Current Trends in Nanomedicine: Notable FDA Approvals and Clinical Trials to Follow

image credit: Love Employee iStock

What are nanomedicines and what makes them nano?

Nanomedicines, as it goes from the name, are nanotechnology-based drugs, used for the treatment, diagnosis or prevention of various diseases. But is “nano” defined just by the size? According to FDA, nanomedicines are the products in the nanoscale range (meaning at least one size dimension being around 1-100 nm) that can exhibit chemical or physical properties, or biological effects which differ compared to larger-scale counterparts. At the same time FDA adds that products outside the mentioned nanoscale range also can be called nanomedicines if they can exhibit similar properties or phenomena attributable to a 1-100 nm scale dimension.

Usually, nanomedicines consist of a carrier and a drug, where the last is also called an active pharmaceutical ingredient (API). However, sometimes the API can be transformed into a nanomedicine itself via manufacturing it in nanoscale size range ( stabilized nanoscale crystals). Notably, the last FDA approval of such nanocrystal drug was in 2015, which is the drug for a rare progressive lung disease. In this article we will focus on some nanomedicines approved by the FDA in the last 5 years, as well as discuss promising ongoing clinical trials. 

Nanotech in medicine: what is it for?

Nanomedicines are considered very effective in treating chronic diseases such as cancer, dementia, and diabetes as they fuel the metabolism of medications in the body. They deliver the drugs to the target site in the right proportion. The market's availability of nanomedical products such as DNA probes, nanosensors, and nanoparticle-based imaging agents is increasing the demand. However, the high cost associated with the nanomedicine manufacturing process and research and development activities may hinder fast nanomedicine market growth.

To concentrate more on the nanotechnology serving the precision drug delivery, it solves various issues of the conventional delivery systems, such as biodistribution and intracellular trafficking. Specifically, nanoparticles are aimed to increase the stability of transported active substances, pass the biological membranes and make the treatment overall safer and more efficient. 

The clinical translation of the technology is getting slowed down for several reasons. Firstly, we don’t fully understand how the differences in physiology and pathology of various animal species compared to humans influence the behavior of nanoparticles in the body. Secondly, there are no two exactly the same patients, and this patient heterogeneity largely influences the effect of the nanoparticles, making the clinical outcome hard to predict and analyze.

According to some analytical sources, drug delivery applications dominated the market in 2021 and captured 30.23% of the overall market share. This segment is expected to maintain its dominance over the next five years. The rise in awareness about the benefits of nanomedicine in drug delivery applications and the increased prevalence of diseases drives the demand for nanomedicines for drug delivery applications.

A schematic image highlighting some biological barriers which nanoparticles can overcome, such as crossing epithelial barriers, organelle-specific intracellular delivery, navigating aggressive tumor microenvironment and targeting immune cells. Image credit: Nature Reviews (2021) (doi.org/10.1038/s41573-020-0090-8)

Lipid-based nanoparticles and liposomes

If we imagine the ball for some outdoor game, let’s say beach volleyball, we already have an imaginary prototype of the liposome -- a sphere composed of phospholipids with an “empty” space inside. Lipid-based nanoparticles (LNPs) are liposome-like structures, which have amphoteric properties and can deliver various drugs packed inside their “vacant empty space”.