Metabolic · FDA Approved
Teduglutide (Gattex)
FDA-approved
01 · 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 degradation by dipeptidyl peptidase-4. This GLP-2 receptor agonist is thought to promote growth of the intestinal mucosa and reduce gastric emptying and secretion, increasing fluid and nutrient absorption (PMID 22982184).
The therapeutic rationale centers on reducing dependence on parenteral nutrition in patients with short bowel syndrome.
02 · Research summary & key findings
Teduglutide (Gattex) received FDA approval in December 2012 for adults with short bowel syndrome dependent on parenteral support. In the pivotal 24-week phase 3 trial, 63 percent of teduglutide patients versus 30 percent on placebo achieved a greater than 20 percent reduction in parenteral support volume, and teduglutide increased plasma citrulline, a marker of mucosal mass (Gastroenterology, 2012) (PMID 22982184). Pediatric approval followed in 2019; in a 24-week pediatric phase 3 trial, 54 to 69 percent of children on teduglutide versus 11 percent on standard care achieved at least a 20 percent reduction in parenteral support (JPEN, 2020) (PMID 31495952).
03 · Regulatory status
Teduglutide (Gattex) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.
Teduglutide (Gattex) is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.
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04 · Administration routes
- Subcutaneous injection
References
- [1]Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure Gastroenterology, 2012. PMID 22982184
- [2]Safety and Efficacy of Teduglutide in Pediatric Patients With Intestinal Failure due to Short Bowel Syndrome: A 24-Week, Phase III Study JPEN J Parenter Enteral Nutr, 2020. PMID 31495952
Primary literature
- PubMed: "Teduglutide"
Peer-reviewed literature indexed by the National Library of Medicine.
- ClinicalTrials.gov: "Teduglutide"
Registered interventional and observational studies, including status and phase.
- PubChem: "Teduglutide"
Chemical structure, molecular properties, and bioactivity data.
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