Gattex (teduglutide)
An approved treatment for Short Bowel Syndrome.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Teduglutide wherever you encounter it, plus the key facts at a glance.
- Generic name
- Teduglutide
- Brand name
- Gattex
- Drug class
- GLP-2 analog
- Manufacturer
- Takeda Pharmaceuticals America (Takeda Pharmaceutical Company Limited)
- How it's taken
- Injection under the skin once a day
A once-daily injection under the skin for adults and children 1 year and older with short bowel syndrome (SBS) who depend on parenteral support, the nutrition and fluids given through a vein[1].
- The FDA approved Gattex for adults on December 21, 2012 and for children 1 year and older on May 16, 2019[2].
- Gattex helps the remaining intestine absorb more, and in the main adult trial 63% of people on it cut their weekly IV volume by at least 20%, against 30% on placebo[1].
- Gattex has no boxed warning, and the FDA ended its safety program (REMS) on August 26, 2026[4].
- Takeda markets Gattex, and Drugs@FDA lists no approved generic[2].
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Where Teduglutide fits
Teduglutide, sold as Gattex, is a GLP-2 medicine FDA-approved for adults and children 1 year and older with short bowel syndrome who depend on parenteral support[1].
- SBS care starts with nutrition, and NORD describes parenteral nutrition through a vein, a diet built around frequent small meals, oral rehydration solutions, and medicines such as loperamide and diphenoxylate for diarrhea and acid reducers[11].
- NORD describes surgery to lengthen or taper the bowel, and small bowel transplant for severe cases, as later options[11].
- Zorbtive, a growth hormone approved for SBS in adults on specialized nutrition support, has 3 of its 4 vial strengths listed as discontinued in Drugs@FDA, and Drugs@FDA lists NutreStore, an L-glutamine powder approved for SBS alongside growth hormone, as discontinued[12][13][14].
- Gattex's adult trials compared it with placebo, and no trial has compared it head to head with another SBS medicine[1].
- A question to bring to a gastroenterologist or intestinal rehabilitation team is how much parenteral support might come down, and how the colonoscopy and lab schedule would fit with current care.
How Teduglutide works
GLP-2 is a hormone made by cells at the end of the small intestine. The label says it increases blood flow to the gut and lowers stomach acid[1]. Teduglutide is a lab-made version of GLP-2 that binds GLP-2 receptors in the gut wall and triggers the local release of growth signals, including IGF-1, nitric oxide and keratinocyte growth factor[1].
In a 21-day study of 17 adults with SBS, most doses tested raised the fluid the gut absorbed by about 750-1000mL a day and made the villi taller and the crypts deeper, the finger-like folds and pockets that do the absorbing[1]. More absorption is why doctors can often lower the amount of parenteral support. Because GLP-2 drives growth of the gut lining, the label also warns that teduglutide could speed the growth of polyps or tumors[1].
Side effects and safety
- Faster growth of polyps or cancer. Gattex may speed the growth of abnormal tissue. It is stopped if a gut, liver, bile duct or pancreas cancer develops, and continued only after weighing benefit and risk for other cancers. Polyps were found in 14 adults in the trials and extensions.
- Blocked intestine. Intestinal or stoma blockage occurred in 3 of 77 adults on the recommended dose in the controlled trials and none on placebo. Gattex is paused while a blockage is treated and may be restarted once it resolves.
- Gallbladder, bile duct and pancreas disease. Gallbladder inflammation, bile duct infection, gallstones and pancreatitis were reported. Bilirubin, alkaline phosphatase, lipase and amylase are checked before starting and at least every 6 months.
- Fluid overload and heart failure. Better fluid absorption can cause swelling or fluid overload, and 2 adults on Gattex had heart failure. Parenteral support is adjusted when fluid overload occurs.
- More absorption of other pills. Gattex may raise levels of oral medicines. People on drugs that need careful dosing, such as benzodiazepines, are watched and may need a lower dose.
