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Safety and effectiveness of glucagon-like peptide-1 receptor agonists in inflammatory bowel disease

Sources: Milani M and Colombo F

For all four peptides on Thursday's agenda BPC-157, TB-500, KPV, and MOTS-C FDA staff reviewed the evidence under the agency's four-part balancing test and reached the same conclusion for each: do not add them to the 503A Bulk Drug Substances List, the only legal pathway for compounding pharmacies to dispense these compounds to patients

In sum, the successful achievement of oral bioavailability for peptides must overcome the pH challenges of the stomach, a host of attacking peptidases in the GI lumen and brush border, low epithelial permeability, as well as the liver first pass effect (Figure 1)

-Bacteriostatic water for injection has been on the FDAs drug shortage list multiple times since 2014, with product demand consistently outpacing supply