Teduglutide
A copy of the gut's own growth signal that helps people with short bowel syndrome need less intravenous feeding
Teduglutide is a modified GLP-2, the hormone that tells the intestinal lining to grow and absorb. Approved in 2012 as Gattex for short bowel syndrome in people who depend on intravenous nutrition or fluids, it is injected once a day and has reduced, and occasionally ended, that dependence.
What is it?
After much of the small intestine has been removed, what remains may not absorb enough fluid and nutrients, and many people depend on parenteral support, nutrition or fluids given into a vein, for years. Teduglutide mimics GLP-2, which signals the remaining lining to grow; in the first phase 3 trial it increased villus height and plasma citrulline, a marker of mucosal mass.
The label covers adults and children from one year old who depend on parenteral support, at 0.05 mg/kg once a day under the skin. Before starting, adults need a colonoscopy and upper endoscopy within six months with any polyps removed, and children a test for blood in the stool, because the drug's first warning is the acceleration of neoplastic growth.
Its warnings follow from what it does. Beyond the risk of speeding the growth of polyps or tumours, the label lists intestinal obstruction, gallbladder, bile-duct and pancreatic disease, and fluid overload as the gut absorbs more. Because a grown lining absorbs more of everything, the label also warns that oral medicines may be absorbed more: altered mental status was seen in adult trial patients taking it with benzodiazepines, and drugs with a narrow therapeutic range need monitoring.
The trials show reduction more often than independence. In the registration trial 63% of patients cut their parenteral volume by more than a fifth, against 30% on placebo, while only three patients in the first trial came off it completely. Real-world data look better still, though clinicians chose patients with better prospects.
The gains continued with time. In STEPS-2, the two-year extension, 65 of 88 patients completed treatment; among completers who had taken teduglutide from the start, 28 of 30 responded and their weekly parenteral volume fell by 7.6 litres (66%), and 13 patients reached full independence from intravenous support. In the smaller STEPS-3 extension, two more patients came off support entirely. The most common adverse events in STEPS-2 were abdominal pain (34%), catheter sepsis (28%) and weight loss (25%).
Children were tested in a 24-week phase 3 study of 59 patients. Parenteral support fell by at least 20% in 69.2% on 0.05 mg/kg and 54.2% on 0.025 mg/kg, against 11.1% on standard care, and five children reached enteral autonomy. Under the skin it is 88% bioavailable and peaks 3 to 5 hours after a dose, and it does not accumulate with daily use (label).
Mechanism of Action
Teduglutide is a long-acting analogue of GLP-2, which signals the remaining intestinal lining to grow and absorb more.
Mucosal growth
In the first phase 3 trial it increased villus height and plasma citrulline, a marker of mucosal mass.
More absorption
A larger absorbing surface lets patients reduce intravenous fluids and nutrition, and also absorb more of some oral medicines (label).
Growth everywhere
The same growth signal is why the label's first warning is acceleration of neoplastic growth and why endoscopy precedes treatment.
Once-daily pharmacokinetics
88% bioavailable under the skin, peaking at 3 to 5 hours, without accumulation on daily dosing (label).
Published Research
The studies behind teduglutide, read from their PubMed abstracts: the registration trials, the long-term extensions, children, and an off-label pilot.
The first trial, and a dose surprise
In 83 patients over 24 weeks, the higher dose, 0.10 mg/kg a day, did not beat placebo on the primary graded response score (8 of 32 against 1 of 16), while 0.05 mg/kg did (16 of 35). Both cut parenteral volume by about 350 mL a day, and the authors suggest the high-dose group's larger starting volumes explain the gap. Three patients were weaned off completely.
The registration trial
In 86 patients randomised to 0.05 mg/kg a day or placebo for 24 weeks, 63% responded with a reduction of more than 20% in parenteral volume, against 30% (p = 0.002). Volume fell by 4.4 litres a week against 2.3, and 54% against 23% dropped at least one infusion day a week.
STEPS-2: two years of treatment
65 of 88 patients completed; 28 of 30 continuous-teduglutide completers responded, with parenteral volume down 7.6 L/week (66%), and 13 patients achieved full enteral autonomy. Common adverse events were abdominal pain (34%), catheter sepsis (28%) and weight loss (25%).
STEPS-3: a further extension
13 of 14 patients completed; parenteral support fell by about half from baseline, two patients became independent and two who had become independent in STEPS-2 stayed so, with no treatment-related serious adverse events.
Children: a 24-week phase 3 study
Among 59 children, at least a 20% cut in parenteral support was reached by 69.2% on 0.05 mg/kg, 54.2% on 0.025 mg/kg and 11.1% on standard care; five reached enteral autonomy, and pyrexia and vomiting were the commonest adverse events.
