Teduglutide: the first GLP-2 drug
Approved in 2012 for short bowel syndrome, it reduces how much intravenous nutrition and fluid people need. It does that by growing intestinal tissue, which is also why the label asks for colonoscopies.
Teduglutide is a modified version of the gut peptide GLP-2. It is sold as Gattex in the United States and Revestive in Europe, made by Takeda, and it is a once daily injection under the skin. It is approved for one condition: short bowel syndrome in people who depend on parenteral support, meaning nutrition or fluids given into a vein.
What it is
Teduglutide has the same 33 amino acids as human GLP-2 except one. The alanine at position 2 is replaced by glycine, which stops the enzyme DPP-4 from cutting it. Natural GLP-2 lasts about 7 minutes in the blood; teduglutide's half-life is about 2 hours in healthy people and 1.3 hours in people with short bowel syndrome, according to the FDA label. It is manufactured in a modified strain of E. coli.
Approvals
- European Union: first authorised on 30 August 2012 as Revestive, for adults. Extended to children aged 1 year and over in 2016. EMA's current overview describes use in adults and children from 4 months of age, corrected for gestational age.
- United States: approved in December 2012 as Gattex for adults. In May 2019 the FDA extended the label to children aged 1 year and older.
The current US indication reads: adults and pediatric patients 1 year of age and older with short bowel syndrome who are dependent on parenteral support.
Dose
The labelled dose is 0.05 mg per kg of body weight once daily, injected into the abdomen, thigh or arm, rotating sites. For moderate to severe kidney impairment (eGFR below 60) the label halves it to 0.025 mg/kg. The prescriber sets the dose; this page describes the label, not a regimen.
The trials
| Trial | Year, journal | n | Duration | Drug and dose | Primary result vs comparator |
|---|---|---|---|---|---|
| STEPS | 2012, Gastroenterology | 86 | 24 weeks | Teduglutide 0.05 mg/kg/day vs placebo | Responders (20% or more cut in PS volume at weeks 20 and 24): 63% vs 30%. PS volume: down 4.4 vs 2.3 L/week |
| STEPS-2 (open-label extension) | 2016, Clin Transl Gastroenterol | 88 enrolled, 65 completed | Up to 30 months | Teduglutide 0.05 mg/kg/day, no placebo | Response in 93% of completers treated from the start; mean PS cut 7.6 L/week (66%) in that group; 13 patients weaned off PS |
| Paediatric phase 3 | 2020, JPEN | 59 | 24 weeks | 0.025 or 0.05 mg/kg/day vs unblinded standard care | 20% or more PS reduction: 54.2% (0.025), 69.2% (0.05) vs 11.1% standard care |
In STEPS, people started at about 13 litres of intravenous support a week (12.9 in the teduglutide group and 13.2 on placebo). The placebo group also came down, by 2.3 litres a week, because the trial reduced support whenever urine output rose by at least 10% over baseline. That built-in weaning is standard in this field, and it is why the gap between groups matters more than either number alone. More people on teduglutide also cut at least one full day of infusions a week: 54% vs 23%. Plasma citrulline, a blood marker of how much working intestinal lining there is, rose on the drug.
STEPS-2 shows the effect kept growing with time in the people who stayed on it, but it was open-label with no comparison group, and the 74% who completed it are likely to be the people doing best. Read it as durability data, not as a second efficacy trial.
What the label warns about
Everything on this list follows from one fact: the drug makes gut tissue grow, and it increases how much the gut absorbs.
- Acceleration of neoplastic growth. Based on its pharmacology and on tumours seen in rat and mouse studies, the label says teduglutide "has the potential to cause hyperplastic changes including neoplasia". In adult trials, three men were diagnosed with cancers (one metastatic adenocarcinoma of unconfirmed origin in a man with prior abdominal radiation, and two lung cancers in heavy smokers), and 14 patients were found to have gut polyps after starting. If a gastrointestinal cancer develops, the drug is stopped.
