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AMIRAVOResearch Library
Hormonal

Teduglutide

Also known as Gattex · Revestive · ALX-0600 · [Gly2]-GLP-2 · Glucagon-like peptide II (2-glycine) (human) · GLP-2 analog

FDA-approvedAHuman trial evidenceWhat this means

Teduglutide is a 33-amino-acid GLP-2 analog, FDA-approved since 2012 as Gattex for adults and children aged 1 year and older with short bowel syndrome who depend on parenteral support.

US status
FDA-approved
Evidence
Grade A
Half-life
Mean terminal half-life approximately 2 hours in healthy subjects and 1.3 hours in people with SBS; cleared mainly by the kidney (label) 1.
Class
Glucagon-like peptide-2 (GLP-2) analog
Studied in: Gut & GI research
More
Log a sample
Dosing referenceCycle-length evidence
Unbranded reference vial illustrating Teduglutide; not an actual product
Research reference, not advice. Label quotes, not a recommendation. Amiravo sells nothing; some links are referrals.Read the full notice

Key takeaways

  • Teduglutide is a GLP-2 analog approved for short bowel syndrome in people aged 1 year and older who depend on parenteral support 1.
  • In the STEPS trial in adults, 63% versus 30% achieved more than 20% reduction in weekly parenteral support volume at weeks 20 and 24 3.
  • Because of its growth-promoting action and rodent tumor findings, the label warns of possible acceleration of neoplastic growth and requires colonoscopy and upper GI endoscopy before and during treatment in adults 1.
  • Other label warnings include intestinal obstruction, gallbladder, biliary and pancreatic disease, fluid overload including heart failure, and increased absorption of oral medicines 1.
  • Teduglutide is not named in the 2026 Prohibited List text reviewed 4.

Development stage

Where Teduglutide sits between laboratory work and regulatory approval.

  1. Preclinical
  2. Phase 1
  3. Phase 2
  4. Phase 3
  5. Approved (current)

Stage comes from the regulatory record and ClinicalTrials.gov studies naming the compound (for compounds approved nowhere, only completed trials or trials with posted results count) (checked 2026-10-24). A registered trial is not a result.

Mechanism of action

Teduglutide is an analog of GLP-2, a peptide secreted by L-cells of the distal intestine that increases intestinal and portal blood flow and inhibits gastric acid secretion 1.

Receptor actions

It binds GLP-2 receptors on intestinal enteroendocrine cells, subepithelial myofibroblasts and enteric neurons, leading to local release of IGF-1, nitric oxide and keratinocyte growth factor 1.

Clinical correlate

In STEPS, teduglutide raised plasma citrulline, a biomarker of mucosal mass, alongside reductions in parenteral support 3.

Molecular structure

PubChem CID 16139605 ↗
2D chemical structure of Teduglutide

2D depiction generated from the PubChem record. Depictions are schematic and do not show salt form, counter-ions or conformation.

Formula
C164H252N44O55S
Molecular weight
3752.1 g/mol
CAS
197922-42-2
InChIKey
CILIXQOJUNDIDU-ASQIGDHWSA-N

Research overview

Human research

Two 24-week randomized, double-blind, placebo-controlled trials in adults with SBS (Study 1/STEPS, n = 86; Study 3, n = 84 across three groups) and their extensions support the label, along with 24-week and 12-week pediatric studies in 41 children aged 1 to under 17 years 1,3.

Animal research

In 2-year subcutaneous studies, teduglutide increased adenomas in the bile duct and jejunum of male rats and papillary gallbladder adenomas in mice, with jejunal adenocarcinomas in male mice at the high dose 1.

In-vitro research

Not reviewed separately for this entry.

Key studies

  1. Jeppesen et al., Gastroenterology (STEPS, NCT00798967) (2012)
    Randomized, double-blind, placebo-controlled, 24 weeks
    Model: Humans (86 adults with SBS and intestinal failure)

    Responders 63% versus 30% (P = .002); mean parenteral support reduction 4.4 versus 2.3 L/week; 54% versus 23% gained at least one day off per week 3.

