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Context, anatomy, and key evidence

← Peptide library

GLP-2 analog

Teduglutide

Published evidence · coverage incomplete
Anatomical contextAnatomy connections are not mapped yet.

No body region is highlighted until this profile has a supported anatomical connection. This does not mean the peptide has no biological effects.

Read published mechanism findings ↓

At a glance

What is it—and why does it matter?

GATTEX contains teduglutide, a 33–amino acid analog of human GLP-2 produced via recombinant DNA technology in a modified Escherichia coli strain. As a GLP-2 analog, teduglutide engages GLP-2 receptors expressed in intestinal enteroendocrine cells, subepithelial myofibroblasts, and enteric neurons, consistent with an intestinal mechanism of action. Teduglutide treatment has reports of intestinal obstruction from both clinical trials and postmarketing surveillance. Recommended teduglutide dosing is weight-based (0.05 mg/kg) with once-daily subcutaneous administration.

Sources for this introduction: [1] [2] [3] [4]

This published profile is a reference in progress. Findings retain their source context; missing topics are marked below.

What is it?

A molecule, not a product name.

Identity

GATTEX contains teduglutide, a 33–amino acid analog of human GLP-2 produced via recombinant DNA technology in a modified Escherichia coli strain.

Sources[1]dailymedThese highlights do not include all the information needed to use GATTEX safely and effectively. See full prescribing information for GATTEX.GATTEX®(teduglutide) for injection, for subcutaneous useInitial U.S. Approval: 2012teduglutide, which is a 33 amino acid glucagon-like peptide-2 (GLP-2) analog manufactured using a strain ofEscherichia colimodified by recombinant DNA technology.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “teduglutide, which is a 33 amino acid glucagon-like peptide-2 (GLP-2) analog manufactured using a strain ofEscherichia colimodified by recombinant DNA technology.”

    These highlights do not include all the information needed to use GATTEX safely and effectively. See full prescribing information for GATTEX.GATTEX®(teduglutide) for injection, for subcutaneous useInitial U.S. Approval: 2012 · 11 DESCRIPTION

    dailymed:66b69c1e-b25c-44d3-b5ff-1c1de9a516fa:3e0f265ab3c2:3e0f265ab3c2

How does it work?

Target, response, and disposition.

Mechanism

As a GLP-2 analog, teduglutide engages GLP-2 receptors expressed in intestinal enteroendocrine cells, subepithelial myofibroblasts, and enteric neurons, consistent with an intestinal mechanism of action.

Sources[1]dailymedThese highlights do not include all the information needed to use GATTEX safely and effectively. See full prescribing information for GATTEX.GATTEX®(teduglutide) for injection, for subcutaneous useInitial U.S. Approval: 2012Teduglutide binds to the glucagon-like peptide-2 receptors located in intestinal subpopulations of enteroendocrine cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Teduglutide binds to the glucagon-like peptide-2 receptors located in intestinal subpopulations of enteroendocrine cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus.”

    These highlights do not include all the information needed to use GATTEX safely and effectively. See full prescribing information for GATTEX.GATTEX®(teduglutide) for injection, for subcutaneous useInitial U.S. Approval: 2012 · 12.1 Mechanism of Action

    dailymed:66b69c1e-b25c-44d3-b5ff-1c1de9a516fa:3e0f265ab3c2:3e0f265ab3c2

What has been studied?

What the evidence says.

This profile does not yet contain a published summary for this topic. This is a coverage gap, not evidence that no research exists.

Risks and interactions

Risks, organized for scanning.

Interactions

The pharmacodynamic effects of teduglutide (GATTEX) can increase gastrointestinal absorption, creating potential for increased absorption of concomitant oral drugs.

Sources[1]dailymedThese highlights do not include all the information needed to use GATTEX safely and effectively. See full prescribing information for GATTEX.GATTEX®(teduglutide) for injection, for subcutaneous useInitial U.S. Approval: 2012Based upon the pharmacodynamic effect of GATTEX, there is a potential for increased absorption of concomitant oral medications.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Based upon the pharmacodynamic effect of GATTEX, there is a potential for increased absorption of concomitant oral medications.”

