De Groot AS, Roberts BJ, Mattei A, Lelias S, Boyle C, Martin WD
Semaglutide and tirzepatide are incretin peptides that act on entirely different receptors to influence appetite, insulin secretion, and energy balance
Officially, the FDA cites: Insufficient large-scale clinical trials Concerns about consistency, sourcing, and manufacturing standards The need to meet formal drug approval requirements Critics argue (fairly) that this system: Favors large pharmaceutical companies Makes it hard to approve naturally occurring peptides Leaves promising, low-risk compounds in regulatory limbo The short version: This FDA restrictive regulatory change of mind wasnt driven by a sudden safety scare, it was driven by regulatory process and economics
*Correspondence: Jing Yao, [email protected] These authors have contributed equally to this work Disclaimer All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers