Teduglutide

Dosing from the Literature

Published for short bowel syndrome: 0.05 mg/kg once a day under the skin, the label dose for adults and children from 1 year (half that with moderate or severe kidney impairment), tested against placebo in two 24-week trials in adults (Gattex label). Not published: a trial of it for tendon, muscle or skin repair, or for any benefit in healthy people.

The rows record doses as the labels and the trials give them, each with its population; they are not recommendations. Every dose was an injection under the skin, once a day unless the row says otherwise.

What It Is

Teduglutide is a peptide of 33 amino acids: the human gut hormone glucagon-like peptide-2 (GLP-2), with glycine in place of alanine at position 2 (Gattex label; Jeppesen et al., 2005). GLP-2 is cut from a larger precursor, proglucagon; in UniProt’s numbering of the 180-amino-acid precursor, which counts its 20-amino-acid signal peptide, GLP-2 is residues 146–178 (UniProt P01275). Its formula is C164H252N44O55S and its molecular weight 3752 Da (Gattex label; PubChem). It is made in E. coli by recombinant DNA technology and sold as a freeze-dried powder for injection under the skin (Gattex label). GLP-2 is made by L-cells in the lower intestine, and it comes from the same gene, proglucagon, as GLP-1, whose receptor agonists are used for type 2 diabetes and obesity (Gattex label; Drucker, 2019). Its development codes include ALX-0600 and TAK-633 (Jeppesen et al., 2005; NCT06973304).

In 1996 Daniel Drucker’s group in Toronto reported that mice carrying proglucagon-making tumors grew extra small-bowel lining; it traced the effect to GLP-2, which enlarged the jejunum and ileum within 4 days of being given to mice (Drucker et al., 1996). The natural hormone does not last: in healthy volunteers, intact GLP-2 had a half-life of 7.2 minutes in the blood, broken down, the authors conclude, by the enzyme DPP-4 (Hartmann et al., 2000). In rats the group showed that DPP-4 limits GLP-2’s effect and that swapping the alanine at position 2 for glycine made a rat version resistant to it (Drucker, Shi et al., 1997). With Allelix Biopharmaceuticals, a Canadian company that funded the work, the group then chose the human version, [hGly2]-GLP-2, later named teduglutide; Allelix merged with NPS Pharmaceuticals in 1999, and NPS took over its development (Drucker, 2019).

The first Phase 3, in 83 adults with short bowel syndrome on IV support, missed its main endpoint at its higher dose, 0.10 mg/kg a day, the dose its statistical plan tested first, so its positive result at 0.05 mg/kg was treated as hypothesis-generating, and regulators asked for a second Phase 3 (Drucker, 2019; Jeppesen et al., 2011). That trial, STEPS, met its endpoint (Jeppesen et al., 2012). The EU authorised teduglutide as Revestive on August 30, 2012 (EMA, 2012). FDA approved Gattex on December 21, 2012 for adults with short bowel syndrome who depend on parenteral support, with a risk-management program (REMS) and a required registry study of colorectal cancer risk (FDA approval letter, 2012); its advisory committee had voted unanimously in favor on October 16, 2012 (Drucker, 2019). FDA extended the US label to children 1 year and older on May 16, 2019 (FDA approval letter, 2019); the EU label covers patients from 4 months of corrected gestational age (Revestive EU label), and Japan approved it in 2021 (Wada et al., 2026). FDA’s letters went to NPS Pharmaceuticals in 2012, to Shire-NPS Pharmaceuticals in 2018 and 2019 and to Takeda in 2025 and 2026, and Drugs@FDA lists Takeda as the sponsor (Drugs@FDA). On August 26, 2026, FDA ended the REMS as no longer necessary (FDA letter, 2026). In the EU a generic, Teduglutide Viatris, was authorised on January 8, 2026 (EMA, 2026).

PubMed returns 386 records for “teduglutide” (October 4, 2026), 322 of which mention short bowel syndrome or intestinal failure, and ClinicalTrials.gov lists 50 studies (searched October 4, 2026).

Mechanism of Action

Most of the work on how GLP-2 acts used the natural hormone in cells, rodents and pigs (Munroe et al., 1999; Ørskov et al., 2005; Guan et al., 2003). Teduglutide’s own data in people are absorption studies, gut biopsies and transit tests (Jeppesen et al., 2005; Berg et al., 2014; Iturrino et al., 2016).

