Regulatory Status of Bioactive Peptides

Abstract

Since the introduction of insulin therapy, bioactive peptides (BP) have played a notable role in medical practice. During the 1920s, in the United States and other key markets, over 60 bioactive peptide drugs were approved, and new peptides continue to enter the clinical research and development pipeline at a steady rate. Beyond its conventional emphasis on endogenous human peptides, BP development has diversified to include a wider variety of structures found from other natural sources or through efforts in medicinal and pharmaceutical chemistry. We maintain a robust BP dataset that has reached clinical human studies, which today includes over 180 peptides in active development. An overview of the BP landscape is given here, including historical perspectives, regulatory status, challenges to market authorization and commercialization, and benchmarks.