A Comprehensive Monograph on ATX-101 (Deoxycholic Acid) for Submental Contouring

Executive Summary

Drug Identity and Indication

This report provides a comprehensive analysis of ATX-101, the investigational designation for a proprietary, injectable formulation of synthetic deoxycholic acid.[1] Deoxycholic acid is a naturally occurring secondary bile acid that functions as a cytolytic agent.[3] ATX-101 is the first and only injectable drug approved by major regulatory bodies for the improvement in the appearance of moderate to severe convexity or fullness associated with submental fat (SMF) in adults, commonly known as a "double chin".[1] It is marketed globally under the brand names Kybella® in the United States and Belkyra® in Canada, Australia, Europe, and South Korea.[7]

Mechanism of Action

The therapeutic effect of ATX-101 is achieved through a process of targeted adipocytolysis. When injected directly into subcutaneous adipose tissue, the deoxycholic acid acts as a detergent, physically disrupting the lipid bilayer of adipocyte cell membranes. This action leads to irreversible cell lysis and the subsequent death of the targeted fat cells.[4] The destruction of adipocytes initiates a localized inflammatory response, characterized by the infiltration of macrophages that clear cellular debris and liberated lipids, followed by the recruitment of fibroblasts, which is thought to stimulate neocollagenesis and contribute to tissue remodeling.[7]

Clinical Efficacy Synopsis