Digestive & weight GLP-2 analog
Teduglutide
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- Also known as
- Gattex
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Teduglutide (sold as Gattex) is a long-acting analog of the hormone GLP-2 that helps the intestine absorb more nutrients, used in short bowel syndrome to reduce dependence on intravenous nutrition. It promotes growth of the intestinal lining, enlarging the absorptive surface. It has been FDA-approved in the U.S. since 2012 and is given as a daily subcutaneous injection.
At a glance
- What it is
- A glucagon-like peptide-2 (GLP-2) analog
- Approved for
- Short bowel syndrome in people dependent on parenteral (intravenous) support
- Key fact
- In extended trials, the large majority of continuously treated patients reduced their parenteral support, and some achieved full independence from it
- Route
- Subcutaneous injection, once daily
- Evidence strength
- FDA approved
Summary
Teduglutide is a GLP-2 analog, FDA-approved since 2012, for short bowel syndrome. Learn how it helps the gut absorb nutrients, who uses it, and key risks.
What is teduglutide?
Teduglutide, sold under the brand Gattex (Revestive in some regions), is a modified version of glucagon-like peptide-2 (GLP-2), a hormone that promotes growth and repair of the intestinal lining. It is used for short bowel syndrome, a condition in which a large portion of the intestine has been removed or is not functioning, leaving patients unable to absorb enough nutrition and often dependent on intravenous (parenteral) feeding. It was developed under the code ALX-0600 and approved in the United States in 2012.
How does teduglutide work?
Teduglutide binds the GLP-2 receptor in the intestine, acting as a longer-lasting version of the natural hormone; a single amino-acid change makes it resistant to the enzyme that normally breaks GLP-2 down within minutes. Stimulating this receptor promotes growth of the intestinal mucosa, increasing the height of the villi and the depth of the crypts, which enlarges the surface available to absorb nutrients and fluid.
In short bowel syndrome, that expanded absorptive surface lets patients take in more nutrition through the gut and depend less on intravenous feeding. In the pivotal program and its extension, the large majority of patients who continued teduglutide reduced their parenteral support, and a subset reached full independence from it. The trade-off is that the same growth-promoting effect requires monitoring of the colon for polyps.
Is it FDA-approved?
Editor’s note
Status: Yes. Teduglutide was approved by the FDA in 2012 for short bowel syndrome in adults dependent on parenteral support, with a later pediatric approval for children 1 year and older. It is given as a once-daily subcutaneous injection.
Category: FDA-approved · Primary body area: Digestive & weight
Yes. Teduglutide was approved by the FDA in 2012 for short bowel syndrome in adults dependent on parenteral support, with a later pediatric approval for children 1 year and older. It is given as a once-daily subcutaneous injection.
What is teduglutide prescribed for?
Teduglutide is prescribed for adults and children with short bowel syndrome who depend on parenteral nutrition or intravenous fluids, to reduce that dependence. Because it stimulates tissue growth, a colonoscopy is recommended before starting, with periodic surveillance afterward.
What are the side effects?
According to the prescribing information, common side effects include:
- Abdominal pain and distension
- Nausea and vomiting
- Upper respiratory tract infection
- Injection-site reactions
- Fluid overload
- Allergic reactions
More serious considerations include:
- Growth of colorectal polyps, so colon surveillance is advised
- Intestinal obstruction
- Gallbladder, biliary, and pancreatic problems
- Fluid overload
Sources: FDA prescribing information for Gattex; the STEPS program and its STEPS-2 extension (Schwartz et al., Clinical and Translational Gastroenterology, 2016, DOI: 10.1038/ctg.2015.69), indexed on PubMed. This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
approved (PDF)
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