• The GLP-2 receptor — A G protein-coupled receptor, cloned in 1999; cells carrying it responded to GLP-2 but not to GLP-1 (Munroe et al., 1999). The Gattex label places it on enteroendocrine cells, subepithelial myofibroblasts and enteric nerve cells of the gut wall, and says its activation releases IGF-1, nitric oxide and keratinocyte growth factor (KGF) locally (Gattex label).
• Resistance to DPP-4 — In healthy volunteers, intact GLP-2 had a half-life of 7.2 minutes; GLP-2(3-33), the hormone minus its first two amino acids, was the only breakdown product found, and a DPP-4 inhibitor stopped the breakdown in blood samples, so the authors attribute it to DPP-4 (Hartmann et al., 2000). The glycine at position 2 blocked the cut in the group’s rat version of the peptide (Drucker, Shi et al., 1997). Teduglutide’s half-life is about 2 hours in healthy volunteers and 1.3 hours in short bowel syndrome; 88% of a dose under the skin reaches the blood, peaking 3–5 hours later, and it is cleared mainly by the kidneys (Gattex label).
• KGF from the cells under the lining — In rat, mouse, marmoset and human intestine, GLP-2 receptors sat mainly on subepithelial myofibroblasts that also make KGF; in mice, an antibody against KGF abolished GLP-2’s growth effect in the colon but not in the small intestine (Ørskov et al., 2005).
• Blood flow and nitric oxide — In young pigs fed by vein for a week, GLP-2 infused into a vein raised gut blood flow by 25% and gut glucose uptake by 90%; blocking nitric oxide synthesis with L-NAME prevented both rises (Guan et al., 2003).
• Mucosal growth in people — In patients with an end-jejunostomy, 21 days of teduglutide raised villus height by 38%, crypt depth by 22% and the mitotic index by 115%; crypt depth and mitotic index did not change in colon biopsies (Jeppesen et al., 2005). In a 24-week Phase 3, villus height and plasma citrulline rose against placebo (Jeppesen et al., 2011); the STEPS investigators describe citrulline as a marker of gut-lining mass (Jeppesen et al., 2012).
• Gut transit: mixed findings — Natural GLP-2, 400 µg twice a day for 35 days, slowed stomach emptying of solids by 30 minutes in 8 patients without a terminal ileum or colon (Jeppesen et al., 2001). In a placebo-controlled trial of 36 healthy volunteers, the 23 given teduglutide 4 mg a day for 10 days showed no difference from placebo in stomach emptying of liquids (Berg et al., 2014); in 8 patients with short bowel syndrome, a week of it did not change stomach emptying, and overall transit was slower than on placebo but not significantly (P = 0.075) (Iturrino et al., 2016). The EU summary lists slower passage of food among the ways it works (EMA, 2023).

What the Research Shows

The results below are from animals. Most come from the Toronto group that discovered GLP-2’s effect on the gut (Drucker et al., 1996) or from a University of Copenhagen group that includes Jens Juul Holst (Thulesen et al., 2004; Ørskov et al., 2005). The human trials are in the next section.

• Gut growth in mice — Given under the skin to mice, h[Gly2]GLP-2, teduglutide’s sequence, increased small- and large-bowel mass more than EGF, LR3 IGF-I, [Gly1]IGF-II or human growth hormone at the doses tested (Drucker, DeForest et al., 1997).
• Colitis in mice — In mice with colitis induced by dextran sulfate, h[Gly2]GLP-2 reversed weight loss, lowered interleukin-1 and increased colon length, crypt depth and mucosal area (Drucker et al., 1999).
• Chemotherapy injury in mice — After irinotecan or 5-fluorouracil, h[Gly2]-GLP-2 improved survival, reduced bacteria in the blood, lessened injury to the gut lining and cut cell death in the crypts; in tumor-bearing mice on irinotecan it did not weaken the chemotherapy (Boushey et al., 2001).
• Newborn piglets after bowel resection — In 72 piglets with 80% of the small bowel removed, teduglutide at 0.1 mg/kg a day increased villus height and the gut’s capacity to process glucose and glutamine, and the effect was larger when 20% of feeding went into the gut instead of a vein (Naberhuis et al., 2017).
• Tumors in mice and rats — In 210 mice given a colon carcinogen, a Gly2 GLP-2 analog injected twice a day after the tumors had formed significantly increased tumor load; natural GLP-2 had a smaller effect (Thulesen et al., 2004). In the label’s two-year studies, teduglutide raised bile-duct and jejunal adenomas in male rats and gallbladder papillary adenomas in mice, and caused jejunal adenocarcinomas in male mice at the highest dose, about 244 times the human exposure (Gattex label).

Human Data

Published: a 21-day open-label pilot, two 24-week placebo-controlled Phase 3 trials in adults with their extensions, pediatric trials of 12 and 24 weeks, and small trials in other diseases. ClinicalTrials.gov lists 50 studies of teduglutide; two trials that give it to people are active or not yet recruiting (searched October 4, 2026).

