College of Pharmacy, University of Illinois at Chicago.
College of Pharmacy, University of Illinois at Chicago College of Medicine, University of Illinois at Chicago.
Clin Infect Dis. 2015 Sep 15;61 Suppl 2:S38-47. doi: 10.1093/cid/civ522.
Telavancin (TD-6424) was discovered in 2000 and became the first marketed semisynthetic lipoglycopeptide in 2009. This parenteral antibacterial agent has a dual mechanism of action and potent in vitro activity against gram-positive pathogens, including methicillin-resistant Staphylococcus aureus and isolates with reduced vancomycin susceptibility. Pharmacokinetic and pharmacodynamic analyses support the concentration-dependent activity and once-daily dosing regimen of telavancin. A changing regulatory approval process, manufacturing obstacles, and the termination of a commercialization partnership have challenged the development and marketing of telavancin. The commercial operations for telavancin have been restored, a new manufacturer has been secured, and reliable product supplies are available for clinical use. In addition, telavancin continues to be supported by ongoing clinical research with the recent launch of the Telavancin Observational Use Registry (TOUR; NCT02288234) in the United States and an international phase 3, randomized trial comparing telavancin with standard therapy for the treatment of patients with complicated S. aureus bacteremia, including endocarditis (NCT02208063).
替拉万星（TD-6424）于 2000 年被发现，并于 2009 年成为首个上市的半合成糖肽类药物。这种注射用抗菌药物具有双重作用机制，对包括耐甲氧西林金黄色葡萄球菌和对万古霉素敏感性降低的分离株在内的革兰氏阳性病原体具有强大的体外活性。药代动力学和药效学分析支持替拉万星的浓度依赖性活性和每日一次的给药方案。不断变化的监管审批程序、制造障碍以及商业化合作关系的终止，给替拉万星的开发和营销带来了挑战。替拉万星的商业运营已恢复，新的制造商已经确定，临床应用有可靠的产品供应。此外，替拉万星继续得到持续的临床研究的支持，最近在美国启动了替拉万星观察性使用登记研究（TOUR；NCT02288234），并开展了一项国际性的 3 期随机试验，比较替拉万星与标准疗法治疗复杂性金黄色葡萄球菌菌血症（包括心内膜炎）患者的疗效（NCT02208063）。
