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Teduglutide

Also known as Gattex, Revestive, ALX-0600, [Gly2]GLP-2

DPP-4-resistant GLP-2 analogue that grows intestinal mucosa in short bowel syndrome.

clinically proven Metabolic & weight approved drug

At a glance

Category
Metabolic & weight
Status
approved drug
Made from
recombinant A 33-amino-acid GLP-2 analogue produced in a recombinant strain of Escherichia coli.
Route
subcutaneous, once daily
Half-life
approximately 2 hours in healthy adults and about 1.3 hours in adults with short bowel syndrome; shorter again in children, roughly 0.7 hours at ages 1-11 and 1.0 hour at ages 12-17 1. Native GLP-2 has a half-life of about 7 minutes
Onset
reductions in parenteral support are usually measured at 20-24 weeks
Molecular weight
3752 Daltons 1
Sequence
HGDGSFSDEMNTILDNLAARDFINWLIQTKITD (33 residues; identical to human GLP-2 except alanine at position 2 replaced by glycine)

Approved by the FDA in December 2012 as Gattex and by the EMA in 2012 as Revestive, for short bowel syndrome in adults dependent on parenteral support; indications were later extended to children aged one year and older, and the current US label covers adults and paediatric patients aged 1 year and older with short bowel syndrome who are dependent on parenteral support 1. It is an orphan medicine, not a weight-loss or general metabolic drug.

Doping status: Not listed by WADA

Checked against the WADA 2026 Prohibited List. For a specific product and country, Global DRO is the lookup athletes are expected to use — the List names substances, not brand names.

Mechanism of action

Glucagon-like peptide-2 (GLP-2) is released by enteroendocrine L cells of the distal small intestine and colon in response to nutrients. It acts on the GLP-2 receptor, a class B G-protein-coupled receptor expressed not on enterocytes themselves but on subepithelial myofibroblasts, enteric neurons and enteroendocrine cells. The trophic signal therefore reaches the epithelium indirectly, largely via IGF-1, keratinocyte growth factor and nitric-oxide-mediated vasodilation.

The consequences are increased crypt cell proliferation and reduced enterocyte apoptosis, taller villi, deeper crypts, greater mucosal surface area, increased mesenteric blood flow, slower gastric emptying and reduced gastric acid secretion. In short bowel syndrome, where absorptive surface has been surgically lost, this translates into more fluid and nutrient absorbed per meal and less need for intravenous fluids and nutrition.

Native GLP-2 is cleaved at the Ala2 position by dipeptidyl peptidase-4 within minutes. Teduglutide replaces that alanine with glycine, which resists DPP-4 cleavage and extends the half-life roughly seventeen-fold, making once-daily subcutaneous dosing feasible.

The same trophic activity is the source of the drug's main safety concern. A signal that drives intestinal crypt proliferation could in principle accelerate growth of existing neoplasia, which is why colonoscopic surveillance is built into the label.

What the research shows

Teduglutide is supported by two pivotal randomised, double-blind, placebo-controlled phase 3 trials in adults with parenteral-support-dependent short bowel syndrome, plus long-term open-label extensions and paediatric studies. The effect is real but partial: most responders reduce parenteral support volume rather than come off it entirely. The population is small and heterogeneous, which limits precision.

Research in humans

The pivotal 24-week trial published in Gastroenterology in 2012 (STEPS) randomised patients to teduglutide 0.05 mg/kg/day or placebo and found significantly more patients achieving at least a 20% reduction in weekly parenteral support volume 2. An earlier phase 3 study compared two dose levels against placebo. Open-label extension studies followed responders for up to two additional years, with sustained and in some cases increasing reductions; a minority of patients achieved full enteral autonomy. Paediatric trials in children aged one and above supported the later label extension.

Animal and lab research

Rodent models of intestinal resection and of chemotherapy- or radiation-induced mucosal injury established the trophic effect of GLP-2 and of the DPP-4-resistant analogue, showing villus lengthening and improved nutrient absorption. Long-term rodent carcinogenicity work informed the neoplasia warnings.

Caveats. Trials were funded by NPS Pharmaceuticals and later Shire/Takeda. Sample sizes are small because the disease is rare, and the patient population differs widely in remnant bowel anatomy, which affects response. The primary endpoint is a surrogate — reduction in parenteral support volume — rather than survival or quality-adjusted outcome, although quality-of-life data were collected. Follow-up beyond a few years is limited, which matters because the principal theoretical harm, neoplasia, would be expected to appear late.

