Teduglutide: evidence, FDA status and research

A daily injection for people with a very short gut who need drip feeding. Trials show it cuts the drip feeding needed.

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Teduglutide is prescribed to help people with very short intestines absorb enough on their own to cut back on intravenous feeding.

Studies say

Randomized and long-term extension data show meaningful reductions in parenteral support volume, with a minority of patients weaning off entirely, which supports the A grade for its approved indication.

Why grade A. Approval rests on the randomized placebo-controlled STEPS trial in adults with short bowel syndrome, followed by a two-year open-label extension (STEPS-2) in 88 patients that documented sustained reductions in parenteral support. The approved use matches the studied use, so it grades A. The outcome measured is volume of intravenous nutrition, not survival. ¹²

FDA. Teduglutide is approved by the FDA as Gattex for adults and children 1 year and older with short bowel syndrome who depend on parenteral support (intravenous nutrition or fluids). Approval came in 2012 for adults, with the pediatric indication added later. ²

Written from 2 cited sources. Fact-checked 2026-10-27: 13 claims checked, 1 corrected. Last refreshed 2026-10-27. Not physician reviewed.

What this means for you

What people take it for: Short bowel syndrome
Can a US doctor prescribe it?: Yes, FDA approved for short bowel syndrome in people who need drip feeding.
Properly tested in people?: Yes, in a controlled trial plus a two-year follow-up of 88 patients.

Evidence checklist

Randomised controlled trial STEPS placebo-controlled trialyes
Human study over 100 people STEPS-2 extension had 88 patientsno
More than one research group Trials run by the developerno information
Clinical outcomes, not surrogate markers Intravenous volume, a proxy outcomeno
Human safety data beyond case reports Trial and label safety datayes

Drawn from the cited studies below. A dash means the sources give no information.

What it is

Teduglutide is a 33-amino-acid analog of glucagon-like peptide-2 (GLP-2), a hormone released by cells in the lower small intestine after a meal. Natural GLP-2 is destroyed within minutes by the enzyme DPP-4. Teduglutide swaps one amino acid at the position DPP-4 attacks, so it circulates for hours and can be given by injection under the skin. ²

The drug treats short bowel syndrome, the state after a large part of the intestine has been removed, often for Crohn's disease, blood-vessel blockage or trauma. People with short bowel syndrome may need parenteral support, which means nutrients or fluids through a central intravenous line, for life. The treatment goal is to reduce how many liters per week they need. ¹²

How it works

GLP-2 makes the intestinal lining grow. It increases the height of villi (the finger-like absorptive projections) and the depth of crypts, slows the passage of food, and increases blood flow to the gut. More absorptive surface means more fluid and calories taken up from what the person eats, so less has to be infused. Growth of intestinal tissue is also why the label warns about polyps, since the drug can make existing abnormal growths larger. ¹²

What human research shows

In the 24-week STEPS trial of 86 adults, 63 percent on teduglutide versus 30 percent on placebo achieved a 20 percent or greater reduction in weekly parenteral support volume, the primary endpoint and the basis for approval. ²

STEPS-2, the two-year open-label extension published in Clinical and Translational Gastroenterology, followed 88 adults from 25 centers in Europe and North America. Among the 30 patients treated for the full 30 months, 28 (93 percent) maintained at least a 20 percent reduction in parenteral support, weekly infusion volume fell by more than half on average, and a minority of patients came off parenteral support entirely. Patients who entered the extension from the placebo arm also responded once started on the drug. ¹

Study	Model	Finding
STEPS (phase 3 trial)	Humans, n=86 adults with short bowel syndrome, randomized double-blind placebo-controlled, 24 weeks	63% of teduglutide patients versus 30% on placebo achieved a 20 percent or greater reduction in weekly parenteral support volume. ²
STEPS-2 extension (Schwartz 2016)	Humans, n=88, open-label, up to 30 months	Of 30 patients treated continuously for 30 months, 28 kept at least a 20 percent reduction in parenteral support and some stopped it entirely. ¹

Safety

The most common side effects on the label, each in 10 percent or more of patients, are abdominal pain, nausea, upper respiratory infection, abdominal distension, injection-site reactions, vomiting, fluid overload and hypersensitivity. Stoma complications, where the opening of the bowel through the abdominal wall becomes enlarged, are frequent in patients who have one. ¹²

Because teduglutide stimulates intestinal growth, the label calls for a colonoscopy before starting and periodically afterward to look for polyps, and the drug is not recommended for people with active gastrointestinal cancer. Intestinal obstruction, gallbladder and pancreatic disease, and fluid overload (including heart failure in people with existing heart disease) are also listed warnings. Patients being weaned off intravenous fluids need monitoring so they do not become dehydrated. ²

Questions for your clinician

How likely is it that I could reduce my intravenous support?
How often do I need colonoscopy while on teduglutide?
What stoma complications should I watch for?

Questions people ask

Is teduglutide FDA-approved?

Yes. It is sold as Gattex and approved for adults and children aged 1 year and older with short bowel syndrome who depend on parenteral support. Approval was in 2012, with pediatric labeling added later. ²

Can teduglutide get someone off intravenous nutrition completely?

Sometimes. In the two-year STEPS-2 extension, a minority of patients who stayed on the drug became independent of parenteral support. The more typical result is a reduction in weekly volume or days of infusion, and benefits tend to appear over months. ¹

Why does the label require colonoscopy?

Teduglutide makes intestinal tissue grow, which is how it improves absorption. That same effect could enlarge existing polyps, so a colonoscopy before starting and then at intervals is part of the prescribing information. ²

What happens if teduglutide is stopped?

The intestinal growth effect is dependent on continued dosing, and parenteral support needs can rise again after discontinuation. Long-term data come from open-label extensions, not from randomized withdrawal studies. ¹²

Citations

Schwartz 2016, Clin Transl Gastroenterol: Long-term teduglutide for intestinal failure with short bowel syndrome (STEPS-2) doi.org
FDA 2021: Gattex (teduglutide) prescribing information accessdata.fda.gov