Innovative Technological Emerging Platform: Exploring PROTAC Research and Regulatory Trends

Proteolysis-Targeting Chimera (PROTAC) is an innovative platform based on targeted protein degradation (TPD), which requires establishment of regulatory and scientific standards for safe and effective commercialization. The goal of this study is to analyze the characteristics of PROTAC technology, review regulatory trends and drug approval cases, and provide basic data to prepare for preemptive regulations in the commercialization process. Molecular Glue (MG) drugs have proven immune-modulating and anti-tumor effects through target protein degradation, and ARV-110, ARV-471, and ARV-766, currently in clinical trials, address previously inaccessible targets, reduce drug resistance, and demonstrate the potential of PROTAC technology. These developments accelerate PROTAC commercialization and highlight the need for a tailored regulatory framework to address unmet medical needs. Through research and cases, we aim to suggest the direction of an effective regulatory system that supports the rapid commercialization of PROTAC.