Teduglutide (Gattex / Revestive)
Teduglutide (rDNA origin); [Gly2]-GLP-2(1-33); recombinant analog of human glucagon-like peptide-2 (GLP-2); marketed as GATTEX (US/Takeda) and Revestive (EU/Takeda)
Teduglutide is an FDA- and EMA-approved GLP-2 receptor agonist indicated for Short Bowel Syndrome (SBS) in adults and pediatric patients aged 1 year and older who are dependent on parenteral support, promoting intestinal mucosal growth and reducing parenteral nutrition dependence. Pivotal RCT (STEPS): 46% responders vs 6% placebo (PMC3112364).
Last updated: 2026-03-13
Safety Summary
Most common adverse effects are gastrointestinal (abdominal pain, nausea, distension, vomiting) and are generally mild to moderate in severity, often decreasing over time. Note: Side effect frequencies vary between FDA label Table 1 (Studies 1 and 3, N=77 GATTEX vs N=59 placebo) and broader pooled safety data (n=566). Both sets of frequencies are reported above where they differ. Key safety monitoring requirements: (1) Colonoscopy/endoscopy at baseline (within 6 months) and yearly/5-yearly to detect polyps (GI neoplasia warning), (2) bilirubin/ALP/lipase/amylase labs every 6 months for biliary/pancreatic disease, (3) fluid status monitoring especially in patients with cardiovascular disease. In patients with stoma, 42% experienced GI stoma complications vs 14% placebo. A case of coma was reported in a patient taking concurrent benzodiazepines (prazepam) due to increased intestinal absorption of the oral medication (prazepam blood level >300 mcg/L). Enhanced absorption may affect any concomitant oral medication, particularly those with narrow therapeutic indices. Anti-drug antibodies were cross-reactive to native GLP-2 in 83% of tested antibody-positive patients, but mostly non-neutralizing with no clinically relevant impact on safety or efficacy. Antibody titers declined with continued therapy. Pediatric safety profile was similar to adults. Long-term safety data (up to 5 years in registries/extensions) showed AEs mostly mild-moderate, decreasing over time, with no new CRC cases despite increased polyp detection. FAERS database analysis confirmed known safety signals and identified disproportional signals for nephrolithiasis, dehydration, and renal AEs, but no cancer signal above background.
Known Side Effects
30% (vs 22% placebo in Studies 1 and 3; 30.0% in pooled data n=566)
18-23% (23% in Studies 1/3 vs 20% placebo; 18.2% pooled)
13-22% (13% vs 12% placebo in Studies 1/3; 22.4% pooled)
12-21% (21% vs 12% placebo in Studies 1/3; 11.8% pooled)
14-20% (20% vs 2% placebo in Studies 1/3; 13.8% pooled)
15.9% (pooled data)
12% (vs 10% placebo)
12% (vs 7% placebo)
10% (vs 7% placebo)
9% (vs 7% placebo)
Common (usually asymptomatic)
7% (vs 3% placebo)
Uncommon but clinically significant; 14 cases across clinical studies
4-9% in clinical studies (dose-dependent); 42% GI stoma complications with stoma vs 14% placebo
Uncommon; 3 cases in placebo-controlled studies
Rare; 2 cases in extension studies
Rare
40-50% over extended treatment (mostly non-neutralizing); 48% at Month 30 in adults, 54% at Month 12 in pediatrics
Who Should NOT Use This
Teduglutide must be discontinued if active GI malignancy is diagnosed due to potential acceleration of neoplastic growth (GLP-2 promotes cell proliferation). FDA label requires colonoscopy screening before initiation.1.
Standard drug hypersensitivity contraindication.
Continuation should be based on benefit-risk assessment.1.
Fluid overload from enhanced absorption can exacerbate CHF. Case report of cardiac failure documented. Monitor volume status closely; reassess treatment if significant cardiac deterioration.4; PMC10184872; FAERS signal.
