Teduglutide
Main evidence: Human clinical trials. Updated 2026-10-28.
What research and users report, not a recommendation or medical advice. Many of these products are not approved for human use. Ask your doctor. Packs report what sources say, each with its evidence label. A claim labelled community, educator, manufacturer or animal has not been validated in humans.
Summary
This pack organizes cited evidence, dosing context, safety cautions, and Australian legal status for Teduglutide.
What the sources say
- Teduglutide is a GLP-2 analogue studied and approved for short bowel syndrome in people dependent on parenteral support; the measured benefit is reduced need for that support, not general "gut healing." (Human clinical trials; Jeppesen et al., Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure, 2012-09-11)
- In the 24-week STEPS randomized trial, 63% of teduglutide participants versus 30% on placebo achieved at least a 20% reduction in parenteral-support volume; mean weekly volume reduction was 4.4 L versus 2.3 L. The study population had short bowel syndrome with intestinal failure. (Human clinical trials; Jeppesen et al., Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure, 2012-09-11)
- A Boston Children's Hospital story describes one child in a clinical trial who moved from parenteral nutrition to a feeding tube after six months of treatment and declined during a study washout; this family account cannot estimate typical benefit. (Community reports; Boston Children's Hospital, Leading the way: Ava's experience with teduglutide, 2019-05-30)
- The Australian TGA assessment for Revestive records an approval decision and classifies the product as a prescription medicine. (Educator material (not peer reviewed); Therapeutic Goods Administration, AusPAR: teduglutide, 2018-04-12)
- The FDA label warns about potential acceleration of neoplastic growth, intestinal or stomal obstruction, biliary and pancreatic disease, and fluid overload including heart failure; it calls for clinical and laboratory monitoring. (Manufacturer information; U.S. FDA, GATTEX (teduglutide) prescribing information (revised 2025-09; accessed 2026-10-28), 2026-10-28)
- The label warns that absorption of concomitant oral medicines may increase and that discontinuation may cause fluid and electrolyte imbalance. (Manufacturer information; U.S. FDA, GATTEX (teduglutide) prescribing information (revised 2025-09; accessed 2026-10-28), 2026-10-28)
- The TGA says unapproved peptide products may not have been assessed for safety, quality or effectiveness and may be incorrectly labelled or non-sterile; these cautions concern unapproved products generally, not the registered Revestive presentation. (Educator material (not peer reviewed); Therapeutic Goods Administration, Peptide products (last updated 2026-09-23), 2026-09-23)
- The TGA warns that therapeutic peptide products not included in the ARTG have not been assessed by the regulator; an online vial labelled "teduglutide" is not thereby shown to be the registered Revestive product. (Educator material (not peer reviewed); Therapeutic Goods Administration, Peptide products (last updated 2026-09-23), 2026-09-23)
- As of 2026-10-28, the TGA AusPAR page lists Revestive (teduglutide), records the decision as approved, and identifies it as a prescription medicine; the approved indication and product instructions should not be broadened to unrelated uses. (Educator material (not peer reviewed); Therapeutic Goods Administration, AusPAR: teduglutide, 2018-04-12)
Sources
- Jeppesen et al., Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure (2012-09-11)
- Boston Children's Hospital, Leading the way: Ava's experience with teduglutide (2019-05-30)
- Therapeutic Goods Administration, AusPAR: teduglutide (2018-04-12)
- U.S. FDA, GATTEX (teduglutide) prescribing information (revised 2025-09; accessed 2026-10-28) (2026-10-28)
- Therapeutic Goods Administration, Peptide products (last updated 2026-09-23) (2026-09-23)
Dosing, stacking and protocol details are not published here.