Infants and children
In open-label phase 3 studies of 0.05 mg/kg a day, parenteral support fell by at least 20% at 24 weeks in 57.1% of infants and 66.7% of children on teduglutide, against 50.0% of infants on standard care, and two children reached full enteral autonomy. The groups were small.
Seven years in routine care
An international registry compared 269 adults treated from 2015 to 2022 with 3,081 who were not. More treated patients were weaned from intravenous support, and centres treating ten or more had higher weaning and lower mortality, but the authors note that clinicians selected patients with better prognostic indicators.
An off-label test: fistulas
A randomised crossover pilot in adults with low-output enterocutaneous fistulas stopped early with six of ten planned patients. Five of the six met the primary endpoint, a 20% fall in fistula output, and one fistula closed; a feasibility study, not evidence of benefit.
Dosing Data
Gattex is injected under the skin once a day at a weight-based dose.
Educational information, not medical advice. Each dose above is tagged with its source: an approved label, a published human study, animal data, or amounts reported by users. None is a recommendation for you. An unapproved compound has no established safe or effective human dose, and products sold for “research use only” are not made or tested for people. Talk to a doctor before acting on anything on this site, including before you start, stop or change any medicine or dose. Full medical disclaimer.
Side Effects & Contraindications
Reported Side Effects
From the trials above and the Gattex prescribing information (DailyMed set 66b69c1e, version 20, effective September 5, 2025).
Contraindications & Cautions
From the label.
Legal Status
Approved for short bowel syndrome.
Frequently Asked Questions
?Who is teduglutide for?
Adults and children from one year old with short bowel syndrome who depend on intravenous nutrition or fluids.
?Does it end the need for intravenous feeding?
Usually it reduces it. In the registration trial 63% cut their volume by more than a fifth; complete weaning happened, but in few patients.
?Why is a colonoscopy needed first?
Because the label's first warning is acceleration of neoplastic growth: adults are scoped within six months before starting and polyps removed.
?What dose is used?
0.05 mg/kg once a day under the skin for adults and children from one year old (label).
?Does the benefit last?
In the STEPS-2 extension, responders kept cutting parenteral volume over two years (by 66% in those treated throughout), and 13 patients came off it completely.
?Does it affect other medicines?
It may increase absorption of oral drugs; the label reports altered mental status with benzodiazepines and asks for monitoring of narrow-therapeutic-index drugs.
?Is it used in children?
Yes, from age one. In a 24-week trial 69.2% of children on the label dose cut parenteral support by at least a fifth, against 11.1% on standard care.
References
- [fda-pi] Gattex (teduglutide) prescribing information, sections 1, 2, 4, 5, 6 and 12.3 (DailyMed SPL version 20, effective September 5, 2025; read October 1, 2026).
- [pubmed] Jeppesen PB, et al. "Randomised placebo-controlled trial of teduglutide in reducing parenteral nutrition and/or intravenous fluid requirements in patients with short bowel syndrome." Gut, 2011;60(7):902-14. PMID: 21317170.
- [pubmed] Jeppesen PB, et al. "Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure." Gastroenterology, 2012;143(6):1473-1481.e3. PMID: 22982184.
- [pubmed] Schwartz LK, et al. "Long-Term Teduglutide for the Treatment of Patients With Intestinal Failure Associated With Short Bowel Syndrome." Clin Transl Gastroenterol, 2016;7(2):e142. PMID: 26844839.
- [pubmed] Seidner DL, et al. "Reduction of Parenteral Nutrition and Hydration Support and Safety With Long-Term Teduglutide Treatment in Patients With Short Bowel Syndrome-Associated Intestinal Failure: STEPS-3 Study." Nutr Clin Pract, 2018;33(4):520-527. PMID: 29761915.
- [pubmed] Kocoshis SA, et al. "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, 2020;44(4):621-631. PMID: 31495952.
- [pubmed] Chiba M, et al. "Efficacy and Safety of Teduglutide in Infants and Children With Short Bowel Syndrome Dependent on Parenteral Support." J Pediatr Gastroenterol Nutr, 2023;77(3):339-346. PMID: 37364133.
- [pubmed] Joly F, et al. "Real-world experience of Teduglutide use in adults with short bowel syndrome: A seven-year international multicenter survey." Clin Nutr, 2025;47:54-67. PMID: 39986179.
- [pubmed] Yeh DD, et al. "Teduglutide for the treatment of low-output enterocutaneous fistula - A pilot randomized controlled study." Clin Nutr ESPEN, 2022;50:49-55. PMID: 35871951.
Sources & Citations
Studies were read from their PubMed records (October 5, 2026); the label and Drugs@FDA are listed below with their read dates.
Medical Disclaimer: This content is for educational and informational purposes only. It is not medical advice, and nothing here is an instruction to obtain or use any compound. Talk to a licensed clinician about your own situation.