Nanoparticles in Clinical Trials: Analysis of Clinical Trials, FDA Approvals and Use for COVID-19 Vaccines

Abstract

Nanoparticles are heterologous small composites that are usually between 1 and 100 nanometers in size. They are applied in many areas of medicine with one of them being drug delivery. Nanoparticles have a number of advantages as drug carriers which include reduced toxic effects, increased bioavailability, and their ability to be modified for specific tissues or cells. Due to the exciting development of nanotechnology concomitant with advances in biotechnology and medicine, the number of clinical trials devoted to nanoparticles for drug delivery is growing rapidly. Some nanoparticles, lipid-based types, in particular, played a crucial role in the developing and manufacturing of the two COVID-19 vaccines—Pfizer and Moderna—that are now being widely used. In this analysis, we provide a quantitative survey of clinical trials using nanoparticles during the period from 2002 to 2021 as well as the recent FDA-approved drugs (since 2016). A total of 486 clinical trials were identified using the clinicaltrials.gov database. The prevailing types of nanoparticles were liposomes (44%) and protein-based formulations (26%) during this period. The most commonly investigated content of the nanoparticles were paclitaxel (23%), metals (11%), doxorubicin (9%), bupivacaine and various vaccines (both were 8%). Among the FDA-approved nanoparticle drugs, polymeric (29%), liposomal (22%) and lipid-based (21%) drugs were the most common. In this analysis, we also discuss the differential development of the diverse groups of nanoparticles and their content, as well as the underlying factors behind the trends.

Enhancing paracellular and transcellular permeability using nanotechnological approaches for the treatment of brain and retinal diseases

“…It will be beneficial to establish standardized criteria for biocompatibility and toxicity to enable meaningful comparisons of nanostructures performance, which is essential for expanding their application in clinical trials. 47 While the future of brain- and eye-related diseases remains unclear, physics, chemistry, cell biology, and nanotechnology have emerged as key players in overcoming persistent hurdles and facilitating the development of promising novel therapeutic concepts.…”

Recent Advances in Formulations for Long-Acting Delivery of Therapeutic Peptides

“…This includes developing new formulations with further extended long-acting delivery, improved bioavailability, and long-term therapeutic effects that can remarkably reduce administration frequency and minimize side effects, enabling them to successfully translate into clinical practice. In this regard, FDA-approved or under-clinical-trial (MP, NP, hydrogel) materials, e.g., PLGA, PLA, orally administrable silica, lipids, liposomes, albumin, polymeric micelles, and PEG are great candidates to be used in long-acting sustained release peptide formulations. − Other materials with long-acting properties, such as biocompatible porous particles and (bio)­polymeric-hydrogels that may be approved for clinical use in the near future, hold great potential for utilization in novel therapeutic peptide formulations.…”

Achieving Precision Healthcare through Nanomedicine and Enhanced Model Systems

“…5,17,19,21,22 Since 2016, lipid-based and liposomal nanoparticles have been the most common in both clinical trials (Figure 2) and FDA-approved drugs. 22 In 2021, over 30 nanoparticles have been approved and used in clinical applications. 23 However, not even choosing the most suitable animal model may lead to higher predictability in clinical trials.…”

“…Wilhelm et al compiled data from clinical studies revealing that only <1% of administered NC dose reached the intended targeted solid tumors . While the number of clinically available nanomedicines is increasing, they are still below the projections for the field as they face additional challenges compared to conventional drug development. ,,,, Since 2016, lipid-based and liposomal nanoparticles have been the most common in both clinical trials (Figure ) and FDA-approved drugs . In 2021, over 30 nanoparticles have been approved and used in clinical applications …”

“…Lipid-based formulations also faced a slight decrease to 8%, while metallic and polymeric drug percentages stayed almost the same (11% and 7%, respectively). Reprinted with permission under a Creative Commons CC BY 4.0 license from ref . Copyright 2023 MDPI.…”