Cited by 2,586Nanoparticle-Based Drug DeliveryNanotechnology research and applicationsAdvanced Drug Delivery Systems

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

Bobo, Daniel, Robinson, Kye J., Islam, Jiaul, Thurecht, Kristofer J., Corrie, Simon R.·2016·Pharmaceutical Research

DOI 10.1007/s11095-016-1958-5

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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.

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Authors: Bobo, D., Robinson, K. J., Islam, J., Thurecht, K. J., & Corrie, S. R.
Affiliations: The University of Queensland (AU)
Monash University (AU)
Corresponding author: Corrie, Simon R.
ORCID: Bobo, Daniel
Robinson, Kye J.
Thurecht, Kristofer J.
Corrie, Simon R.
Venue: Pharmaceutical Research
Publisher: Springer Science and Business Media LLC
Published: 2016-06-14
Volume: 33
Issue: 10
Pages: 2373-2387
ISSN: 0724-8741 (ISSN-L)
1573-904X
DOI: 10.1007/s11095-016-1958-5
OpenAlex: W2421275313
Cited by: 2,586
References: 94
Citations by year: 2026: 173 · 2025: 202 · 2024: 218 · 2023: 250 · 2022: 302 · 2021: 382 · 2020: 391 · 2019: 323 · 2018: 234 · 2017: 96 · 2016: 12
FWCI: 11.86
Type: journal article
Language: en
Open access: closed
Licence: www.springer.com/tdm (tdm)
www.springer.com/tdm (vor)
Locations: Pharmaceutical Research (publishedVersion)
PubMed (publishedVersion)
Funders: Centre of Excellence in Convergent BioNano Science and Technology (CE140100036)
National Health and Medical Research Council (APP1099231)
Australian Research Council (FT110100284, DP140100951)
Topics: Physical Sciences › Materials Science › Biomaterials › Nanoparticle-Based Drug Delivery
Physical Sciences › Materials Science › General Materials Science › Nanotechnology research and applications
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Advanced Drug Delivery Systems
Keywords: nanomedicine, nanoparticle drug delivery, liposomes, polymeric nanoparticles, nanocrystals, micelles, protein nanoparticles, inorganic nanoparticles, metal nanoparticles, theranostics, active targeting, nanomaterial classification, regulatory approval
MeSH terms: Clinical Trials as Topic, Humans, Tissue Distribution, United States, Drug Approval, Nanomedicine, Nanoparticles

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

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