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Teduglutide

GLP-2 analogue

Status

Approved

Approved by FDA (Gattex) and the EU (Revestive) in 2012 and in Japan since 2021 for short bowel syndrome in adults and children aged 1 year and older (in the US, those dependent on parenteral support).

Evidence

Moderate

Placebo-controlled 24-week RCTs of about 85 adults each plus paediatric and extension studies; consistent but small because the disease is rare.

Teduglutide is a lab-made version of the gut hormone GLP-2 with one amino acid changed so it lasts longer. It is approved as a daily injection for short bowel syndrome in people who depend on intravenous (parenteral) nutrition or fluids.

Structure

33 residues

Point at a bead, or focus the chain and use the arrow keys, to name it. Pick a chemistry to highlight it.

Sequence as text
H-H-G-D-G-S-F-S-D-E-M-N-T-I-L-D-N-L-A-A-R-D-F-I-N-W-L-I-Q-T-K-I-T-D-OH

What it is used for

  • Short bowel syndrome in adults and children 1 year and older who depend on parenteral support (approved)

How it works

Teduglutide mimics GLP-2, a hormone released by L-cells of the distal intestine. It binds GLP-2 receptors on intestinal enteroendocrine cells, subepithelial myofibroblasts and enteric neurons, triggering local release of mediators including IGF-1, nitric oxide and keratinocyte growth factor. This increases intestinal blood flow, slows transit, reduces stomach acid secretion and increases villus height and crypt depth, so the remaining bowel absorbs more fluid and nutrients. It is cleared mainly by the kidneys.

How strong the evidence is

ModerateAt least one good randomised trial, or consistent smaller human trials.

In the pivotal 24-week trial (Study 1, STEPS; Jeppesen 2012), 63% of 43 adults on teduglutide versus 30% of 43 on placebo achieved at least a 20% cut in weekly parenteral support volume (p=0.002), with mean reductions of 4.4 versus 2.3 litres per week, and 54% versus 23% gained at least one day a week off infusions. The label also draws on a second 24-week placebo-controlled trial and long-term extensions, and 41 children aged 1 to 17 were treated in two paediatric studies.

Risks and side effects

  • May accelerate growth of existing tumours and intestinal polyps; the label calls for colonoscopy before treatment in adults and at intervals afterwards.
  • Intestinal obstruction, and gallbladder, bile duct and pancreatic disease.
  • Fluid overload and fluid and electrolyte shifts, including when treatment is stopped.
  • Increased absorption of oral medicines, which may need dose reduction.
  • Common: abdominal pain, nausea, upper respiratory infections, bloating, injection-site reactions and stoma complications.

Label dosing

Label: 0.05 mg/kg by subcutaneous injection once daily for adults and children 1 year and older, reduced to 0.025 mg/kg once daily in moderate to severe kidney impairment.

Summarised from the official prescribing information. Not a recommendation: dosing is decided with a prescriber.

Regulatory status

RegionYearApproved for
USFDA2012Short bowel syndrome in patients dependent on parenteral support (now adults and children 1 year and older)
EUEMA2012Short bowel syndrome in patients aged 1 year and above
JPMHLW2021Short bowel syndrome

Status by country

JurisdictionStatusSource
USUnited StatesAuthorised medicineSource 1
EUEuropean UnionAuthorised medicineSource 2
UKUnited KingdomAuthorised medicineSource 7
AUAustraliaAuthorised medicineSource 8
CACanadaAuthorised medicineSource 9
Whether a medicine containing it is authorised, checked in each regulator’s records on Oct 1, 2026.

Status of every peptide by country

Trials of Teduglutide to watch

  1. Phase 3Active, not recruiting

    Teduglutide in Chinese adults with SBS(opens the source in a new tab)

    A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome

    Primary completion expected Feb 10, 202713 participantsSponsor: TakedaNCT06973304

All trials to watch

Timeline

  1. 2027

    1. Teduglutide in Chinese adults with SBS

  2. 2021

    1. Approved, JP (MHLW)Short bowel syndrome

  3. 2012

    1. Approved, US (FDA)Short bowel syndrome in patients dependent on parenteral support (now adults and children 1 year and older)
    2. Approved, EU (EMA)Short bowel syndrome in patients aged 1 year and above

Sources

  1. 01GATTEX (teduglutide) for injection: Prescribing Information(opens the source in a new tab) DailyMed, US National Library of Medicine, 2025
  2. 02Revestive: EPAR(opens the source in a new tab) European Medicines Agency, 2026
  3. 03Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure(opens the source in a new tab) Gastroenterology, 2012
  4. 04Six-Month Safety and Effectiveness of Teduglutide in Patients with Short Bowel Syndrome in Japan: Interim Analysis of Post-marketing Surveillance(opens the source in a new tab) Advances in Therapy, 2025
  5. 05PubChem Compound Summary: Teduglutide (CID 16139605)(opens the source in a new tab) NCBI PubChem, 2026
  6. 06UniProtKB P01275: Pro-glucagon (GCG), human(opens the source in a new tab) UniProt, 2026
  7. 07Revestive 5 mg powder and solvent for solution for injection: Summary of Product Characteristics(opens the source in a new tab) electronic medicines compendium (emc), 2025
  8. 08REVESTIVE teduglutide 5 mg powder for solution for injection vial with diluent pre-filled syringe (274911)(opens the source in a new tab) Therapeutic Goods Administration
  9. 09Drug Product Database: Revestive (DIN 02445727)(opens the source in a new tab) Health Canada, 2026
  1. Not approvedKPVAlpha-MSH-derived tripeptide (research chemical)3 WADA banned
  2. ApprovedLinaclotideGuanylate cyclase-C agonist14
  3. Not approvedBPC-157Synthetic gastric pentadecapeptide (research chemical)15 WADA banned
  4. Not approvedIpamorelinGrowth hormone secretagogue (ghrelin receptor agonist)5 WADA banned

Educational information, not medical advice. Talk to a licensed clinician before starting, stopping or changing any medicine.