  2. GATTEX prescribing information, Studies 2 and 4 (extensions) (2025)
    Open-label and blinded uncontrolled extensions
    Model: Humans (adults with SBS)

    Of 30 patients completing 30 months, 93% had at least 20% reduction in parenteral support and 10 were weaned off; in Study 4, 75% of earlier responders sustained response at 1 year 1.

  3. GATTEX prescribing information, pediatric studies (2025)
    24-week and 12-week studies with extensions
    Model: Humans (41 children aged 1 to under 17 with SBS)

    Safety profile similar to adults; anti-teduglutide antibodies in 54% at month 12 versus 24% in adults 1.

Dosing as stated on the FDA label

Quoted from the prescribing information for reference. Prescribing decisions belong to a licensed clinician; this is not a recommendation or instruction for use.

Full dosing reference, study durations and vial arithmetic →
  • Short bowel syndrome dependent on parenteral support (GATTEX): 0.05 mg/kg subcutaneously once daily for adults and pediatric patients aged 1 year and older 1.
  • Moderate or severe renal impairment or end-stage renal disease (eGFR below 60 mL/min/1.73 m2): 0.025 mg/kg once daily 1.
  • The label requires baseline colonoscopy and upper GI endoscopy with polyp removal (adults) or fecal occult blood testing (children) within 6 months before starting, plus bilirubin, alkaline phosphatase, lipase and amylase at baseline and every 6 months 1.
  • Twice the recommended dose (0.1 mg/kg/day), tested in Study 3, is not a recommended dosage per the label 1.

Published adverse-event data

Reported in the cited trials or product labels. Frequencies apply to the stated population and do not transfer to other settings.

  • Abdominal pain
    30% versus 22% placebo
    Adults with SBS, Studies 1 and 3 (24 weeks) 1 · Not graded in label table
  • Nausea
    23% versus 20%
    Same 1 · Not graded
  • Upper respiratory tract infection
    21% versus 12%
    Same 1 · Not graded
  • Abdominal distension
    20% versus 2%
    Same 1 · Not graded
  • Gastrointestinal stoma complication
    42% (13/31) versus 14% (3/22)
    Adults with a stoma in placebo-controlled studies 1 · Not graded
  • Intestinal obstruction/stenosis
    4% (recommended dose) and 9% (twice the recommended dose) versus 0% placebo
    Adult placebo-controlled studies 1 · Label advises temporary discontinuation
  • Peripheral edema / congestive heart failure
    10% versus 3% / 2 CHF cases on teduglutide
    Adult placebo-controlled studies 1 · One CHF case serious

Emerging safety signals

  • Three adult male trial participants on the recommended dose were diagnosed with malignancies (one metastatic adenocarcinoma, two lung cancers), and colorectal villous adenomas occurred in extension studies; the label advises discontinuing if intestinal malignancy develops 1. 1 (2025)
  • Cholecystitis occurred in 3 patients on teduglutide (all with prior gallbladder disease) and none on placebo in adult controlled studies; pancreatitis has also been reported 1. 1 (2025)
  • Increased intestinal absorption may raise exposure to oral drugs that need titration or have a narrow therapeutic index; in a controlled study one patient taking prazepam deteriorated to coma in the first week, resolving after both drugs were stopped 1. 1 (2025)

What is not known: Long-term cancer risk in humans is not established; the warning rests on its pharmacology and rodent tumor findings 1. Antibody formation is more frequent in children at 12 months, though no link with adverse events or loss of response was observed in the small number studied 1.

Background viewing

We haven't found a clinician video focused on Teduglutide yet. Meanwhile, this widely watched talk covers the science of aging in general. It does not discuss Teduglutide.

David Sinclair, PhD (Harvard Medical School) on the biology of aging
The Diary Of A CEO · 6.9M views · 2026

These creators are not affiliated with Amiravo and do not endorse Amiravo or any product linked on this site. Nothing here is medical advice. Video views counted on YouTube as of Oct 24, 2026.

