Feature Article
The big picture on nanomedicine: the state of investigational and approved nanomedicine products

https://doi.org/10.1016/j.nano.2012.05.013Get rights and content

Abstract

Developments in nanomedicine are expected to provide solutions to many of modern medicine's unsolved problems, so it is no surprise that the literature contains many articles discussing the subject. However, existing reviews tend to focus on specific sectors of nanomedicine or to take a very forward-looking stance and fail to provide a complete perspective on the current landscape. This article provides a more comprehensive and contemporary inventory of nanomedicine products. A keyword search of literature, clinical trial registries, and the Web yielded 247 nanomedicine products that are approved or in various stages of clinical study. Specific information on each was gathered, so the overall field could be described based on various dimensions, including FDA classification, approval status, nanoscale size, treated condition, nanostructure, and others. In addition to documenting the many nanomedicine products already in use in humans, this study indentifies several interesting trends forecasting the future of nanomedicine.

From the Clinical Editor

In this one of a kind review, the state of nanomedicine commercialization is discussed, concentrating only on nanomedicine-based developments and products that are either in clinical trials or have already been approved for use.

Section snippets

Scope of analysis

The definitions of “nanotechnology” and “nanomedicine” continue to be an area of controversy, with no universally accepted classification. Because an operational definition is required for the purposes of this study, nanomedicine is taken as the use of nanoscale or nanostructured materials in medicine, engineered to have unique medical effects based on their structures, including structures with at least one characteristic dimension up to 300 nm. Nanomedicine takes advantage of two general

Methods

We used a structured sequence of Internet searches to identify nanomedicine applications and products. Targeted searches on PubMed.gov, Google, and Google Scholar, and a number of clinical trial registries produced a range of resources, including journal articles, consumer websites, commercial websites, clinical trial summaries, manufacturer documents, conference proceedings, and patents. All of those were used to identify potential nanomedicine applications and products. Information was

Results

The targeted search of clinical trial registries yielded 1,265 potentially relevant clinical trial results. Duplicate results and trials involving clearly non-nano applications or products were eliminated, leaving 789 clinical trials with potential nanomedicine applications or products. The application/product name and company was identified for each of these trials, yielding a total of 141 unique applications and products (many were associated with multiple trials). Thirty-eight of these were

Discussion

This study identified a significant number of nanomedicine products approved for or nearing in-human use. It is difficult to extrapolate these numbers directly, because growth in medical industries is so heavily influenced by swings in the economy and regulatory processes. However, we observed some definite trends related to the future of nanomedicine. The most prominent theme throughout is the relative adolescence of the field. Although all the applications identified represent significant

Acknowledgments

The contents of this article are solely the responsibility of the authors and do not necessarily represent the views of NIH or NHGRI. Thanks to the “Nanodiagnostics and Nanotherapeutics: Building Research Ethics and Oversight” Working Group for valuable input on methodology and analysis.

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    No conflict of interest was reported by the authors of this article.

    This work was supported by National Institutes of Health (NIH) / National Human Genome Research Institute (NHGRI) grant #1-RC1-HG005338-01 (S. M. Wolf, PI; J. McCullough, R. Hall, and J. Kahn, Co-Is), through the University of Minnesota's Consortium on Law and Values in Health, Environment & the Life Sciences.

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