A lab-made copy of GLP-2, a gut hormone, with one amino acid swapped so it lasts hours instead of minutes. It makes the remaining bowel lining grow and absorb more fluid and nutrients.
Evidence. Approved first in the EU (Revestive, August 2012), then by the FDA (Gattex, December 2012), for short bowel syndrome in people who depend on IV nutrition or fluids, in adults and in children from age 1 (US) or 4 months (EU, UK). In STEPS (86 adults, 24 weeks), 63% vs 30% on placebo cut their weekly IV volume by at least 20%. FDA ended the drug’s special safety program (REMS) in August 2026.
What it’s used for
Approved uses first, then uses tested in people, then claims that rest on animal studies or user reports.
Short bowel syndrome
LabelApproved for adults (and children) who depend on IV nutrition or fluids. In STEPS, 63% vs 30% on placebo cut weekly IV volume by at least 20% over 24 weeks.
Coming off IV nutrition completely
LabelPossible for a minority: in the extension studies, 13 of 88 adults stopped IV support entirely within 30 months; most others needed less but not none.
Crohn’s disease
TrialNot shown: in an 8-week pilot trial of 100 adults with active Crohn’s disease, response was only numerically higher than placebo (44% vs 32% at the highest dose). Not an approved use.
Leaky gut or gut repair without short bowel
No studyUnproven: no study has tested it for leaky gut, IBS or general gut health. Its label warns that it may speed the growth of polyps and tumors.
Label: an approved use. Trial: tested in people, with the result. No study: nothing published supports it.
Approved in the US as Gattex (2012) for short bowel syndrome in adults and children 1 year and older who depend on parenteral support (IV nutrition or fluids). FDA ended its REMS safety program on August 26, 2026.
Approval history
2012EU (EMA): Revestive: short bowel syndrome, the first approval anywhere
2012US FDA: Gattex: short bowel syndrome in adults dependent on IV support
2015Canada: Revestive: short bowel syndrome
2019US FDA: Gattex: extended to children 1 year and older
2026EU (EMA): Teduglutide Viatris: first EU generic
2026US FDA: Gattex: REMS safety program ended
European Union
Prescription only. Revestive (EMA, 2012) for short bowel syndrome; a generic, Teduglutide Viatris, was authorized in 2026. EMA’s committee backed glepaglutide (Zeydovio) in September 2026.
United Kingdom
Prescription-only medicine licensed by the MHRA: Revestive 5 mg and 1.25 mg, for short bowel syndrome.
Canada
Prescription drug: Revestive (Takeda), approved in 2015 and marketed since then.
Australia
Prescription only (Schedule 4). Revestive has current product information.
Sport (WADA 2026)
Not banned in sportNot named on the 2026 list, and S0 doesn’t apply to an approved drug. GLP-2 analogs aren’t among the S2 hormones or growth factors the list names; WADA hasn’t said whether S2.3’s catch-all for other growth factors covers them.
Sport status follows the WADA Prohibited List in force since January 1, 2026; athletes should confirm with their anti-doping organization. Checked October 5, 2026. Status outside the US checked October 7, 2026 against EMA, MHRA, Health Canada and TGA records. By country: EU, UK, Canada, Australia. Status of every compound.
How it works
Teduglutide binds the GLP-2 receptor on hormone-making cells, support cells and nerve cells in the gut wall. These cells then release local signals, including IGF-1, nitric oxide and keratinocyte growth factor, that make the bowel lining grow: the finger-like villi get taller and the crypts deeper, so the remaining gut absorbs more fluid and nutrients. One amino acid change protects it from the enzyme DPP-4, so it lasts hours, not minutes.
LabelBased on the product label.
Not known
Who will respond, and how much, can’t be predicted well, and some people take up to a year. Whether years of extra gut growth raise bowel cancer risk in people is unknown; a 10-year registry is tracking it.
Protocol
Label
Gattex, Revestive
Adults: 0.05 mg/kg under the skin once a day (3.5 mg at 70 kg); 0.025 mg/kg when kidney function (eGFR) is under 60. The EU label judges the effect at 6 months.
Trial
Jeppesen 2011
0.10 mg/kg once a day, twice the label dose, was no better than 0.05 mg/kg over 24 weeks and isn’t an approved dose.
