Captisol, brought to you by Ligand
2033 Becker Drive, Suite 310
Lawrence, KS 66047
T: (858) 550-5632
W: www.captisol.com

CAPTISOL LEGACY

Captisol^® is a patent-protected, chemically modified beta cyclodextrin (specifically, sulfobutylether beta-cyclodextrin, or SBECD) designed to optimize the solubility, stability, and bioavailability of drugs that are otherwise difficult to deliver. Invented by scientists at the University of Kansas’ Higuchi Biosciences Center for drug development and formulation, Captisol has enabled 16 FDA-approved products—including Gilead’s VEKLURY^® (remdesivir), Amgen’s KYPROLIS^® (carfilzomib), Baxter International’s NEXTERONE^®, Pfizer’s VFEND IV^®, Sage Therapeutics’ ZULRESSO^®, Novartis’ MEKINIST^® (approved March 2023), and most recently SQ Innovations’ Lasix^® ONYU (furosemide). Manufactured by CyDex Pharmaceuticals (a Ligand Company), Captisol stands out as the leading pharmaceutical-grade SBECD, recognized for its excellent safety and consistency record. Many Captisol-enabled products are currently in various stages of development.

We maintain a broad global patent portfolio for Captisol with approximately 440 issued patents worldwide relating to the technology (including 45 in the U.S.) and with the latest expiration date in 2035. Other patent applications covering methods of making Captisol, if issued, extend to 2041. We maintain both Type IV and Type V DMFs with the FDA. These DMFs contain manufacturing and safety information relating to Captisol that our licensees can reference when developing Captisol-enabled drugs. We also have active DMFs in Canada, Japan, and China.

SEAMLESS TRANSITION TO CLINICAL TRIALS

Captisol may increase systemic exposure for toxicology studies of investigative compounds and has a proven clinical safety record. In early development, Captisol formulations can lead to a seamless transition from nonclinical safety to clinical trials. Captisol has helped more than 10 million patients in over 120 countries.

MULTIPLE ADMINISTRATION ROUTES ENSURE TARGETED DELIVERY

Captisol’s chemical structure was designed to create new products by improving solubility, stability, bioavailability, and dosing of active pharmaceutical ingredients. Routes of administration investigated include parenteral, oral, ophthalmic, nasal, topical, and inhalation products. Once inside the body, Captisol releases the drug agent, which then travels to its target. The interaction between Captisol and the agent is not permanent, and Captisol is safely expressed from the kidneys.

PATENTED AND VALIDATED MANUFACTURING

Of all modified cyclodextrins, Captisol is an ingredient in the most approved products in the U.S. Manufactured under cGMP at multiple locations, using a patented and validated all-aqueous process, annual manufacturing capacity has been increased to 500 MT. Captisol is supplied in ultra-low endotoxin, ultra-low bioburden, low-chloride forms. Pack sizes available for R&D use include 100g, 1kg, 5kg and 20kg. Commercial pack sizes include 1kg, 5kg, and, 20kg, with the ability to fill metric-ton orders.

FORMULATION SERVICES AVAILABLE

The scientists at Ligand Pharmaceuticals have developed in-house and aided clients in developing parenteral, oral, ophthalmic, nasal and, inhalation formulations with Captisol and other cyclodextrins. With the recent addition of internal resources and analytical tools, we can provide greater responsiveness for collaborative feasibility and development programs. In addition, the Captisol team has successfully completed or assisted with orphan designations and approvals, preclinical, CMC and clinical development for ANDA, 505b2 and traditional NDA programs.

Contact us today to learn more or request a sample!

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