Exblifep (cefepime/enmetazobactam) / Allecra - LARVOL DELTA

Cefepime/enmetazobactam for invasive infections caused by extended-spectrum beta-lactamase-producing Enterobacterales: a real-world case series. (PubMed, Infection) - "Cefepime/enmetazobactam showed favorable clinical results and may represent a carbapenem-sparing treatment option in selected patients with invasive ESBL-E infections. Real-world data remain limited and further studies are needed to specify the most suitable patient population."

Journal • Real-world evidence • Infectious Disease • Pneumonia • Respiratory Diseases

Superior in vitro Activity of Cefepime-Enmetazobactam Over Ceftazidime-Avibactam and Piperacillin-Tazobactam Against 3rd Generation cephalosporin resistant Enterobacterales. (PubMed, Jpn J Infect Dis) - "The rise of extended-spectrum β-lactamase (ESBL) and carbapenem-resistant Enterobacterales (CRE) has severely limited treatment options in India. FPE-aztreonam synergy was infrequent (≤4%). Cefepime-enmetazobactam demonstrated superior in vitro activity to CZA and Piperacillin Tazobactam against ESBL-producing but carbapenem-susceptible Enterobacterales, making it a potent carbapenem-sparing option."

Journal • Preclinical • Infectious Disease • Pneumonia

A Study to Investigate PK, Safety, Tolerability of Cefepime-enmetazobactam in Pediatric Participants With cUTI (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Orchid Pharma Europe GmbH | Trial completion date: Mar 2026 ➔ May 2029 | Trial primary completion date: Sep 2025 ➔ May 2029

Trial completion date • Trial primary completion date • Infectious Disease • Nephrology • Pediatrics

Spectrophotometric determination of cefepime and enmetazobactam in pharmaceutical formulations and human plasma using chemometric modeling, metaheuristic wavelength selection, and comprehensive sustainability assessment. (PubMed, BMC Chem) - "The proposed approach offers a rapid, cost-effective, and environmentally sustainable alternative for routine pharmaceutical quality control and proof-of-concept evaluation in processed post-extraction-fortified human plasma. Further comprehensive bioanalytical validation is warranted to support routine clinical application."

Journal

Real-world outcomes of cefepime/enmetazobactam for Enterobacterales infections: a retrospective descriptive study. (PubMed, Microbiol Spectr) - "Four isolates were ertapenem-resistant but remained susceptible to imipenem and meropenem; no carbapenemase production was confirmed. Clinical cure was achieved in all patients, microbiological eradication was documented in most cases, and no in-hospital deaths occurred. These findings suggest that cefepime/enmetazobactam may be a useful and well-tolerated carbapenem-sparing option for selected resistant gram-negative infections, while emphasizing the need for larger studies to confirm its role in routine clinical practice."

Journal • Real-world evidence • Retrospective data • Infectious Disease • Pneumonia • Respiratory Diseases

CP-CUTI: Cefepime/Enmetazobactam for Bacteremic Complicated Urinary Tract Infections (clinicaltrials.gov) - P=N/A | N=200 | Not yet recruiting | Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

New trial • Infectious Disease • Nephrology

An update on beta-lactam-beta-lactamase inhibitor combinations for the treatment of carbapenem-resistant gram-negative pathogens. (PubMed, Expert Opin Drug Metab Toxicol) - "This expert review summarizes the pharmacology, clinical efficacy, and safety of approved and emerging BLBLIs, including ceftolozane - tazobactam, cefepime - enmetazobactam, ceftazidime - avibactam, meropenem - vaborbactam, imipenem - relebactam, aztreonam - avibactam, and sulbactam - durlobactam. However, their impact is threatened by the rising prevalence of metallo-β-lactamases and the persistent therapeutic gap in carbapenem-resistant A. baumannii. Future success will depend on next-generation inhibitors with broader enzyme coverage, optimized dosing strategies guided by PK/PD principles, and robust antimicrobial stewardship to preserve long-term efficacy."

Journal • Review • Infectious Disease

Combating antimicrobial resistance in ESBL- and AmpC-producing Enterobacterales: In vitro evaluation of cefepime-enmetazobactam. (PubMed, Indian J Med Microbiol) - "Cefepime-enmetazobactam showed higher or comparable in vitro activity against ESBL- and/or AmpC-producing Enterobacterales compared to conventional BL/BLI options. Hence, it can serve as an effective alternative treatment for resistant pathogens."

Journal • Preclinical • Infectious Disease • Pneumonia

AT-202: A study to investigate pharmacokinetics, safety, and tolerability of Cefepime-Enmetazobactam administered by intra-venous infusion over 2 hours in participants aged from birth to less than 18 years hospitalized with cUTI including AP. (clinicaltrialsregister.eu) - P1/2 | N=30 | Active, not recruiting | Sponsor: Allecra Therapeutics | Suspended ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Nephrology

Evaluation of in vitro synergy of cefepime/enmetazobactam combined with aztreonam against metallo-β-lactamase-producing Enterobacterales. (PubMed, J Antimicrob Chemother) - No abstract available

Journal • Preclinical

A Review of β-Lactamase Inhibitors in Clinical Use and Development: Mechanisms, Spectrum, and Therapeutic Applications. (PubMed, Int J Microbiol) - "As the efficacy of conventional treatments diminishes, reliance on last-resort agents like carbapenems and colistin has increased, in turn accelerating resistance to these precious final-line options...A paramount, ongoing challenge remains the development of effective inhibitors against metallo-β-lactamases (MBLs), though promising candidates like taniborbactam and xeruborbactam are now in clinical development. This review synthesizes the current knowledge on these innovative inhibitors, from recently approved combinations like ceftazidime/avibactam and cefepime/enmetazobactam to those in advanced clinical trials, and critically examines the associated therapeutic challenges, including the emergence of resistance. By integrating mechanistic insights with clinical perspectives, this article is aimed at informing the ongoing battle against antimicrobial resistance and guiding the future development of life-saving therapeutic strategies."