Frequency
Once daily
Route
Subcutaneous injection (label)
Timing
The label sets no time of day; each dose is injected within 3 hours of mixing.
Cycle
Long-term while it helps. The EU label assesses the effect at 6 months, reconsiders it at 12 months if there’s no overall improvement, and continues it in people who have come off IV nutrition.
Week 15913172125
Continuous, shown over 26 weeks
Common protocols
The ways Teduglutide is most often run, each tagged with where it comes from.
Standard dose (Gattex, Revestive)
Label
Dose
0.05 mg/kg
How often
Once daily
How long
Long-term; the EU label reviews it at 6 and 12 months
Adults. IV support is lowered in steps as absorption improves; in STEPS, weekly IV volume fell 4.4 L vs 2.3 L on placebo over 24 weeks.
Reduced kidney function
Label
Dose
0.025 mg/kg
How often
Once daily
How long
Long-term
For eGFR under 60 mL/min, including kidney failure: exposure rises as kidney function falls, so the US label halves the dose.
Double dose (trial only)
Trial
Dose
0.10 mg/kg
How often
Once daily
How long
24 weeks
No better than 0.05 mg/kg in the first phase 3 trial (Jeppesen 2011), and blockages were more frequent (9% vs 4%). Not an approved dose.
Dosing by body weight
Label
0.05 mg/kg. Adults: once daily under the skin; 0.025 mg/kg when eGFR is under 60. Kit vials are mixed to 10 mg/mL, and at most 0.38 mL can be drawn.
Taking it
Where it goes
Under the skin of the belly, thighs or upper arms, alternating sites (label). Never into a vein or muscle.
If you miss a dose
Label: inject a missed dose as soon as possible that day; never take 2 doses on the same day.
Fluid overload is most common early, as absorption improves (EU label), so IV support is reviewed often and cut in steps.
Label
Week 24
In STEPS, 63% vs 30% on placebo cut weekly IV volume by at least 20%; the mean drop was 4.4 vs 2.3 L a week, from about 13 L.
Label
Month 30
Of 30 people treated from the start of STEPS, 93% had at least a 20% cut; weekly IV volume fell 7.55 L on average (66%), and 10 stopped IV support.
Label
After stopping
The labels warn that fluid and salt imbalance can return, so fluid status is checked after stopping.
Label
Side effects and what to do
Belly pain (label: 30% vs 22% on placebo) and bloating (20% vs 2%)
Common early. Severe pain or swelling, vomiting or no stoma output can mean a blockage: the label says to pause it and get care.
Stoma problems (label: 42% vs 14% among people with a stoma)
Stomas can swell or change as the lining grows. Report changes to the care team.
Fluid overload or leg swelling (label: 12% vs 7%)
Sudden weight gain, swollen ankles or breathlessness: IV fluids may need lowering (label).
Nausea 23% vs 20%, vomiting 12% vs 10% (label)
Usually mild. Ongoing vomiting can upset fluid balance in short bowel syndrome.
Injection-site reactions (label: 13% vs 12%; EU pooled data 26% vs 5%)
Bruising, redness or pain. Rotate sites.
Stop and get medical help
Severe belly pain or swelling, vomiting or no stoma output (possible blockage), yellow skin or upper belly pain (gallbladder or pancreas), or sudden weight gain with breathlessness: get prompt medical care (label).
Can it cause …?
The side effects people ask about most, answered one by one. Each answer says where it comes from.
Tiredness
Not reportedTiredness isn’t a listed side effect in the US or EU labels; the placebo-controlled trials gave it to 109 adults for 24 weeks.
Headache
LabelHeadache was very common in the EU label’s pooled trials (16% of 109 adults), though it isn’t in the US label’s list of reactions more common than placebo.
Nausea or vomiting
LabelNausea 23% vs 20% and vomiting 12% vs 10% on placebo in the 24-week trials.
Diarrhea or constipation
LabelBelly pain 30% vs 22%, bloating 20% vs 2% and gas 9% vs 7% on placebo; blockage of the bowel or stoma hit 4%, with none on placebo.
Dizziness
LabelDizziness isn’t listed in the US label. The EU label lists fainting as uncommon (under 1 in 100) and says it could affect driving.
