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Furthermore, the prevalence of metallo\u2010\u03b2\u2010lactamase (MBL)\u2010producing CRE and CR\u2010PA is increasing, which are capable of hydrolyzing nearly all \u03b2\u2010lactam antibiotics. Cefepime\u2010taniborbactam (FTB) is a novel bicyclic boronate \u03b2\u2010lactam\u2010\u03b2\u2010lactamase inhibitor combination with direct inhibitory activity against MBLs (Ambler Class B), in addition to Ambler Class A, C, and D serine\u2010\u03b2\u2010lactamases. FTB has demonstrated high in\u00a0vitro activity against CRE and CR\u2010PA, including isolates producing NDM, VIM, KPC, AmpC, OXA\u201048, and extended\u2010spectrum \u03b2\u2010lactamases (ESBLs). Furthermore, FTB has demonstrated in\u00a0vitro activity against\n                    <jats:italic>Stenotrophomonas maltophilia<\/jats:italic>\n                    and\n                    <jats:italic>Burkholderia cepacia<\/jats:italic>\n                    complex. Resistance to FTB is observed in isolates producing IMP, as well as MBL variants NDM\u20109, NDM\u201030, and VIM\u201083. FTB remains susceptible to non\u2010\u03b2\u2010lactamase resistance mechanisms, including penicillin\u2010binding protein 3 (PBP3) target mutations. The pharmacodynamic driver of taniborbactam efficacy is the ratio of the area under the curve to the minimum inhibitory concentration (AUC\/MIC), and the study dose of FTB 2\u2009g\/0.5\u2009g every 8\u2009h infused over 2\u2009h achieves sufficient serum and tissue exposures to maintain therapeutic efficacy. Both components are primarily renally eliminated as unchanged drug; therefore, dose adjustments for renal impairment are required. The clinical efficacy of FTB was demonstrated in the phase III Cefepime Rescue with Taniborbactam in Complicated Urinary Tract Infection (CERTAIN\u20101) trial, where it demonstrated both non\u2010inferiority and superiority (prespecified analysis) to meropenem in the composite of clinical and microbiologic success at the test of cure for the treatment of complicated urinary tract infection. The safety of FTB was demonstrated throughout its clinical development. Thirteen percent of patients experienced a treatment\u2010related adverse drug event in the phase III clinical trial, with 3% of patients requiring discontinuation of the study agent. Cefepime\u2010taniborbactam appears to be a promising addition to the antibiotic arsenal, particularly as the prevalence of infections caused by MBL\u2010producing organisms continues to rise.\n                  <\/jats:p>","DOI":"10.1002\/phar.70036","type":"journal-article","created":{"date-parts":[[2025,6,21]],"date-time":"2025-06-21T02:53:44Z","timestamp":1750474424000},"page":"448-461","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Cefepime\u2010taniborbactam: Ushering in the era of metallo\u2010\u03b2\u2010lactamase inhibition"],"prefix":"10.1002","volume":"45","author":[{"ORCID":"https:\/\/orcid.org\/0009-0000-2277-7089","authenticated-orcid":false,"given":"Sean R.","family":"Van Helden","sequence":"first","affiliation":[{"name":"Anti\u2010Infective Research Laboratory, Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences Wayne State University  Detroit Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3861-9725","authenticated-orcid":false,"given":"Mohammed","family":"Al Musawa","sequence":"additional","affiliation":[{"name":"Anti\u2010Infective Research Laboratory, Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences Wayne State University  Detroit Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-6232-6804","authenticated-orcid":false,"given":"Callan R.","family":"Bleick","sequence":"additional","affiliation":[{"name":"Anti\u2010Infective Research Laboratory, Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences Wayne State University  Detroit Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4480-6159","authenticated-orcid":false,"given":"Shelbye R.","family":"Herbin","sequence":"additional","affiliation":[{"name":"John D. 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