Gastrointestinal Peptides

Gastrointestinal peptides regulate a wide range of digestive functions including intestinal secretion, motility, mucosal barrier integrity, and intestinal growth. Several peptides in this category have achieved FDA approval for conditions that previously had limited treatment options.

Linaclotide and plecanatide are guanylate cyclase-C agonists approved for irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC), working by stimulating chloride and water secretion into the intestinal lumen while also reducing visceral pain signaling. Teduglutide, a GLP-2 analog, is approved for short bowel syndrome and promotes intestinal mucosal growth and adaptation. Larazotide is a first-in-class tight junction regulator in Phase 3 development for celiac disease. Secretin, the first hormone ever identified (1902), is FDA-approved as a diagnostic agent for pancreatic function testing. Relamorelin, a ghrelin receptor agonist, has been investigated in Phase 2-3 trials for diabetic gastroparesis and gastrointestinal motility disorders.

The clinical evidence for approved compounds in this category is robust, supported by large randomized controlled trials. Investigational agents like larazotide and relamorelin have demonstrated proof-of-concept efficacy but have not yet achieved regulatory approval.