Teduglutide: Research & Studies
Scientific evidence, clinical trials, and research findings
๐TL;DR
- โข4 clinical studies cited
- โขOverall evidence level: high
- โข5 research gaps identified
Research Studies
Teduglutide Reduces Need for Parenteral Support Among Patients with Short Bowel Syndrome with Intestinal Failure
Jeppesen PB, Pertkiewicz M, Messing B, et al. (2012) โข Gastroenterology
Phase 3 STEPS trial. 24-week randomized, double-blind, placebo-controlled study of teduglutide 0.05 mg/kg/day in 86 adults with SBS-IF dependent on parenteral support for at least 12 months.
Key Findings
- 63% responders in teduglutide group vs 30% placebo (P=0.002)
- Mean PN volume reduction of 4.4 L/week with teduglutide vs 2.3 L/week placebo (P<0.001)
- Plasma citrulline increased significantly, indicating mucosal growth
- Safety profile consistent with prior trials
Limitations: Relatively small sample size (n=86). 24-week duration may not capture full intestinal adaptation. Open-label extension limits long-term blinded comparison.
Randomised Placebo-Controlled Trial of Teduglutide in Reducing Parenteral Nutrition and/or Intravenous Fluid Requirements in Patients with Short Bowel Syndrome
Jeppesen PB, Gilroy R, Pertkiewicz M, et al. (2011) โข Gut
Phase 3 study (Study 004). 24-week trial of 83 patients randomized to teduglutide 0.10 mg/kg/day, 0.05 mg/kg/day, or placebo.
Key Findings
- 0.05 mg/kg/day dose achieved significant response rate vs placebo (P=0.007)
- 0.10 mg/kg/day did not reach significance vs placebo (P=0.16)
- Three patients completely weaned off parenteral support
- Villus height and plasma citrulline significantly increased
- Lean body mass significantly increased with teduglutide
Limitations: Small placebo group (n=16). Higher dose unexpectedly less effective. Graded response scoring may have been insensitive to partial responders.
Safety and Efficacy of Teduglutide in Pediatric Patients with Intestinal Failure due to Short Bowel Syndrome: A 24-Week, Phase III Study
Kocoshis SA, Merritt RJ, Hill S, et al. (2020) โข Journal of Parenteral and Enteral Nutrition
Phase 3 pediatric trial evaluating teduglutide 0.025 and 0.05 mg/kg/day in 59 children (1-17 years) with SBS-IF. Included standard of care control arm.
Key Findings
- All 59 enrolled patients completed the 24-week study
- Both dose groups achieved significant reductions in parenteral support
- Safety profile consistent with adult studies
- Supported FDA expansion of indication to pediatric patients
Limitations: Non-blinded standard of care arm. Small sample size per treatment group. Age heterogeneity across the 1-17 year range.
The Discovery of GLP-2 and Development of Teduglutide for Short Bowel Syndrome
Drucker DJ (2019) โข ACS Pharmacology and Translational Science
Comprehensive review by the discoverer of GLP-2 describing the journey from serendipitous observation of intestinal growth in proglucagon- producing tumor-bearing mice to the development of teduglutide.
Key Findings
- GLP-2 discovered through observation that proglucagon tumors induced intestinal growth
- DPP-4 identified as critical determinant of GLP-2 bioactivity
- [Gly2] substitution selected for DPP-4 resistance while maintaining receptor activity
- SBS chosen as therapeutic target due to defined unmet need and mechanistic rationale
Limitations: Narrative review by the peptide discoverer. Not a systematic review.
Unlock full research citations
Free access to all clinical studies, citations, and evidence summaries.
150+ peptide profiles ยท 30+ comparisons ยท 18 research tools
Community Experience Data
See how community outcomes align with (or diverge from) the research findings above.
