based BL/BLI combinations, including cefepime/enmetazobactam (FEP/EMT), cefepime/taniborbactam (FTB), cefepime/zidebactam (FPZ), and cefepime/nacubactam (FEP/NAC)...FPZ combines β-lactamase inhibition and β-lactam - enhancer activity, retaining activity against XDR Enterobacterales and P. aeruginosa, including cefiderocol- or aztreonam/avibactam (ATM/AVI)-resistant strains. FEP/NAC shows promise against carbapenem- and MBL-producing strains, though clinical data remain limited. Optimal use relies on rapid molecular diagnostics, susceptibility testing, and antimicrobial stewardship to maximize efficacy and limit the emergence of resistance."

Journal • Review • Infectious Disease

Ceftazidime-avibactam resistance evolution in Pseudomonas aeruginosa and implications for cross-resistance to other novel β-lactams. (PubMed, Antimicrob Agents Chemother) - "Cross-resistance was common between ceftazidime-avibactam and ceftolozane-tazobactam, less common for imipenem-relebactam and cefepime-zidebactam, and lowest for cefiderocol. These findings have important implications for sequential treatment of P. aeruginosa infections."

Journal • Infectious Disease

Pyelonephritis Caused by Pseudomonas aeruginosa: From Treatable Infection to Therapeutic Dead-End, Rescued by an Investigational Antibiotic. (PubMed, Microb Drug Resist) - "Urine culture grew P. aeruginosa resistant to meropenem, and molecular testing confirmed the presence of NDM...Given the lack of effective alternative antibiotics and the patient's deteriorating clinical course with underlying renal impairment precluding the use of colistin, investigational drug cefepime/zidebactam (WCK 5222) was initiated under compassionate ground...He received 37 days of cefepime/zidebactam, during which he showed rapid clinical improvement, resolution of pyelonephritis, and sterile urine cultures. This case underscores how infections such as cUTI or pyelonephritis, usually considered manageable, can become untreatable in NDM-endemic settings and highlights cefepime/zidebactam as a promising therapeutic option for highly resistant P. aeruginosa."

Journal • Cardiovascular • Coronary Artery Disease • Diabetes • Heart Failure • Hypertension • Infectious Disease • Metabolic Disorders • Nephrology • Renal Disease

Global healthcare major Wockhardt has cleared a major regulatory hurdle as the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) gave a favourable recommendation for its novel antibiotic, Zaynich (Zidebactam/Cefepime), for the treatment of Gram-negative infections. (Indian Pharma Post)

Approval • Infectious Disease

Cefepime Combined with Late-Generation β-Lactamase Inhibitors: Mechanisms of Action, In Vitro Activity, PK/PD Characteristics, Clinical Evidence and Resistance Mechanisms. (PubMed, Antibiotics (Basel)) - "Cefepime combined with late-generation β-lactamase inhibitors-enmetazobactam, zidebactam, and taniborbactam-represents a promising strategy to treat multidrug-resistant Gram-negative infections...It also highlights future directions, including the establishment of clinical breakpoints, evaluation in severe infections, and exploration of combination strategies to counteract complex resistance. Overall, these agents exemplify a strategic evolution in β-lactam therapy, offering versatile options to reduce carbapenem reliance while maintaining high efficacy against multidrug-resistant Gram-negative pathogens."

Journal • PK/PD data • Preclinical • Review • Infectious Disease • Nephrology

Comparative in vitro efficacy of aztreonam-avibactam and other alternatives (cefepime-taniborbactam, cefepime-zidebactam, and cefiderocol) against metallo-β-lactamase-producing Enterobacterales isolated in 2024 in France. (PubMed, Antimicrob Agents Chemother) - "Cefepime-taniborbactam and cefiderocol showed reduced overall activity (76.4% and 74.9% susceptibility, respectively), with reduced efficacy mainly observed among NDM-producing isolates. Comparison with 1,465 isolates from 2023 showed no increase in aztreonam-avibactam resistance."

Journal • Preclinical

Real-World Evidence and Multidrug Resistant Infections: How Can We Leverage RWE to Improve Patient Outcome with the Novel Beta-Lactam and Beta-Lactam/Beta-Lactamase Inhibitor Combinations. (PubMed, Infect Drug Resist) - "A comprehensive literature search was performed on PubMed-MEDLINE from January 2015 to September 2025 for identifying pivotal trials and real-world evidence concerning the use of cefiderocol and of novel beta-lactam/beta-lactamase inhibitor combination (BL/BLIc) including those of tomorrow (ie, ceftolozane-tazobactam, ceftazidime-avibactam, meropenem-vaborbactam, imipenem-relebactam, cefepime-enmetazobactam, cefepime-taniborbactam, cefepime-zidebactam, sulbactam-durlobactam, aztreonam-avibactam). Real-world evidence concerning both well-designed observational studies and PK/PD models may represent a mandatory tool for overcoming issues associated with pivotal trials evaluating novel BL/BLIc. The implementation of dedicated well-designed real-world studies would be warranted for ensuring a constant update of proposed therapeutic algorithms."

HEOR • Journal • Real-world evidence • Review • Infectious Disease

WCK 5222: a case report highlighting a solution for colistin-heteroresistant infection (ESCMID Global 2026) - No abstract available

Case report • Clinical • Infectious Disease

Real-world experience with compassionate use of zidebactam/cefepime (ZID/FEP) in patients with Gram-negative bacterial infections lacking safe and effective treatment options (ESCMID Global 2026) - No abstract available

Clinical • Gram negative • Real-world • Real-world evidence • Infectious Disease

NDM Escherichia coli with aztreonam/avibactam and/or cefiderocol resistance in immunocompromised paediatric patients and use of cefepime/zidebactam (ESCMID Global 2026) - No abstract available

Clinical • Pediatrics

A case series of compassionate use of novel antibiotic WCK 5222 (zidebactam/cefepime) in treatment of diverse infections caused by metallo-β-lactamase (MBL) producing Gram-negative pathogens (ESCMID Global 2026) - No abstract available

Clinical • Gram negative • Infectious Disease

Isolates from zidebactam/cefepime (ZID/FEP) compassionate use under the genomic lens: continued in vitro activity of ZID/FEP against diverse XDR Gram-negative pathogens (ESCMID Global 2026) - No abstract available

Gram negative • Preclinical • Infectious Disease

Assessment of impact of variation in standard in vitro testing parameters including physiologically relevant conditions on zidebactam/cefepime MICs (ESCMID Global 2026) - No abstract available

Preclinical

Safety and tolerability of zidebactam/cefepime (ZID-FEP, WCK 5222) vs meropenem in adults with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP) in a global, randomised, double-blind phase III (Enhance 1) trial (ESCMID Global 2026) - No abstract available

Clinical • P3 data • Infectious Disease • Nephrology

Zidebactam/cefepime (ZID/FEP): determination of ZID and FEP pharmacodynamic targets against carbapenem-resistant Enterobacterales (CREs) in a neutropenic murine lung infection model (ESCMID Global 2026) - No abstract available

PK/PD data • Preclinical • Infectious Disease • Respiratory Diseases