MetabolicFDA Approved

Teduglutide (Gattex)

Overview

Teduglutide is a recombinant analogue of human glucagon-like peptide-2 (GLP-2) comprising 33 amino acids with a single amino acid substitution that confers resistance to enzymatic degradation by dipeptidyl peptidase-4. This GLP-2 receptor agonist enhances intestinal epithelial barrier function, promotes mucosal growth, and increases mesenteric blood flow, thereby improving nutrient and fluid absorption. The therapeutic rationale centers on reducing dependence on parenteral nutrition in patients with short bowel syndrome by augmenting remnant bowel adaptive capacity.

Key Research Findings

Teduglutide received FDA approval in 2012 for adults with short bowel syndrome dependent on parenteral support, based on pivotal phase 3 trial data published in Gastroenterology (2011) demonstrating significant reductions in parenteral nutrition volume. Pediatric approval followed in 2019 after the phase 3 trial results were published in JPEN (2017), confirming efficacy and safety in children aged one year and older.

Route of Administration

Subcutaneous injection

Regulatory Status

FDA Approved

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