• Open-label pilot, 16 patients, 21 days (Jeppesen et al., 2005) — Adults with short bowel syndrome took 0.03, 0.10 or 0.15 mg/kg a day under the skin, once or twice a day, with no placebo group. Pooled and compared with each patient’s own baseline, absorption of fluid (wet weight) rose by 743 g a day and energy lost in stool fell by 808 kJ (193 kcal) a day; the gains had reversed after three weeks off the drug. The most common side effects were an enlarged stoma nipple and mild swelling of the lower legs.
• Phase 3, 83 adults, 24 weeks (Jeppesen et al., 2011) — Adults who had depended on IV support for at least 12 months took 0.10 mg/kg (32), 0.05 mg/kg (35) or placebo (16) once a day. The main endpoint, a graded response score, was not met at 0.10 mg/kg (8 of 32 against 1 of 16, P = 0.16); because the plan tested 0.10 mg/kg first, the better result at 0.05 mg/kg (16 of 35, P = 0.007) counted only as hypothesis-generating (Jeppesen et al., 2011; Drucker, 2019). At week 24 both doses had cut IV volume by about 350 mL a day, against about 130 mL a day on placebo (P = 0.08), and three patients came off IV support. By the label’s responder measure, 46% on 0.05 mg/kg and 6% on placebo cut IV support by at least 20% (Gattex label).
• Extension to 52 weeks (O’Keefe et al., 2013) — In a 28-week double-blind extension without a placebo group, 52 patients took the same doses for 52 weeks in all; at week 52, 68% on 0.05 mg/kg and 52% on 0.10 mg/kg had cut IV support by at least 20%, and four came off it. Headache (35%), nausea (31%) and abdominal pain (25%) were the most common adverse events, and seven patients withdrew because of adverse events.
• STEPS, 86 adults, 24 weeks (Jeppesen et al., 2012) — Adults with intestinal failure took 0.05 mg/kg or placebo once a day (43 each); IV support was cut whenever 48-hour urine volume rose 10% or more above baseline. 27 of 43 on teduglutide (63%) and 13 of 43 on placebo (30%) cut weekly IV support by at least a fifth at weeks 20 and 24 (P = 0.002). Weekly IV volume fell by 4.4 L on teduglutide and 2.3 L on placebo, from about 13 L, and 54% against 23% dropped at least one infusion day a week. Quality-of-life scores improved from baseline but not significantly more than on placebo (Jeppesen et al., 2013).
• STEPS-2, up to 30 months (Schwartz et al., 2016) — In the 2-year open-label extension, 65 of 88 patients (74%) finished. Of the 30 treated for 30 months in all, 28 (93%) had cut IV support by at least 20%, and the 30 cut it by 7.6 L a week on average (66%); 13 patients across the study came off IV support entirely (Schwartz et al., 2016; Gattex label). The most common adverse events were abdominal pain (34%), catheter sepsis (28%) and weight loss (25%).
• Coming off IV support (Iyer et al., 2017) — Pooling five trials, 16 of 134 adults on 0.05 mg/kg reached full independence from IV support, after a median of 5 years on it and 89 weeks of teduglutide.
• Pooled response over time (Bioletto et al., 2022) — A meta-analysis of 10 studies, two placebo-controlled trials and eight observational studies, put the share of adults cutting IV support by at least 20% at 64% at 6 months, 77% at 1 year and 82% at 2 years or more, and the share weaned off at 11%, 17% and 21%. Patients whose colon was still connected responded less often but were weaned more often.
• Children (Carter et al., 2017; Kocoshis et al., 2020) — In a 12-week open-label trial of 42 children aged 1–17, parenteral nutrition volume fell by a median 41% on 0.025 mg/kg and 25% on 0.05 mg/kg, against 0% on standard care, and four children came off it (Carter et al., 2017). In a 24-week Phase 3 of 59 children, in which patients chose teduglutide or standard care, 69.2% of 26 on 0.05 mg/kg and 54.2% of 24 on 0.025 mg/kg cut IV support by at least 20%, against 11.1% of 9 on standard care, and three on 0.05 mg/kg came off it (Kocoshis et al., 2020; Gattex label). In the extension, 13 of the 15 earlier responders needed teduglutide again after it was stopped (Gattex label).
• Infants (EMA, 2023) — In a study of infants aged 4–12 months of corrected age, 3 of 5 on teduglutide and 1 of 5 on standard care cut parenteral nutrition by at least a fifth at 24 weeks.
• Other uses, none approved — In a placebo-controlled, dose-ranging pilot of 100 adults with moderate-to-severe Crohn’s disease, randomized 1:1:1:1 to placebo or 0.05, 0.10 or 0.20 mg/kg a day for 8 weeks, response and remission rates were numerically higher in every teduglutide group than on placebo, highest at 0.20 mg/kg (44% response and 32% remission, against 32% and 20%); 71 completed (Buchman et al., 2010; NCT00072839). In a placebo-controlled Phase 2 trial in 32 adults with HIV, 17 of them assigned to 0.05 mg/kg a day for 6 months (one withdrew before starting it and one declined to take it), teduglutide raised plasma citrulline against placebo (P = 0.04) and lowered a PET measure of carotid-artery inflammation (P = 0.01, in 5 against 10 patients analysed), with no significant difference in soluble CD14, a marker of monocyte activation (NCT02431325). Of the 17 assigned to teduglutide, 9 finished, against 12 of 15 on placebo; 3 on teduglutide and none on placebo left because of adverse events, no serious adverse events or deaths were reported in either group, and the results are posted on the registry, not published in a journal (NCT02431325). In a five-arm trial of 125 children in hospital with complicated severe malnutrition in Zambia and Zimbabwe, the 26 given 0.05 mg/kg a day for 14 days had a lower combined score of stool markers of gut damage than children given standard care alone (P = 0.07, against a pre-set threshold of P < 0.10; the treatments were not blinded), and no adverse event was judged related to any study treatment, including the death from tuberculosis of one child on teduglutide (Chandwe et al., 2024). In a retrospective survey of 17 patients with steroid-refractory gut graft-versus-host disease given it as salvage therapy, 11 responded (Brehm et al., 2025).
• Use in practice, Japan (Wada et al., 2026) — In a company-run surveillance of 123 patients aged 2–83, after 6 months 11.9% (12 of 101 assessed) had come off IV support and 42.4% (39 of 92) had cut it by at least 20%.

The evidence meter on the Teduglutide card reads “Approved drug” because Gattex is FDA-approved for short bowel syndrome, a gut use (Gattex label). The approval covers people whose short bowel leaves them dependent on IV nutrition or fluids; the trials in other diseases above are small, and short bowel syndrome is the label’s only indication (Gattex label).

Reconstitution & Storage

Gattex comes as a 5 mg vial of white freeze-dried powder, with 0.5 mL of sterile water for injection in a prefilled syringe, a separate needle for mixing and a 1 mL dosing syringe with a 27-gauge needle (Gattex label). The label has each vial mixed with its 0.5 mL of water, giving 10 mg/mL; at most 0.38 mL, holding 3.8 mg, can be drawn from a vial, and the label allows 3 hours from mixing to injection and says to discard what is left (Gattex label). Its instructions are written for patients and caregivers trained by a healthcare provider; this page does not repeat them.

