BPC-157 as an Investigational Peptide Therapeutic: Biopharmaceutical Challenges, Formulation Strategies, and Translational Development Barriers

Plain-language summary

This 2025 narrative review critically evaluates BPC-157 from a biopharmaceutical and drug-development perspective, examining its physicochemical and pharmacokinetic properties, formulation challenges across routes of administration, and the regulatory barriers that currently limit clinical advancement. Despite over three decades of preclinical research demonstrating cytoprotective and regenerative activity across multiple organ systems, the authors note that no approved formulation, validated dosing regimen, or completed Phase II clinical trial yet exists. The review highlights the pharmacokinetic–pharmacodynamic disconnect observed in preclinical studies as a key translational challenge.