CLINICAL TRIALS PROFILE FOR TEDUGLUTIDE

All Clinical Trials for Teduglutide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00081458 ↗	Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome	Completed	Shire	Phase 3	2004-05-25	The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS).
NCT00172185 ↗	Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)	Completed	Shire	Phase 3	2005-01-10	The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.
NCT00308438 ↗	Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008	Completed	Shire	Phase 2	2004-03-01	The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.
NCT00798967 ↗	Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects	Completed	Nycomed	Phase 3	2008-11-25	Teduglutide is an investigative medicine being evaluated as a possible treatment for people with parenteral nutrition (PN) dependent Short Bowel Syndrome (SBS). Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. This study was designed to provide evidence of efficacy, safety, and tolerability of teduglutide 0.05 mg/kg daily in SBS subjects.

Clinical Trial Conditions for Teduglutide

Condition Name

Condition Name for Teduglutide
Intervention	Trials
Short Bowel Syndrome	18
Hyperlipidemias	4
Healthy Volunteers	2
Atrial Fibrillation	1

Condition MeSH

Condition MeSH for Teduglutide
Intervention	Trials
Syndrome	18
Short Bowel Syndrome	18
Hyperlipoproteinemias	4
Hyperlipidemias	4

Clinical Trial Locations for Teduglutide

Trials by Country

Trials by Country for Teduglutide
Location	Trials
United States	110
Canada	22
Japan	18
United Kingdom	16
Germany	10

Trials by US State

Trials by US State for Teduglutide
Location	Trials
New York	10
Ohio	9
California	7
Pennsylvania	7
Texas	6

Clinical Trial Progress for Teduglutide

Clinical Trial Phase

Clinical Trial Phase for Teduglutide
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	17
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for Teduglutide
Clinical Trial Phase	Trials
Completed	28
Active, not recruiting	3
Not yet recruiting	2

Clinical Trial Sponsors for Teduglutide

Sponsor Name

Sponsor Name for Teduglutide
Sponsor	Trials
Shire	21
Takeda	4
University Health Network, Toronto	4

Sponsor Type

Sponsor Type for Teduglutide
Sponsor	Trials
Industry	32
Other	18
NIH	2

Teduglutide: Clinical Trials, Market Analysis, and Projections

Introduction to Teduglutide

Teduglutide, a glucagon-like peptide-2 (GLP-2) analogue, has been at the forefront of treatment for Short Bowel Syndrome (SBS) with intestinal failure. This drug has shown promising results in restoring intestinal structural and functional integrity, thereby reducing the need for parenteral support.

Clinical Trials Overview

Adult Studies

A significant 24-week placebo-controlled study evaluated the efficacy of teduglutide in reducing parenteral support in patients with SBS. The study involved 83 patients randomized to receive either teduglutide at doses of 0.10 mg/kg/day or 0.05 mg/kg/day, or a placebo. The results indicated that teduglutide at a dose of 0.05 mg/kg/day had a statistically significant effect in reducing parenteral volumes compared to the placebo group. This study also noted that teduglutide increased villus height, plasma citrulline concentration, and lean body mass, highlighting its intestinotrophic and pro-absorptive effects[1].

Pediatric Studies

A clinical trial (TED-C14-006) was conducted to evaluate the safety and efficacy of teduglutide in children up to the age of 17 with SBS who are dependent on parenteral support. This study involved 59 participants and included treatment arms with teduglutide doses of 0.05 mg/kg and 0.025 mg/kg, as well as a standard-of-care arm. The trial spanned approximately 7 months, including a 24-week treatment period and a 4-week follow-up period. This study aims to extend the use of teduglutide to pediatric patients, a demographic that has limited treatment options for SBS[4].

Market Analysis

Current Market Trends

The teduglutide market is driven by the increasing prevalence of Short Bowel Syndrome with Intestinal Failure (SBS-IF) and the growing demand for innovative therapies to reduce the burden of parenteral support. Market reports indicate that the global teduglutide market is expected to grow significantly from 2025 to 2031, with a notable increase in revenue and market share. The Asia Pacific region is predicted to grow at the fastest CAGR during this period due to rising investments in research and development, the presence of leading market players, and increasing awareness about the disease[2][5].

