Teduglutide

Gattex (US), Revestive (EU, UK, Australia and elsewhere), ALX-0600, [Gly2]GLP-2, rDNA GLP-2 analogue

Recovery, repair & tissue

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Note on this profile. Teduglutide is an approved prescription medicine for a rare, serious condition, started by specialists in intestinal failure. It is not a research-only compound and has no meaningful documented community use. This page explains the published science; use outside its approved indication is unapproved.

Summary

Class: Synthetic 33-amino-acid analogue of human glucagon-like peptide-2 (GLP-2), made by recombinant DNA, with alanine at position 2 replaced by glycine so DPP-4 cannot degrade it
Mechanism: Mimics the gut hormone GLP-2: thickens and lengthens the intestinal lining, increases blood flow and nutrient absorption, and slows transit — so people with very short bowels absorb more from what they eat and need less intravenous feeding
Routes studied: Subcutaneous once daily (approved)
Half-life: ~2 hours (native GLP-2 lasts ~7 minutes)
Storage: Unopened kits at room temperature up to 25 °C (do not freeze); reconstituted solution used within 3 hours
Regulatory status: Approved medicine (US 2012, EU 2012, UK, Australia, Canada, Japan, others)

Doses are as reported in studies or by the community — never recommendations.

1What it is

GLP-2 is a 33-amino-acid hormone cut from the same proglucagon precursor as GLP-1 and oxyntomodulin and released by L cells in the ileum and colon after meals. Where GLP-1 manages blood sugar and appetite, GLP-2 looks after the gut itself: it is the main hormonal signal that tells the intestinal lining to grow and adapt. After bowel resection the remaining gut normally undergoes "adaptation" partly driven by GLP-2 — but people whose terminal ileum and colon have been removed lose most of their L cells and therefore most of their GLP-2.

Teduglutide is GLP-2 with a single amino-acid swap that protects it from DPP-4, extending its from minutes to about two hours. It was developed by NPS Pharmaceuticals (later Shire, now Takeda) and approved in 2012 for adults with short bowel syndrome (SBS) who depend on parenteral support — intravenous nutrition or fluids. The pediatric indication followed in 2019 (US) and the EU extended it to infants from 4 months †. Community/self-directed use: essentially none documented; the drug is expensive, specialist-initiated and has no plausible use outside intestinal failure.

2How it's thought to work

GLP-2 receptor. a class B GPCR found mainly on enteroendocrine cells, enteric neurons and subepithelial myofibroblasts — not on the absorptive cells themselves. Activation releases secondary growth signals (IGF-1, keratinocyte growth factor, ErbB ligands) that drive crypt cell proliferation and reduce apoptosis.

Result. taller villi and deeper crypts (increased absorptive surface), greater intestinal blood flow, reduced gastric acid and motility, and improved barrier function. In SBS this translates to less fluid and nutrient loss in stool or stoma output.

Why the growth effect is also the main safety concern. anything that stimulates intestinal growth could in principle accelerate the growth of polyps or tumours already present, which is why colonoscopy is required before and during treatment.

A DPP-4-resistant GLP-2 analogue. The receptor is not on the absorptive cell but on its neighbours, which answer with growth signals; villi grow taller and absorptive surface increases.Schematic — not to scale

3What the research shows

Reduction of parenteral support in adult SBS

STEPS (Jeppesen 2012, Gastroenterology): 86 adults on parenteral support were randomised to teduglutide 0.05 mg/kg/day or placebo for 24 weeks. 63% of teduglutide patients versus 30% on placebo achieved a ≥20% reduction in weekly parenteral volume at weeks 20 and 24 (the primary endpoint); mean reduction was 4.4 L/week versus 2.3 L/week. An earlier 24-week trial (Jeppesen 2011, Gut) had shown a similar response at 0.05 mg/kg and no advantage for 0.10 mg/kg. [1][2]

Long-term use and weaning off parenteral nutrition

In the STEPS-2 two-year open-label extension (Schwartz 2016, Clin Transl Gastroenterol), 93% of continuing responders maintained their response, 13 of 88 patients came off parenteral support entirely, and parenteral days per week fell by a mean of ~1.4. Registry data through the 2020s report similar trends; most patients who stop teduglutide see parenteral needs rise again. [3]

Graded A/B

Children with SBS

A 24-week study in 59 children aged 1–17 (Kocoshis 2020, JPEN; basis for the 2019 US pediatric approval) found 69% of those on 0.05 mg/kg/day achieved ≥20% reduction in parenteral volume (mean −42%), and 3 of 26 came off intravenous feeding entirely. A separate study supported extension to infants ≥4 months in the EU †. [4]

Graded B/C

Other indications

Small studies in Crohn's disease (a Phase 2 reported remission signals but was not pursued), chemotherapy-induced mucositis and graft-versus-host disease are early or inconclusive. Rodent models show protection against NSAID enteropathy and radiation injury.

Graded A (in progress)

Next-generation GLP-2 analogues

Longer-acting analogues designed for weekly dosing — apraglutide (Ironwood) and glepaglutide (Zealand) — completed Phase 3 trials in 2023–2024. Apraglutide's STARS trial met its primary endpoint in stoma patients (2024); glepaglutide's EASE-1 was positive and its US application received a complete response letter in 2024 †. Neither is approved as of this review †.

