Nanoparticles in clinical trials: data analysis from ClinicalTrials.gov

In our lab, we enjoy discovery in basic science. We also stay abreast of nanomedicine and clinical development of nanoparticle-based drugs and diagnostics. Here, we discuss nanoparticle products that have ever been in clinical development. We analyzed the ClinicalTrials.gov database for trials that have been initiated up until early 2018. We found over 260 clinical trials that used ~100 unique nanoparticle-based products for a variety of human conditions.

Active ingredients in nanoparticle-based products

These ~100 nanoparticle products and product candidates that have been studied in human trials so far encompass approximately 70 unique active ingredients delivered in a variety of vehicles. These active ingredients include small organic molecules, proteins, a peptide, nucleic acids, inorganic molecules, vaccines, and a few other unique entities. As expected, small molecules are the most prevalent class, mainly due to chemotherapy agents for variety of oncology applications.

ActiveIngredients_byMolType

Not all active ingredients have been approved (at the time of the data analysis in 2018), either alone or as a nanoparticle. The approved molecules are dominated by small organic molecules and inorganic molecules. In contrast, not-yet-FDA-approved active ingredients include nucleic acids and vaccines, indicating critical role that nanoparticles play in delivery of these more complex biologic components.

ActiveIngr_Status_Molecule

Below is the list of nanoparticle products by molecular type of active ingredients.

ProductName_byMoleculeTypeTherapeutic areas

Initiated clinical trials using nanoparticles have covered several therapeutic areas, with oncology being the most dominant. This is consistent with the above discussion on the chemotherapy agent delivery. However, pain, hematology, cardiovascular, and infectious disease areas have been targeted as well.

InitiatedTrails_byTA

Vehicles

As expected, liposome assembly continues to be the main method for nanoparticle synthesis. This is due to established science and safety for use in humans.

drug_delivery_DB_vehicle

Full database is available on request, please contact us.

Post cover image: First-in-human nanoparticle trial, circa 2000 B.C.

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