• Storage (label) — The label has kits kept at 2–8 °C before dispensing and at room temperature up to 25 °C after it, with a 90-day use-by date, and says not to freeze them (Gattex label).
• What is in the vial (label) — 5 mg of teduglutide with L-histidine, mannitol and two sodium phosphates, and no preservative (Gattex label). The EU also has a 1.25 mg vial for small children, at 2.5 mg/mL once mixed (Revestive EU label).
• Lab-reagent powder — One chemical supplier’s product insert describes teduglutide as a solid of at least 98% purity, stored at −20 °C and labelled “for research only — not for human or veterinary diagnostic or therapeutic use” (a supplier’s product insert, read October 4, 2026). No study has tested such a product in people.

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Side Effects & Risks

• Common in the adult trials — In the two placebo-controlled trials (77 on teduglutide, 59 on placebo), abdominal pain occurred in 30% against 22%, nausea in 23% against 20%, upper respiratory infections in 21% against 12%, abdominal swelling in 20% against 2%, injection-site reactions in 13% against 12%, vomiting in 12% against 10%, fluid overload in 12% against 7%, and allergic-type skin reactions in 10% against 7% (Gattex label). The EU label puts injection-site reactions at 26% against 5% (Revestive EU label).
• Stoma problems — Among 53 patients with a stoma, 42% (13 of 31) on teduglutide and 14% (3 of 22) on placebo had stoma complications (Gattex label).
• Polyps and cancers — In the adult trials, 14 patients were diagnosed with gut polyps after starting study treatment: one on placebo and one on teduglutide in the controlled trials, and 12 in the extension studies, including colorectal villous, tubular and serrated adenomas; three men in an extension developed cancers, a metastatic adenocarcinoma of unconfirmed origin in a man with earlier abdominal radiation and two lung cancers in heavy smokers (Gattex label). In the STEPS series, colon polyps were found in 12% of patients before treatment and 18% after 24–36 months; of the seven examined under the microscope, five were adenomas and none was malignant (Armstrong et al., 2020). A 2021 case report describes new adenomas in the duodenum and jejunum after 41 months of treatment (Pevny et al., 2021). A 2015 case report describes metastatic alveolar rhabdomyosarcoma, a sarcoma, diagnosed in the nasopharynx about three months after a 69-year-old woman started teduglutide; its authors judged a causal role unlikely, given the short interval, but suggest the drug may have sped the cancer’s growth, and the cancer regressed completely after teduglutide was stopped and chemotherapy given (Zyczynski et al., 2015).
• Bowel blockage — Intestinal obstruction or narrowing occurred in 3 of 77 patients on 0.05 mg/kg and 3 of 32 on 0.10 mg/kg in the controlled trials, none on placebo, and in 6 more patients in the extensions; of the 8 with an episode in the extensions, 2 needed endoscopic widening and 1 surgery (Gattex label).
• Gallbladder and pancreas — In the controlled trials, three patients on 0.05 mg/kg, all with earlier gallbladder disease, developed cholecystitis, against none on placebo; one gallbladder perforated. A pancreatic pseudocyst and, in the extensions, acute and chronic pancreatitis were also reported (Gattex label).
• Fluid overload and heart failure — Swelling of the legs occurred in 10% on teduglutide and 3% on placebo, and two patients on it developed congestive heart failure; the label links fluid overload to the drug’s increase in fluid absorption (Gattex label).
• More of other drugs absorbed — One patient taking the sedative prazepam slipped into a coma in the first week of teduglutide, with a prazepam level above 300 µg/L, and recovered after both were stopped; the label flags oral drugs dosed by titration or with a narrow therapeutic index (Gattex label).
• Antibodies — Antibodies against teduglutide appeared in 17% of adults at 6 months and 48% at 30 months, and in 54% of children at 12 months, with no link to safety problems or lost effect (Gattex label).
• Children — In 89 children treated for a median of 52 weeks, the most common adverse events were vomiting (51.7%), fever (43.8%) and upper respiratory infections (41.6%); three serious events judged related, an ileus, D-lactic acidosis and a blockage from hard stools, all resolved, and one cecal polyp and no neoplasia were found (Hill et al., 2021).
• Stopping it — The label warns that stopping can upset fluid and electrolyte balance (Gattex label); in the 2005 pilot, the absorption gains had reversed three weeks after the last dose (Jeppesen et al., 2005).
• Where the labels differ — The US label lists no contraindications. The EU label rules it out in active or suspected cancer, after a cancer of the gut, liver, bile ducts or pancreas in the past five years, and in allergy to the drug or to trace residues of tetracycline (Gattex label; Revestive EU label).
• Pregnancy and breastfeeding — Case reports have not identified a drug-related risk in pregnancy, and the label advises against breastfeeding during treatment, citing the tumors seen in animals (Gattex label).
• WADA — Not prohibited: Global DRO, the medicine lookup run by UK Anti-Doping, the US Anti-Doping Agency, Sport Integrity Canada and Swiss Sport Integrity, lists teduglutide, and Revestive in the UK, as not prohibited in or out of competition, with no WADA classification (Global DRO, searched October 5, 2026). Teduglutide is not named on the 2026 Prohibited List. Its S0 section covers substances not addressed elsewhere on the List “with no current approval by any governmental regulatory health authority for human therapeutic use”; teduglutide is approved in the US and the EU, so S0 does not apply (World Anti-Doping Agency, 2026). Section S2.3 prohibits “other growth factors or growth factor modulators affecting muscle, tendon or ligament protein synthesis/degradation, vascularisation, energy utilization, regenerative capacity or fibre type switching”, and the Gattex label says teduglutide releases IGF-1 and keratinocyte growth factor in the gut wall; Global DRO does not place it in that class (World Anti-Doping Agency, 2026; Gattex label; Global DRO, searched October 5, 2026).

