The development, evidence, and current use of ATX-101 for the treatment of submental fat.

Overview

ATX-101 (deoxycholic acid) is the first pharmaceutical therapy approved by the FDA for the reduction in submental fat. Deoxycholic acid is an endogenous secondary bile acid that normally solubilizes dietary fat, contributing to its breakdown and absorption within the gut. This article reviews the identification of deoxycholic acid as a lipolytic agent, and the mechanism of action, pharmacokinetics, and pharmacodynamics of ATX-101. In addition to phase I/II trials, four Phase III clinical trials have evaluated safety and efficacy of ATX-101. These studies helped establish the appropriate dosage, administration techniques, warnings, and side effects of ATX-101. ATX-101 is effective in treating submental fat. Adverse events, although common, are mild and transient.