FDA-approved, Captisol-enabled® medications are marketed by partners including Amgen, Pfizer, Merck & Co., Melinta Therapeutics, Acrotech Biopharma L.L.C. and Baxter International. Ligand also has License and Supply Agreements (LSAs) in place with a number of other 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 their 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 80 volumes, has been updated over time and now supports the use of Captisol cyclodextrins in parenteral formulations as well as support for other routes of delivery. In addition, there is a Type V US DMF for Chemistry, Manufacturing and Controls (CMC) and DMFs have also been established in China and Japan. Multiple FDA divisions and ex-US regulatory agencies have evaluated the data package and permitted the use of Captisol cyclodextrins in clinical trials.
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.