Intestinal growth effects may worsen pre-existing strictures or cause obstruction.2.
Enhanced intestinal absorption may increase blood levels of concomitant oral drugs. A coma was reported in one patient on prazepam (benzodiazepine) due to increased absorption. Monitor and potentially reduce doses of narrow-therapeutic-index drugs.5, 7.1.
No adequate human pregnancy data. Animal studies showed adverse developmental effects. Use only if benefit outweighs risk.
Breastfeeding is not recommended due to potential for tumorigenicity in the breastfed infant (based on nonclinical carcinogenicity data). Teduglutide was detected in rat milk.2.
Talk to Your Doctor
Before considering Teduglutide (Gattex / Revestive), discuss it with your healthcare provider. Ask about potential interactions with your current medications, whether it is appropriate for your health conditions, and what monitoring may be needed.
Sources: [1-13]
Evidence Assessment
FDA-approved (NDA 203441, original approval December 21, 2012 for adults; pediatric expansion May 16, 2019) and EMA-authorized (Revestive, August 30, 2012). Also approved by TGA (Australia), Health Canada, and PMDA (Japan). Evidence base includes two adult Phase III RCTs (STEPS: NCT00172185; Study 3: NCT00798967), pediatric Phase III (NCT02682381), multiple open-label extension studies (STEPS-2, STEPS-3), Japanese Phase III studies, population PK analyses, and extensive real-world/registry data. Biosimilar (Teduglutide Viatris) approved in EU 2025. Over 361 PubMed-indexed publications as of March 2026
1Randomised placebo-controlled trial of teduglutide in reducing parenteral nutrition and/or intravenous fluid requirements in patients with short bowel syndrome (STEPS)NCT00172185
Jeppesen PB et al. - Gut (2011) - Phase III RCT (STEPS) - 83 randomized (35 at 0.05 mg/kg, 32 at 0.10 mg/kg, 16 placebo)
Responder rate (>=20% reduction in parenteral support at weeks 20/24): 0.05 mg/kg/day 46% vs placebo 6% (p=0.007). Mean daily parenteral volume reduction approximately 353 mL/day in active arms. 0.10 mg/kg/day was not statistically significant (25% vs 6%, p=0.16).
Limitations: Small sample (rare disease), 24-week duration, industry-sponsored (NPS/Shire)
2Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failureNCT00798967PMID 22982184
Jeppesen PB et al. - Gastroenterology (2012) - Phase III RCT (Study 3/STEPS confirmatory) - 86
Responder rate: 63% (27/43) GATTEX vs 30% (13/43) placebo (p=0.002). Mean PS reduction -4.4 L/week vs -2.3 L/week.
Limitations: Small sample, industry-sponsored, 24-week duration
3Long-Term Teduglutide for the Treatment of Patients With Intestinal Failure Associated With Short Bowel SyndromeNCT00798967
Schwartz LK et al. - Clinical and Translational Gastroenterology (2016) - Open-label extension (STEPS-2) - Multiple cohorts pooled (88 enrolled per Opus; broader pooling per Gemini)
Sustained and progressive reductions in parenteral support over 30 months. Up to 66% PS volume reduction. Some patients achieved enteral autonomy. Consistent safety profile without new signals.
Limitations: Open-label, no placebo control, attrition
4Reduction of Parenteral Nutrition and Hydration Support and Safety With Long-Term Teduglutide Treatment in Patients With Short Bowel Syndrome-Associated Intestinal Failure: STEPS-3 Study
Jeppesen PB et al. - Nutrition in Clinical Practice (2018) - Open-label extension (STEPS-3)
Continued PS reductions beyond STEPS-2 with acceptable safety profile.
Limitations: Open-label extension, limited by original sample size
5Safety and Efficacy of Teduglutide in Pediatric Patients With Intestinal Failure due to Short Bowel Syndrome: A 24-Week, Phase III StudyNCT02682381
(2020) - Phase III pediatric study - 59
Significant PS volume/calorie/infusion reduction vs standard of care (p<0.05). Safety profile similar to adults.
