The landscape of nanomedical clinical trials

纳米医学临床试验概况

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Abstract

Nanotechnology has transformed healthcare, leading to the clinical adoption of numerous nanomedical products. To evaluate their clinical translation, we analyzed all trials registered on ClinicalTrials.gov using a novel nanomedicine lexicon developed through expert curation and generative AI. This approach identified 4114 nanomedical clinical trials (out of more than 500,000) forming the Nanomedical Clinical Trials (NanoCT) dataset. Our analysis reveals a 38 % rise in nanomedical trials in recent years. While oncology remains dominant (30 %), emerging applications-particularly in infectious diseases, driven by the rise of mRNA vaccines-demonstrate the field's expanding therapeutic scope. This diversification is further evidenced by the growing use of micelles, polymeric, and metallic nanoparticles, marking a shift from the dominance of liposomal formulations. Despite significant advancements, nanomedical trials account for only 0.8 % of all registered clinical trials, highlighting key translational challenges such as regulatory complexities, high production costs, and clinical design limitations. Addressing these barriers requires the establishment of a universally accepted nanomedical lexicon to enhance data harmonization, streamline regulatory pathways, and improve interdisciplinary communication. This comprehensive analysis provides critical insights into the trajectory of nanohealth, identifies obstacles to clinical translation, and outlines strategies to maximize its future impact in medicine.

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