Nanoparticles, nanocarriers and nanomaterials are now more commonly known in the science world and by nanotechnology enthusiasts. These words have gained significant backing and have driven this technology to be utilized for applications within other fields, such as drug delivery for advancement and optimization.

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Richard Feynman, who is referred to as the father of nanotechnology, is one of the leading theoretical physicists in the world due to his innovative vision of physics and the future. Although the term nanotechnology had not yet been used, the concept of this novel field had been planted and has grown exponentially in recent years. This has included the growth of nanotechnology within drug delivery, such as through nanocarriers.

Nanocarriers can be described as colloidal nanoparticles that are used for transporting therapeutic substances to a target site. These carrier molecules usually include 1-100 nanometers in diameter, which is useful for applications such as drug delivery due to the natural interaction between nanocarriers and biological systems.

These nanoscale carriers have a sustained circulatory presence and drug release, enabling them to overcome many challenges in conventional drug delivery systems. These challenges can include overcoming the endosome-lysosomal mechanism, crossing the blood-brain barrier, and passing barriers that would be difficult for larger drug molecules. Additionally, targeting the areas of concern is also an advantage for using nanocarriers in drug delivery, as the surface of these particles can be functionalized with ligands, enabling these particles to be directed effectively.

This is significant for drug delivery as it can ensure that drugs are being targeted to the areas of concern as opposed to systemic delivery of the drug, which causes all cells to experience side effects of the drug. Directing drugs to target sites is beneficial to minimize toxicity to healthy cells and tissue, which would be especially significant for cancer drugs as these drugs can cause significant damage to healthy tissues and even result in organ failure.

Nanomedicine, including nanocarriers that hold active substances or drugs, require Food and Drug Administration (FDA) approval before it can be made available to patients.

This can be challenging due to the FDA approval process being estimated to take approximately 10-15 years, as well as costing $1 billion for every new drug being developed. The reason behind this is to be comprehensive in ensuring new drugs are both effective and safe for use, with pre-clinical stages involving animal studies as well as stages that investigate the most appropriate dose.

Nanomedicines have been scrutinized more than most conventional drugs due to being relatively new, which is demonstrated by trends in FDA-approved nanomedicines. Since the mid-1990s, the average number of nanomedicines that have received FDA approval for specific clinical indications per 5-year period has been approximately 13 drugs.

The highest peak of FDA approvals for nanomedicine has been between 2001 and 2005, and most FDA approvals for nanomedicine as a whole has included liposomal and polymeric nanoparticles, predominantly.

The growth of nanotechnology-based medicine has been estimated to grow exponentially for drug delivery, with a predicted CAGR of 11.6% between 2022 and 2027. The projection for this market has also been estimated to reach 391.5 billion USD by the year 2026.

With a healthy FDA pipeline for nanomedicine products under development, the progression of this field may be remarkably optimistic.

An example of a nanomedicine product under development includes Clenes ALS drug, which utilizes a gold nanocrystal suspension. This drug aims to potentially re-myelinate and has neuroprotective effects to aid the rare neurodegenerative disease, ALS. This disease is characterized by motor neuron death and can rapidly progress, with an average life expectancy of four years after diagnosis.

With other companies such as Amylyx Pharmaceuticals also developing an ALS drug and currently undergoing FDA review, Clene Nanomedicine hopes to learn and fine-tune outcome measures for their clinical trial, RESTORE-ALS, which has recently reported a significant decrease in mortality within this trial.

Nanomedicine drugs such as Clene may find it challenging to gain FDA approval due to testing heterogeneous populations. It can be difficult to measure survival in late-stage clinical trials, which is the case for ALS, because of fast disease progression. These challenges can subsequently affect FDA review; however, with further trialing and time, there is hope that the efficacy of significant drugs can be observed and therefore gain FDA approval.

Nanomedicine holds a significant role in many fields and the advancement of society as a whole, and the natural progression of nanocarriers in drug delivery may be revolutionary for medicine. This is especially true for diseases that may not have a treatment yet, such as neurodegenerative diseases, including ALS.

With this market being predicted to grow exponentially in the foreseeable future, as well as with the development of many nanomedicines within the FDA pipeline, the future of nanomedicine and nanocarriers is very promising.

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(2022) Clene Reports Significantly Decreased Mortality in RESCUE-ALS Long-Term Open Label Extension Trial. Invest.clene.com.Available at:https://invest.clene.com/PressReleases/news-details/2022/Clene-Reports-Significantly-Decreased-Mortality-in-RESCUE-ALS-Long-Term-Open-Label-Extension-Trial/default.aspx.

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Nanocarriers in Drug Delivery; Where are We Now? - AZoNano