Leveraging Nonclinical Safety Findings To Expedite Next-Generation GLP-1RAs Development

By Yafei Chen, Tara Arndt, and Wendell P. Davis

In this study, we performed a comprehensive and retrospective review of the US FDA regulatory documents, specifically the Pharmacology & Toxicology Review, for approved GLP-1 receptor agonists (GLP-1RAs). Our objective was to compile a detailed database containing essential information on the chemical structure, administration route, dosage, dosing frequency, pharmacokinetics (PK), and both nonclinical and clinical adverse effects of these approved therapies.

By synthesizing and analyzing this regulatory data, we aimed to achieve two key objectives: 1) identify potential safety concerns or adverse effects associated with novel GLP-1RA candidate drugs currently under early development at Altasciences, and 2) provide critical insights and expert guidance to enhance the development of innovative, transformative GLP-1RA therapies. See how this approach enabled a more informed and strategic pathway for advancing next-generation treatments within this class of drugs.