- Stopping treatment. Fluid and salt balance is monitored after Gattex is stopped.
- Adults: colonoscopy and upper endoscopy with polyp removal within 6 months before starting, again after 1 year, then at least every 5 years
- Children: a stool blood test within 6 months before starting and every year, colonoscopy or sigmoidoscopy after 1 year and every 5 years
- Bilirubin, alkaline phosphatase, lipase and amylase before starting and at least every 6 months
- Fluid status and swelling, especially with heart disease
- Levels or side effects of oral medicines that need careful dosing
- Fluid and salt balance after stopping
Gattex has no boxed warning[1]. In the 2 placebo-controlled adult trials, the most common side effects on Gattex against placebo were belly pain (30% against 22%), nausea (23% against 20%), upper respiratory infections (21% against 12%), a swollen belly (20% against 2%), injection site reactions (13% against 12%), vomiting (12% against 10%), fluid overload such as swelling of the legs (12% against 7%) and allergic-type skin reactions (10% against 7%)[1].
Among people with a stoma, stoma problems affected 42% on Gattex against 14% on placebo[1]. The label's warnings cover faster growth of polyps or cancers, blocked intestines (3 of 77 adults on the recommended dose in the controlled trials, none on placebo), gallbladder, bile duct and pancreas disease, and fluid overload including heart failure, seen in 2 adults[1].
Polyps were found in 14 adults across the trials and extensions[1]. In one extension study, 3 men were diagnosed with cancer: one with metastatic adenocarcinoma of unknown origin who had had abdominal radiation decades earlier, and 2 heavy smokers with lung cancer[1]. Because Gattex can increase the absorption of other oral medicines, one adult taking the benzodiazepine prazepam fell into a coma in the first week, which resolved after both drugs were stopped[1].
Stopping Gattex can upset fluid and salt balance[1]. In children 1 to 17, the safety profile was similar to adults[1]. Case reports in pregnancy have not shown a drug-related risk, and the label does not recommend breastfeeding during treatment[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Teduglutide
Gattex is injected under the skin once a day at a dose of 0.05mg/kg of body weight, for adults and children alike[1]. People with an eGFR below 60, meaning moderate to severe kidney impairment or kidney failure, take half that dose, 0.025mg/kg once a day[1]. Injection sites rotate among the belly, thighs and upper arms. Each dose is mixed at home: 0.5mL of sterile water from a prefilled syringe is added to a 5mg vial of powder, rolled gently and never shaken, and used within 3 hours; no more than 0.38mL (3.8mg) can be drawn from a vial[1].
Adults or caregivers give the injections, and self-injection by children has not been tested. The 5mg kit is not recommended for children under 10kg[1]. A missed dose is taken as soon as possible that day, never as 2 doses on the same day. Gattex comes as a 1-vial kit or a 30-vial kit; vials are refrigerated before dispensing and can be kept at room temperature up to 25°C for 90 days after the pharmacy dispenses them[1].
Availability and cost
Only available as the brand-name product.
A daily injection made by recombinant DNA technology and taken for the long term. The label gives no price. Takeda's co-pay program covers eligible commercially insured patients, and Drugs@FDA lists no therapeutic equivalent to Gattex.
Help paying for Gattex
With private insurance, the drugmaker's copay card can lower what you pay for Gattex. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE, but charity funds often can. Of the 4 charity funds for Short Bowel Syndrome, 4 were open on October 26, 2026. Pick your insurance below to see which offers fit you.
- Copay help
Eligible patients may pay as little as $0 per Gattex prescription. Patients must be enrolled in Takeda Patient Support and have commercial insurance; other terms and conditions apply, and the page states no maximum.
For: private insurance · source - Insurance and case manager help
A support specialist helps people get treatment when they need it, coordinates with the specialty pharmacy to fill and ship Gattex, can arrange nursing support and offers referrals to community resources.
The official page does not say who qualifies. Ask the program. · source
Good to know: Call Monday through Friday, 8:30 AM to 8:00 PM ET. The page does not describe a free-drug program.