Based on 25+ community reports
View community protocolsExplore research gaps across all peptides โ | View clinical trial pipeline โ
๐Research Gaps & Future Directions
- โขIdentification of biomarkers that predict individual response to teduglutide (not all SBS-IF patients respond equally)
- โขOptimal duration of treatment and whether treatment can be discontinued after intestinal adaptation is achieved
- โขPotential applications beyond SBS (radiation enteritis, graft-versus-host disease of the gut, inflammatory bowel disease)
- โขHead-to-head comparison with next-generation GLP-2 analogs (apraglutide, glepaglutide) that have longer half-lives
- โขLong-term neoplasia risk with decades of treatment promoting intestinal cell proliferation
Research Overview#
Teduglutide has one of the most robust clinical evidence bases of any peptide therapeutic, with Phase 2, Phase 3, pediatric Phase 3, and long-term extension studies spanning over a decade. The evidence supported regulatory approval in multiple jurisdictions and has been complemented by extensive real-world data.
Phase 3 STEPS Trial (PMID 22982184)#
The STEPS (Study of Teduglutide Effectiveness in Parenteral Nutrition-Dependent Short-Bowel Syndrome Subjects) trial was the pivotal study supporting FDA approval. This 24-week, randomized, double-blind, placebo-controlled trial enrolled 86 adults with SBS-IF who had been dependent on parenteral support for at least 12 months.
Patients received teduglutide 0.05 mg/kg/day (n=43) or placebo (n=43) by subcutaneous injection. The primary endpoint was the percentage of patients achieving a 20% or greater reduction in weekly parenteral nutrition volume at weeks 20 and 24.
Results demonstrated clear efficacy: 63% of teduglutide-treated patients were responders compared to 30% in the placebo group (P=0.002). The mean reduction in PN volume was 4.4 L/week with teduglutide versus 2.3 L/week with placebo (P<0.001). Plasma citrulline, a biomarker of intestinal mucosal mass, increased significantly in the teduglutide group.
Phase 3 Study 004 (PMID 21317170)#
This earlier Phase 3 study in 83 patients tested two teduglutide doses (0.05 and 0.10 mg/kg/day) against placebo. The 0.05 mg/kg/day dose showed significant efficacy (P=0.007), while the higher 0.10 mg/kg/day dose did not reach statistical significance (P=0.16). Importantly, three patients were completely weaned off parenteral support, and histological analysis confirmed increased villus height in the teduglutide groups. This dose-finding result established 0.05 mg/kg/day as the optimal dose.
Pediatric Phase 3 (PMID 31495952)#
The pediatric Phase 3 trial enrolled 59 children aged 1-17 years with SBS-IF. Both the 0.025 mg/kg/day (n=24) and 0.05 mg/kg/day (n=26) dose groups demonstrated significant reductions in parenteral support requirements over 24 weeks. All enrolled patients completed the study, and the safety profile was consistent with adult data. This study supported the 2019 expansion of the FDA indication to pediatric patients.
Long-Term Extension Data#
The STEPS-2 and STEPS-3 extension studies followed teduglutide-treated patients for up to 30 months, demonstrating sustained and continued reductions in parenteral support. Key long-term findings include:
- Progressive PN volume reductions with continued treatment
- Achievement of complete enteral autonomy in a subset of patients
- Stable safety profile with no new safety signals
- Real-world data extending to 10 years of treatment
Evidence Quality Assessment#
| Criterion | Assessment | Details |
|---|---|---|
| Phase 3 (adults) | Positive | Two positive Phase 3 trials |
| Phase 3 (pediatric) | Positive | Efficacy confirmed in children |
| Long-term data | Strong | Up to 10 years real-world data |
| Safety database | Extensive | Over 500 patients across clinical program |
| Regulatory approval | FDA + EMA | Approved in US, EU, and multiple other countries |
| Publication quality | High | Published in Gastroenterology, Gut, JPEN |
Related Reading#
Frequently Asked Questions About Teduglutide
Explore Further
Medical Disclaimer
This website is for educational and informational purposes only. The information provided is not intended to diagnose, treat, cure, or prevent any disease. Always consult with a qualified healthcare professional before using any peptide or supplement.