{"id":"teduglutide","name":"Teduglutide","aliases":["Gattex","Revestive","GLP-2 analogue","ALX-0600"],"url":"https://lyoresearch.com/compounds/teduglutide","class":{"id":"gut-peptides","name":"Gut and intestinal peptides","url":"https://lyoresearch.com/classes/gut-peptides"},"summary":"Teduglutide is a 33-amino-acid analogue of glucagon-like peptide-2, approved since 2012 as Gattex in the US and Revestive in the EU for short bowel syndrome in people dependent on parenteral support. In the pivotal STEPS trial, 63% of treated patients reduced their intravenous feeding volume against 30% on placebo over 24 weeks. It is given by daily subcutaneous injection and is prescription-only everywhere LYO covers.","overall_grade":"A","overall_grade_meaning":"established in humans","human_trials":"STEPS phase 3 (n=86) and its extensions","regulatory_status":"Approved (Rx)","molecule":{"formula":"C164H252N44O55S","molecular_weight":"3752.1","cas":"197922-42-2","pubchem_cid":16139605,"sequence":"HGDGSFSDEMNTILDNLAARDFINWLIQTKITD","sequence_note":null,"note":null},"pharmacokinetics":{"basis":"label","route":"Subcutaneous injection, once daily","half_life":"About 2 hours in healthy subjects and about 1.3 hours in short bowel syndrome","licensed_regimen":"0.05 mg/kg once daily","product":"Gattex","source":{"title":"Gattex prescribing information (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=66b69c1e-b25c-44d3-b5ff-1c1de9a516fa"}},"outcomes":[{"outcome":"Reduced parenteral support in short bowel syndrome","grade":"A","grade_meaning":"established in humans","effect_size":"moderate","adverse":false,"human_studies":"1 phase 3 RCT (STEPS, n=86, 24 wk)","evidence":"STEPS randomised 86 adults dependent on parenteral support to daily teduglutide or placebo. The response endpoint — a 20–100% reduction in weekly parenteral volume at weeks 20 and 24 — was reached by 63% against 30% on placebo.","references":[{"citation":"Jeppesen PB, Pertkiewicz M, Messing B, et al. Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure (STEPS).","where":"Gastroenterology, 2012;143:1473–1481","url":"https://pubmed.ncbi.nlm.nih.gov/22982184/"}],"verbatim":{"text":"There were significantly more responders in the teduglutide group (27/43 [63%]) than the placebo group (13/43 [30%]; P = .002).","citation":"Jeppesen PB, Pertkiewicz M, Messing B, et al. Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure (STEPS).","url":"https://pubmed.ncbi.nlm.nih.gov/22982184/"}},{"outcome":"Days free of intravenous feeding","grade":"A","grade_meaning":"established in humans","effect_size":"moderate","adverse":false,"human_studies":"1 phase 3 RCT (STEPS, n=86, 24 wk)","evidence":"The outcome patients feel: more than half of treated patients gained at least one night a week off parenteral support, against under a quarter on placebo.","references":[{"citation":"Jeppesen PB, Pertkiewicz M, Messing B, et al. Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure (STEPS).","where":"Gastroenterology, 2012;143:1473–1481","url":"https://pubmed.ncbi.nlm.nih.gov/22982184/"}],"verbatim":{"text":"The percentage of patients with a 1-day or more reduction in the weekly need for parenteral support was greater in the teduglutide group (21/39 [54%]) than in the placebo group (9/39 [23%]; P = .005).","citation":"Jeppesen PB, Pertkiewicz M, Messing B, et al. Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure (STEPS).","url":"https://pubmed.ncbi.nlm.nih.gov/22982184/"}},{"outcome":"Colorectal neoplasia risk","grade":"A","grade_meaning":"established in humans","effect_size":"small","adverse":true,"human_studies":"Label; approval programme","evidence":"Because teduglutide is trophic to intestinal mucosa, the Gattex label requires colonoscopy before starting and at intervals thereafter, and lists colorectal polyps and the theoretical risk of neoplasia. An intended mechanism that is also the main long-term caution.","references":[{"citation":"Gattex (teduglutide) prescribing information.","where":"DailyMed, read 29 Oct 2026","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=66b69c1e-b25c-44d3-b5ff-1c1de9a516fa"}]},{"outcome":"Gastrointestinal and stoma adverse effects","grade":"A","grade_meaning":"established in humans","effect_size":"moderate","adverse":true,"human_studies":"Approval programme","evidence":"Abdominal pain and distension, nausea, stoma complications and fluid overload are the common adverse effects in the label — the predictable consequences of making remaining bowel absorb more.","references":[{"citation":"Gattex (teduglutide) prescribing information.","where":"DailyMed, read 29 Oct 2026","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=66b69c1e-b25c-44d3-b5ff-1c1de9a516fa"}]}],"regions":[{"region":"European Union","status":"Approved, prescription-only","note":"Revestive authorised centrally since 2012 for short bowel syndrome in adults and children aged 4 months and above."},{"region":"United States","status":"Approved, prescription-only","note":"Gattex approved in 2012 for adults and, since 2019, children aged 1 year and above dependent on parenteral support."},{"region":"United Kingdom","status":"Licensed, prescription-only","note":"Revestive licensed by the MHRA."},{"region":"Australia","status":"Registered, Schedule 4","note":"Revestive registered on the ARTG."},{"region":"Canada","status":"Authorised, prescription-only","note":"Revestive authorised with a Drug Identification Number."},{"region":"Sport (WADA)","status":"Not prohibited","note":"GLP-2 analogues are not named on the Prohibited List."}],"faq":[{"q":"What does teduglutide do?","a":"It makes the remaining small intestine absorb more, so people with short bowel syndrome need less intravenous nutrition. In the pivotal trial 63% reduced their parenteral volume against 30% on placebo, and more than half gained at least one night a week off the drip."},{"q":"Why does the label require colonoscopy?","a":"Because the drug's mechanism is to make intestinal mucosa grow. The same trophic signal creates a theoretical risk of colorectal neoplasia, so surveillance is built into the label."},{"q":"Is teduglutide related to the GLP-1 obesity drugs?","a":"Only distantly — both come from the same proglucagon precursor, but GLP-2 acts on the intestinal lining rather than on appetite and insulin. Teduglutide does not cause weight loss; it increases absorption."}],"references":[{"cite":"Jeppesen PB, Pertkiewicz M, Messing B, et al. Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure (STEPS).","where":"Gastroenterology, 2012;143:1473–1481","url":"https://pubmed.ncbi.nlm.nih.gov/22982184/","note":"86 randomised, 24 weeks. NCT00798967."},{"cite":"Gattex (teduglutide) prescribing information.","where":"DailyMed, read 29 Oct 2026","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=66b69c1e-b25c-44d3-b5ff-1c1de9a516fa","note":"Route, half-life, licensed regimen, colonoscopy requirement, and the 33-amino-acid structure."},{"cite":"PubChem compound record: teduglutide.","where":"PubChem, read 29 Oct 2026","url":"https://pubchem.ncbi.nlm.nih.gov/compound/16139605","note":"Formula, molecular weight, CAS and the sequence used on this page."}],"last_reviewed":"2026-10-29","literature_searched_to":"2026-10-29","changelog":[{"date":"2026-10-29","note":"Initial publication. Grade A on STEPS and the approval programme."}],"license":"CC BY 4.0 — cite as “LYO Research” with a link.","methodology":"https://lyoresearch.com/methodology"}