Limitations: Open-label comparison to SOC (partial blinding), small sample
6Efficacy, safety, and pharmacokinetics of teduglutide in adult Japanese patients with short bowel syndrome and intestinal failure: two phase III studies with an extensionNCT03663582
Nakamura S et al. - BMC Gastroenterology (2022) - Phase III (Japanese adult population) + extension - 18 (Phase 3); 11 (extension interim)
50% of patients (9/18) achieved >=20% PS reduction at 24 weeks. Mean PS reduction -30.1% +/- 25.9%. Extension: all 11 patients achieved >=20% reduction with mean -57.1% +/- 28.5%. Anti-drug antibody titers declined over time.
Limitations: Small sample, single-country population, open-label
7Long-term treatment with teduglutide: a 48-week open-label single-center clinical trial in children with short bowel syndrome
Lambe C et al. / Goulet O, Ruemmele F - American Journal of Clinical Nutrition (2023) - Open-label pediatric study (48-week) - 14
Median PNDI decreased from 0.75 to 0.50 at week 48. 67% (6/9) achieved >=20% PN volume reduction. Safety consistent with adult profile.
Limitations: Small sample, single-center, open-label, no control
8The real-world analysis of adverse events with teduglutide: a pharmacovigilance study based on the FAERS database
- Frontiers in Pharmacology (2024) - Pharmacovigilance (FAERS database analysis) - FAERS database (population-level)
Confirmed known safety signals (GI AEs, fluid overload, polyps). Detected disproportional signals for nephrolithiasis, hepatobiliary events, dehydration, renal AEs. No cancer signal above background. Long-term safety profile consistent with clinical trial data.
Limitations: Retrospective, voluntary reporting, reporting bias inherent in FAERS, no denominator
9Cost-effectiveness of teduglutide in adult patients with short bowel syndrome - a European socioeconomic perspectivePMID 38431119
(2024) - Health economic modeling
Teduglutide can meet typical European cost-effectiveness thresholds depending on assumptions about parenteral support costs and QoL gains.
Limitations: Model-based, assumption-dependent
10Analysis of the Effect of Teduglutide Treatment on Intestinal Malabsorption and Paneth Cell Numbers in Patients With Steroid-refractory Gastrointestinal Graft Versus Host DiseaseNCT04290429
Zeiser R (University of Freiburg) (2020) - Early Phase 1 (off-label exploratory in GI-GVHD) - 6
Teduglutide evaluated in steroid-refractory GI-GVHD. Exploratory use investigating mucosal healing and Paneth cell regeneration.
Limitations: Very small sample (n=6), off-label indication, single-center
11Long-term outcomes and adverse effects of teduglutide in patients with short bowel syndrome: Highlighting hyperamylasemia and hyperlipasemiaPMID 37941451
- PubMed (2023) - Observational/retrospective
Elevated amylase/lipase frequently observed during long-term teduglutide use; usually asymptomatic. No increase in pancreatitis risk identified.
Limitations: Retrospective; limited sample details available.
12The Discovery of GLP-2 and Development of Teduglutide for Short Bowel Syndrome
Drucker DJ - ACS Pharmacology & Translational Science (2020) - Review (historical/translational)
Comprehensive history of GLP-2 discovery and teduglutide development from bench to FDA approval. Describes SAR, preclinical pharmacology, and clinical development pathway.
Limitations: Narrative review.
13Population pharmacokinetics of teduglutidePMID 34402197
Marier JF et al. - Journal of Clinical Pharmacology (2021) - Population PK analysis - ~256 individuals (pooled)
One-compartment model with first-order absorption. CL/F ~10.5-12.4 L/hr. t1/2 varies with body weight (0.9-3.0 h). Covariates: body weight, sex, injection site.
Limitations: Model-dependent estimates; pooled across heterogeneous studies.