What it is used for

  • Short bowel syndrome in adults and children aged one year and older who are dependent on parenteral support 1
  • Investigated for other intestinal conditions, including some inflammatory and post-radiation mucosal injury settings, without approval for those indications

Dosing

Dose
0.05 mg/kg body weight per day
Frequency
Once daily
Route
Subcutaneous, rotating between the four quadrants of the abdomen, the thighs and the arms
Duration
Long-term; response is formally assessed at around six months and the label directs discontinuation if no benefit is seen
  • The dose is reduced to 0.025 mg/kg once daily in moderate and severe renal impairment and in end-stage renal disease — the US label sets the threshold at an estimated glomerular filtration rate below 60 ml/min/1.73 m2 1.
  • Colonoscopy with removal of polyps is required before starting treatment; for adults the label directs a repeat at one year and then at least every five years thereafter, and for children annual blood screening plus colonoscopy after one year and then every five years 1.
  • Parenteral support volume is typically reduced stepwise as fluid tolerance improves, guided by fluid balance and laboratory monitoring, not by a fixed schedule.
  • These figures come from the approved US and EU product information. Teduglutide is a hospital-supervised orphan drug; this is a description, not a self-treatment protocol.

These figures describe what the literature and published protocols report. They are not advice and not a dosing instruction.

Reconstitution

Vial sizes
5 mg single-dose vial (adult kit), 1.25 mg single-dose vial (paediatric or low-weight kit)
Solvent
Sterile water for injection, supplied in a prefilled syringe within the kit
Storage
Vials and diluent are stored at room temperature (below 25 °C), not frozen. Once reconstituted the solution must be used within about three hours and any remainder discarded — there is no multi-dose use.

Worked example

The 5 mg vial is reconstituted with 0.5 ml of sterile water, giving 10 mg/ml; the volume drawn up depends on the patient's weight at 0.05 mg/kg. The 1.25 mg vial is reconstituted with 0.5 ml to give 2.5 mg/ml.

Bacteriostatic water is not the diluent for this product; the kit supplies sterile water and the solution contains no preservative, which is why it cannot be stored after mixing. The vial is gently rolled between the palms rather than shaken, and the solution should be clear and colourless.

Work it out for Teduglutide

Safety

Side effects

  • Abdominal pain and abdominal distension — among the adverse reactions occurring in at least 10% of patients 1
  • Nausea and vomiting
  • Injection site reactions
  • Headache
  • Upper respiratory tract infection — also in the at-least-10% group, alongside injection site reaction, vomiting, fluid overload and hypersensitivity 1
  • Stoma complications in patients with a stoma, including swelling or narrowing of the stoma
  • Fluid overload, congestive heart failure in susceptible patients, as absorption of fluid increases — fluid imbalance and fluid overload is a labelled warning 1
  • Cholecystitis, cholangitis, biliary tract disease and pancreatitis — biliary and pancreatic disease is a labelled warning 1
  • Intestinal obstruction, particularly in patients with strictures — a labelled warning 1
  • Colorectal polyps; acceleration of neoplastic growth is the first warning in the US label and the reason colonoscopic surveillance is mandated 1

Do not use if

  • The US prescribing information states no contraindications at all; the restrictions below come from the EU product information and from the labelled warnings, not from a US contraindications section 1
  • Active gastrointestinal malignancy
  • Active malignancy elsewhere within the preceding five years, per the EU product information
  • Hypersensitivity to teduglutide or to tetracycline residues (a residue of the manufacturing process)
  • Caution and close monitoring in cardiovascular disease, where fluid overload can precipitate heart failure
  • Caution in existing biliary or pancreatic disease
  • Colonoscopy must be current before initiation; treatment should not be started if colonic polyps are unresolved

Interactions

No formal drug-drug interaction programme has been completed. Because teduglutide increases intestinal absorptive capacity, it can raise the absorption of orally administered drugs; the US label makes increased absorption of concomitant oral medication a formal warning and directs monitoring, with dose reduction where a drug requires careful titration or has a narrow therapeutic index, naming benzodiazepines specifically 1. The label also notes potential interaction relevance for oral contraceptives and warfarin monitoring, since absorption changes rather than metabolism drive the effect.

Sources