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

Pharmaceutical Research volume 33, pages 2373–2387 (2016)Cite this article

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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Fig. 1

Abbreviations

CHOP:

Chemotherapy containing cyclophosmphamide, doxorubicin, vincristine, and prednisolone

CKD:

Chronic Kidney Disease

CMC:

Critical micelle concentration

cRGDY:

Cyclic arginine-glycine-aspartic acid

EPR:

Enhanced permeability and retention

IDE:

Investigational device exemption

IND:

Investigational New Drug

MTAs:

Molecularly targeted agents

NABs:

Albumin bound nanoparticles

NCL:

Nanotechnology Characterization Laboratory

NDA:

New Drug Application

NIR:

Near-infrared

NP:

Nanoparticle

PEG:

Poly (ethylene glycol)

PLGA:

Polyactide-co-glycolic acid

PPX:

Poliglumex

PSMA:

Prostate-specific membrane antigen

PTCL:

Peripheral T-cell lymphomas

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ACKNOWLEDGMENTS AND DISCLOSURES

We acknowledge funding from the National Health and Medical Research Council (APP1099231 KJT), the Australian Research Council (FT110100284, DP140100951 (KJT), DE130100800 (SRC)), National Breast Cancer Foundation (NC-14-037), and Centre of Excellence in Convergent BioNano Science and Technology (CE140100036 (SRC, KJT)) and thank the Ochsner Clinical School of New Orleans, LA (DPB).

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Authors and Affiliations

  1. Centre for Advanced Imaging, University of Queensland, St Lucia, QLD, 4072, Australia

    Daniel Bobo, Kristofer J. Thurecht & Simon R. Corrie

  2. Australian Institute for Bioengineering and Nanotechnology, University of Queensland, St Lucia, QLD, 4072, Australia

    Daniel Bobo, Jiaul Islam, Kristofer J. Thurecht & Simon R. Corrie

  3. School of Medicine, Faculty of Medicine and Biomedical Sciences, University of Queensland, St Lucia, QLD, 4072, Australia

    Daniel Bobo

  4. ARC Centre of Excellence in Convergent Bio-Nano Science and Technology, Queensland node, St Lucia, 4072, QLD, Australia

    Daniel Bobo, Kye J. Robinson, Jiaul Islam, Kristofer J. Thurecht & Simon R. Corrie

  5. Department of Chemical Engineering, Monash University, Clayton, VIC, 3800, Australia

    Kye J. Robinson, Jiaul Islam & Simon R. Corrie

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Bobo, D., Robinson, K.J., Islam, J. et al. Nanoparticle-Based Medicines: A Review of FDA-Approved Materials and Clinical Trials to Date. Pharm Res 33, 2373–2387 (2016). https://doi.org/10.1007/s11095-016-1958-5

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  • DOI: https://doi.org/10.1007/s11095-016-1958-5

KEY WORDS

  • clinical trials
  • FDA
  • nanomedicine
  • nanoparticles
  • nanopharmaceuticals
  • nanotherpeutics