Bloodwork & Monitoring

For an approved drug, the label sets the checks. What the Gattex label lists, and what the trials measured:

• Before starting (label) — Adults: colonoscopy and upper endoscopy, with polyps removed, within 6 months before the first dose. Children: a fecal occult blood test, with colonoscopy or sigmoidoscopy and upper endoscopy if there is new or unexplained blood. Everyone: bilirubin, alkaline phosphatase, lipase and amylase (Gattex label).
• During treatment (label) — Adults: colonoscopy and upper endoscopy (or other imaging) at the end of the first year, then at least every 5 years. Children: a fecal occult blood test every year, and colonoscopy or sigmoidoscopy after a year and every 5 years after that. Everyone: the same four blood tests every 6 months (Gattex label). For adults, the EU label lists a colonoscopy at the start, yearly colonoscopies (or other imaging) for the first 2 years, then at least every 5 years; for children, a fecal occult blood test before starting and every year, and colonoscopy or sigmoidoscopy after a year and every 5 years after that (Revestive EU label).
• When it is stopped (label) — Fluid and electrolyte status (Gattex label).
• Other medicines (label) — Side effects of oral drugs that are dosed by titration or have a narrow therapeutic index (Gattex label).
• What the trials tracked — 48-hour urine volumes, which set when IV support was cut, and plasma citrulline as a marker of gut-lining mass (Jeppesen et al., 2012); gut biopsies, in which no dysplasia was seen after 6 months in 77 patients (Tappenden et al., 2013).
• Which tests fit a given person — A question for a licensed healthcare provider. This page can’t answer it.

Commonly Stacked With

Teduglutide was given on top of parenteral support in its adult and pediatric Phase 3 trials (Gattex label; Jeppesen et al., 2011; Jeppesen et al., 2012; Kocoshis et al., 2020); the 21-day pilot held parenteral supplements constant and included three patients who needed none (Jeppesen et al., 2005). One mouse study tested it with other compounds on this site; no human study has tested it with another compound on this site (PubMed and Europe PMC, searched October 4, 2026).

