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CLINICAL TRIALS PROFILE FOR GATTEX KIT

All Clinical Trials for Gattex Kit

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00072839 ↗	Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease	Completed	Shire	Phase 2	2003-11-12	The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.
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.
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.
NCT00798967 ↗	Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects	Completed	Shire	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.
NCT00819468 ↗	Pharmacokinetics (PK) of 20 mg Teduglutide in Participants With Moderately Impaired Hepatic Function Compared to Healthy Participants	Completed	NPS Pharma	Phase 1	2007-07-26	This is a study to compare the pharmacokinetic profile of teduglutide in healthy participants with normal hepatic function with participants who have moderate hepatic impairment.

Clinical Trial Conditions for Gattex Kit

Condition Name

Condition Name for Gattex Kit
Intervention	Trials
Short Bowel Syndrome	6
Crohn's Disease	1
Hepatic Impairment	1
HIV	1

Condition MeSH

Condition MeSH for Gattex Kit
Intervention	Trials
Syndrome	6
Short Bowel Syndrome	6
Intestinal Fistula	1
Fistula	1

Clinical Trial Locations for Gattex Kit

Trials by Country

Trials by Country for Gattex Kit
Location	Trials
United States	57
Canada	13
Germany	6
United Kingdom	6
France	4

Trials by US State

Trials by US State for Gattex Kit
Location	Trials
Pennsylvania	6
New York	6
Ohio	5
Georgia	5
Florida	4

Clinical Trial Progress for Gattex Kit

Clinical Trial Phase

Clinical Trial Phase for Gattex Kit
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	6
Phase 2	3

Clinical Trial Status

Clinical Trial Status for Gattex Kit
Clinical Trial Phase	Trials
Completed	11
Not yet recruiting	1

Clinical Trial Sponsors for Gattex Kit

Sponsor Name

Sponsor Name for Gattex Kit
Sponsor	Trials
Shire	9
Massachusetts General Hospital	2
Nycomed	1

Sponsor Type

Sponsor Type for Gattex Kit
Sponsor	Trials
Industry	13
Other	7
NIH	2

Gattex Kit: Clinical Trials, Market Analysis, and Projections

Introduction to Gattex Kit

Gattex Kit, also known as teduglutide, is a glucagon-like peptide-2 (GLP-2) analog used for the treatment of Short Bowel Syndrome (SBS). It is marketed by Takeda Pharmaceuticals USA and has been a significant player in the SBS treatment market.

Clinical Trials Overview

Study 1: Randomized, Double-Blind, Placebo-Controlled Trial

In the primary clinical trial, patients with SBS were randomized to receive either Gattex (0.05 mg/kg/day) or a placebo. The study involved a period of optimization and stabilization of parenteral nutrition (PN)/intravenous (IV) volume before randomization. The results showed that 63% of patients treated with Gattex achieved a response, defined as a reduction of 20% or greater in weekly PN/IV volume, compared to 30% of placebo-treated patients[1].

Study 2: 2-Year Open-Label Extension

This study extended the treatment period for patients who had participated in Study 1. It demonstrated that patients who received Gattex continuously over 30 months maintained their response, with 96% of responders from Study 1 sustaining their response in Study 2[1].

Study 3: Dose Comparison Trial

In this trial, patients were randomized to receive either Gattex at 0.05 mg/kg/day, Gattex at 0.1 mg/kg/day (twice the recommended dose), or a placebo. The results indicated that 46% of patients treated with the recommended dose of Gattex achieved a response, compared to 6% on placebo[1].

Study 4: Blinded, Uncontrolled Extension

This extension of Study 3 showed that patients who continued on Gattex for up to an additional 28 weeks maintained significant reductions in PN/IV volume, with 68% of patients achieving a 20% or greater reduction[1].

Study 5: Pediatric Clinical Trial

A 24-week study in pediatric patients aged 1 through 17 years demonstrated that 69% of patients treated with Gattex at 0.05 mg/kg/day had a reduction in parenteral support volume of at least 20%, and 12% achieved enteral autonomy[1][5].

Market Analysis

Current Market Status

Gattex is the only GLP-2 analog available for the treatment of SBS and has been commercially available in North America and several European countries. It has been awarded orphan drug status in the U.S. until 2019 and in Europe until 2024, which has enhanced its market share and revenue[3][4].

Market Growth

The global short bowel syndrome market was valued at US$ 564 million in 2018 and is projected to expand at a Compound Annual Growth Rate (CAGR) of 27% from 2019 to 2027. The strong growth of the GLP-2 segment, driven by Gattex, is attributed to the increase in prescriptions, the rise in the number of patients on Gattex therapy, and the high cost of the drug[3][4].

Regional Dominance

North America is the dominant region in the SBS market, largely due to the increased prescriptions of Gattex in the U.S. Europe is the second major region, driven by the approval and increased awareness of Revestive (the European brand name for Gattex)[3].

Market Projections

Generic Entry

The earliest date for generic entry of Gattex is estimated to be May 16, 2026, based on the expiration of its patents and regulatory exclusivity. However, this date may change due to patent challenges or generic licensing[2].

Competitive Landscape

The market is expected to see increased competition as more drugs enter the pipeline. However, Gattex's strong market position, reinforced by its orphan drug status and ongoing clinical trials, is likely to maintain its market share in the near future[3][4].

Impact of Awareness and Education

Pre-marketing strategies, such as the use of educational websites like ShortBowelSupport.com, have contributed to the market expansion by raising awareness among patients, families, and healthcare professionals[3].

Key Takeaways

• Clinical Efficacy: Gattex has demonstrated significant efficacy in reducing parenteral nutrition dependency in both adult and pediatric patients with SBS.
• Market Dominance: Gattex is the leading GLP-2 analog in the SBS market, with strong sales in North America and Europe.
• Growth Projections: The SBS market is expected to grow at a CAGR of 27% from 2019 to 2027, driven by the increasing use of Gattex.
• Generic Entry: The earliest generic entry is projected for May 16, 2026, subject to patent and regulatory developments.
• Competitive Landscape: Despite upcoming competition, Gattex's market position is expected to remain strong due to its orphan drug status and ongoing clinical trials.

FAQs

What is Gattex used for?

Gattex is used for the treatment of Short Bowel Syndrome (SBS) in patients who are dependent on parenteral nutrition.

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

Clinical trials have shown that Gattex significantly reduces parenteral nutrition dependency in both adult and pediatric patients with SBS, with response rates ranging from 46% to 69% depending on the study.

When is the generic version of Gattex expected to enter the market?

The generic version of Gattex is expected to enter the market on or after May 16, 2026, subject to patent and regulatory developments.

What is the current market size and growth projection for the SBS market?

The global SBS market was valued at US$ 564 million in 2018 and is projected to grow at a CAGR of 27% from 2019 to 2027.

Is Gattex available in all regions?

Gattex is commercially available in North America and selected countries in Europe, including the U.K., Germany, France, Italy, Spain, and the Nordics.

Sources

1. Policies & Guidelines: Intestinal obstruction has been reported with Gattex in clinical trials. AGA Clinical Practice Update ... Gattex. teduglutide (rdna) for inj kit. 5 MG. Blue.
2. DrugPatentWatch: When will the patents on GATTEX KIT expire ... - DrugPatentWatch.
3. Biospace: Short Bowel Syndrome Market: FDA-approved Drugs Bolster ...
4. Biospace: Short Bowel Syndrome Market: Increase in Clinical Trials or Pipeline ...
5. Gattex.com: GATTEX® Results in Children 1 Year of Age and Older with SBS.