Nanoparticle-based medicines: a review of FDA-approved materials and clinical trials to date

Bobo, Daniel, Robinson, Kye J., Islam, Jiaul, Thurecht, Kristofer J. and Corrie, Simon R. (2016) Nanoparticle-based medicines: a review of FDA-approved materials and clinical trials to date. Pharmaceutical Research, 33 10: 2373-2387. doi:10.1007/s11095-016-1958-5


Author Bobo, Daniel
Robinson, Kye J.
Islam, Jiaul
Thurecht, Kristofer J.
Corrie, Simon R.
Title Nanoparticle-based medicines: a review of FDA-approved materials and clinical trials to date
Journal name Pharmaceutical Research   Check publisher's open access policy
ISSN 1573-904X
0724-8741
Publication date 2016-10-01
Year available 2016
Sub-type Critical review of research, literature review, critical commentary
DOI 10.1007/s11095-016-1958-5
Open Access Status Not yet assessed
Volume 33
Issue 10
Start page 2373
End page 2387
Total pages 15
Place of publication New York, NY, United States
Publisher Springer New York LLC
Language eng
Abstract 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 clinicaltrials.gov 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.
Keyword Clinical trials
FDA
Nanomedicine
Nanoparticles
Nanopharmaceuticals
Nanotherpeutics
Q-Index Code C1
Q-Index Status Provisional Code
Grant ID APP1099231
FT110100284
NC-14-037
CE140100036
Institutional Status UQ

Document type: Journal Article
Sub-type: Critical review of research, literature review, critical commentary
Collections: HERDC Pre-Audit
Admin Only - School of Medicine
School of Medicine Publications
Australian Institute for Bioengineering and Nanotechnology Publications
Centre for Advanced Imaging Publications
 
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