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

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.

Nanomedicine and epigenome. Possible health risks

“…More than 50 FDA-approved nanodrugs are currently in clinical use (Table 1) and more than 77 nano-based products are being evaluated in Phase I e III clinical trials (Bobo et al, 2016).…”

“…PLA and PLGA are FDA-approved biodegradable and biocompatible NMs especially for cancer-related human applications (Faraji and Wipf, 2009;Khan et al, 2016). Since approval of Abraxane (albumin based drug delivery vehicle containing paclitaxel) for the treatment of patients with metastatic breast cancer by the FDA, there is increased interest in the fabrication of similar protein-based nanocarriers in cancer treatment (Bobo et al, 2016). A polymeric NM formulation of docetaxel is currently under phase 1 clinical trials in patients with advanced solid malignancies (NCT00103791).…”

Controlled release of targeted anti-leukemia drugs azacitidine and decitabine monitored using surface-enhanced Raman scattering (SERS) spectroscopy

“…Targeted delivery of anti-cancer drugs offers considerable reduction in damage to healthy cells and other side effects while increasing the overall drug efficacy in cancer treatment [1][2][3][4][5][6] . Unlike the traditional intravenous drug infusion approach, the targeted drug delivery systems are based on carriers seeking out the cancer cells rather than equally affecting all cells, healthy and unhealthy.…”

Overcoming tumor cell chemoresistance using nanoparticles: lysosomes are beneficial for (stearoyl) gemcitabine-incorporated solid lipid nanoparticles

“…DNA MMR pathway is critical for mediating the cytotoxic effect of O 6 -methylguanine, which is programed to correct errors in DNA base pairing, and defects in this system cause resistance to temozolomide. 20 Another mechanism of resistance to alkylating agents is the BER pathway that can repair N 7 -methylguanine and N 3 -methyladenine DNA adducts. Cells that are defective in MMR are generally resistant to temozolomide.…”