Trouble sleeping
LabelSleep problems 5% vs 0% on placebo (insomnia in 3 people, oversleeping in 1); the EU label lists insomnia as common.
Hair loss
Not reportedHair loss isn’t listed in the US or EU labels; the trials treated 109 adults for 24 weeks, with extensions of up to 30 months.
Acne, rash or skin changes
LabelInjection-site reactions 13% vs 12% on placebo (26% vs 5% in EU pooled data); rash or itching from allergy 10% vs 7%; bruising 5% vs 2%.
Water retention or swelling
LabelFluid overload or leg swelling in 12% vs 7% on placebo, as the gut absorbs more fluid. Heart failure occurred in 2 of 77 adults.
Joint or muscle pain
Not reportedJoint or muscle pain isn’t a listed side effect in the US or EU labels, based on 24-week trials in 109 adults.
Anxiety, low mood or irritability
LabelAnxiety is listed as common (1 to 10 in 100) in the EU label; the US label doesn’t list mood changes.
Low or high blood sugar
Not reportedBlood sugar changes aren’t listed in the US or EU labels; the placebo-controlled trials treated 109 adults for 24 weeks.
Fast heartbeat or blood pressure changes
LabelHeart failure tied to fluid overload occurred in 2 of 77 adults (3%) in trials. At 5 times the dose, it didn’t prolong the heart’s QT interval.
More hunger
LabelLess appetite, not more: decreased appetite was 7% vs 3% on placebo in the 24-week trials.
Liver strain
LabelGallbladder and bile duct problems (cholecystitis, gallstones, cholangitis) occurred in trials; the label calls for bilirubin and alkaline phosphatase tests every 6 months.
Kidney problems
LabelNo direct kidney harm is listed, but short bowel syndrome brings dehydration that can injure the kidneys, especially as IV fluids are cut or the drug stops (EU label).
Cancer risk
LabelCaused gut and bile duct tumors in rodents and may speed existing tumors; 14 adults in trials developed gut polyps. The label calls for colonoscopy before and during use.
Label: from the prescribing information. Not reported: studied in people and not reported. A side effect that hasn’t been reported can still happen, especially with long or high-dose use. Any of these across every compound: the side-effect finder.
Who should avoid it
What its label rules out or warns about, most important first.
Active or recent cancer
LabelThe EU label rules out active or suspected cancer, and gut, liver-bile or pancreatic cancer in the past 5 years; the US label says to use it only if benefits outweigh risks.
Colon polyps or a history of them
LabelPolyp and tumor growth may speed up, so the label calls for colonoscopy with polyp removal before starting and repeat checks during treatment.
Bowel narrowing or a past blockage
LabelBlockages of the bowel or stoma occurred in trials, none on placebo; the label says to pause treatment while one is managed.
Gallbladder, bile duct or pancreas disease
LabelCholecystitis struck 3 trial patients, all with past gallbladder disease, and pancreatitis was reported; the label calls for blood tests every 6 months.
Heart disease or high blood pressure
LabelExtra fluid absorption can cause fluid overload and heart failure; the EU label advises close monitoring, especially in the first weeks.
Pregnancy or breastfeeding
LabelNo human safety data. The EU label prefers to avoid it in pregnancy; the US label advises against breastfeeding because of possible harm, including tumor growth, in the infant.
Users of narrow-margin oral drugs
LabelTheir absorption can rise: one patient on prazepam, a benzodiazepine, went into a coma, so the label advises monitoring and lower doses if needed.
Interactions
Only interactions stated on a product label or measured in a human study are listed.
Oral drugs that need careful dosing or have a narrow safety margin (such as benzodiazepines)
LabelTeduglutide can raise their absorption. A patient on prazepam slipped into a coma in the first week; the label says to watch for side effects and lower the other drug’s dose if needed.
Drugs cleared by liver CYP450 enzymes
LabelNo interaction studies were done in people; in lab tests teduglutide didn’t block these enzymes (EU label).
Label: a product label rules it out, warns about it or lists the interaction. This isn’t a complete list: a pharmacist or doctor can check a specific medicine or condition. Every documented interaction, by medicine: drug interactions.
Special situations
What the label and studies say about pregnancy, breastfeeding, kidney and liver problems, age and surgery.
