A LIGAND TECHNOLOGY
Sorrento Valley Blvd, Suite 110
Diego, CA 92121
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. Eight
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
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 US 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.
complimentary 20 g sample, please visit www.captisol.com.
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