Nanoparticle Therapeutics in Clinical Perspective: Classification, Marketed Products, and Regulatory Landscape

Abstract

Nanoparticle-based therapeutics, emerging from advances in nanotechnology, outperform traditional drug therapies by virtue of their distinct biological properties that enhance therapeutic efficacy, reduce toxicity, and enable precise targeting. Since the 1980s, the number of nanoparticle-based pharmaceutical products has expanded considerably, capturing a significant portion of the pharmaceutical market. These systems function as therapeutic agents or as vehicles for delivering active pharmaceutical or diagnostic compounds to targeted areas. However, despite their transformative potential, the development of comprehensive and harmonized regulatory frameworks for nanomedicines remains a critical challenge. This review provides a current overview of market-approved nanoparticle therapeutics, analyzing global regulatory strategies, including pre-clinical testing, safety assessments, manufacturing processes, and quality control standards. By discussing the existing shortcomings, this review highlights the importance of adaptive regulatory pathways in a global context. It aims to support researchers and stakeholders in navigating the regulatory landscape, facilitating the successful commercialization and clinical translation of nanoparticle-based therapeutics.

Keywords: marketed products; nanomedicines; nanoparticles; regulatory approval; regulatory guidelines.

Figure 1

Schematic representation of different classes of nanoparticles.

Figure 2

The general structure of the liposomes. Adapted with permission from ref. [28], Copyright Springer Nature 2021.

Figure 3

Schematic illustration comparing the structures of SLN, made entirely of solid lipids, and NLC, which contain both solid and liquid lipids. Both are stabilized by a neutral surfactant depicted in gray. Adapted with permission from ref. [47], Copyright Frontiers Media S.A. 2020.

Figure 4

Diagrammatic depiction of the structural design of a nanocapsule compared to a nanosphere. The image is in the public domain and credited to the National Institutes of Health/Department of Health and Human Services.

Figure 5

Typical architecture of dendrimers. Adapted with permission from ref. [100], Copyright Taylor & Francis 2016.

Figure 6

Schematic depiction of polymeric micelles. Self‐assembly of di‐block copolymers into a polymeric micelle takes place above the CMC. The hydrophobic drug is encapsulated into the hydrophobic core. Adapted with permission from ref. [113], Copyright Springer Nature 2022.

Figure 7

Basic structure of polymer‐drug conjugates. Adapted with permission from ref. [146], Copyright MDPI 2023.

Figure 8

Diagram illustrating the preparation of Protein nanoparticles via Desolvation. Adapted with permission from ref. [184], Copyright Elsevier 2020.

Figure 9

Schematic representation of nanogel preparation via self‐assembly or polymerization and its stimuli‐triggered drug release. Adapted with permission from ref. [187], Copyright Elsevier 2016.

Figure 10

A diagram illustrating the nanocrystallization process used to enhance the physicochemical properties of drugs with low solubility. Adapted with permission from ref. [213], Copyright Springer Nature 2022.

Figure 11

Development and modification of SWCNT for drug delivery applications. A) Diagram showing how SWCNTs are formed with both ends sealed. B) Diagram outlining the process for creating drug delivery systems using carbon nanotubes. Adapted with permission from ref. [280], Copyright Springer Nature 2011.