At a glance
- Teduglutide is an FDA-approved drug, marketed as Gattex (first approval: December 21, 2012).
- PubMed lists 371 publications mentioning it, including 22 randomized controlled trials and 24 animal-only studies.
- ClinicalTrials.gov lists 50 registered studies testing it (5 active).
- FDA's adverse event system (FAERS) holds 13,686 reports mentioning it; 11,518 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| NDA203441 | GATTEX KIT | Approved, marketed | December 21, 2012 | TAKEDA PHARMS USA |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Development of Teduglutide purity certified reference material (GBW09342) through amino acid-based isotope dilution mass spectrometry and sulfur-based isotope dilution inductively coupled plasma mass spectrometry.
- Characteristics associated with response to teduglutide in pediatric short bowel syndrome-associated intestinal failure: Post hoc analysis of open-label long-term extension trials.
- Diffuse gallbladder epithelial proliferation after teduglutide exposure: A case report.
- Teduglutide for intestinal failure following multivisceral transplantation complicated by graft rejection and PTLD: A case report.
- Gut-derived glucagon-like peptides attenuate T cell-induced intestinal injury.
- Novel variant and enteroendocrine hormone deficiency in a patient with proline and glutamate-rich protein with a coiled coil domain 1 (PERCC1) associated enteropathy: New diagnostic and therapeutic insights.
- Dietary and Parenteral Nutritional Management of Short Bowel Syndrome with Intestinal Failure in Adults: A Narrative Review.
- Biological Insights into Intestinal Adaptation from Preclinical Models of Short Bowel Syndrome.
- Effectiveness, safety, and quality of life outcomes of teduglutide treatment in adult patients with short bowel syndrome-associated intestinal failure: A systematic literature review of real-world studies.
- Safety and long-term effectiveness of teduglutide in children with intestinal failure due to short bowel syndrome: a multicenter, post-marketing cohort study.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 50
- Active
- 5
- With posted results
- 20
Conditions studied
Show 40 more studies
All 50 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 13,686
- Serious
- 11,518
- With death outcome
- 1,175
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.