Perspective on non-clinical evaluation of peptide drugs containing non-natural/modified structures

Abstract

From 2018, an AMED research group “Research on regulatory Issues for ensuring quality and safety of next-generation medium-size peptide drugs” (lead by Dr. Demizu) was launched. Two subgroups on quality of substance/formulation and non-clinical safety were constructed with industry and regulatory members, and have been discussing about points to consider for evaluation of peptide with non-natural/modified structures. Although the discussion is still on-going and no conclusion has been reached, the general direction has been building by comparison with peptide drugs with only a natural structure.