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Legal Status

Related Compounds

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References

1. Takeda Pharmaceuticals America, Inc. GATTEX (teduglutide) for injection, for subcutaneous use. Prescribing information, Medication Guide and Instructions for Use (revised 09/2025; initial U.S. approval 2012). DailyMed set ID 66b69c1e-b25c-44d3-b5ff-1c1de9a516fa, version 20, effective September 5, 2025. dailymed.nlm.nih.gov. Read October 4, 2026.
2. U.S. Food and Drug Administration. Drugs@FDA: NDA 203441, GATTEX KIT (teduglutide 5 mg/vial, powder, subcutaneous), sponsor Takeda Pharms USA, marketing status prescription; original approval December 21, 2012 (type 1, new molecular entity; orphan); efficacy supplements approved June 26, 2014, December 18, 2018 and May 16, 2019; labeling supplements to September 5, 2025 (S-24); REMS modifications to August 26, 2026 (S-28). accessdata.fda.gov/scripts/cder/daf/ (NDA 203441). Read October 5, 2026. The openFDA copy (api.fda.gov/drug/drugsfda.json, read October 4, 2026) lists the submissions to S-24 only.
3. U.S. Food and Drug Administration. Letters for NDA 203441: approval letter (replacement), effective December 21, 2012, to NPS Pharmaceuticals, Inc., for adults with short bowel syndrome dependent on parenteral support, with a REMS and a required long-term registry study with colorectal cancer as its primary outcome (postmarketing requirement 1978-1); supplement S-012 approval, December 18, 2018, and S-013 approval, May 16, 2019, to Shire-NPS Pharmaceuticals, Inc., the latter extending the indication to pediatric patients 1 year of age and older; S-023 REMS modification, August 13, 2025, and S-28 approval, August 26, 2026, to Takeda Pharmaceuticals U.S.A., Inc., the latter eliminating the REMS. accessdata.fda.gov/drugsatfda_docs/appletter/. Read October 4, 2026.
4. European Medicines Agency (EMA). Revestive (teduglutide): European public assessment report. Overview (last updated May 2023); marketing authorisation issued 30 August 2012, holder Takeda Pharmaceuticals International AG Ireland Branch; product information (summaries of product characteristics for the 1.25 mg and 5 mg vials, updated May 23, 2025). ema.europa.eu/en/medicines/human/EPAR/revestive. Read October 4, 2026.
5. European Medicines Agency (EMA). Teduglutide Viatris: European public assessment report. Generic medicine of Revestive; opinion adopted 13 November 2025; marketing authorisation issued 8 January 2026, holder Viatris Limited. ema.europa.eu/en/medicines/human/EPAR/teduglutide-viatris. Read October 4, 2026.
6. Health Canada. Summary Basis of Decision (SBD) for Revestive (teduglutide, 5 mg, powder for solution, subcutaneous; DIN 02445727), issued November 9, 2015: Notice of Compliance issued to NPS Pharma Holdings Limited on September 4, 2015, for adult patients with short bowel syndrome who are dependent on parenteral support; its post-authorization activity table lists the indication for pediatric patients 1 year of age and above (Notice of Compliance, August 13, 2019), the transfer to Takeda Canada Inc. (2020) and the date of first sale, October 28, 2015. dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00267. Drug Product Database: REVESTIVE, DIN 02445727, Takeda Canada Inc., status marketed. health-products.canada.ca. Read October 5, 2026.
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14. Jeppesen PB, Hartmann B, Thulesen J, Graff J, et al. Glucagon-like peptide 2 improves nutrient absorption and nutritional status in short-bowel patients with no colon. Gastroenterology. 2001;120(4):806-815. PMID: 11231933. DOI: 10.1053/gast.2001.22555.
15. Drucker DJ. The Discovery of GLP-2 and Development of Teduglutide for Short Bowel Syndrome. ACS Pharmacol Transl Sci. 2019;2(2):134-142. PMID: 32219218. DOI: 10.1021/acsptsci.9b00016. (Full text at PMC7088900, read October 4, 2026: Allelix funding; “[hGly2]-GLP-2, later designated teduglutide”; the 1999 merger with NPS; the advisory committee of October 16, 2012; the patent license between Takeda and the University of Toronto, Toronto General Hospital (UHN) and Daniel Drucker.)
16. Ørskov C, Hartmann B, Poulsen SS, Thulesen J, Hare KJ, Holst JJ. GLP-2 stimulates colonic growth via KGF, released by subepithelial myofibroblasts with GLP-2 receptors. Regul Pept. 2005;124(1-3):105-112. PMID: 15544847. DOI: 10.1016/j.regpep.2004.07.009.
17. Guan X, Stoll B, Lu X, Tappenden KA, et al. GLP-2-mediated up-regulation of intestinal blood flow and glucose uptake is nitric oxide-dependent in TPN-fed piglets. Gastroenterology. 2003;125(1):136-147. PMID: 12851879.
18. Drucker DJ, Yusta B, Boushey RP, DeForest L, Brubaker PL. Human [Gly2]GLP-2 reduces the severity of colonic injury in a murine model of experimental colitis. Am J Physiol. 1999;276(1):G79-G91. PMID: 9886982. DOI: 10.1152/ajpgi.1999.276.1.G79.
19. Boushey RP, Yusta B, Drucker DJ. Glucagon-like peptide (GLP)-2 reduces chemotherapy-associated mortality and enhances cell survival in cells expressing a transfected GLP-2 receptor. Cancer Res. 2001;61(2):687-693. PMID: 11212269.
20. Thulesen J, Hartmann B, Hare KJ, Kissow H, et al. Glucagon-like peptide 2 (GLP-2) accelerates the growth of colonic neoplasms in mice. Gut. 2004;53(8):1145-1150. PMID: 15247183. DOI: 10.1136/gut.2003.035212.
21. Naberhuis JK, Deutsch AS, Tappenden KA. Teduglutide-Stimulated Intestinal Adaptation Is Complemented and Synergistically Enhanced by Partial Enteral Nutrition in a Neonatal Piglet Model of Short Bowel Syndrome. JPEN J Parenter Enteral Nutr. 2017;41(5):853-865. PMID: 26304601. DOI: 10.1177/0148607115602891.