4Reported side effects and interactions

Literature-reported

Common (literature). abdominal pain (~30–38%), injection-site reactions, nausea, abdominal distension, headache, upper respiratory infection, vomiting; in people with a stoma, swelling or enlargement of the stoma is very common (~40%) and may require refitting.

Serious / warnings (label). acceleration of neoplastic growth — colonoscopy of the whole colon with polyp removal is required before starting, after one year, then at least every five years; contraindicated with active GI malignancy and not recommended with any active non-GI malignancy; intestinal obstruction (sometimes requiring dose interruption); gallbladder, biliary and pancreatic disease (cholecystitis, cholangitis, pancreatitis — check bilirubin, alkaline phosphatase, lipase and amylase before and during treatment); fluid overload and heart failure as absorption improves and parenteral volumes lag behind.

Community-reported

none documented.

Interactions. improved absorption can raise blood levels of oral medicines with a narrow therapeutic window (e.g. benzodiazepines, antiepileptics, warfarin); doses may need adjusting as the gut recovers. Antibodies to teduglutide develop in a minority and have not been linked to loss of effect.

Markers researchers commonly monitor

These follow the label and intestinal-failure practice:

Marker	Why it's watched
Parenteral support volume and days per week	the primary efficacy measure; adjusted downward in steps as urine output rises.
Urine output and body weight	the first signs that absorption has improved; also the early warning for fluid overload.
Electrolytes, magnesium, phosphate, renal function	shift as parenteral volumes are cut.
Bilirubin, alkaline phosphatase, lipase, amylase	at baseline and every 6 months for biliary and pancreatic warnings.
Colonoscopy	before starting, at one year, then at least every five years (sooner if polyps found).
Plasma citrulline	a research marker of enterocyte mass; rises with teduglutide.
Drug levels of narrow-window oral medicines	because absorption improves.

Free for everyone. Safety information is never behind a paywall.

5Reconstitution and handling

Supplied as a kit of 5 mg vials with prefilled 0.5 mL syringes; after the solution is 10 mg/mL and the weight-based dose (0.05 mg/kg) is drawn up in a 1 mL syringe — e.g. 3.5 mg (0.35 mL) for a 70 kg adult. Inject once daily into the abdomen, thigh or arm, rotating sites; use within 3 hours of mixing. Patients are trained by their intestinal-failure team. The site calculator is not needed for the approved product.

6Commonly studied alongside

Semaglutide and other GLP-1 analogues (same proglucagon family, different job — GLP-1 agonists have also been explored in SBS to slow transit), oxyntomodulin, apraglutide and glepaglutide (investigational longer-acting GLP-2 analogues), somatostatin analogues such as octreotide (used in high-output stoma), growth hormone (somatropin, previously approved for SBS in the US as Zorbtive).

Informational cross-links. Not stack recommendations.

7Regulatory status by region

Region	Status (checked —)
United States	FDA-approved (Gattex, Dec 2012; pediatric ≥1 year May 2019); orphan drug
European Union	EMA-authorised (Revestive, Aug 2012); indication extended to children, now from 4 months of age †
United Kingdom	MHRA-licensed (Revestive); NICE-recommended for adults and children with SBS under managed access †
Australia	TGA-registered (Revestive); PBS-listed for SBS †
South Africa	Not registered with SAHPRA; available only via Section 21 named-patient access †
Sport	Not specifically listed by WADA; not a GH secretagogue †

8Open questions

Does long-term GLP-2 agonism increase colorectal cancer risk in people, or is the signal confined to animal models?
Which patients will achieve full independence from parenteral nutrition, and can treatment ever be stopped without relapse?
Will once-weekly analogues match teduglutide's effect with better adherence?

9References

1Jeppesen PB et al. (2012). Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure (STEPS). Gastroenterology. PubMed · DOI
2Jeppesen PB et al. (2011). Randomised placebo-controlled trial of teduglutide in reducing parenteral nutrition and/or intravenous fluid requirements in patients with short bowel syndrome. Gut. PubMed · DOI
3Schwartz LK et al. (2016). Long-term teduglutide for the treatment of patients with intestinal failure associated with short bowel syndrome (STEPS-2). Clin Transl Gastroenterol. PubMed · DOI
4Kocoshis SA et al. (2020). Safety and efficacy of teduglutide in pediatric patients with intestinal failure due to short bowel syndrome: a 24-week, phase III study. JPEN J Parenter Enteral Nutr. PubMed · DOI
5Drucker DJ, Yusta B (2014). Physiology and pharmacology of the enteroendocrine hormone glucagon-like peptide-2. Annu Rev Physiol. PubMed · DOI
6Takeda. Gattex (teduglutide) for injection — US prescribing information; Revestive EU Summary of Product Characteristics (current). PubMed
7European Medicines Agency. Revestive — EPAR product information and variation assessment report (paediatric extension). PubMed

References are being resolved to PubMed/DOI identifiers; links search PubMed for the citation until then.

† Being confirmed by our reviewers against current sources.

10Community

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11Page history

30 Oct 2026Profile published — awaiting medical review

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