    These highlights do not include all the information needed to use GATTEX safely and effectively. See full prescribing information for GATTEX.GATTEX®(teduglutide) for injection, for subcutaneous useInitial U.S. Approval: 2012 · 7.1 Potential for Increased Absorption of Oral Medications

    dailymed:66b69c1e-b25c-44d3-b5ff-1c1de9a516fa:3e0f265ab3c2:3e0f265ab3c2

Safety findings

Teduglutide treatment has reports of intestinal obstruction from both clinical trials and postmarketing surveillance.

Sources[1]dailymedThese highlights do not include all the information needed to use GATTEX safely and effectively. See full prescribing information for GATTEX.GATTEX®(teduglutide) for injection, for subcutaneous useInitial U.S. Approval: 2012Intestinal obstruction has been reported in clinical studies[see Adverse Reactions (6.1)]and postmarketing.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Intestinal obstruction has been reported in clinical studies[see Adverse Reactions (6.1)]and postmarketing.”

    These highlights do not include all the information needed to use GATTEX safely and effectively. See full prescribing information for GATTEX.GATTEX®(teduglutide) for injection, for subcutaneous useInitial U.S. Approval: 2012 · 5.2 Intestinal Obstruction

    dailymed:66b69c1e-b25c-44d3-b5ff-1c1de9a516fa:3e0f265ab3c2:3e0f265ab3c2

Products and regulatory status

Same ingredient. Different records.

Regulatory status

Teduglutide (GATTEX) has an approved indication for Short Bowel Syndrome (SBS) in patients (adults and pediatric patients aged ≥1 year) who require parenteral support.

Sources[1]dailymedThese highlights do not include all the information needed to use GATTEX safely and effectively. See full prescribing information for GATTEX.GATTEX®(teduglutide) for injection, for subcutaneous useInitial U.S. Approval: 2012GATTEX®is indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “GATTEX®is indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support.”

    These highlights do not include all the information needed to use GATTEX safely and effectively. See full prescribing information for GATTEX.GATTEX®(teduglutide) for injection, for subcutaneous useInitial U.S. Approval: 2012 · 1 INDICATIONS AND USAGE

    dailymed:66b69c1e-b25c-44d3-b5ff-1c1de9a516fa:3e0f265ab3c2:3e0f265ab3c2

Administration context

The practical clinical context.

Administration

Teduglutide (GATTEX) is administered via the subcutaneous route; intravenous and intramuscular routes are not indicated.

Sources[1]dailymedThese highlights do not include all the information needed to use GATTEX safely and effectively. See full prescribing information for GATTEX.GATTEX®(teduglutide) for injection, for subcutaneous useInitial U.S. Approval: 2012GATTEX is for subcutaneous injection only. Not for intravenous or intramuscular administration.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “GATTEX is for subcutaneous injection only. Not for intravenous or intramuscular administration.”

    These highlights do not include all the information needed to use GATTEX safely and effectively. See full prescribing information for GATTEX.GATTEX®(teduglutide) for injection, for subcutaneous useInitial U.S. Approval: 2012 · 2.2 Recommended Dosage and Administration for Adults and Pediatric Patients 1 Year of Age and Older

    dailymed:66b69c1e-b25c-44d3-b5ff-1c1de9a516fa:3e0f265ab3c2:3e0f265ab3c2

Administration

Teduglutide lyophilized powder is reconstituted using 0.5 mL preservative-free Sterile Water for Injection to produce a 10 mg/mL sterile solution.

