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Cefepime\u2010zidebactam (FEP\u2010ZID) is a novel \u03b2\u2010lactam\/\u03b2\u2010lactam enhancer combination that offers a mechanistically distinct approach to overcoming resistance in Gram\u2010negative organisms. Zidebactam contributes three complementary mechanisms: inhibition of Class A and C \u03b2\u2010lactamases, direct antibacterial activity via PBP2 inhibition, and enhancement of cefepime activity through a reduction in the pharmacodynamic exposure required for bactericidal effect, allowing FEP\u2010ZID to achieve substantial reductions in bacterial burden even in isolates with elevated minimum inhibitory concentrations (MICs). FEP\u2010ZID was recently approved in the United States for the treatment of complicated urinary tract infection (cUTI), including acute pyelonephritis, caused by Enterobacterales and\/or\n                    <jats:styled-content style=\"fixed-case\">\n                      <jats:italic>Pseudomonas aeruginosa<\/jats:italic>\n                    <\/jats:styled-content>\n                    . FEP\u2010ZID demonstrates broad in\u00a0vitro and in\u00a0vivo activity against isolates producing Class A, B, C, and D \u03b2\u2010lactamases, as well as organisms harboring PBP3 alterations that are otherwise associated with reduced susceptibility to currently available MBL\u2010active therapies. This spectrum extends across carbapenem\u2010resistant Enterobacterales,\n                    <jats:styled-content style=\"fixed-case\">\n                      <jats:italic>P. aeruginosa<\/jats:italic>\n                    <\/jats:styled-content>\n                    , and\n                    <jats:styled-content style=\"fixed-case\">\n                      <jats:italic>Acinetobacter baumannii<\/jats:italic>\n                    <\/jats:styled-content>\n                    , and includes activity against isolates with porin loss and efflux upregulation, resistance mechanisms that commonly limit the utility of other \u03b2\u2010lactam\u2010based agents. In\u00a0vivo infection models utilizing humanized regimens have demonstrated bactericidal activity against isolates with FEP\u2010ZID MICs up to 64\u2009\u03bcg\/mL. The Phase 3 ENHANCE I trial demonstrated noninferiority and subsequent superiority over meropenem in cUTI (including acute pyelonephritis), driven primarily by microbiological response, with favorable outcomes observed across many baseline pathogens, including extended\u2010spectrum \u03b2\u2010lactamase\u2010producing isolates and patients with concomitant bacteremia. Compassionate use experience further suggests possible utility in severe multidrug\u2010resistant infections across multiple infection types, including bloodstream, osteoarticular, and intra\u2010abdominal infections caused by MBL\u2010producing organisms. Collectively, available preclinical and clinical evidence positions FEP\u2010ZID as a mechanistically distinct option for difficult\u2010to\u2010treat Gram\u2010negative infections, with additional clinical study needed to define its role beyond the currently approved indication.\n                  <\/jats:p>","DOI":"10.1002\/phar.70208","type":"journal-article","created":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T03:44:11Z","timestamp":1791863051000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Cefepime\u2010Zidebactam: Leveraging \u03b2\u2010Lactam Enhancement Against Difficult\u2010to\u2010Treat and Metallo\u2010\u03b2\u2010Lactamase\u2010Producing Gram\u2010Negative Pathogens"],"prefix":"10.1002","volume":"46","author":[{"ORCID":"https:\/\/orcid.org\/0009-0000-2277-7089","authenticated-orcid":false,"given":"Sean R.","family":"Van 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