ATX-101 (medical), sodium deoxycholate for subcutaneous injection, is being evaluated as a treatment for the reduction of localized fat deposits. This includes treatment of superficial lipomas (benign tumors of soft tissue composed of mature fat cells), fat deposits in the submental region of the face/neck, and localized fat deposits in other parts of the body. Deoxycholic acid is a naturally occurring bile acid produced by the liver as one of several end products of cholesterol metabolism. As a naturally occurring component of the human body, deoxycholate is considered a ‘biocompatible’ detergent that solubilizes fat in the small intestine. ATX-101 demonstrates a relative selectivity for fat over other tissues.
Kythera has U.S. INDs open to study ATX-101 in both aesthetic and medical indications. Kythera has completed a multi-dose, dose-escalating, Phase I/II safety and pharmacokinetic study of ATX-101 under a U.S. IND for the treatment of superficial lipomas. A U.S. multi-center Phase II study for treatment of superficial lipomas and a multi-national Phase II study evaluating the product’s safety and effectiveness for the reduction of unwanted submental fat are currently ongoing.
ATX-101 is a patent-protected proprietary compound that is based on technology that Kythera acquired through a broad licensing agreement with Los Angeles Biomedical Institute at Harbor-UCLA Medical Center.