Sources[1]dailymedThese highlights do not include all the information needed to use GATTEX safely and effectively. See full prescribing information for GATTEX.GATTEX®(teduglutide) for injection, for subcutaneous useInitial U.S. Approval: 2012Reconstitute each vial of GATTEX by slowly injecting the 0.5 mL of preservative-free Sterile Water for Injection provided in the prefilled syringe. A 10 mg/mL sterile solution is obtained after reconstitution.
Reported result
10 mg/mL after reconstitution
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Reconstitute each vial of GATTEX by slowly injecting the 0.5 mL of preservative-free Sterile Water for Injection provided in the prefilled syringe. A 10 mg/mL sterile solution is obtained after reconstitution.”

    These highlights do not include all the information needed to use GATTEX safely and effectively. See full prescribing information for GATTEX.GATTEX®(teduglutide) for injection, for subcutaneous useInitial U.S. Approval: 2012 · 2.6 Preparation Instructions

    dailymed:66b69c1e-b25c-44d3-b5ff-1c1de9a516fa:3e0f265ab3c2:3e0f265ab3c2

Dose records

Recommended teduglutide dosing is weight-based (0.05 mg/kg) with once-daily subcutaneous administration.

Sources[1]dailymedThese highlights do not include all the information needed to use GATTEX safely and effectively. See full prescribing information for GATTEX.GATTEX®(teduglutide) for injection, for subcutaneous useInitial U.S. Approval: 2012The recommended dosage of GATTEX is 0.05 mg/kg once daily administered by subcutaneous injection.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “The recommended dosage of GATTEX is 0.05 mg/kg once daily administered by subcutaneous injection.”

    These highlights do not include all the information needed to use GATTEX safely and effectively. See full prescribing information for GATTEX.GATTEX®(teduglutide) for injection, for subcutaneous useInitial U.S. Approval: 2012 · 2.2 Recommended Dosage and Administration for Adults and Pediatric Patients 1 Year of Age and Older

    dailymed:66b69c1e-b25c-44d3-b5ff-1c1de9a516fa:3e0f265ab3c2:3e0f265ab3c2

Dose records

Renal impairment (eGFR <60 mL/min/1.73 m2) requires a reduced teduglutide dose of 0.025 mg/kg once daily.

Sources[1]dailymedThese highlights do not include all the information needed to use GATTEX safely and effectively. See full prescribing information for GATTEX.GATTEX®(teduglutide) for injection, for subcutaneous useInitial U.S. Approval: 2012The recommended dosage in adult and pediatric patients with moderate and severe renal impairment and end-stage renal disease (estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m2) is 0.025 mg/kg once daily
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “The recommended dosage in adult and pediatric patients with moderate and severe renal impairment and end-stage renal disease (estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m2) is 0.025 mg/kg once daily”

    These highlights do not include all the information needed to use GATTEX safely and effectively. See full prescribing information for GATTEX.GATTEX®(teduglutide) for injection, for subcutaneous useInitial U.S. Approval: 2012 · 2.3 Dosage Adjustment for Renal Impairment

    dailymed:66b69c1e-b25c-44d3-b5ff-1c1de9a516fa:3e0f265ab3c2:3e0f265ab3c2

Research status + gaps

What still needs better answers?

  • No publishable claim yet for: contraindication, effect
  • 2 compiled claim(s) withheld by automated assurance: assurance_score_below_0.72 (2), current_regulatory_source_required (1), extraction_ambiguity (1), extraction_confidence_not_high (1), high_risk_requires_regulatory_or_two_independent_sources (2), no_direct_support (2)

These are the limits of this profile, not an exhaustive list of scientific uncertainties.

References + discovery

Open the records yourself.

  1. These highlights do not include all the information needed to use GATTEX safely and effectively. See full prescribing information for GATTEX.GATTEX®(teduglutide) for injection, for subcutaneous useInitial U.S. Approval: 2012 ↗

    dailymed · published 2025-09-05 · retrieved 2026-09-04T22:25:04Z

Publication history and provenance

Version 2 · Automated assessment · 2026-09-04T22:25:04Z

81c6cb05e9681de8801238dbee2faba8e214819c587569eab1e55b1cfe40b5ee