Ligand-owned, Captisol® was invented in 1990 by scientists at the University of Kansas Higuchi Biosciences Center for use in drug development and formulation.
The Captisol® technology is used to address the limitations of currently marketed drugs. FDA-approved, Captisol-enabled® medications are marketed by: Pfizer, Bristol-Myers Squibb 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, oral, and inhalation.
The regulatory acceptance of Captisol® is supported by extensive safety 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 support for other routes of delivery. Multiple FDA divisions and ex-US regulatory agencies 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 review. In 1999, a Drug Master File 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 a number of ongoing clinical trials by leading pharmaceutical and biotech companies, Captisol® is recognized as a valuable and vital delivery technology whose use could mean the success or failure of a development program.
The University of Kansas' Higuchi Biosciences Center
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