A 33-amino-acid analog of glucagon-like peptide-2 (CAS 197922-42-2) with glycine in place of alanine at position 2, which resists DPP-4 degradation and extends its half-life. It activates GLP-2 receptors on intestinal enteroendocrine cells, subepithelial myofibroblasts and enteric neurons, increasing villus height and intestinal absorption. FDA-approved by Takeda as Gattex, and approved in the EU as Revestive, for adults and children with short bowel syndrome who depend on parenteral support. It acts on the gut lining, not the GLP-1 weight-loss pathway.
For research purposes only. Not medical advice.
Teduglutide is a 33-residue peptide, His-Gly-Asp-Gly-Ser-Phe-Ser-Asp-Glu-Met-Asn-Thr-Ile-Leu-Asp-Asn-Leu-Ala-Ala-Arg-Asp-Phe-Ile-Asn-Trp-Leu-Ile-Gln-Thr-Lys-Ile-Thr-Asp, with a molecular weight of 3752 daltons on the Gattex label. The label describes the approved drug substance as manufactured in a strain of Escherichia coli modified by recombinant DNA technology.
The label's mechanism section frames the drug through its native hormone. GLP-2 is secreted by L-cells of the distal intestine and is known to increase intestinal and portal blood flow and to inhibit gastric acid secretion. Teduglutide binds GLP-2 receptors on enteroendocrine cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus. Activation of those receptors, the label says, results in the local release of multiple mediators, including insulin-like growth factor 1 (IGF-1), nitric oxide and keratinocyte growth factor.
The FDA approved Gattex (NDA 203441) on December 21, 2012, for adults with short bowel syndrome who are dependent on parenteral support. A supplement approved on May 16, 2019 extended the indication to pediatric patients 1 year of age and older. In the EU, Revestive received a marketing authorisation valid throughout the Union on 30 August 2012.
Those approvals, and not the bulk-substance nominations that decide most research peptides, set teduglutide's US status. Under section 503A, a bulk substance depends on FDA's bulks list only when it has no USP monograph and is not a component of an FDA-approved drug, and teduglutide is the active ingredient of Gattex. It is absent from both tables of FDA's Category 2 page (content current as of April 22, 2026) and from the 503A (updated May 14, 2026) and 503B (updated March 21, 2025) bulk-substance nomination categories.
FDA's biologics regulations define a protein as an alpha amino acid polymer with a specific, defined sequence of more than 40 amino acids (21 CFR 600.3(h)(6)). At 33 residues teduglutide falls below that line, and Gattex is still listed in Drugs@FDA as a new drug application. FDA's May 2021 guidance on synthetic peptides referring to drugs of rDNA origin named teduglutide as one of five such products, teriparatide among them, and called all five peptides rather than proteins. FDA withdrew that guidance on July 28, 2026, saying it no longer reflects the agency's current scientific thinking. Our post on the July 2026 generic-peptide guidances covers the change.
The Warnings and Precautions section of the Gattex label has five parts:
The neoplastic-growth section also covers intestinal polyps, identified in clinical studies and reported postmarketing, and sets out colonoscopy surveillance for adult and pediatric patients.
STEPS (study CL0600-020, NCT00798967), listed as Study 1 in the label's adult section, was a 24-week Phase 3 trial published by Jeppesen and colleagues in Gastroenterology in December 2012. Its ClinicalTrials.gov record lists Shire as sponsor. After a period of optimizing and stabilizing parenteral support, 86 adults with short bowel syndrome were randomized to teduglutide or placebo. A responder was a patient with at least a 20% reduction in weekly parenteral support volume from baseline at both week 20 and week 24. In the intent-to-treat population of all randomized patients, 63% (27 of 43) responded on teduglutide versus 30% (13 of 43) on placebo (P = .002). At week 24, mean volume had fallen 4.4 liters per week from a 12.9-liter baseline, against 2.3 liters from 13.2 on placebo.
The label's pediatric efficacy section describes study TED-C14-006 (NCT02682381), a 24-week Phase 3 study listed under Shire and completed in 2017, in 59 patients aged 1 through 17 years who depended on parenteral support. Patients chose teduglutide or standard of care, and those choosing teduglutide were randomized double-blind to one of two dose levels. In the label's intent-to-treat analysis of patient diary data, 69% (18 of 26) of patients at the recommended dosage reached at least a 20% reduction in parenteral support volume at week 24, and 12% (3 of 26) achieved enteral autonomy. The standard-of-care arm was chosen, not randomized, so there is no placebo comparison.
Teduglutide is the international nonproprietary name, and Gattex (US) and Revestive (EU) are its brand names. The STEPS record on ClinicalTrials.gov lists ALX-0600 as another name for the study drug, and PubChem's synonym list includes [Gly2]GLP-2, shorthand for the glycine substitution at position 2. Many research-peptide vendors use "GLP2" as a generational code for tirzepatide, so a product with that label can mean either compound, a collision the GLP agonist category page explains. Our post on what GLP-3 means covers the full GLP-1, GLP-2 and GLP-3 code series.
The FDA approved teduglutide as Gattex (new drug application 203441) on December 21, 2012, for adults with short bowel syndrome who are dependent on parenteral support. A supplemental approval on May 16, 2019 extended the indication to pediatric patients 1 year of age and older. In the European Union the same molecule is authorised as Revestive, under a marketing authorisation issued on 30 August 2012.
STEPS was a 24-week Phase 3 trial in 86 adults with short bowel syndrome who depended on parenteral support, published by Jeppesen and colleagues in Gastroenterology in 2012. A responder was a patient whose weekly parenteral support volume fell by at least 20% from baseline at both week 20 and week 24. In the intent-to-treat analysis of all randomized patients, 63% of the teduglutide group (27 of 43) responded versus 30% of the placebo group (13 of 43), P = .002. At week 24, mean parenteral support volume had fallen by 4.4 liters per week with teduglutide and by 2.3 liters per week with placebo.
As a drug. FDA's biologics regulations define a protein as an alpha amino acid polymer with a specific, defined sequence of more than 40 amino acids, and teduglutide has 33. Gattex is approved under a new drug application even though its active ingredient is made in E. coli by recombinant DNA technology. FDA's 2021 guidance on synthetic peptides referring to drugs of rDNA origin named teduglutide as one of five such peptides. FDA withdrew that guidance on July 28, 2026.
The Gattex prescribing information warns of possible acceleration of neoplastic growth, based on the drug's pharmacologic activity and tumor findings in rat and mouse carcinogenicity studies, and of intestinal polyps seen in clinical studies and postmarketing. It also warns of intestinal obstruction, gallbladder, biliary and pancreatic disease, fluid overload including congestive heart failure, and increased absorption of oral medicines taken at the same time. The label also sets out colonoscopy surveillance and laboratory monitoring of biliary and pancreatic markers.
Teduglutide's CAS Registry Number is 197922-42-2.
