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

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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Registry

Crossref · 10.1007/s11095-016-1958-5

Cites

91 of 91 references verified0 citation errors · 0 not checkable

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Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • Due to promising outcomes from animal studies, colloidal carriers are now moving into clinical trials in humans.

    “Due to promising outcomes from animal studies, colloidal carriers are now moving into clinical trials in humans (71, 330)”

    From Blood-Brain Barrier: From Physiology to Disease and Back (2019) · cites this paper as [71]

Cites

1 retracted

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3 of the 94 references couldn’t be matched to a known paper.

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Related

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
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
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 › Engineering › Biomedical Engineering › 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

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

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