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Teduglutide (Gattex, Revestive)

Also known as Gattex and Revestive.

Approved in the US and the EU since 2012 for short bowel syndrome. Long-term cancer-risk data are still accumulating and need years more surveillance.

HisGlyAspGlySerPheSerAspGluMetAsnThrIleLeuAspAsnLeuAlaAlaArgAspPheIleAsnTrpLeuIleGlnThrLysIleThrAsp
33 amino acids, in order. End caps, bridges and anything attached to the chain are not drawn. Source: PubChem.
Human evidence
Grade A

Large trials

Completed randomized trials
4+

The plus sign marks a floor: the record counts more trials than it lists.

Approved?
US and EU

Approved in the US and the EU

Sport (WADA)
Not named

Not named on WADA's list. That is not clearance.

Checked on .

How we count a trial
Short answer

As of September 2026, teduglutide has been approved in the US and the EU since 2012 for short bowel syndrome. The FDA added children aged 1 and older in 2019. Long-term cancer-risk data are still accumulating. A vial that reached you outside a pharmacy was not in any of the trials, and a label alone cannot show you what is inside.

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What is teduglutide?

Teduglutide is a lab-made, 33-amino-acid version of human GLP-2, a natural gut hormone, changed to resist rapid breakdown. NPS Pharmaceuticals brought it to market, and it later passed to Shire and then Takeda. The FDA approved it in 2012 for adults with short bowel syndrome who depend on IV nutrition, then for children aged 1 and older in 2019.

Does teduglutide work?

For short bowel syndrome in people who depend on IV nutrition, the FDA reviewed the trials and approved it. It has held EMA approval since 2012.

What we found. 4+ completed randomized trials counted on the record. 3 study rows listed below, and one of them is a long-term extension. The number shows with a plus sign until every trial is listed.

Studies on the teduglutide record: each study, what it was tested in, its status and what it shows.
STEPS trial, the main Phase 3 trialPeopleCompleted. The key trial for FDA approvalPeople with short bowel syndrome needed a smaller volume of IV nutrition and fluids
STEPS-2, the long-term extensionPeopleCompletedThe reduction in IV support continued with long-term use, up to several years
Phase 3 trial in children aged 1 to 17PeopleCompleted. Approved in 2019It supported a lower dependence on IV nutrition
How we count a trial

Is teduglutide safe?

The key concerns on the record include a potential for faster growth of polyps in the intestine, which calls for colonoscopy checks. It also names gallbladder and pancreas effects. Its growth-promoting action raises a theoretical concern about tumors in the intestine, and long-term cancer-risk data are still accumulating. This is the picture for the approved product. A vial from another source is a different matter, taken up in the vial section.

What is in a vial sold as teduglutide?

STEPS and the other trials above stand behind the approved product, which the record names as Gattex and Revestive. On this record there is no sign of teduglutide being sold outside pharmacies. A vial that reached you another way was not in those trials, and the checklist lists what to ask the seller.

What don't we know?

  • Whether long-term use raises cancer risk in the intestine. The data are still accumulating.
  • What registries running ten years or more will show about colon and rectum polyps and tumors.
  • What a vial labeled teduglutide contains when no pharmacy supplied it.

The other side

Teduglutide comes with a prescription and a doctor's care, colonoscopy checks included. In its main trial, people needed a smaller volume of IV nutrition and fluids. The cancer question is one the record calls theoretical, and the data to answer it are still accumulating.

What would change this record?

  • Registry data covering ten years or more that track polyps and tumors of the colon and rectum in treated patients.

Change log

  • Record checked. No change logged yet.
Every change on the Table

Three questions to ask next

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More questions about teduglutide

What is teduglutide used for?

Short bowel syndrome. The FDA approved it in 2012 for adults who depend on IV nutrition, and in 2019 for children aged 1 and older.

Is teduglutide the same as Gattex?

Gattex is one of two brand names for teduglutide. The other is Revestive. The record does not say which name is used where.

Is teduglutide a GLP-2 medicine?

Yes. It is a lab-made version of human GLP-2, a natural gut hormone, changed to resist rapid breakdown.

Does teduglutide cause cancer?

Nobody knows yet. The record calls the concern theoretical and says long-term cancer-risk data are still accumulating.

Is teduglutide banned in sport?

It is not named on WADA's list. That is not clearance, and this record holds no sport source. If you compete, check the current List.
Sources

Record checked on . Each source shows the date it was checked.

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