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Gattex (Teduglutide) - Summary

 
 



GATTEX SUMMARY

The active ingredient in GATTEX (teduglutide [rDNA origin]) for injection is teduglutide (rDNA origin), which is a 33 amino acid glucagon-like peptide-2 (GLP-2) analog manufactured using a strain of Escherichia coli modified by recombinant DNA technology.

GATTEX® (teduglutide [rDNA origin]) for injection is indicated for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support. [see Clinical Pharmacology]


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NEWS HIGHLIGHTS

Published Studies Related to Gattex (Teduglutide)

A randomized, double-blind, placebo-controlled, multiple-dose, parallel-group clinical trial to assess the effects of teduglutide on gastric emptying of liquids in healthy subjects. [2014]
subjects, as measured by the pharmacokinetics of acetaminophen... CONCLUSIONS: Teduglutide 4 mg/day for 10 days does not affect gastric emptying of

Study of teduglutide effectiveness in parenteral nutrition-dependent short-bowel syndrome subjects. [2013]
Loss of intestinal absorptive capacity from congenital defect, surgical resection or mucosal disease results in short bowel syndrome (SBS)-associated intestinal failure. In the past, few medical management options were available besides dietary modification, controlling diarrhea or high stomal output, and providing parenteral fluid, electrolyte and nutrient support (parenteral support)...

Teduglutide enhances structural adaptation of the small intestinal mucosa in patients with short bowel syndrome. [2013]
dysplastic transformation... CONCLUSIONS: Although this histologic substudy of biopsy samples was not powered

Teduglutide, a novel mucosally active analog of glucagon-like peptide-2 (GLP-2) for the treatment of moderate to severe Crohn's disease. [2010]
placebo-controlled, double-blinded, dose-ranging study... CONCLUSIONS: Teduglutide is a novel and potentially effective therapy for

Pharmacokinetics, safety, and tolerability of teduglutide, a glucagon-like peptide-2 (GLP-2) analog, following multiple ascending subcutaneous administrations in healthy subjects. [2008]
Teduglutide, a glucagon-like peptide-2 (GLP-2) analog, is currently being evaluated for the treatment of short-bowel syndrome, Crohn's disease, and other gastrointestinal disorders. The pharmacokinetics, safety, and tolerability of teduglutide in healthy subjects (N = 64) were assessed following daily subcutaneous administrations for 8 days in a double-blinded, randomized, placebo-controlled, ascending-dose study...

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Clinical Trials Related to Gattex (Teduglutide)

Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458) [Completed]

Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects [Completed]
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.

Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome [Completed]
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).

A Double-Blind Multi-Dose Tolerability and Pharmacokinetic Study of Teduglutide [Completed]
The primary objective of the study was to study the safety and tolerability of teduglutide following a once or possibly twice daily subcutaneous injection for eight consecutive days in healthy subjects. A secondary objective was to study the pharmacokinetics of teduglutide following a once or possibly twice daily injection for eight consecutive days in healthy subjects.

Short Bowel Syndrome and Teduglutide VS Placebo [Active, not recruiting]
Investigator plans to examine the gastrointestinal (GI) physiologic profile of Teduglutide, a Glucagon-like Peptide 2 Analog as a possible intestinotrophic growth factor capable of inducing small bowel adaptation and regeneration in patients with short bowel syndrome (SBS), with the potential to decrease parenteral nutrition dependence.

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Page last updated: 2015-08-10

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