Teduglutide
Teduglutide is an injectable GLP-2 analog used for short bowel syndrome with intestinal failure in patients dependent on parenteral support. In the pivotal Phase 3 STEPS trial, a higher proportion of teduglutide-treated patients than placebo achieved a 20 to 100 percent reduction in weekly parenteral support volume. It is approved by the FDA, EMA, and TGA and is given by subcutaneous injection under specialist supervision.
Mechanism
In plain terms, teduglutide is a lab-made version of a gut hormone that helps the remaining intestine absorb more fluid and nutrients, lowering the need for intravenous feeding. Technically, it is a recombinant analog of glucagon-like peptide-2 in which the alanine at position 2 is replaced by glycine, making it resistant to dipeptidyl peptidase-4 degradation and extending its half-life; it activates the GLP-2 receptor on intestinal subepithelial cells to promote mucosal growth, increase intestinal blood flow, and slow gastric emptying and secretion.
Regulatory Status by Region
- United States (FDA)Approved. Gattex (teduglutide) for adults with short bowel syndrome who are dependent on parenteral support, December 2012; use later extended to pediatric patients.
- Australia (TGA)Registered on the ARTG as Revestive (ARTG 274911) since May 2017 for adults with short bowel syndrome dependent on parenteral support; prescription medicine.
- European Union (EMA)Authorized. Revestive (teduglutide) received an EU-wide marketing authorisation in August 2012 for short bowel syndrome.
- WADANot listed on the WADA Prohibited List.
Key Studies
- STEPS Phase 3 trial in short bowel syndrome; Jeppesen PB et al. (opens in a new tab) (Gastroenterology 2012;143(6):1473-1481.e3; DOI 10.1053/j.gastro.2012.09.007; PMID 22982184; NCT00798967)
- Randomised placebo-controlled Phase 3 trial of teduglutide in short bowel syndrome; Jeppesen PB et al. (opens in a new tab) (Gut 2011;60(7):902-914; DOI 10.1136/gut.2010.218271; PMID 21317170)
Related Clinical Trials
- Glucagon-like Peptide 2 (GLP-2) in Undernourished Women Improving From Histology-Confirmed Environmental Enteric Dysfunction (EED)Phase 2 · Not Yet Recruiting
- A Study of Teduglutide in Chinese Children and Teenagers With Short Bowel SyndromeN/A · Recruiting
- A Study of Teduglutide in Chinese Adults With Short Bowel SyndromePhase 3 · Recruiting
- TED_ORG: Study on Short Bowel SyndromeN/A · Recruiting
- A Study of Teduglutide (Revestive®) in Participants With Short Bowel Syndrome (SBS) in CanadaN/A · Completed
- Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and ComplicationsPhase 3 · Withdrawn
- A Study With Teduglutide (Revestive®) in Adults With Short Bowl SyndromeN/A · Completed
- A Study of Teduglutide in Japanese Children With Short Bowel Syndrome Aged 4 Months or OlderPhase 3 · Completed
Latest research
- Efficacy and safety of teduglutide in children with short bowel syndrome: a narrative review. (opens in a new tab)
Pediatric surgery international · Aug 20, 2026
- Weaning infants with short bowel syndrome associated intestinal failure from parenteral nutrition: An ERNICA multicentre survey. (opens in a new tab)
Intestinal Failure (New York, N.Y.) · Aug 7, 2026
Common Questions
- What is Teduglutide?
- Teduglutide is a recombinant glucagon-like peptide-2 (GLP-2) analog approved to reduce dependence on parenteral (intravenous) support in people with short bowel syndrome. The FDA approved it as Gattex in December 2012 and the EMA authorized it as Revestive in August 2012.
- Is Teduglutide approved for medical use?
- Teduglutide is approved for one or more medical uses in at least one major jurisdiction. United States (FDA): Approved. Gattex (teduglutide) for adults with short bowel syndrome who are dependent on parenteral support, December 2012; use later extended to pediatric patients. European Union (EMA): Authorized. Revestive (teduglutide) received an EU-wide marketing authorisation in August 2012 for short bowel syndrome. Australia (TGA): Registered on the ARTG as Revestive (ARTG 274911) since May 2017 for adults with short bowel syndrome dependent on parenteral support; prescription medicine.
- How does Teduglutide work?
- In plain terms, teduglutide is a lab-made version of a gut hormone that helps the remaining intestine absorb more fluid and nutrients, lowering the need for intravenous feeding. Technically, it is a recombinant analog of glucagon-like peptide-2 in which the alanine at position 2 is replaced by glycine, making it resistant to dipeptidyl peptidase-4 degradation and extending its half-life; it activates the GLP-2 receptor on intestinal subepithelial cells to promote mucosal growth, increase intestinal blood flow, and slow gastric emptying and secretion.
- Is Teduglutide legal in Australia?
- Teduglutide in Australia (TGA): Registered on the ARTG as Revestive (ARTG 274911) since May 2017 for adults with short bowel syndrome dependent on parenteral support; prescription medicine.
- Is Teduglutide banned in sport?
- Teduglutide under the World Anti-Doping Agency (WADA) code: Not listed on the WADA Prohibited List.