Charity funds for Short Bowel Syndrome
- From a charity · NORD RareCareShort Bowel Syndrome Medical Assistance fundOpen
Pays for: Medical and medication costs.
The foundation says: “Accepting new applications and re-enrollments for current year” - From a charity · NORD RareCareShort Bowel Syndrome Premium Copay Assistance fundOpen
Pays for: Insurance premiums and copays.
The foundation says: “Accepting new applications and re-enrollments for current year” - From a charity · The Assistance FundShort Bowel Syndrome fundOpen
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
- From a charity · TotalAssist (formerly PAN Foundation)Short Bowel Syndrome fundOpen
Pays for: Out-of-pocket costs for approved medications, up to $6,000 per year. Requires health insurance (any kind).
Access and eligibility
Adults and children 1 year and older with short bowel syndrome who depend on parenteral support[1]. Safety and effectiveness under 1 year have not been established, and the 5mg kit is not recommended for children under 10kg. The adult trials enrolled people who had needed parenteral nutrition for at least 12 months, at least 3 times a week. Adults need a colonoscopy and upper endoscopy within 6 months before starting, and children need a stool blood test. For people at higher risk of cancer, the label says Gattex should be used only if the benefits outweigh the risks. People with an eGFR below 60 take half the dose, and Gattex has not been studied in severe liver impairment[1].
Source: Gattex Financial Support & Patient Support
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
Study 1, STEPS (NCT00798967), randomly assigned 86 adults who had needed parenteral support for at least 12 months, at least 3 times a week, to Gattex or placebo for 24 weeks[1][6]. A response, at least a 20% cut in weekly IV volume at weeks 20 and 24, came in 63% (27 of 43) on Gattex against 30% (13 of 43) on placebo, and weekly IV volume fell 4.4 liters against 2.3 liters from about 13 liters a week[1].
In the 2-year open-label extension (NCT00930644), 28 of 30 people who completed 30 months had at least a 20% cut, the average cut was 7.55 liters a week (66%), and 10 came off parenteral support entirely[1][7]. An earlier 24-week trial (NCT00081458) found responses in 46% on the recommended dose against 6% on placebo, though its main graded endpoint was not met for the higher dose[1][8].
In children aged 1 to 17 (NCT02682381), families chose Gattex or standard care, and 69% (18 of 26) on the recommended dose cut parenteral support volume by at least 20% over 24 weeks, 38% dropped at least 1 infusion day a week and 12% (3 of 26) came off it entirely[1][9]. In the children's extension (NCT02954458), 13 of 15 who had responded needed Gattex again after stopping it[1][10].
Development history
NPS Pharmaceuticals submitted the application on November 30, 2011, and the FDA approved Gattex for adults with SBS who depend on parenteral support on December 21, 2012, as a new molecular entity with orphan status, under NDA 203441[3][2]. The approval came with a REMS, a required FDA safety program[4]. The FDA approved label changes with new clinical data in June 2014 and December 2018[2].
On May 16, 2019 the FDA extended the approval to children 1 year and older after priority review, and Takeda announced it the next day as the first US-approved therapy for children with SBS on parenteral support that improves absorption[2][5]. On August 26, 2026 the FDA approved the end of the Gattex REMS, finding it no longer necessary because adverse event rates stayed stable, about 80% of prescriptions from 2020 to 2024 came from specialists, and the prescribers interviewed knew the risks and the recommended monitoring[4].
The label updated in September 2025 reports the current safety and dosing information[1].
Explore Short Bowel Syndrome trials
Common questions about Teduglutide
▸What is Teduglutide (Gattex)?