- Colonoscopy schedule. Adults need a colonoscopy and upper GI endoscopy, with polyps removed, within 6 months before starting; again at the end of the first year; then no less often than every 5 years. Children need annual faecal occult blood testing, with colonoscopy or sigmoidoscopy after 1 year and every 5 years.
- Intestinal obstruction. Reported in trials and after approval. The drug is paused if a bowel or stoma obstruction develops.
- Gallbladder, bile duct and pancreas. Bilirubin, alkaline phosphatase, lipase and amylase are checked within 6 months before starting and at least every 6 months on treatment.
- Fluid overload, including heart failure. As the gut absorbs more, the intravenous volume has to come down. If it does not, fluid builds up.
- Increased absorption of oral medicines. Drugs with a narrow margin, the label names benzodiazepines as an example, may need lower doses.
The most common adverse reactions (10% or more) were abdominal pain, nausea, upper respiratory tract infection, abdominal distension, injection site reaction, vomiting, fluid overload and hypersensitivity. In the placebo-controlled studies, stoma complications were reported in 42% of people with a stoma on teduglutide vs 14% on placebo. When treatment stops, the label says to watch fluid and electrolyte balance, because the absorptive gain fades.
Where it sits now
Teduglutide is the reference drug the newer GLP-2 analogues are compared with. Glepaglutide is injected twice weekly and apraglutide once weekly, both aiming to replace a daily injection. Neither has a head-to-head trial against teduglutide, so cross-trial comparisons of percentages are not reliable: the trials used different populations, weaning rules and endpoints.
What to log
People on teduglutide are asked to keep track of a lot: the daily dose by weight, injection site, weekly intravenous volume, urine output, weight, and blood tests every few months, with colonoscopy dates on top. Peptide AI's dose log, injection site rotation and bloodwork tracking keep those on one timeline to bring to the clinic.
Questions people ask
What is teduglutide used for?
Short bowel syndrome in adults and children (from 1 year in the US) who depend on parenteral support, meaning nutrition or fluid given into a vein. It is a once daily injection of 0.05 mg/kg.
How well does teduglutide work?
In the 86-patient STEPS trial, 63% on teduglutide vs 30% on placebo cut their intravenous support volume by more than 20% at weeks 20 and 24. Weekly volume fell 4.4 litres vs 2.3 litres.
Why does teduglutide need colonoscopies?
Because it makes gut tissue grow, the label warns it may accelerate neoplastic growth. Adults need a colonoscopy within 6 months before starting, after the first year, then at least every 5 years.
When was teduglutide approved?
In the EU on 30 August 2012 (Revestive) and in the US in December 2012 (Gattex). The US label was extended to children aged 1 year and older in May 2019.
What are the common side effects of teduglutide?
Abdominal pain, nausea, upper respiratory infection, abdominal swelling, injection site reactions, vomiting, fluid overload and hypersensitivity, each in 10% or more of patients in trials.
Is teduglutide a weight loss drug?
No. It increases how much the gut absorbs. It has no approval or trial evidence for weight loss, and in short bowel patients weight and lean mass usually go up.
Sources
- Gattex (teduglutide) prescribing information, Takeda, via DailyMed (label version of September 2025)
- Revestive: EPAR, European Medicines Agency
- U.S. FDA approves Gattex (teduglutide) for children 1 year of age and older with short bowel syndrome, Takeda, May 2019
- Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure (STEPS), Gastroenterology, 2012
- Long-term teduglutide for the treatment of patients with intestinal failure associated with short bowel syndrome (STEPS-2), Clinical and Translational Gastroenterology, 2016
- Safety and efficacy of teduglutide in pediatric patients with intestinal failure due to short bowel syndrome: a 24-week, phase III study, Journal of Parenteral and Enteral Nutrition, 2020
- In vivo and in vitro degradation of glucagon-like peptide-2 in humans, Journal of Clinical Endocrinology and Metabolism, 2000
