Cyclodextrin-based therapeutics delivery systems: A review of current clinical trials

Posted by

Cyclodextrins (CDs) and their polymers are gaining momentum as advanced drug delivery systems. A recent review (https://www.sciencedirect.com/science/article/pii/S2590257125000203) highlights their progress in clinical research, focusing on formulations already tested in humans and the ongoing trials shaping their future. By linking structure, properties, and applications, this work bridges medical theory with practical use and underscores the importance of expanding clinical investigations, especially for cyclodextrin-based polymers.

These polymers stand out for their ability to improve solubility, stability, and biocompatibility while offering controlled, prolonged drug release compared to simple inclusion complexes. Broader clinical studies will not only optimize polymer synthesis but also unlock new therapeutic opportunities.

The review also points to artificial intelligence (AI) as a powerful tool to accelerate trial design and support medical applications.

Together, these advances lay the groundwork for the commercialization of cyclodextrin-based therapies, paving the way for safer and more effective treatments that can improve patient care.

Especially the Table 2 and Table 3 can be useful for the cyclodextrin researchers. Table 2 gives a comprehensive list of clinical trials involving cyclodextrin-based formulations categorized by condition, including cyclodextrin type, active pharmaceutical ingredient (API), route of administration, and NCT identifiers. Table 3 contains all the clinical trials involving cyclodextrin polymers. There have been only two: the polymer studied in several clinical trials is a linear CD polymer conjugated to Camptothecin (CLRX101/IT-101) and only one phase 1a/1b clinical trial was performed with a cationic linear CD polymer (CALAA-01) for siRNA delivery. 

Gjylije Hoti, Neha Bajwa, Fabrizio Caldera, Preet Amol Singh, Ibrahim Hussein, Claudio Cecone, Adrián Matencio, Rita Spagnolo, Monica Argenziano, Roberta Cavalli, Jitender Madan, Francesco Trotta (2025) Cyclodextrin-based therapeutics delivery systems: A review of current clinical trials. Current Research in Pharmacology and Drug Discovery 9, 100232. https://doi.org/10.1016/j.crphar.2025.100232

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.