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
Mounjaro is a dual-hormone agonist, meaning it mimics both GLP-1 and GIP hormones, whereas Ozempic only mimics GLP-1
Monami M, Nreu B, Scatena A, Cresci B, Andreozzi F, Sesti G, Mannucci E
The receptor interactions create effects that may differ substantially from single-receptor approaches