Teduglutide

Origin and structure

GLP-2 (glucagon-like peptide-2) is a 33-amino-acid hormone that the L cells of the gut lining release after a meal. It is cut from the same precursor, proglucagon, as GLP-1, but it does a different job. In 1996 Daniel Drucker's group at the University of Toronto found that in mice carrying proglucagon-producing tumours the lining of the small bowel grew markedly, and traced the effect to GLP-2. Natural GLP-2 does not last: the enzyme DPP-4 clips off its first two amino acids, and in people intact GLP-2 has a half-life in the blood of about 7 minutes.

In 1997 the same group reported that replacing the alanine at position 2 with glycine makes GLP-2 resistant to DPP-4, and that this analogue increased the weight of the small bowel in rats, which natural GLP-2 did not. Teduglutide is the human version of that analogue: 33 amino acids (HGDGSFSDEMNTILDNLAARDFINWLIQTKITD), with a molecular weight of 3,752 daltons. After an injection under the skin about 88% reaches the blood, and its half-life is about 2 hours in healthy people and 1.3 hours in people with short bowel syndrome; the medicines are injected once a day.

NPS Pharmaceuticals developed it under the code ALX-0600, and in December 2012 the FDA approved that company's US application; Takeda now holds the licences in the EU and the US. Revestive and Gattex contain teduglutide made in E. coli bacteria by recombinant DNA technology, and the EU product information rules out people who are hypersensitive to trace residues of tetracycline. The EU generic Teduglutide Viatris, authorised in January 2026, is made by chemical peptide synthesis instead.

How it works

Short bowel syndrome is what remains when much of the small intestine has been removed or does not work. In the main adult trial the most common causes were vascular disease, in which the gut's blood supply fails, and Crohn's disease; in the main trial in children, more than half of those on the licensed dose had been born with gastroschisis, a defect in the abdominal wall. If the remaining bowel cannot absorb enough water and nutrients, people depend on parenteral support: nutrition and fluids infused straight into a vein. Adults in the main trial had needed it for six years on average, on almost six days a week.

Teduglutide binds the GLP-2 receptor. The receptors sit on hormone-producing cells in the gut lining, on supporting cells beneath it (subepithelial myofibroblasts) and on nerves in the gut wall, and these respond by releasing other signals, including IGF-1, nitric oxide and keratinocyte growth factor. The lining grows: the villi get taller and the crypts deeper, so there is more surface to absorb from. GLP-2 also increases blood flow to the gut, reduces stomach acid secretion and slows the passage of food. In a 21-day dose-finding study in 17 people with short bowel syndrome, teduglutide raised fluid absorption by about 750 to 1,000 ml a day at most of the doses tested; the changes in the lining had gone within three weeks of stopping.

That growth effect is also the main safety concern: the same signal could make polyps or tumours in the gut grow faster, which is why the labels require bowel checks before and during treatment.

Is teduglutide approved?

Yes, as a prescription medicine for short bowel syndrome in the EU and the US. It is not approved for any other condition.

In the Netherlands Revestive is prescription-only, and it entered the reimbursement system only in 2025. In 2018 the Zorginstituut advised against admitting it to the basic package: teduglutide reduced the amount of intravenous feeding, but patients remained partly dependent on it and no difference in quality of life could be shown against placebo, and the institute formally concluded that, added to best supportive care, it had a lower therapeutic value than placebo.

Since 1 April 2025 it has been reimbursed under a conditional admission that runs until 1 April 2030, during which extra data on its effectiveness are collected. It covers adults who are stable after surgery and either needed total parenteral nutrition at least three times a week for at least 12 months after a resection for inflammatory bowel disease, or needed more than 14 litres of parenteral nutrition a week for at least 12 months; and children from 6 months to 18 years who depend on parenteral support for at least 30% of their calories or fluids, once natural adaptation has been ruled out as far as possible. In both groups it is reimbursed only for patients who take part in the accompanying research.

• EU: Revestive was designated an orphan medicine in December 2001 and authorised on 30 August 2012 for adults with short bowel syndrome who are stable after a period of intestinal adaptation following surgery. It was extended to children from 1 year in June 2016 and to infants from 4 months corrected gestational age in June 2023. Its orphan status ended in September 2024, at the end of 12 years of market exclusivity, and on 8 January 2026 the European Commission authorised the first generic, Teduglutide Viatris. Revestive is still under additional monitoring.
• US: Gattex was approved on 21 December 2012 for adults with short bowel syndrome who depend on parenteral support, and on 16 May 2019 for children from 1 year. The US label has no contraindications but carries warnings for acceleration of tumour growth, intestinal obstruction, gallbladder, bile-duct and pancreatic disease, and fluid overload. Drugs@FDA lists no generic.

