Reviewed & approved by Dr. Nova Reyes · Last checked 2026-10-25. ← Back to Evidence Library
title: "Teduglutide: What the evidence says" slug: teduglutide status: Draft (v1), pending review by Dr. Nova Reyes (Batch F #63) last_checked: 2026-10-25 evidence_verdict: "Short bowel syndrome on parenteral support (labeled): Moderate · "Gut repair" uses: No human data" card_verdict: "Moderate (short bowel syndrome on IV nutrition) · "Gut repair" uses: No human data" related: [dapiglutide, larazotide, bpc-157]
Draft (v1), pending review. Not public. · ← Library · DRAFT · not published · last checked 2026-10-25
Teduglutide: what the evidence says
At a glance
What it is: a 33-amino-acid analog of GLP-2, a gut hormone that grows the intestinal lining, sold as Gattex for short bowel syndrome in people who depend on IV nutrition (parenteral support). R1, R2 Gray-market sellers market "GLP-2" for gut repair.
What the evidence says: in the 86-person STEPS trial, 63% on teduglutide vs 30% on placebo cut their IV nutrition volume by more than 20% at 24 weeks. R3 In an earlier 83-person trial, the lower of two amounts worked and the higher one did not reach significance. R4
Biggest risks: it can speed the growth of existing tumors or polyps, so the label requires colonoscopy before starting and stopping if a GI cancer develops; gallbladder, bile duct and pancreas problems; bowel obstruction; and fluid overload. R1
Rating
| Human Human evidence | Moderate for short bowel syndrome with parenteral dependence (two RCTs, 83–86 people) R3, R4; No human data for "gut repair" or leaky-gut uses in people without short bowel syndrome |
| Animal Animal / lab evidence | Rat and mouse tumor findings drive the neoplastic-growth warning (label) R1 |
| Regulatory | FDA-approved: Gattex NDA 203441 (Dec 21, 2012) R2 · WADA: not named on the 2026 List R5 |
| Established human dose | For labeled use: on the FDA label (weight-based) R1. Study details lists what trials used |
Evidence verdict: Short bowel syndrome on parenteral support (labeled): Moderate · "Gut repair" uses: No human data Card verdict: Moderate (short bowel syndrome on IV nutrition) · "Gut repair" uses: No human data Card note: Tumor-growth warning; never tested for general gut health, see page.
This page reports what studies used. It is not dosing advice.
Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source
About the evidence: both trials were sponsored by the original developer (NPS Pharmaceuticals, later acquired by Shire/Takeda), with small samples typical of a rare disease.
What is it?
Teduglutide mimics GLP-2, which makes the intestinal lining grow and absorb more. In short bowel syndrome, where much of the intestine has been removed, that can reduce the need for IV feeding. R1, R3 Related pages: Dapiglutide, Larazotide, BPC-157.
Does it work?
- Human STEPS (phase 3): 86 adults: responders 27/43 (63%) vs 13/43 (30%); IV volume fell 4.4 vs 2.3 L per week. R3
- Human Earlier phase 3: 83 adults: the lower amount beat placebo (16/35 graded responders); the higher amount did not (p=0.16). Three patients came fully off IV support. R4
Is it safe?
- Human Acceleration of neoplastic growth: discontinue if intestinal malignancy develops; polyps were seen in trials and postmarketing; colonoscopy and upper endoscopy before starting. R1
- Human Biliary and pancreatic disease: cholecystitis, cholangitis, gallstones and pancreatitis reported; labs before and every 6 months. R1
- Human Trials: discontinuations for side effects similar to placebo (2 vs 3 in STEPS). R3
Gray-market "research use only" Teduglutide: extra risks
Not the approved product. "Research GLP-2" or "teduglutide" vials are not Gattex; identity, strength and sterility are unknown. Unknown Using a growth-promoting gut hormone without the label's cancer screening removes the main safeguard.
What we don't know
- Unknown Any benefit in people with a normal-length intestine
- Unknown Long-term cancer risk outside monitored patients
- Unknown Quality of gray-market GLP-2 products
Is it legal?
US: FDA-approved as Gattex (NDA 203441) for adults and children 1 year and older with short bowel syndrome who depend on parenteral support. R1, R2 EU, UK and others: UNVERIFIED. WADA: not named on the 2026 Prohibited List R5; whether a catch-all class applies: UNVERIFIED.
Study details
Study details
These are amounts researchers used, not recommendations. ### R3 Human RCT: STEPS (Jeppesen 2012) | Study | People / model | Route | Amount used | Follow-up | Reported | Side effects / limitations | Citation | |---|---|---|---|---|---|---|---| | Jeppesen 2012 | 86 adults with SBS and intestinal failure | Subcutaneous | 0.05 mg/kg/day | 24 weeks | Responders 63% vs 30% | Small; rare disease | [PMID 22982184](https://pubmed.ncbi.nlm.nih.gov/22982184/) · [NCT00798967](https://clinicaltrials.gov/study/NCT00798967) | ### R4 Human RCT: earlier phase 3 (Jeppesen 2011) | Study | People / model | Route | Amount used | Follow-up | Reported | Side effects / limitations | Citation | |---|---|---|---|---|---|---|---| | Jeppesen 2011 | 83 adults with SBS | Subcutaneous | 0.05 or 0.10 mg/kg/day | 24 weeks | Lower amount significant; higher amount not (p=0.16) | Mixed by dose | [PMID 21317170](https://pubmed.ncbi.nlm.nih.gov/21317170/) |Full reference list (PubMed, ClinicalTrials.gov, openFDA and DailyMed entries checked Oct 25, 2026)
- R1 DailyMed. GATTEX (teduglutide) label, Takeda, effective Sep 5, 2025. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=66b69c1e-b25c-44d3-b5ff-1c1de9a516fa
- R2 FDA. Drugs@FDA data (openFDA drugsfda), NDA 203441 (Gattex), original approval 2012-12-21, checked Oct 25, 2026. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:teduglutide
- R3 Jeppesen PB, et al. Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure. Gastroenterology. 2012. PMID 22982184
- R4 Jeppesen PB, et al. Randomised placebo-controlled trial of teduglutide in reducing parenteral nutrition and/or intravenous fluid requirements in patients with short bowel syndrome. Gut. 2011. PMID 21317170
- R5 WADA. The 2026 Prohibited List (in force 1 January 2026). https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
Disclaimer
This page is for education and harm reduction, not medical advice or a recommendation to use Teduglutide. Talk to a clinician you trust before using any drug, and report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).
Approved for Adam Greene by Dr. Nova Reyes, 2026-10-25.