22. Jeppesen PB, Sanguinetti EL, Buchman A, Howard L, et al. Teduglutide (ALX-0600), a dipeptidyl peptidase IV resistant glucagon-like peptide 2 analogue, improves intestinal function in short bowel syndrome patients. Gut. 2005;54(9):1224-1231. PMID: 16099790. DOI: 10.1136/gut.2004.061440.
23. Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B, O’Keefe SJ. 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):902-914. PMID: 21317170. DOI: 10.1136/gut.2010.218271. (Full text at PMC3112364, read October 5, 2026: the step-down procedure that tested 0.10 mg/kg first; at week 24, parenteral volume fell by 128 mL a day on placebo, and by 2.5 L a week on both doses against 0.9 L on placebo, P = 0.08.)
24. O’Keefe SJ, Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B. Safety and efficacy of teduglutide after 52 weeks of treatment in patients with short bowel intestinal failure. Clin Gastroenterol Hepatol. 2013;11(7):815-23.e1-3. PMID: 23333663. DOI: 10.1016/j.cgh.2012.12.029.
25. Jeppesen PB, Pertkiewicz M, Messing B, Iyer K, 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. DOI: 10.1053/j.gastro.2012.09.007.
26. Jeppesen PB, Pertkiewicz M, Forbes A, Pironi L, et al. Quality of life in patients with short bowel syndrome treated with the new glucagon-like peptide-2 analogue teduglutide — analyses from a randomised, placebo-controlled study. Clin Nutr. 2013;32(5):713-721. PMID: 23587733. DOI: 10.1016/j.clnu.2013.03.016.
27. Schwartz LK, O’Keefe SJ, Fujioka K, Gabe SM, 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. DOI: 10.1038/ctg.2015.69.
28. Iyer KR, Kunecki M, Boullata JI, Fujioka K, et al. Independence From Parenteral Nutrition and Intravenous Fluid Support During Treatment With Teduglutide Among Patients With Intestinal Failure Associated With Short Bowel Syndrome. JPEN J Parenter Enteral Nutr. 2017;41(6):946-951. PMID: 27875291. DOI: 10.1177/0148607116680791.
29. Bioletto F, D’Eusebio C, Merlo FD, Aimasso U, et al. Efficacy of Teduglutide for Parenteral Support Reduction in Patients with Short Bowel Syndrome: A Systematic Review and Meta-Analysis. Nutrients. 2022;14(4):796. PMID: 35215445. DOI: 10.3390/nu14040796.
30. Tappenden KA, Edelman J, Joelsson B. Teduglutide enhances structural adaptation of the small intestinal mucosa in patients with short bowel syndrome. J Clin Gastroenterol. 2013;47(7):602-607. PMID: 23426461. DOI: 10.1097/MCG.0b013e3182828f57.
31. Armstrong D, Forbes A, Jeppesen PB, Lee HM, Nagy P, Seidner DL. Colon polyps in patients with short bowel syndrome before and after teduglutide: Post hoc analysis of the STEPS study series. Clin Nutr. 2020;39(6):1774-1777. PMID: 31522784. DOI: 10.1016/j.clnu.2019.08.020.
32. Carter BA, Cohran VC, Cole CR, Corkins MR, et al. Outcomes from a 12-Week, Open-Label, Multicenter Clinical Trial of Teduglutide in Pediatric Short Bowel Syndrome. J Pediatr. 2017;181:102-111.e5. PMID: 27855998. DOI: 10.1016/j.jpeds.2016.10.027.
33. Kocoshis SA, Merritt RJ, Hill S, Protheroe S, 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. DOI: 10.1002/jpen.1690.
34. Hill S, Carter BA, Cohran V, Horslen S, et al. Safety Findings in Pediatric Patients During Long-Term Treatment With Teduglutide for Short-Bowel Syndrome-Associated Intestinal Failure: Pooled Analysis of 4 Clinical Studies. JPEN J Parenter Enteral Nutr. 2021;45(7):1456-1465. PMID: 33305440. DOI: 10.1002/jpen.2061.
35. Marier JF, Beliveau M, Mouksassi MS, Shaw P, et al. Pharmacokinetics, safety, and tolerability of teduglutide, a glucagon-like peptide-2 (GLP-2) analog, following multiple ascending subcutaneous administrations in healthy subjects. J Clin Pharmacol. 2008;48(11):1289-1299. PMID: 18974283. DOI: 10.1177/0091270008320605.
36. Berg JK, Kim EH, Li B, Joelsson B, Youssef NN. A randomized, double-blind, placebo-controlled, multiple-dose, parallel-group clinical trial to assess the effects of teduglutide on gastric emptying of liquids in healthy subjects. BMC Gastroenterol. 2014;14:25. PMID: 24517114. DOI: 10.1186/1471-230X-14-25.
37. Iturrino J, Camilleri M, Acosta A, O’Neill J, et al. Acute Effects of a Glucagon-Like Peptide 2 Analogue, Teduglutide, on Gastrointestinal Motor Function and Permeability in Adult Patients With Short Bowel Syndrome on Home Parenteral Nutrition. JPEN J Parenter Enteral Nutr. 2016;40(8):1089-1095. PMID: 26223941. DOI: 10.1177/0148607115597644.
38. Buchman AL, Katz S, Fang JC, Bernstein CN, Abou-Assi SG; Teduglutide Study Group. Teduglutide, a novel mucosally active analog of glucagon-like peptide-2 (GLP-2) for the treatment of moderate to severe Crohn’s disease. Inflamm Bowel Dis. 2010;16(6):962-973. PMID: 19821509. DOI: 10.1002/ibd.21117.
39. Chandwe K, Bwakura-Dangarembizi M, Amadi B, Tawodzera G, et al. Malnutrition enteropathy in Zambian and Zimbabwean children with severe acute malnutrition: A multi-arm randomized phase II trial. Nat Commun. 2024;15(1):2910. PMID: 38632262. DOI: 10.1038/s41467-024-45528-0. (Full text at PMC11024201, read October 4, 2026: teduglutide 0.05 mg/kg daily under the skin, from 1.25 mg vials; no adverse events judged related to the study treatments.)
40. Brehm N, Biavasco F, Clausen J, Jung J, et al. Teduglutide for treatment-refractory severe intestinal acute graft-versus-host disease - a multicenter survey. Bone Marrow Transplant. 2025;60(6):873-878. PMID: 40229535. DOI: 10.1038/s41409-025-02586-2.
41. Pevny S, Pape UF, Elezkurtaj S, Rieger A, et al. De Novo Development of Distal Jejunal and Duodenal Adenomas After 41 Months of Teduglutide Treatment in a Patient With Short-Bowel Syndrome: A Case Report. JPEN J Parenter Enteral Nutr. 2021;45(3):652-656. PMID: 32740933. DOI: 10.1002/jpen.1982.