What the research shows

The approvals rest on two placebo-controlled 24-week trials in 169 adults, their open-label extensions and smaller studies in children and infants. The main outcome in all of them was the volume of parenteral support, and a response meant cutting the weekly volume by at least 20%. The main results:

• Study 004 (Gut 2011): 83 adults were randomised to 0.05 or 0.10 mg/kg a day or placebo for 24 weeks. On the lower dose 46% responded against 6% on placebo, and across both teduglutide groups the weekly volume fell by 2.5 litres, against 0.9 litres on placebo. The higher dose missed its primary endpoint; the authors suggest this was because that group started with larger volumes. Three teduglutide-treated patients came off parenteral support completely.
• STEPS (Gastroenterology 2012): 86 adults received 0.05 mg/kg a day or placebo for 24 weeks. On teduglutide 63% responded, against 30% on placebo, and the weekly volume fell by 4.4 litres from 12.9, against 2.3 litres from 13.2. Of those with data, 54% gained at least one day a week off parenteral support, against 23% on placebo.
• Quality of life in STEPS (Clin Nutr 2013): scores on a quality-of-life scale for short bowel syndrome improved from baseline on teduglutide, but not significantly more than on placebo.
• STEPS-2 (Clin Transl Gastroenterol 2016): 88 patients took teduglutide in an open-label extension for up to two more years, and 65 completed it. Of the 30 who completed 30 months of treatment, 28 (93%) had responded, with the weekly volume down by 7.6 litres (66%) on average. Thirteen patients across all groups came off parenteral support completely, and weight and blood albumin stayed stable.
• Children aged 1 to 17 (24-week trial, JPEN 2020): of 59 children, those who chose teduglutide were randomised double-blind to 0.025 or 0.05 mg/kg a day, while 9 chose standard care. On 0.05 mg/kg, 18 of 26 (69%) responded against 1 of 9 (11%) on standard care, and 3 came off parenteral support. In an earlier 12-week study, 3 of 15 children on 0.05 mg/kg were weaned, but 2 of them needed parenteral nutrition again within four weeks of stopping.
• Infants aged 4 to 12 months (corrected for prematurity): in a controlled study of 10 infants, 3 of 5 on teduglutide and 1 of 5 on standard care cut their volume by at least 20%; none was weaned completely.
• Meta-analysis (Nutrients 2022): pooling 10 adult studies, 2 randomised trials and 8 observational studies, the response rate was 64% after 6 months, 77% after a year and 82% after two years or more, and complete weaning 11%, 17% and 21%; the two-year figures rest on three studies. People whose colon was still connected responded less often but were weaned more often.
• Crohn's disease (Inflamm Bowel Dis 2010): in a placebo-controlled pilot in 100 people with active disease, response after 8 weeks was 44% on the highest dose against 32% on placebo, only a numerical difference. No larger Crohn's trial followed, and it is not approved for this use.

Side effects and warnings

In the two placebo-controlled adult trials, about 52% of people on teduglutide had side effects judged related to it, against 36% on placebo. The most frequent were abdominal pain and swelling (45%), respiratory infections (28%), nausea (26%), injection-site reactions (26%), headache (16%) and vomiting (14%), mostly mild or moderate, and 38% of those with a stoma had stoma complications such as a swollen stoma. Fluid overload, with swollen ankles or breathlessness, occurred mainly in the first four weeks, as the bowel began to absorb more; congestive heart failure was also seen. Because people with short bowel syndrome dehydrate easily, the labels ask for parenteral support to be lowered carefully and for close monitoring when treatment stops.

The long-term question is cancer. In two-year studies teduglutide caused benign tumours of the bile ducts and small bowel in male rats and of the gallbladder in mice, and small-bowel adenocarcinomas in male mice at the highest dose; one jejunal adenocarcinoma was also found in a male rat on the lowest dose. In the adult trials, 14 patients developed polyps of the gut after starting, most of them in the extension studies, including several adenomas. Three cancers were diagnosed, all in the STEPS-2 extension: a metastatic adenocarcinoma of unknown origin in a man who had had abdominal radiotherapy two decades earlier, and two lung cancers in heavy smokers. At the Beaujon hospital near Paris, polyps were found in 10 of 35 patients treated for at least a year, mostly in the small bowel, and 3 were adenomas with low-grade dysplasia. After that 2023 report the EU added upper-gut endoscopy to its monitoring advice in 2024. The EU product information says the trials could neither confirm nor exclude a higher cancer risk.