Pregnancy
LabelCase reports haven’t shown a drug-related risk, and rat and rabbit studies at very high exposures showed no harm. The EU label says it’s preferable to avoid it in pregnancy.
Breastfeeding
LabelUnknown whether it reaches human milk; it does in rats. The US label advises against breastfeeding because of possible serious harm, including tumor growth, in the infant.
Kidney problems
LabelExposure rises as kidney function falls, so the US label halves the dose when eGFR is under 60. Dehydration from short bowel syndrome can itself injure the kidneys.
Liver problems
LabelNo dose change in mild or moderate liver impairment; not studied in severe impairment. Gallbladder and bile duct problems are a listed risk.
Older adults
LabelOf 134 trial patients on the label dose, 19 were 65 or older and 5 were 75 or older; no overall differences in safety or effect were seen.
Children and teens
LabelApproved for children 1 year and older in the US, and from 4 months corrected age in the EU and UK. Vial Guide doesn’t show children’s doses.
Surgery and anesthesia
PrecautionNo label advice on anesthesia. It can cause bowel or stoma blockage and fluid shifts; tell the surgical team about it, especially before belly surgery.
Label: what the prescribing information says. Precaution: not studied, so the caution follows from how it works or from a related drug. Ages are given as approved or studied; this site never gives doses for children. Across every compound: pregnancy, breastfeeding, kidney disease, liver disease, older adults and surgery.
Tracking and pairing
Worth tracking
Colonoscopy and upper endoscopy: before starting, after 1 year, then at least every 5 years (US label)
Bilirubin, alkaline phosphatase, lipase and amylase every 6 months
Weight, fluid status and electrolytes, especially when starting and stopping
Effects of narrow-margin oral drugs, whose absorption may rise
Often paired with
Usually run on its own.
Human studies
5 key published human studies, with how many people took part. Animal studies aren’t listed here.
201286 people
63% vs 30% on placebo cut weekly IV volume by at least 20%; mean drop 4.4 vs 2.3 L a week; 54% vs 23% gained at least 1 day a week off IV support.
Design
Randomized double-blind placebo-controlled trial (STEPS) in adults with short bowel syndrome dependent on IV support
Dose
0.05 mg/kg once daily
Length
24 weeks
Jeppesen et al., Gastroenterology 2012, PMID 22982184
201183 people
The lower dose met the main graded-response goal and the higher dose didn’t; 46% on 0.05 mg/kg vs 6% on placebo cut IV volume by 20% or more (label analysis).
Design
Randomized double-blind placebo-controlled trial of two doses in adults with short bowel syndrome
Dose
0.05 or 0.10 mg/kg once daily
Length
24 weeks
Jeppesen et al., Gut 2011, PMID 21317170
201688 people
Among completers treated from the start, 93% kept at least a 20% cut and weekly IV volume fell 7.6 L (66%); 13 people stopped IV support entirely.
Design
Open-label 2-year extension (STEPS-2), no control group
Dose
0.05 mg/kg once daily
Length
Up to 30 months in all
Schwartz et al., Clin Transl Gastroenterol 2016, PMID 26844839
201814 people
IV support stayed about half its starting level (cuts of 9.8 and 3.9 L a week in the two groups); 2 more people stopped IV support; no treatment-related serious events.
Design
Open-label 1-year extension (STEPS-3), no control group
Dose
0.05 mg/kg once daily
Length
Up to 42 months in all
Seidner et al., Nutr Clin Pract 2018, PMID 29761915
200516 people
Fluid absorption rose by about 743 g a day and stool weight fell by 711 g a day; villus height in the small bowel rose 38%.
Design
Open-label dose-ranging pilot study in short bowel syndrome
Registered trials that are still running, or that finished without published results, most important first. Checked on ClinicalTrials.gov, October 7, 2026.
