Nanoparticle-Based Medicines: A Review of FDA-Approved Materials and Clinical Trials to Date

Pharm Res. 2016 Oct;33(10):2373-87. doi: 10.1007/s11095-016-1958-5. Epub 2016 Jun 14.


In this review we provide an up to date snapshot of nanomedicines either currently approved by the US FDA, or in the FDA clinical trials process. We define nanomedicines as therapeutic or imaging agents which comprise a nanoparticle in order to control the biodistribution, enhance the efficacy, or otherwise reduce toxicity of a drug or biologic. We identified 51 FDA-approved nanomedicines that met this definition and 77 products in clinical trials, with ~40% of trials listed in started in 2014 or 2015. While FDA approved materials are heavily weighted to polymeric, liposomal, and nanocrystal formulations, there is a trend towards the development of more complex materials comprising micelles, protein-based NPs, and also the emergence of a variety of inorganic and metallic particles in clinical trials. We then provide an overview of the different material categories represented in our search, highlighting nanomedicines that have either been recently approved, or are already in clinical trials. We conclude with some comments on future perspectives for nanomedicines, which we expect to include more actively-targeted materials, multi-functional materials ("theranostics") and more complicated materials that blur the boundaries of traditional material categories. A key challenge for researchers, industry, and regulators is how to classify new materials and what additional testing (e.g. safety and toxicity) is required before products become available.

Keywords: FDA; clinical trials; nanomedicine; nanoparticles; nanopharmaceuticals; nanotherpeutics.

Publication types

  • Review
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Clinical Trials as Topic* / legislation & jurisprudence
  • Clinical Trials as Topic* / methods
  • Drug Approval* / methods
  • Humans
  • Nanomedicine / legislation & jurisprudence
  • Nanomedicine / trends*
  • Nanoparticles / administration & dosage*
  • Nanoparticles / metabolism
  • Tissue Distribution / drug effects
  • Tissue Distribution / physiology
  • United States / epidemiology