Central administration of GLP-1RAs or SGLT-2is could increase the expression of c-Fos in neurons within the PVN, amygdala, NTS, AP, and ARC, 56,96 which was consistent with the expression of GLP-1R/SGLT-2 in the whole CNS
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
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Impaired glucose tolerance has been reported in 21-64% at diagnosis and diabetes mellitus in 20-47% (1015)
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