ObservationalNCT01990040
International registry of 1,806 people with short bowel syndrome: colorectal cancer and other long-term risks with or without teduglutide, over 10 years
Active, not recruiting; completion expected June 2032
Phase 3NCT06973304
Open-label 24-week study of daily teduglutide in 13 Chinese adults with short bowel syndrome: share cutting IV support by at least 20%
Active, not recruiting; completion expected July 2027
Phase 2NCT07537686
GAME: a 30-day course in 55 undernourished women with environmental enteric dysfunction (gut damage from repeated infections): gut-lining biopsy scores
Not yet recruiting; completion expected December 2027
ObservationalNCT05023382
All-case safety surveillance of 250 people treated with Revestive in Japan, followed for up to 36 months
The evidence is two 24-week placebo-controlled trials in 169 adults with short bowel syndrome, plus open-label extensions of up to 42 months in fewer people, without control groups. Responses vary, and most people still need some IV support. Long-term cancer risk is unknown: the trials were too small and short to detect it, so screening rules rest on rodent tumors and the polyps seen in trials. It hasn’t been shown to help other gut problems.
How it’s supplied
Kits of 5 mg single-dose powder vials, each with a prefilled syringe of 0.5 mL sterile water, mixed to 10 mg/mL. EU products also come in 1.25 mg vials. Mixed exactly as the kit directs and injected under the skin once a day by the patient or a caregiver, at a dose set by body weight. It’s used as supplied, so the calculator and dose log don’t apply.
Kit vials hold 5 mg of powder, mixed with the 0.5 mL of sterile water in the supplied syringe to 10 mg/mL. The label says to roll the vial gently, never shake it, and inject within 3 hours; at most 0.38 mL (3.8 mg) can be drawn from a vial.
Datasheet
Half-life
about 2 hoursLabelSubcutaneous injection in healthy adults; 1.3 hours in people with short bowel syndrome. Levels peak 3–5 hours after the injection.
Type
Peptide, 33 amino acids
Molecular weight
3,752 g/mol
Formula
C164H252N44O55S
Sequence
HGDGSFSDEMNTILDNLAARDFINWLIQTKITDHuman GLP-2 with glycine in place of alanine at position 2
Storage before use
Powder in single-dose vials, sold as kits with prefilled syringes of sterile water. Refrigerate at 2–8 °C until dispensed; after dispensing, keep at room temperature up to 25 °C for up to 90 days. Don’t freeze.
After mixing or opening
Mix with the 0.5 mL of water supplied, roll gently without shaking, inject within 3 hours and discard the rest.
Half-life: Gattex prescribing information, section 12.3 (DailyMed, rev. September 2025)
Gattex is teduglutide made in E. coli by recombinant DNA, sold as powder with its own diluent. Each vial holds 5 mg, but only 3.8 mg (0.38 mL) can be drawn after mixing, and mixed solution lasts 3 hours.
Cautions
May speed the growth of existing tumors: rodents developed gut and bile duct tumors, so the label calls for colonoscopy and upper endoscopy before starting, after 1 year, then at least every 5 years.
Bowel or stoma blockage occurred in 4% of adults on the label dose in trials, none on placebo; stoma problems were 42% vs 14%.
Gallbladder, bile duct and pancreas problems, including cholecystitis and pancreatitis, have occurred; the label calls for blood tests every 6 months.
Fluid overload (12% vs 7%) and heart failure have occurred as the gut absorbs more; IV fluids are adjusted, and stopping can cause dehydration.
Can raise absorption of oral drugs: one patient on prazepam, a benzodiazepine, slipped into a coma in the first week.
Questions
What is teduglutide?
A lab-made copy of GLP-2, a gut hormone, with one amino acid swapped so it lasts hours instead of minutes. It makes the remaining bowel lining grow and absorb more fluid and nutrients.
How does teduglutide work?
Teduglutide binds the GLP-2 receptor on hormone-making cells, support cells and nerve cells in the gut wall. These cells then release local signals, including IGF-1, nitric oxide and keratinocyte growth factor, that make the bowel lining grow: the finger-like villi get taller and the crypts deeper, so the remaining gut absorbs more fluid and nutrients. One amino acid change protects it from the enzyme DPP-4, so it lasts hours, not minutes. Who will respond, and how much, can’t be predicted well, and some people take up to a year. Whether years of extra gut growth raise bowel cancer risk in people is unknown; a 10-year registry is tracking it.
Is teduglutide FDA-approved?
Approved in the US as Gattex (2012) for short bowel syndrome in adults and children 1 year and older who depend on parenteral support (IV nutrition or fluids). FDA ended its REMS safety program on August 26, 2026.