In adults, the EU product information asks for a colonoscopy with removal of polyps at the start, yearly colonoscopies for the first two years and then at least every five years, plus upper-gut endoscopy or imaging before and during treatment; the US label asks for colonoscopy and upper endoscopy within six months before starting, after one year and then at least every five years. Children get a yearly test for hidden blood in the stool and a colonoscopy after one year and every five years. In the EU it may not be used in people with active or suspected cancer, or with a cancer of the digestive tract, liver, bile ducts or pancreas in the past five years; the US label stops treatment if a gastrointestinal cancer is found. The labels also warn about gallbladder and bile-duct inflammation, pancreatitis and bowel obstruction, and about higher absorption of other oral medicines, especially those with a narrow therapeutic range. Antibodies against teduglutide were found in 48% of adults tested at 30 months, with no measurable effect on safety or efficacy. The EU product information advises avoiding it in pregnancy and breastfeeding as a precaution.

Teduglutide versus newer GLP-2 analogues

Teduglutide needs a daily injection because it is cleared within hours, and longer-acting GLP-2 analogues are now trying to follow it. Glepaglutide, from Zealand Pharma and given twice a week in its main trial, received a positive opinion from the EMA's medicines committee (CHMP) on 17 September 2026 as Zeydovio, for adults with short bowel syndrome; the European Commission had not yet decided when this page was checked in October 2026. In the US the FDA turned glepaglutide down in December 2024 and asked for a second placebo-controlled trial, EASE SBS 5, which started in February 2026. Apraglutide, a once-weekly analogue from Ironwood Pharmaceuticals, is in a second phase 3 trial, STARS-2 (NCT07742735), which was recruiting in 2026.

No registered trial compares either of them directly with teduglutide. For now teduglutide is the only GLP-2 analogue approved in the EU or the US, and the only one licensed for children.

Frequently asked questions

Is teduglutide the same as Ozempic or other GLP-1 drugs?

No. GLP-1 and GLP-2 are both cut from proglucagon in the L cells of the gut, but they act on different receptors. GLP-1 drugs such as semaglutide (Ozempic, Wegovy) lower blood sugar and appetite. Teduglutide acts on the GLP-2 receptor, which makes the bowel lining grow and absorb more. It is not a weight-loss medicine: in the two-year STEPS-2 extension, body weight stayed stable while intravenous feeding was cut.

Is Revestive reimbursed in the Netherlands?

Since 1 April 2025, for specific patients and under conditions. Revestive is prescription-only, and in 2018 the Zorginstituut advised against reimbursement. It is now conditionally admitted to the basic package until 1 April 2030: for adults who have needed long-term parenteral nutrition after a resection for inflammatory bowel disease, or more than 14 litres a week, and for children from 6 months who get at least 30% of their calories or fluids intravenously. Only patients who take part in the accompanying research on its effectiveness qualify.

Can teduglutide get people off parenteral nutrition?

Some, not most. In the 24-week trials only a few came off it completely, such as 2 of 35 adults on the licensed dose in Study 004 and 3 of 26 children in the main paediatric trial. With longer treatment more did: 13 of the 88 patients in the STEPS-2 extension, and a 2022 meta-analysis estimated 21% after two years or more. For most the gain is less parenteral support and fewer infusion days, not none, and in the studies that stopped treatment the effect faded again.

Does teduglutide cause cancer?

That has not been shown in people, but it cannot be ruled out. Teduglutide makes gut tissue grow, and in two-year studies it caused bowel and bile-duct tumours in rats and gallbladder and bowel tumours in mice. In the adult trials 14 patients developed polyps, including adenomas, and a hospital near Paris found polyps in 10 of 35 patients treated for a year or more, mostly in the small bowel. The EU product information says the trials could neither confirm nor exclude a higher risk, which is why bowel checks are part of treatment.

Is teduglutide used for gut healing outside short bowel syndrome?

It is approved only for short bowel syndrome. In a placebo-controlled pilot in 100 people with active Crohn's disease, response after 8 weeks was 44% on the highest dose against 32% on placebo, only a numerical difference, and no larger Crohn's trial followed. Registered studies in other conditions, such as intestinal fistulas, graft-versus-host disease and gut damage from malnutrition, have been early-phase studies. Its growth effect on the bowel lining is also the reason the labels require polyp checks.

Is teduglutide banned in sport?

Not by name. Teduglutide does not appear on the WADA Prohibited List 2026, and as an approved medicine it does not fall under class S0, the class for unapproved substances that names BPC-157. Class S2.3 also covers unnamed growth factors that affect muscle, tendon or ligament, blood-vessel growth, energy use or regenerative capacity, but the list does not mention GLP-2 analogues there. Athletes who need it can ask the Dopingautoriteit how the rules apply to them.

Storage and handling

Store according to product-label instructions and batch handling notes. Lyophilized research peptides are commonly kept dry, protected from light, and handled with clean laboratory technique.

References

Checked against these sources on 28 October 2026.

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