Journal • Review • Infectious Disease

Evaluation of cefepime/enmetazobactam gradient strip and disk diffusion test for CTX-M producing Enterobacterales. (PubMed, J Glob Antimicrob Resist) - "These data demonstrate a good in vitro activity of cefepime/enmetazobactam against CTX-M producing E. coli and K. pneumoniae . Moreover, DD proved reliable and reproducible for routine testing while gradient strips underestimated MIC values which could be critical for isolates near the breakpoint."

Journal • Infectious Disease • Pneumonia

Cefepime/enmetazobactam steady-state concentrations in spondylodiscitis-relevant tissues: an experimental porcine study. (PubMed, Eur Spine J) - "Both cefepime and enmetazobactam consistently reached theoretically effective unbound steady-state tissue levels in relevant target tissues for spondylodiscitis, irrespective of the dosing regimen."

Journal • Preclinical • Infectious Disease

Ventilator-Associated Pneumonia Due to ESBL-Producing Escherichia coli Successfully Treated with Cefepime/Enmetazobactam: A European Case Report. (PubMed, Infect Dis Ther) - "No relapse or adverse events occurred. This case supports the potential role of FEP/META as a carbapenem-sparing option for ESBL-related VAP and highlights the importance of pharmacokinetic/pharmacodynamic considerations in optimizing antimicrobial stewardship strategies."

Journal • CNS Disorders • Critical care • Infectious Disease • Orthopedics • Pneumonia • Respiratory Diseases

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

Acupuncture inhibits ferroptosis and epithelial-mesenchymal transition to attenuate proteinuria in diabetic kidney disease. (PubMed, Tissue Cell) - "Acupuncture can alleviate oxidative stress injury, improve renal function, and reduce proteinuria by inhibiting renal cell FeP and blocking the EMT process. The mechanism is related to the regulation of GPX4/SLC7A11/ACSL4 and E-cadherin/N-cadherin/α-SMA expression, and this therapeutic effect has the advantages of acupoint specificity and multi-target action."

Journal • Diabetic Nephropathy • Nephrology • Renal Disease • ACSL4 • B2M • CDH1 • CDH2 • GPX4 • KIM1 • SLC7A11

Synergistic activity of cefepime/enmetazobactam with meropenem, piperacillin, piperacillin/tazobactam, cefiderocol and fosfomycin against Klebsiella pneumoniae carrying blaKPC allelic variants. (PubMed, J Antimicrob Chemother) - No abstract available

Journal • Infectious Disease • Pneumonia

Cefepime-enmetazobactam for complicated urinary tract infections: Redefining ESBL therapy. (PubMed, Indian J Med Res) - "In the Phase 3 ALLIUM trial, CPM-EMT achieved superior overall treatment success versus piperacillin-tazobactam in patients with complicated UTI and acute pyelonephritis, including ESBL subgroups...It is not appropriate for empiric use in haemodynamically unstable ICU patients or where carbapenemase prevalence (e.g., NDM-β-lactamase, OXA-48-like, KPC) is high; mechanism-directed alternatives (e.g., ceftazidime-avibactam with or without aztreonam, cefiderocol) are preferred. Evidence gaps include paediatric dosing/safety, Indian real-world comparative outcomes, Pseudomonas-specific efficacy, and cost-effectiveness. Implementation in India should integrate rapid diagnostics, local antibiograms, and optimised dosing within AMSP pathways to preserve carbapenems without compromising outcomes."

Journal • Review • Infectious Disease • Nephrology • Pediatrics • Renal Disease

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

Activity of Cefepime/Enmetazobactam in Carbapenem-Resistant Gram-Negative Bacteria: Real-World Evidence from a German Tertiary Care Center. (PubMed, Microb Drug Resist) - "Susceptibility varied across resistance genotypes and included isolates carrying resistance determinants formally not targeted by META. FEP/META could be an option for carbapenem-resistant organisms if other recommended therapies fail."

HEOR • Journal • Real-world evidence • Infectious Disease • Nephrology • Pneumonia

Effectiveness of cefepime/enmetazobactam against highly multidrug-resistant bacterial isolates recovered from war-associated wounds in Ukraine (ESCMID Global 2026) - No abstract available

Domiciliary use of cefepime/enmetazobactam in a portable infusion pump: a pioneering experience (ESCMID Global 2026) - No abstract available

In vitro activity of cefepime/enmetazobactam vs meropenem against Enterobacterales producing blaOXA-48-like carbapenemase and blaCTX-M extended-spectrum β-lactamase (ESCMID Global 2026) - No abstract available

Preclinical

Role of OmpK36 in cefepime/enmetazobactam resistance in KPC-producing K. pneumoniae (ESCMID Global 2026) - No abstract available

Infectious Disease • Pneumonia

In vitro activity of cefepime/enmetazobactam vs ceftazidime/avibactam against ESBL and OXA-48 Enterobacterales (ESCMID Global 2026) - No abstract available

Preclinical