What is the usual teduglutide dose?
From the label (Gattex, Revestive): Adults: 0.05 mg/kg under the skin once a day (3.5 mg at 70 kg); 0.025 mg/kg when kidney function (eGFR) is under 60. The EU label judges the effect at 6 months. From human studies (Jeppesen 2011): 0.10 mg/kg once a day, twice the label dose, was no better than 0.05 mg/kg over 24 weeks and isn’t an approved dose. These are the amounts sources reference, not recommendations.
How is teduglutide given?
Mixed exactly as the kit directs and injected under the skin once a day by the patient or a caregiver, at a dose set by body weight. The label sets no time of day; each dose is injected within 3 hours of mixing.
Who should avoid teduglutide?
Active or recent cancer: The EU label rules out active or suspected cancer, and gut, liver-bile or pancreatic cancer in the past 5 years; the US label says to use it only if benefits outweigh risks. Colon polyps or a history of them: Polyp and tumor growth may speed up, so the label calls for colonoscopy with polyp removal before starting and repeat checks during treatment. Bowel narrowing or a past blockage: Blockages of the bowel or stoma occurred in trials, none on placebo; the label says to pause treatment while one is managed. The “Who should avoid it” section lists 4 more groups and 2 interactions.
What is the half-life of teduglutide?
About 2 hours, according to the prescribing information. Subcutaneous injection in healthy adults; 1.3 hours in people with short bowel syndrome. Levels peak 3–5 hours after the injection.
How should teduglutide be stored?
Powder in single-dose vials, sold as kits with prefilled syringes of sterile water. Refrigerate at 2–8 °C until dispensed; after dispensing, keep at room temperature up to 25 °C for up to 90 days. Don’t freeze. Mix with the 0.5 mL of water supplied, roll gently without shaking, inject within 3 hours and discard the rest.
Is teduglutide banned in sport?
No. Not named on the 2026 list, and S0 doesn’t apply to an approved drug. GLP-2 analogs aren’t among the S2 hormones or growth factors the list names; WADA hasn’t said whether S2.3’s catch-all for other growth factors covers them.
Has teduglutide been studied in people?
Yes. The human studies section lists 5 published studies. The largest, from 2016, included 88 people. Among completers treated from the start, 93% kept at least a 20% cut and weekly IV volume fell 7.6 L (66%); 13 people stopped IV support entirely.
How long has teduglutide been studied in people?
Trial STEPS-3 treated 14 adults for up to 42 months; STEPS-2 followed 88 adults for up to 30 months. A registry is tracking colorectal cancer over 10 years.
Does teduglutide come in other forms, like a pill or nasal spray?
Label Only a daily injection under the skin is approved; no oral or nasal form exists. Longer-acting GLP-2 drugs given once or twice weekly, such as glepaglutide, are in regulatory review.
Can you drink alcohol while taking teduglutide?
Precaution The labels don’t address alcohol. Heavy drinking can add to dehydration and pancreatitis, both relevant risks in short bowel syndrome treated with teduglutide.
Can teduglutide be taken with semaglutide or tirzepatide?
Trial No study has paired teduglutide with semaglutide or tirzepatide. In 9 people with short bowel syndrome, 3-day infusions of natural GLP-1, GLP-2 or both each cut stool losses compared with placebo.
What happens if you take too much teduglutide?
Label Per the label, the highest dose studied, 80 mg a day for 8 days, caused no unexpected effects; careful monitoring is advised. Call Poison Help (1-800-222-1222), or emergency services for severe symptoms.
Sources
Gattex prescribing information (Takeda, DailyMed, rev. September 2025)
Revestive UK summary of product characteristics (Takeda, rev. December 20, 2024)
Drugs@FDA and FDA letters for Gattex, NDA 203441: original approval (December 21, 2012), children 1 year and older (S-013, May 16, 2019), REMS eliminated (S-028, August 26, 2026)
EMA medicines data: Revestive (authorized August 30, 2012), Teduglutide Viatris (generic, authorized January 8, 2026) and Zeydovio (glepaglutide, positive opinion September 17, 2026)
Jeppesen et al., STEPS trial of teduglutide (Gastroenterology 2012) PMID 22982184