An IQ team just published in Drug Metabolism and Disposition an article titled:
A link to the article is: https://dmd.aspetjournals.org/content/early/2023/08/17/dmd.123.001437.abstract.
ABSTRACTTherapeutic peptides (TPeps) have expanded from the initial endogenous peptides to complexmodified peptides through medicinal chemistry efforts for almost a century. Different from smallmolecules and large proteins, the diverse submodalities of TPeps have distinct structures andcarry different absorption, distribution, metabolism, and excretion (ADME) properties. There isno distinct regulatory guidance for the industry on conducting ADME studies (what, how, andwhen) for TPeps. Therefore, the Peptide ADME Working Group sponsored by the Translationaland ADME Sciences Leadership Group of the International Consortium for Innovation andQuality in Pharmaceutical Development (IQ) was formed with the goal to develop a white paperfocusing on metabolism and excretion studies to support discovery and development of TPeps. Inthis paper, the key learnings from an IQ industry survey and FDA/EMA submission documentsof TPeps approved between 2011 and 2022 are outlined in detail. In addition, a comprehensiveassessment of in vitro and in vivo metabolism and excretion studies, mitigation strategies forTPep metabolism, analytical tools to conduct studies, regulatory status, and MIST considerationsare provided. Finally, an industry recommendation on conducting metabolism and excretionstudies is proposed for regulatory filing of TPeps.