Key Factors Affecting the Market

• Increasing Prevalence of SBS-IF: The growing number of patients relying on parenteral support for essential fluids and nutrients is a major driver of the market.
• Clinical Trials and Novel Therapies: Ongoing and planned clinical trials, such as those involving apraglutide and vurolenatide, are expected to boost market growth by offering new treatment options[3].
• Regional Growth: The Asia Pacific region is expected to dominate the market due to its robust research and development activities and collaborations among market players[3].

Market Projections

The global teduglutide market is forecasted to experience significant growth, with a projected CAGR from 2025 to 2031. The market size, revenue, and volume share are expected to increase, driven by the demand for advanced treatment options and the expanding patient population. The market reports provide detailed analyses, including competitor analysis, regional analysis, and segment analysis, which are crucial for understanding the market dynamics and making informed decisions[2][5].

Impact on Clinical Practice

Reduction in Parenteral Support

Teduglutide has the potential to significantly reduce the burden of parenteral support in patients with SBS-IF. By promoting intestinal repair and growth, and increasing fluid and nutrient absorption, teduglutide can help patients achieve greater independence from intravenous fluids and nutrients. This reduction not only improves the quality of life for patients but also decreases the associated healthcare costs and complications[1].

Expansion of Treatment Options

The approval and ongoing trials of teduglutide are expanding the limited clinical treatment options available for SBS patients. This includes the potential extension of teduglutide treatment to pediatric patients, which could revolutionize the management of SBS in this demographic[4].

Key Takeaways

• Clinical Efficacy: Teduglutide has shown significant efficacy in reducing parenteral support in adult patients with SBS-IF and is being evaluated for pediatric use.
• Market Growth: The global teduglutide market is expected to grow substantially from 2025 to 2031, driven by increasing prevalence and demand for innovative therapies.
• Regional Dominance: The Asia Pacific region is anticipated to dominate the market due to robust R&D activities and market collaborations.
• Clinical Impact: Teduglutide has the potential to reduce the burden of parenteral support, improving patient quality of life and reducing healthcare costs.

FAQs

What is teduglutide used for?

Teduglutide is used for the treatment of Short Bowel Syndrome (SBS) with intestinal failure, aiming to reduce the need for parenteral support by enhancing intestinal absorption.

What are the key findings from the clinical trials of teduglutide?

Clinical trials have shown that teduglutide significantly reduces parenteral volumes, increases villus height, plasma citrulline concentration, and lean body mass, and is safe and well-tolerated in patients with SBS-IF[1].

Which regions are expected to drive the growth of the teduglutide market?

The Asia Pacific region is expected to grow at the fastest CAGR during the forecast period due to rising investments in R&D, presence of leading market players, and increasing awareness about SBS[3].

What are the potential future developments in the treatment of SBS using GLP-2 analogues?

Future developments include the introduction of new GLP-2 analogues like apraglutide and vurolenatide, which are currently in clinical trials and offer prolonged activity and potential benefits for SBS patients[3].

How does teduglutide impact the quality of life for patients with SBS-IF?

Teduglutide improves the quality of life by reducing the dependence on parenteral support, thereby decreasing the associated healthcare costs, complications, and improving patient independence and overall well-being[1].

Sources

1. Gut, "Randomised placebo-controlled trial of teduglutide in reducing parenteral support in patients with short bowel syndrome with intestinal failure," 2011.
2. Cognitive Market Research, "Teduglutide Market Report 2024 (Global Edition)," 2023.
3. Research and Markets, "Short Bowel Syndrome Market Analysis & Forecast 2024-2034," 2023.
4. ClinicalTrials.Takeda, "TED-C14-006 | Clinical Trial Summary," 2023.
5. Cognitive Market Research, "Teduglutide Drugs Market Report 2025 (Global Edition)," 2023.

Last updated: 2025-01-03