Despite the massive interest and recent developments in the field of nanomedicine, only a limited number of formulations have found their way to the clinics. This shortcoming reveals the challenges facing the clinical translation of this technology. In the current article, we summarize and evaluate the status, market situation, and clinical profiles of the reported nanomedicines, the shortcomings limiting their clinical translation, as well as some approaches designed to break through this barrier. Moreover, some emerging technologies that have the potential to compete with nanomedicines are highlighted. Lastly, we identify the key factors that should be considered in nanomedicine-related research to be clinically-translatable. These can be classified into five areas: rational design during the research and development stage, the recruitment of representative preclinical models, careful design of clinical trials, development of specific and uniform regulatory protocols, and calls for non-classic sponsorship. This new field of endeavor was firmly established during the last two decades and more in-depth progress is expected in the coming years.

尽管纳米医学领域引起了广泛的兴趣和最近的发展，但只有有限数量的制剂能够进入临床。这一缺点揭示了该技术的临床转化所面临的挑战。在本文中，我们总结和评估了已报道的纳米药物的现状、市场情况和临床概况，限制其临床转化的缺点，以及旨在突破这一障碍的一些方法。此外，还强调了一些有可能与纳米药物竞争的新兴技术。最后，我们确定了在纳米医学相关研究中应考虑的关键因素，以实现临床转化。这些可以分为五个领域：研发阶段的合理设计，招募具有代表性的临床前模型，精心设计临床试验，制定具体和统一的监管协议，并呼吁非经典赞助。在过去的二十年中，这一新的努力领域已经牢固确立，预计未来几年将取得更深入的进展。