PeptideTrace
ApprovedGLP-2 AnalogueMetabolic

Teduglutide (Gattex, Revestive)

A

Evidence Grade A — Regulatory approved. 346 published studies. 50 registered clinical trials.

50 trials346 studiesUSEUCA

Medically reviewed by a licensed medical professional

Licensed Indications

  • Short Bowel Syndrome

User Experience Reports

Loading...

Overview

Teduglutide (sold as Gattex) is a treatment for short bowel syndrome — a serious condition where people have lost so much intestine (through surgery or disease) that they cannot absorb enough nutrition from food and depend on intravenous feeding to survive. Teduglutide helps the remaining intestine adapt and absorb more, reducing or sometimes eliminating the need for IV nutrition.

Also Known As

Teduglutide is also known by these brand and alternate names:

Research Activity

346studies
Human 246
Animal 21
In-vitro 10
Reviews 86

346 published studies: 246 human, 21 animal, 10 in-vitro, 86 reviews

Regulatory Status

US
FDA-approved(FDA)
EU
EMA-authorised(EMA)
CA
Health Canada approved(Health Canada)

Legal Status

USPrescription drug (Rx)
EUPrescription medicine (EU centralised authorisation)
CAPrescription drug

Summary

Teduglutide is marketed as Gattex (approved December 2012 for adults; May 2019 for children aged 1 year and older). It is indicated for patients with short bowel syndrome who are dependent on parenteral (intravenous) nutrition support.

In clinical trials, 63% of patients on teduglutide achieved a meaningful reduction in their intravenous nutrition requirements, and some patients were able to discontinue intravenous feeding entirely. This is transformative for patients whose daily lives revolve around hours-long infusions of intravenous nutrition. Teduglutide requires monitoring for intestinal polyps, and colonoscopy is recommended before starting treatment and at regular intervals. It carries a theoretical risk of accelerating growth of pre-existing intestinal tumours.

Mechanism of Action

GLP-2 is a gut hormone that tells the intestinal lining to grow, repair, and absorb nutrients more efficiently. In people with short bowel syndrome, the remaining intestine cannot compensate for what was lost. Teduglutide amplifies the natural GLP-2 signal, causing the remaining intestinal tissue to adapt — villi (the finger-like projections that absorb nutrients) grow longer, the intestinal wall thickens, and blood flow to the gut increases. Over time, this enhanced absorption can reduce or eliminate the need for intravenous nutrition.

Research Summary

In clinical trials, 63% of patients on teduglutide meaningfully reduced their intravenous nutrition needs, and approximately 10% were able to stop IV feeding entirely during long-term follow-up. For patients whose daily lives revolve around hours-long infusions through a central line — with constant risks of bloodstream infection and liver damage — any reduction is transformative. Teduglutide is the only targeted therapy for short bowel syndrome. It requires colonoscopy before starting treatment and at regular intervals, because the mechanism (stimulating intestinal growth) carries a theoretical concern about accelerating growth of any pre-existing intestinal polyps. Malignant transformation has not been observed. A long-acting competitor (glepaglutide, requiring weekly rather than daily injection) is in late-stage development.

Clinical Trials

PeptideTrace tracks 50 registered clinical trials for Teduglutide sourced from ClinicalTrials.gov.

NCT07537686Phase IINot Yet Recruiting

Glucagon-like Peptide 2 (GLP-2) in Undernourished Women Improving From Histology-Confirmed Environmental Enteric Dysfunction (EED)

International Centre for Diarrhoeal Disease Research, BangladeshEndpoint: Composite EED (Environmental Enteric Dysfunction) Histopathologic ScoreCompletion: 2027-12-30
NCT07319832N/ARecruiting

A Study of Teduglutide in Chinese Children and Teenagers With Short Bowel Syndrome

TakedaEndpoint: Percentage of Participants Who Achieve at Least a 20% Reduction from Baseline in Weekly Parenteral Support (PS) Volume at Week 24Completion: 2027-09-30
NCT06973304Phase IIIRecruiting

A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome

TakedaEndpoint: Percentage of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Week 20 and Maintained Through Week 24Completion: 2027-07-28
NCT07400783N/ARecruiting

TED_ORG: Study on Short Bowel Syndrome

Meyer Children's Hospital IRCCSEndpoint: Intestinal organoid diameter after in vitro exposure to teduglutideCompletion: 2026-10-01
NCT05371028N/ACompleted

A Study of Teduglutide (Revestive®) in Participants With Short Bowel Syndrome (SBS) in Canada

TakedaEndpoint: Change From Baseline in Weekly Volume of Parenteral Nutrition (PN)/Intravenous (IV) Fluid Requirement at Week 24Completion: 2025-02-19
View all 50 trials on ClinicalTrials.gov →

