Gilead’s Captisol-enabled Remdesivir Approved for Use in Renally Impaired Patients
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Captisol®
Addressing GLP Formulation Needs for Novel Compounds
Captisol® is a proven solubilizing technology designed to overcome various formulation challenges. Captisol® may enable increased systemic exposure for toxicology studies of investigative compounds and has a proven safety record.
Solubility
Captisol® is a cyclic sugar with a large hydrophobic cavity and a hydrophilic exterior. The hydrophobic core weakly associates with a large range of compounds. Captisol® and the investigative compound form a complex that results in greatly enhanced aqueous solubility.
Formulation and Toxicokinetics
Captisol® formulations are suitable for both parenteral and non-parenteral routes of administration.
Nonclinical Safety
Captisol® is a modified cyclodextrin specifically designed for safety. Captisol® has been extensively characterized in acute and chronic GLP toxicology studies. A large database characterizing Captisol® effects in numerous species have been assembled and updated annually.
Regulatory Acceptance
Captisol® has an excellent clinical safety record and is currently being used as an excipient in multiple FDA approved prescription drugs (Nexterone®, Abilify®, Kyprolis®, Geodon®, VFend®). Captisol® enabled products have been approved in more than 50 countries. Captisol® formulation in early development can lead to a seamless transition from nonclinical safety to clinical trials.
