Now Ligand-owned, Captisol® was invented and initially developed by scientists at the University of Kansas' Higuchi Biosciences Center for specific use in drug development and formulation.
The Captisol® technology is also used to address the limitations of currently marketed drugs. Eight FDA-approved, Captisol-enabled® medications are marketed by: Pfizer, Merck and Baxter International. Captisol® also has License and Supply Agreements (LSAs) in place with a number of pharmaceutical companies worldwide with Captisol-enabled® product candidates. Routes of administration investigated include parenteral, oral, ophthalmic, nasal, topical and inhalation products.
The regulatory acceptability of Captisol® is supported by extensive safety and clinical studies demonstrating its excellent systemic safety profile. In 1999, a Type V Drug Master File (DMF) was filed with the FDA. This regulatory safety data package, which includes greater than 70 volumes, supports the use of Captisol® in parenteral formulations as well as for other routes of delivery. Multiple FDA divisions have evaluated the data package and permitted the use of Captisol® in clinical trials.
Captisol® is an established enabling technology with substantial characterization, safety documentation and regulatory history. In 1999, a DMF Type V, containing preclinical and clinical safety data for Captisol® was filed with the U.S. Food and Drug Administration. Published in scientific articles and utilized in numerous ongoing clinical trials by leading pharmaceutical and biotech companies, Captisol® is globally recognized as a valuable delivery technology.
The University of Kansas' Higuchi Biosciences Center