Regulatory status

Status
FDA-approved as GATTEX (NDA 203441, original approval December 21, 2012) for adults and pediatric patients 1 year of age and older with short bowel syndrome who are dependent on parenteral support; label reviewed from the September 18, 2025 DailyMed version 1,2.
United States (FDA)
FDA-approved under NDA 203441 (GATTEX KIT, Takeda), original approval December 21, 2012 per Drugs@FDA 2; current indication per the September 2025 label covers adults and children aged 1 year and older with SBS dependent on parenteral support 1.
Sport (WADA)
Teduglutide is not named in the 2026 Prohibited List text reviewed; as an approved drug it is outside S0, but S2.3 covers other growth factors or modulators affecting tissue regenerative capacity, so status should be confirmed with the relevant anti-doping organization 4.

Status varies by country and changes over time. How we describe regulatory status.

Quality and testing notes

Identity can be confirmed against the 33-residue sequence with Gly at position 2 (PubChem formula C164H252N44O55S, MW about 3752) by mass spectrometry, with HPLC purity, host-cell protein and endotoxin testing for recombinant material [1, 5].

How purity testing works · Reading a certificate of analysis

Check a Teduglutide certificate of analysis against its expected mass (3,752.1 Da)

Storage and handling

Follow the current GATTEX label for kit storage and the reconstituted solution; research material per supplier documentation.

Frequently asked questions

What is teduglutide approved for?
Short bowel syndrome in adults and children aged 1 year and older who depend on parenteral support 1.
How does teduglutide differ from GLP-1 drugs?
It is a GLP-2 analog acting on intestinal GLP-2 receptors to influence intestinal blood flow, secretion and local growth mediators, not a GLP-1 receptor agonist 1.
How much did it reduce parenteral support in trials?
In STEPS, mean weekly parenteral support fell 4.4 L versus 2.3 L with placebo over 24 weeks 3.
Why are colonoscopies required?
Because it may accelerate neoplastic growth based on its pharmacology and rodent tumors; the label requires colonoscopy and upper GI endoscopy before treatment and at 1 year in adults 1.
What is its half-life?
About 2 hours in healthy subjects and 1.3 hours in people with SBS 1.
Is teduglutide banned in sport?
It is not named in the 2026 list text reviewed 4.

Latest indexed research

Search all studies on Teduglutide (PubMed, Europe PMC, ClinicalTrials.gov)

Listed by publication type from the index record. Inclusion is not an endorsement; open the source to read the findings.

Revision history

Meaningful changes to this entry, with dates and sources. Last reviewed Oct 24, 2026. Typo and layout fixes are not listed.

  • New section· entryOct 24, 2026

    New research reference added: Teduglutide.

Last reviewed October 24, 2026 by the Amiravo editorial team.

Read our editorial policy · Report an error on this page

Need the math?

Laboratory arithmetic with every formula shown.

For research use only. Not for human or veterinary use. Not a drug, food, or dietary supplement. This page is educational and is not medical advice.

Unbranded reference vial illustrating Teduglutide; not an actual product

Unbranded reference image. Amiravo does not produce, supply or sell this compound.

Specifications

Molecular formula
C164H252N44O55S
Molecular weight
3,752.1 g/mol
CAS number
197922-42-2
PubChem CID
16139605
FDA UNII
7M19191IKG
Sequence
HGDGSFSDEMNTILDNLAARDFINWLIQTKITD
Type
Single compound

Identifiers from PubChem. Verify against the supplier’s documentation for your lot.

Research stats

How much has been published, not how good it is.

PubMed records
365
Indexed as human research
258
Animal-only research
21
Randomized controlled trials
22
Registered trials
50
Trials with posted results
20
FDA adverse-event reports (FAERS)
9,301
NIH-funded projects naming it
32
2006: 42007: 22008: 42009: 62010: 42011: 82012: 102013: 172014: 122015: 132016: 142017: 212018: 222019: 282020: 412021: 312022: 282023: 352024: 392025: 412026: 4420062026
PubMed records per year (current year is partial).

Counts from title/abstract searches of PubMed, ClinicalTrials.gov, openFDA and NIH RePORTER, checked 2026-10-24. Names shared with other substances can inflate counts. FAERS reports are spontaneous and do not establish cause. Funding shows interest, not evidence. Method

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