19 April 2016 / Accepted: 26 May 2016 / Published online: 14 June 2016 | Daniel Bobo, Kye J. Robinson, Jiaul Islam, Kristofer J. Thurecht, Simon R. Corrie
This review provides an up-to-date overview of nanomedicines, including those currently approved by the US FDA and those in clinical trials. Nanomedicines are defined as therapeutic or imaging agents that incorporate nanoparticles to enhance efficacy, reduce toxicity, or control biodistribution. The review identifies 51 FDA-approved nanomedicines and 77 products in clinical trials, with a significant increase in trials starting in 2014 and 2015. The materials used are predominantly polymeric, liposomal, and nanocrystalline, but there is a growing trend towards more complex materials such as micelles, protein-based nanoparticles, and inorganic/medical particles. The review highlights recent approvals and emerging materials, emphasizing the need for active targeting, multifunctionality, and the development of more sophisticated materials. Key challenges include classifying new materials and ensuring safety and toxicity testing before clinical use. The review also discusses the regulatory process for nanomedicines, which is similar to that for other drugs, and the importance of understanding the physicochemical properties and manufacturing processes of these materials.This review provides an up-to-date overview of nanomedicines, including those currently approved by the US FDA and those in clinical trials. Nanomedicines are defined as therapeutic or imaging agents that incorporate nanoparticles to enhance efficacy, reduce toxicity, or control biodistribution. The review identifies 51 FDA-approved nanomedicines and 77 products in clinical trials, with a significant increase in trials starting in 2014 and 2015. The materials used are predominantly polymeric, liposomal, and nanocrystalline, but there is a growing trend towards more complex materials such as micelles, protein-based nanoparticles, and inorganic/medical particles. The review highlights recent approvals and emerging materials, emphasizing the need for active targeting, multifunctionality, and the development of more sophisticated materials. Key challenges include classifying new materials and ensuring safety and toxicity testing before clinical use. The review also discusses the regulatory process for nanomedicines, which is similar to that for other drugs, and the importance of understanding the physicochemical properties and manufacturing processes of these materials.