PeptideTrace
ApprovedGLP-2 Analogue

Teduglutide

Gattex, Revestive

A

Evidence Grade A — Regulatory approved. 342 published studies. 44 registered clinical trials.

44 trials342 studiesUSEUCA

Licensed Indications

  • Short Bowel Syndrome

User Experience Reports

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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.

Research Activity

342studies
Human 243
Animal 20
In-vitro 10
Reviews 85

342 published studies: 243 human, 20 animal, 10 in-vitro, 85 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

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
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
NCT03953170Phase IIIWithdrawn

Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Endpoint: Change in daily 24 hr ileostomy collectionCompletion: 2022-12-29
NCT04883606N/ACompleted

A Study With Teduglutide (Revestive®) in Adults With Short Bowl Syndrome

TakedaEndpoint: Percentage of Participants Achieving Response of 20 Percent (%) to 100% Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Month 1Completion: 2023-07-24
View all 44 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

Related Compounds

Exenatide

Approved
GLP-1 Receptor Agonist

Exenatide was the first GLP-1 receptor agonist approved anywhere, reaching the market as Byetta in April 2005. The once-weekly formulation Bydureon followed in 2012. Clinical trials showed blood sugar reductions (HbA1c) of 1.6–1.9% and modest weight loss of 2–4 kg. The EXSCEL cardiovascular outcomes trial, involving over 14,700 patients, showed a trend toward cardiovascular benefit but narrowly missed statistical significance. While exenatide was groundbreaking as the first in its class, it has been largely overtaken by newer GLP-1 treatments that offer greater efficacy, less frequent dosing, and proven cardiovascular benefits. It remains available and in clinical use, particularly in combination products.

Lixisenatide

Approved
GLP-1 Receptor Agonist

Lixisenatide was marketed as Adlyxin in the US (approved July 2016), though it has since been discontinued in the US market. The ELIXA cardiovascular trial, involving over 6,000 patients, was the first cardiovascular outcomes trial for any GLP-1 medication to report results. It showed a neutral cardiovascular profile — neither harmful nor beneficial — meeting safety requirements but not demonstrating the heart benefits later shown by semaglutide and liraglutide. Lixisenatide found its primary clinical role in combination with basal insulin, marketed as Soliqua (lixisenatide plus insulin glargine). This combination addresses both fasting blood sugar (via insulin) and post-meal spikes (via lixisenatide) in a single daily injection. As a standalone treatment, it has been largely superseded by more potent GLP-1 medications.

Pramlintide

Approved
Amylin Analogue

Pramlintide is marketed as Symlin (approved March 2005) and remains the only approved amylin-based treatment. It is used alongside mealtime insulin in both type 1 and type 2 diabetes. Clinical trials showed modest blood sugar improvements (HbA1c reductions of 0.2–0.6%) and approximately 2.3 kg of weight loss — less dramatic than GLP-1 treatments but meaningful as an add-on therapy. Symlin carries a boxed warning for severe hypoglycaemia, particularly when combined with insulin, and requires careful dose adjustment. Practical uptake has been limited by the need for separate injections at each meal alongside existing insulin injections. Despite its modest clinical impact, pramlintide remains the only medication that addresses the amylin deficiency in diabetes, filling a distinct biological role that GLP-1 treatments do not cover.