A once-daily injection under the skin for adults and children 1 year and older with short bowel syndrome (SBS) who depend on parenteral support, the nutrition and fluids given through a vein[1]. The FDA approved Gattex for adults on December 21, 2012 and for children 1 year and older on May 16, 2019[2]. Gattex helps the remaining intestine absorb more, and in the main adult trial 63% of people on it cut their weekly IV volume by at least 20%, against 30% on placebo[1]. Gattex has no boxed warning, and the FDA ended its safety program (REMS) on August 26, 2026[4]. Takeda markets Gattex, and Drugs@FDA lists no approved generic[2].
▸How does Teduglutide work?
GLP-2 is a hormone made by cells at the end of the small intestine. The label says it increases blood flow to the gut and lowers stomach acid[1]. Teduglutide is a lab-made version of GLP-2 that binds GLP-2 receptors in the gut wall and triggers the local release of growth signals, including IGF-1, nitric oxide and keratinocyte growth factor[1]. In a 21-day study of 17 adults with SBS, most doses tested raised the fluid the gut absorbed by about 750-1000mL a day and made the villi taller and the crypts deeper, the finger-like folds and pockets that do the absorbing[1]. More absorption is why doctors can often lower the amount of parenteral support. Because GLP-2 drives growth of the gut lining, the label also warns that teduglutide could speed the growth of polyps or tumors[1].
▸What are the side effects of Teduglutide?
Gattex has no boxed warning[1]. In the 2 placebo-controlled adult trials, the most common side effects on Gattex against placebo were belly pain (30% against 22%), nausea (23% against 20%), upper respiratory infections (21% against 12%), a swollen belly (20% against 2%), injection site reactions (13% against 12%), vomiting (12% against 10%), fluid overload such as swelling of the legs (12% against 7%) and allergic-type skin reactions (10% against 7%)[1]. Among people with a stoma, stoma problems affected 42% on Gattex against 14% on placebo[1]. The label's warnings cover faster growth of polyps or cancers, blocked intestines (3 of 77 adults on the recommended dose in the controlled trials, none on placebo), gallbladder, bile duct and pancreas disease, and fluid overload including heart failure, seen in 2 adults[1]. Polyps were found in 14 adults across the trials and extensions[1]. In one extension study, 3 men were diagnosed with cancer: one with metastatic adenocarcinoma of unknown origin who had had abdominal radiation decades earlier, and 2 heavy smokers with lung cancer[1]. Because Gattex can increase the absorption of other oral medicines, one adult taking the benzodiazepine prazepam fell into a coma in the first week, which resolved after both drugs were stopped[1]. Stopping Gattex can upset fluid and salt balance[1]. In children 1 to 17, the safety profile was similar to adults[1]. Case reports in pregnancy have not shown a drug-related risk, and the label does not recommend breastfeeding during treatment[1].
▸How is Teduglutide taken?
Gattex is injected under the skin once a day at a dose of 0.05mg/kg of body weight, for adults and children alike[1]. People with an eGFR below 60, meaning moderate to severe kidney impairment or kidney failure, take half that dose, 0.025mg/kg once a day[1]. Injection sites rotate among the belly, thighs and upper arms. Each dose is mixed at home: 0.5mL of sterile water from a prefilled syringe is added to a 5mg vial of powder, rolled gently and never shaken, and used within 3 hours; no more than 0.38mL (3.8mg) can be drawn from a vial[1]. Adults or caregivers give the injections, and self-injection by children has not been tested. The 5mg kit is not recommended for children under 10kg[1]. A missed dose is taken as soon as possible that day, never as 2 doses on the same day. Gattex comes as a 1-vial kit or a 30-vial kit; vials are refrigerated before dispensing and can be kept at room temperature up to 25°C for 90 days after the pharmacy dispenses them[1].
▸Is Teduglutide FDA approved?
Yes, Teduglutide (Gattex) is FDA approved (2012) for the treatment of Short Bowel Syndrome.
▸What tests do you need before and during Gattex?
Adults need a colonoscopy and upper endoscopy within 6 months before starting, and everyone gets blood tests for the gallbladder and pancreas[1].
Adults: colonoscopy and upper endoscopy with removal of any polyps before starting, again after 1 year, then at least every 5 years.