Regulatory Timeline

2012
Regulatory

FDA ORIG 1

2014
Regulatory

FDA SUPPL 2

2015
Regulatory

FDA SUPPL 4

2015
Regulatory

FDA SUPPL 5

2015
Regulatory

FDA SUPPL 6

2015
Regulatory

Health Canada Market Authorisation

2016
Regulatory

FDA SUPPL 7

2016
Regulatory

FDA SUPPL 8

2017
Regulatory

FDA SUPPL 10

2018
Regulatory

FDA SUPPL 12

2019
Regulatory

FDA SUPPL 13

2020
Regulatory

FDA SUPPL 19

2021
Regulatory

FDA SUPPL 18

2021
Regulatory

FDA SUPPL 20

2023
Regulatory

FDA SUPPL 16

2024
Regulatory

FDA SUPPL 21

2024
Regulatory

FDA SUPPL 22

2025
Regulatory

FDA SUPPL 23

2025
Regulatory

FDA SUPPL 24

2026
Regulatory

EMA Marketing Authorisation

Scientific Detail

Overview (Scientific)

Teduglutide is a 33-amino-acid analogue of glucagon-like peptide-2 (GLP-2), an intestinotrophic hormone. A single amino acid substitution (Gly2→Ala) confers resistance to DPP-4 degradation, extending the half-life from approximately 7 minutes (native GLP-2) to approximately 2 hours.

Mechanism of Action (Scientific)

Teduglutide activates the GLP-2 receptor (GLP-2R), which is expressed on intestinal subepithelial myofibroblasts (not enterocytes directly). GLP-2R activation stimulates downstream signaling that promotes intestinal mucosal growth, including increased villus height, crypt depth, and mesenteric blood flow. This produces enhanced absorptive surface area, increased nutrient and fluid absorption, and slowed gastric motility. GLP-2 is distinct from GLP-1—it has no incretin effect and does not affect glucose metabolism.

Summary (Scientific)

Teduglutide is marketed as Gattex (Takeda, approved December 21, 2012 for adults; May 17, 2019 for pediatric patients ≥1 year). Indicated for short bowel syndrome (SBS) in patients dependent on parenteral support. The STEPS trial (N=86; 24 weeks) demonstrated that 63% of teduglutide-treated patients achieved ≥20% reduction in parenteral support volume versus 30% with placebo (P=0.002). Mean PS volume reduction: 4.4 L/week versus 2.3 L/week. Three patients achieved complete enteral autonomy. Requires colonoscopy screening for polyps before and during treatment.

Related Compounds

Linaclotide

Approved
Guanylate Cyclase-C Agonist

Linaclotide is marketed as Linzess (approved August 2012). It is taken as a daily oral capsule on an empty stomach, at least 30 minutes before the first meal. The recommended dose is 290 mcg for IBS-C and 72 or 145 mcg for chronic constipation. In clinical trials, approximately 34% of IBS-C patients met the composite improvement endpoint compared to 17% on placebo. Diarrhoea is the most common side effect (approximately 20%) and the leading reason for discontinuation. Linaclotide has a boxed warning against use in children under 6 years due to deaths in young mice, though no such events have been reported in humans. It competes with plecanatide (which targets the same pathway) and other IBS-C treatments.

Elamipretide

Approved
Mitochondria-Targeted Tetrapeptide (Approved)

Elamipretide (Forzinity) was approved by the FDA for Barth syndrome based on the TAZPOWER trial. The randomised crossover phase (12 patients) did not meet its primary endpoints, but the open-label extension (168 weeks) demonstrated durable improvements in walking distance and muscle strength that formed the basis for approval. Barth syndrome affects approximately 1 in 300,000–400,000 births. A larger Phase III trial in primary mitochondrial myopathy (218 patients, MMPOWER-3) did not meet its primary endpoint, and the drug was not approved for that broader indication. Elamipretide remains approved exclusively for Barth syndrome. See also SS-31 (#158) for the research compound context.

Glucagon

Approved
Counter-Regulatory Peptide Hormone

Glucagon has been available as an emergency injection since the 1960s and remains the standard rescue treatment for severe hypoglycaemia. Recent innovation has focused on making it easier to administer in emergencies. Baqsimi, approved in 2019, was the first needle-free option as a nasal powder. Gvoke, also approved in 2019, eliminated the need to mix and reconstitute the medication before injection — a significant advance since severe hypoglycaemia often impairs the ability to follow complex preparation steps. Dasiglucagon (Zegalogue), a next-generation stable liquid glucagon approved in 2021, further improved on the convenience of rescue administration. Beyond emergency rescue, glucagon's receptor is now a major research target — dual and triple agonists combining glucagon receptor activity with GLP-1 (such as survodutide and retatrutide) are in advanced clinical trials for obesity and metabolic disease.

Related Research

This content is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional before making decisions about your health.