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FDA approved for specific usesStrong human evidence for approved uses

Plain-English fact sheet

Teduglutide

Also known as Gattex, Revestive, GLP-2 analog

Digestive and gut health

Teduglutide is an intestinal-growth peptide medicine for a narrowly defined short bowel syndrome population, not a general gut-healing or recovery product.

Quick answer

Teduglutide is FDA approved as Gattex for adults and children 1 year and older with short bowel syndrome who depend on parenteral support. It is not approved for routine gut health, inflammatory bowel disease, food intolerance, or wellness.

By the PeptideFactSheets Editorial Team. Use the source links to verify status, evidence, risks, and unknowns; our editorial policyexplains the boundaries. Clinician review appears only when a named reviewer is shown.

What is Teduglutide?

Teduglutide is a long-acting analog of glucagon-like peptide 2, a hormone that supports intestinal growth, blood flow, and absorption.

Its clinical endpoint is reduced need for parenteral nutrition or fluids in short bowel syndrome, not a vague measure of gut repair.

Why are people interested in it?

It is a strong example of a peptide improving organ function through tissue adaptation rather than weight or hormone-release effects.

Its growth-promoting mechanism also explains important polyp, neoplasia, obstruction, and fluid-related safety concerns.

Current regulatory status

FDA approved for specific uses

Gattex is FDA approved for adults and pediatric patients 1 year of age and older with short bowel syndrome who are dependent on parenteral support.

What is it approved for?

  • Treatment of short bowel syndrome with dependence on parenteral support in the age groups specified by the Gattex label

FDA approval path

FDA approved

FDA approved for short bowel syndrome

Teduglutide is approved under the Gattex label for short bowel syndrome with parenteral-support dependence in specified age groups.

Step 7 of 7

  1. DiscoveryBasic research
  2. PreclinicalLab and animal work
  3. Phase 1Initial human testing
  4. Phase 2Condition-focused trials
  5. Phase 3Confirmatory trials
  6. FDA reviewApplication review
  7. ApprovedLabel-specific use

What is it being studied for?

Short bowel syndrome
Intestinal absorption
Parenteral-support reduction
Pediatric intestinal failure

Investigational areas

  • Long-term intestinal autonomy and outcomes in selected intestinal-failure populations

Evidence snapshot

Strong human evidence for approved uses

Randomized trials support reduced parenteral-support requirements in the labeled population. That evidence does not transfer to general digestive symptoms or unapproved gut-healing claims.

Potential benefits being researched

  • Controlled trials found that more participants reduced parenteral-support volume than with placebo.
  • Some long-term studies report further support reduction, but response varies and the therapy does not restore normal anatomy.

Potential does not mean proven. Study design, population, endpoint, and regulatory review matter.

Known or possible risks

  • The label warns about accelerated neoplastic growth and requires attention to gastrointestinal polyps and malignancy risk.
  • Intestinal obstruction, biliary and pancreatic disease, and fluid overload are important labeled risks.
  • Increased absorption can change exposure to other oral medicines.

What we still do not know

  • Very long-term malignancy and polyp outcomes
  • Which patients can achieve durable independence from parenteral support
  • How pediatric outcomes evolve across growth and development
  • Whether benefits persist after treatment ends

Plain-English takeaway

Teduglutide has a meaningful, narrow intestinal-failure role. Its evidence cannot be repackaged as proof of a general gut-repair peptide.

Research and reference links

Use these primary and reputable sources to verify status and read beyond this summary. Trial registries may list studies without proving a benefit.

  1. 1
    fdaFDA prescribing information: Gattex

    Current indication, warnings, adverse reactions, and clinical studies.

  2. 2
    pubmedRandomized teduglutide short bowel syndrome trial

    Controlled evidence for reduced parenteral nutrition and fluid requirements.

  3. 3
    pubmedPhase 3 and extension study in Japan

    Small longer-term study illustrating response durability and population limits.