Children: a stool blood test before starting and every year, with colonoscopy or sigmoidoscopy after 1 year and every 5 years while on Gattex.
Blood tests: bilirubin, alkaline phosphatase, lipase and amylase before starting and at least every 6 months.
Why: Gattex makes the gut lining grow and may speed the growth of polyps or tumors.
Source: Gattex prescribing information, September 2025.
▸Can people get off TPN with Gattex?
Some did in the trials, but most people cut parenteral support rather than stopping it[1].
Adults: in the 2-year extension, 10 of 30 people who completed 30 months of Gattex came off parenteral support entirely, and 28 of 30 cut it by at least 20%.
Children: 3 of 26 on the recommended dose came off parenteral support within 24 weeks, and 69% cut it by at least 20%.
After stopping: in the children's extension, 13 of 15 who had responded needed Gattex again after stopping it.
Ask: how much IV support might come down depends on the remaining bowel and is a question for the SBS care team.
Source: Gattex prescribing information, September 2025.
▸Does Gattex still have a REMS?
No. The FDA approved the end of the Gattex REMS on August 26, 2026[4].
Why: the FDA found that adverse event rates stayed stable, about 80% of prescriptions from 2020 to 2024 came from specialists, and the prescribers interviewed knew the risks and the recommended monitoring.
What stays: the label's warnings and its colonoscopy and lab schedule are unchanged.
History: the REMS began with the approval on December 21, 2012.
Source: FDA supplement approval letter, NDA 203441/S-28, August 26, 2026.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- Takeda Pharmaceuticals America via DailyMed · 2025-09-05. GATTEX- teduglutide injection, powder, lyophilized, for solution GATTEX- teduglutide kit. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=66b69c1e-b25c-44d3-b5ff-1c1de9a516fa
- FDA · 2012-12-21. GATTEX KIT approval history, NDA 203441. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203441
- FDA Center for Drug Evaluation and Research · 2012-12-21. Approval Package for: APPLICATION NUMBER: 203441Orig1s000. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203441Orig1s000Approv.pdf
- FDA · 2026-08-26. NDA 203441/S-28 SUPPLEMENT APPROVAL. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/203441Orig1s028ltr.pdf
- Takeda via PR Newswire (BioSpace) · 2019-05-17. U.S. FDA Approves GATTEX® (teduglutide) for Children 1 Year of Age and Older With Short Bowel Syndrome (SBS). https://www.biospace.com/article/releases/u-s-fda-approves-gattex-teduglutide-for-children-1-year-of-age-and-older-with-short-bowel-syndrome-sbs-/?s=74
- ClinicalTrials.gov. Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects. https://clinicaltrials.gov/study/NCT00798967
- ClinicalTrials.gov. Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS). https://clinicaltrials.gov/study/NCT00930644
- ClinicalTrials.gov. Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome. https://clinicaltrials.gov/study/NCT00081458
- ClinicalTrials.gov. Short Bowel Syndrome Research Study for Children Up To 17 Years of Age on Parenteral Nutrition. https://clinicaltrials.gov/study/NCT02682381
- ClinicalTrials.gov. Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS). https://clinicaltrials.gov/study/NCT02954458
- National Organization for Rare Disorders. Short Bowel Syndrome - Symptoms, Causes, Treatment | NORD. https://rarediseases.org/rare-diseases/short-bowel-syndrome/
- FDA. ZORBTIVE approval history, BLA 021597. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021597
- FDA · 2004-06-10. NUTRESTORE approval history, NDA 021667. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021667
- FDA openFDA drug label · 2018-12-11. NutreStore (L-glutamine powder for oral solution) label, set id cd3fb572-c5b1-43da-aea2-31208985f544. https://api.fda.gov/drug/label.json?search=set_id:cd3fb572-c5b1-43da-aea2-31208985f544
- Takeda. GATTEX® (teduglutide) Financial Support & Patient Support. https://www.gattex.com/insurance-and-copay-assistance