a Department of Pharmacy Practice and Translational Research , University of Houston College of Pharmacy , Houston , TX , USA.
Expert Opin Investig Drugs. 2019 Apr;28(4):303-310. doi: 10.1080/13543784.2019.1582640. Epub 2019 Feb 26.
Ridinilazole is a novel antibiotic being developed for the treatment of Clostridioides difficile infection (CDI). Ridinilazole has completed two phase II trials and phase III trials which are denoted Ri-CoDIFy 1 and 2, are planned (ClinicalTrials.gov identifiers: NCT03595553 and NCT03595566). Areas covered: This article covers the chemistry, mechanism of action, in vitro microbiology versus C. difficile and host microbiota, pre-clinical and clinical efficacy, pharmacokinetics, pharmacodynamics and safety and tolerability of ridinilazole. Expert opinion: Ridinilazole is a novel antibiotic with ideal properties for the treatment of CDI. Given the promising results from the phase II clinical trial, ridinilazole may have the capability to lower the risk for CDI recurrence thus improving sustained clinical response rates - a current unmet medical need. Assuming a positive phase III trial, ridinilazole will enter a market with heightened awareness on the importance of prevention of CDI. This along with further research into the economic consequences and decreased patient quality of life associated with recurrent CDI, should provide clinicians with further evidence for the need for therapy that limits CDI recurrence and improves sustained clinical cure.
利奈唑胺是一种新型抗生素，用于治疗艰难梭菌感染（CDI）。利奈唑胺已经完成了两项 II 期临床试验和 III 期临床试验，分别称为 Ri-CoDIFy1 和 2，计划进行（ClinicalTrials.gov 标识符：NCT03595553 和 NCT03595566）。涵盖领域：本文涵盖了利奈唑胺的化学、作用机制、体外微生物学与艰难梭菌和宿主微生物群、临床前和临床疗效、药代动力学、药效学以及安全性和耐受性。专家意见：利奈唑胺是一种新型抗生素，具有治疗 CDI 的理想特性。鉴于 II 期临床试验的良好结果，利奈唑胺有可能降低 CDI 复发的风险，从而提高持续临床应答率-这是目前未满足的医疗需求。如果 III 期临床试验结果为阳性，利奈唑胺将进入一个对预防 CDI 重要性认识度提高的市场。此外，对与复发性 CDI 相关的经济后果和患者生活质量下降的进一步研究，应向临床医生提供更多证据，证明需要进行限制 CDI 复发和提高持续临床治愈率的治疗。