42. Zyczynski LE, McHugh JB, Gribbin TE, Schuetze SM. Alveolar Rhabdomyosarcoma in a 69-Year-Old Woman Receiving Glucagon-Like Peptide-2 Therapy. Case Rep Oncol Med. 2015;2015:107479. PMID: 26266067. DOI: 10.1155/2015/107479.
43. Wada M, Nakamura S, Hayashi A, Otake R, Miyamoto M, Tanaka T. Six-Month Safety and Effectiveness of Teduglutide in Patients with Short Bowel Syndrome in Japan: Interim Analysis of Post-marketing Surveillance. Adv Ther. 2026;43(1):425-441. PMID: 41324792. DOI: 10.1007/s12325-025-03398-y. (Full text at PMC12858502, read October 4, 2026: approved in Japan since 2021 for patients with a corrected age of 4 months or more and a body weight of 10 kg or more.)
44. Raghu VK, Binion DG, Smith KJ. Cost-effectiveness of teduglutide in adult patients with short bowel syndrome: Markov modeling using traditional cost-effectiveness criteria. Am J Clin Nutr. 2020;111(1):141-148. PMID: 31665212. DOI: 10.1093/ajcn/nqz269.
45. ClinicalTrials.gov. Registrations of teduglutide: NCT00072839 (Phase 2 pilot in Crohn’s disease, CL0600-008, ages 18 and older, 100 enrolled, completed 2005), NCT00081458 (Phase 3, CL0600-004, 84 enrolled, completed 2007), NCT00172185 (its extension, 65), NCT00798967 (Phase 3 STEPS, 86, completed 2011), NCT00930644 (STEPS-2, 88), NCT01952080 (pediatric, 12 weeks, 42), NCT02682381 (pediatric Phase 3, 24 weeks, 59), NCT02431325 (Phase 2 in HIV, 32, completed January 2021, results posted), NCT05371028 (retrospective study of Revestive in routine care in Canada, Takeda, 52, completed 2025), NCT04877431 (post-authorization study of Revestive in Argentina, Takeda, 45, completed 2023), NCT06973304 (Phase 3 in Chinese adults, TAK-633, active, not recruiting, 13 enrolled, estimated primary completion February 2027), NCT07537686 (Phase 2 in undernourished women with environmental enteric dysfunction, not yet recruiting, 55 planned, estimated primary completion October 2027), NCT07319832 (observational, Chinese children, recruiting) and NCT01990040 (registry TED-R13-002, observational, 1,806 enrolled, primary outcome colorectal cancer over 10 years, estimated primary completion June 2032). Sponsors: Shire, Takeda, Massachusetts General Hospital, icddr,b. clinicaltrials.gov, API v2. Read October 4, 2026 (NCT05371028 and NCT04877431, October 5, 2026).
46. FDA. Drugs@FDA: ZORBTIVE (somatropin), BLA 021597, EMD Serono, original approval December 1, 2003 (orphan); and the Zorbtive label (2003): indicated for the treatment of short bowel syndrome in patients receiving specialized nutritional support. accessdata.fda.gov/drugsatfda_docs/label/2003/20604s026_zorbtive_lbl.pdf. Read October 4, 2026.
47. A laboratory-reagent supplier’s product insert for teduglutide ([Gly2]hGLP-2; ≥98%; supplied as a solid; storage −20 °C; “This product is for research only — not for human or veterinary diagnostic or therapeutic use”). Read October 4, 2026. The supplier is not named: Kalios doesn’t name or link vendors.
48. Code of Federal Regulations. 21 CFR 216.23, Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act; and 21 CFR 216.24, Drug products withdrawn or removed from the market for reasons of safety or effectiveness. ecfr.gov. Read October 4, 2026.
49. 21 U.S.C. 353a, Pharmacy compounding (section 503A of the Federal Food, Drug, and Cosmetic Act), subsection (b)(1). law.cornell.edu/uscode/text/21/353a. Read October 5, 2026.
50. FDA. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (categories 1–3). Updated May 14, 2026. fda.gov/media/94155/download.
51. FDA. Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act (categories 1–3). Updated March 21, 2025. fda.gov/media/94164/download.
52. World Anti-Doping Agency. Prohibited List 2026 (in effect January 1, 2026). S0, Non-approved substances; S2.3, Growth factors and growth factor modulators. wada-ama.org.
53. Global DRO (Global Drug Reference Online), a partnership of Sport Integrity Canada, Swiss Sport Integrity, UK Anti-Doping and the United States Anti-Doping Agency. Teduglutide (ingredient; nation of purchase United States) and Revestive (brand; United Kingdom): not prohibited in competition or out of competition; WADA classification: none. globaldro.com. Searched October 5, 2026.
54. Searches of October 4, 2026: PubMed, “teduglutide” (386 records), with “short bowel OR intestinal failure” (322), with “randomized controlled trial[pt]” (23), with growth hormone or somatropin (19; no human combination study), with BPC-157, larazotide, KPV, thymosin, TB-500 or insulin-like growth factor (7; no combination study), with liraglutide, semaglutide, exenatide or GLP-1 (22; no combination trial), with tendon, ligament, muscle injury, wound healing, skin or sport (6; no human study of those uses), with HIV (3; no publication of NCT02431325); Europe PMC, “teduglutide AND HIV”; ClinicalTrials.gov, “teduglutide” (50 studies), “teduglutide tendon” (none), “teduglutide healthy” (12, safety and physiology studies); openFDA Drugs@FDA, “teduglutide” (one application, NDA 203441); EMA medicines data (Revestive; Teduglutide Viatris); web searches for FDA warning letters naming teduglutide (none) and for teduglutide sold as a research peptide (laboratory-reagent catalogues only; suppliers not named). October 5, 2026: Global DRO, “Teduglutide” (United States) and “Revestive” (United Kingdom); ClinicalTrials.gov, “teduglutide Crohn” (2 studies); a web search for FDA import alerts naming teduglutide (none); Health Canada’s Drug Product Database, “Revestive” (one product, DIN 02445727).

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