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Product

Teduglutide

Aliases
Gattex, TAK-633
Name
Gattex
INN Name
teduglutide
FDA Approved
Yes

8 clinical trials

1 organization

5 indications

1 document

Indication
Short Bowel Syndrome
Indication
Healthy Control Participants
Indication
Graft-Versus-Host Disease
Indication
HIV
Indication
Ileostomy
Clinical trial
Special Drug Use Investigation of Revestive Subcutaneous Injection 3.8 mg (All-case Surveillance)
Status: Recruiting, Estimated PCD: 2030-07-31
Clinical trial
A Phase 3, Open-label Safety Study of Teduglutide in Japanese Pediatric Patients With Short Bowel Syndrome Who Are Dependent on Parenteral Support, Aged 4 Months of Corrected Gestational Age or Older, and Requiring the Dosing of 1.25 mg Formulation
Status: Completed, Estimated PCD: 2023-09-27
Clinical trial
An Open-Label, Extension Study of Teduglutide in Japanese Subjects With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004
Status: Completed, Estimated PCD: 2022-01-13
Clinical trial
A Randomized, Open-label, Two-treatment, Two-period, Single-dose, Crossover Study to Evaluate the Bioavailability of Teduglutide Administered Subcutaneously by Syringe Injection Versus Pen Injector in Healthy Adult Subjects
Status: Completed, Estimated PCD: 2021-08-20
Clinical trial
Analysis of the Effect of Teduglutide Treatment on Intestinal Malabsorption and Paneth Cell Numbers in Patients With Steroid-refractory Gastrointestinal Graft Versus Host Disease (SR-GI-GVHD).
Status: Completed, Estimated PCD: 2019-12-06
Clinical trial
Pediatric Teduglutide Registry: Clinical Use of Teduglutide in Children With Intestinal Failure, a Multicenter Post-marketing Evaluation
Status: Completed, Estimated PCD: 2023-08-31
Clinical trial
A Study to Investigate Gastrointestinal Epithelial Integrity and Arterial Inflammation in Individuals With and Without HIV
Status: Completed, Estimated PCD: 2020-01-21
Clinical trial
Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications
Status: Withdrawn, Estimated PCD: 2022-11-25
Document
DailyMed Label: Gattex
Organization
Takeda Pharmaceuticals America, Inc.