Teduglutide

Generic Name: Teduglutide

Brand Names: Gattex, Revestive

Drug Type: Biotech

Chemical Formula: -

CAS Number: 197922-42-2

Unique Ingredient Identifier: 7M19191IKG

Background: Teduglutide is a glucagon-like peptide-2 (GLP-2) analogue. It is made up of 33 amino acids and is manufactured using a strain of Escherichia coli modified by recombinant DNA technology. Teduglutide differs from GLP-2 by one amino acid (alanine is substituted by glycine). The significance of this substitution is that teduglutide is longer acting than endogeno...

Indication: Teduglutide is indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support.

Associated Conditions: Short Bowel Syndrome (SBS)

Associated Therapies: -

Clinical Trials

A Study of the Gut Barrier and Blood Vessel Inflammation in Individuals With and Without HIV

Phase 2

Completed

Conditions: HIV

Interventions: Drug: Teduglutide
Drug: Placebo

First Posted Date: 2015-05-01

Last Posted Date: 2023-06-12

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 32

Registration Number: NCT02431325

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome (SBS)

Phase 3

Completed

Conditions: Short Bowel Syndrome

Interventions: Drug: Teduglutide

First Posted Date: 2015-01-19

Last Posted Date: 2021-06-09

Lead Sponsor: Shire

Target Recruit Count: 11

Registration Number: NCT02340819

Locations: 🇯🇵
Hospital of Hyogo College of Medicine, Hyogo, Nishinomiya, Japan
🇯🇵
Osaka University Hospital, Department of Pediatric Surgery, Osaka, Suita, Japan
🇯🇵
Tohoku University Hospital, Sendai, Aoba-ku, Japan

and more 2 locations

Short Bowel Syndrome and Teduglutide Versus Placebo

Phase 4

Completed

Conditions: Short Bowel Syndrome

Interventions: Drug: Teduglutide
Drug: Placebo

First Posted Date: 2014-03-28

Last Posted Date: 2016-02-22

Lead Sponsor: Mayo Clinic

Target Recruit Count: 8

Registration Number: NCT02099084

Locations: 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States

A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome

Phase 3

Completed

Conditions: Short Bowel Syndrome

Interventions: Drug: teduglutide

First Posted Date: 2013-09-27

Last Posted Date: 2021-06-09

Lead Sponsor: Shire

Target Recruit Count: 42

Registration Number: NCT01952080

Locations: 🇺🇸
Arkansas Children's Hospital, Little Rock, Arkansas, United States
🇺🇸
University of Tennessee Health Science Center Le Bonheur Pediatric Specialists, Memphis, Tennessee, United States
🇺🇸
University of Wisconsin School of Medicine and Public Health Surgery, Madison, Wisconsin, United States

and more 16 locations

A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021

Phase 3

Completed

Conditions: Short Bowel Syndrome

Interventions: Drug: Teduglutide

First Posted Date: 2012-03-22

Last Posted Date: 2021-06-10

Lead Sponsor: Shire

Target Recruit Count: 14

Registration Number: NCT01560403

Locations: 🇺🇸
Scripps Clinic & Research Foundation, La Jolla, California, United States
🇺🇸
Emory University School of Medicine, Atlanta, Georgia, United States
🇺🇸
Mount Sinai Medical Center, New York, New York, United States

and more 2 locations

Effect of Teduglutide on Gastric Emptying in Healthy Subjects

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Placebo
Drug: teduglutide

First Posted Date: 2010-09-27

Last Posted Date: 2021-06-04

Lead Sponsor: Shire

Target Recruit Count: 36

Registration Number: NCT01209351

Locations: 🇺🇸
Cetero Clinical Research, San Antonio, Texas, United States

Effects of Teduglutide on Cardiac Repolarisation and Conduction in Healthy Male and Female Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Teduglutide

First Posted Date: 2009-12-09

Last Posted Date: 2012-05-07

Lead Sponsor: Nycomed

Target Recruit Count: 72

Registration Number: NCT01028924

Locations: 🇩🇪
Nycomed GmbH, Konstanz, Germany

Pharmacokinetics of 10 mg Teduglutide in Subjects With Renal Impairment Compared to Healthy Subjects With Normal Renal Function

Phase 1

Completed

Conditions: Renal Impairment

Interventions: Drug: Teduglutide

First Posted Date: 2009-12-09

Last Posted Date: 2012-05-07

Lead Sponsor: Nycomed

Target Recruit Count: 36

Registration Number: NCT01028768

Locations: 🇩🇪
Nycomed GmbH, Konstanz, Germany

Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)

Phase 3

Completed

Conditions: Short Bowel Syndrome

Interventions: Drug: teduglutide

First Posted Date: 2009-06-30

Last Posted Date: 2021-06-11

Lead Sponsor: Shire

Target Recruit Count: 88

Registration Number: NCT00930644

Locations: 🇵🇱
Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Chirurgii Ogolnej i Transplantacyjnej, Lublin, Poland
🇺🇸
Cleveland Clinic Foundation, Cleveland, Ohio, United States
🇺🇸
Mount Sinai Medical Center, New York, New York, United States

and more 20 locations

A Double-Blind Multi-Dose Tolerability and Pharmacokinetic Study of Teduglutide

Phase 1

Completed

Conditions: Pharmacokinetics and Safety of Elevated Doses

Interventions: Drug: teduglutide
Drug: tedguglutide

First Posted Date: 2009-01-12

Last Posted Date: 2021-05-25

Lead Sponsor: Shire

Target Recruit Count: 95

Registration Number: NCT00820885

Locations: 🇺🇸
Northwest Kinetics, Tacoma, Washington, United States

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