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奥马环素:全球首次获批。

Omadacycline: First Global Approval.

机构信息

Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand.

出版信息

Drugs. 2018 Dec;78(18):1931-1937. doi: 10.1007/s40265-018-1015-2.

DOI:10.1007/s40265-018-1015-2
PMID:30471003
Abstract

Paratek Pharmaceuticals are developing omadacycline (NUZYRA™), a first-in-class orally active aminomethylcycline antibacterial, as a treatment for various bacterial infections. The drug, which is available in intravenous and oral formulations, has a broad spectrum of antibacterial activity and was recently approved in the USA as a treatment for the treatment of community acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) in adults. This article summarizes the milestones in the development of omadacycline leading to this first global approval for the treatment of CABP and ABSSSI.

摘要

Paratek 制药公司正在开发 omadacycline(NUZYRA™),这是一种首创的口服活性氨甲基环素类抗菌药物,用于治疗各种细菌感染。该药物有静脉注射和口服两种剂型,具有广谱抗菌活性,最近在美国获得批准,用于治疗成人社区获得性细菌性肺炎(CABP)和急性细菌性皮肤和皮肤结构感染(ABSSSI)。本文总结了 omadacycline 开发过程中的重要里程碑,最终使其在全球范围内首次获批用于治疗 CABP 和 ABSSSI。

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Omadacycline: First Global Approval.奥马环素:全球首次获批。
Drugs. 2018 Dec;78(18):1931-1937. doi: 10.1007/s40265-018-1015-2.
2
Once-daily oral omadacycline versus twice-daily oral linezolid for acute bacterial skin and skin structure infections (OASIS-2): a phase 3, double-blind, multicentre, randomised, controlled, non-inferiority trial.每日口服奥马环素与每日口服利奈唑胺治疗急性细菌性皮肤和皮肤结构感染(OASIS-2):一项 3 期、双盲、多中心、随机、对照、非劣效性试验。
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Omadacycline: A Novel Oral and Intravenous Aminomethylcycline Antibiotic Agent.奥马环素:一种新型口服和静脉注射氨甲基环素抗生素药物。
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Drugs Today (Barc). 2018 Mar;54(3):209-217. doi: 10.1358/dot.2018.54.3.2800620.
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Ann Pharmacother. 2019 May;53(5):486-500. doi: 10.1177/1060028018818094. Epub 2018 Dec 7.
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本文引用的文献

1
Activities of Omadacycline and Comparators against Anaerobic Bacteria.奥马环素及对照药物对厌氧菌的活性。
Antimicrob Agents Chemother. 2018 Mar 27;62(4). doi: 10.1128/AAC.00047-18. Print 2018 Apr.
2
Pharmacokinetics and Safety of Omadacycline in Subjects with Impaired Renal Function.奥马环素在肾功能损害受试者中的药代动力学和安全性。
Antimicrob Agents Chemother. 2018 Jan 25;62(2). doi: 10.1128/AAC.02057-17. Print 2018 Feb.
3
Comparison of Omadacycline and Tigecycline Pharmacokinetics in the Plasma, Epithelial Lining Fluid, and Alveolar Cells of Healthy Adult Subjects.
LC-MS/MS quantification of omadacycline in human plasma for therapeutic drug monitoring: method development and clinical application.
用于治疗药物监测的人血浆中奥马环素的液相色谱-串联质谱定量分析:方法开发与临床应用
Sci Rep. 2025 Jul 29;15(1):27728. doi: 10.1038/s41598-025-13396-3.
4
Omadacycline successfully treated severe pneumonia after moxifloxacin treatment failure: Case series.莫西沙星治疗失败后奥马环素成功治疗重症肺炎:病例系列
Front Pharmacol. 2025 Mar 10;16:1559857. doi: 10.3389/fphar.2025.1559857. eCollection 2025.
5
Omadacycline for Diverse Infections in China: A Real-World Analysis of Efficacy and Safety.奥马环素在中国治疗多种感染的疗效与安全性的真实世界分析
Infect Dis Ther. 2024 Dec;13(12):2509-2526. doi: 10.1007/s40121-024-01065-3. Epub 2024 Oct 22.
6
Staph wars: the antibiotic pipeline strikes back.葡萄球菌之战:抗生素管道奋起反击。
Microbiology (Reading). 2023 Sep;169(9). doi: 10.1099/mic.0.001387.
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Omadacycline for treatment of acute bacterial infections: a meta-analysis of phase II/III trials.奥马环素治疗急性细菌性感染的疗效:II/III 期临床试验的荟萃分析。
BMC Infect Dis. 2023 Apr 14;23(1):232. doi: 10.1186/s12879-023-08212-0.
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Asymmetric Synthesis of US-FDA Approved Drugs over Five Years (2016-2020): A Recapitulation of Chirality.五年(2016 - 2020年)来美国食品药品监督管理局批准药物的不对称合成:手性概述
Pharmaceuticals (Basel). 2023 Feb 22;16(3):339. doi: 10.3390/ph16030339.
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The Development of Third-Generation Tetracycline Antibiotics and New Perspectives.第三代四环素类抗生素的发展及新展望
Pharmaceutics. 2021 Dec 5;13(12):2085. doi: 10.3390/pharmaceutics13122085.
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比较奥马环素和替加环素在健康成年受试者血浆、上皮衬液和肺泡细胞中的药代动力学。
Antimicrob Agents Chemother. 2017 Aug 24;61(9). doi: 10.1128/AAC.01135-17. Print 2017 Sep.
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and Activity of Omadacycline against Two Biothreat Pathogens, Bacillus anthracis and Yersinia pestis.奥马环素对两种生物威胁病原体炭疽芽孢杆菌和鼠疫耶尔森菌的活性。
Antimicrob Agents Chemother. 2017 Apr 24;61(5). doi: 10.1128/AAC.02434-16. Print 2017 May.
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Pharmacodynamic Evaluation of Omadacycline (PTK 0796) against Streptococcus pneumoniae in the Murine Pneumonia Model.奥马环素(PTK 0796)在小鼠肺炎模型中对肺炎链球菌的药效学评价
Antimicrob Agents Chemother. 2017 Apr 24;61(5). doi: 10.1128/AAC.02368-16. Print 2017 May.
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Discovery, pharmacology, and clinical profile of omadacycline, a novel aminomethylcycline antibiotic.新型氨基甲基环素类抗生素奥马环素的发现、药理学及临床概况
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A randomized, evaluator-blind, phase 2 study comparing the safety and efficacy of omadacycline to those of linezolid for treatment of complicated skin and skin structure infections.一项随机、评价者盲、2 期研究比较了奥马环素与利奈唑胺治疗复杂性皮肤和皮肤结构感染的安全性和疗效。
Antimicrob Agents Chemother. 2012 Nov;56(11):5650-4. doi: 10.1128/AAC.00948-12. Epub 2012 Aug 20.