Teduglutide

Overview

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 endogenous GLP-2 as it is more resistant to proteolysis from dipeptidyl peptidase-4. FDA approved on December 21, 2012.

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)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome	2025/05/15	NCT06973304	Phase 3	Recruiting	Takeda
A Study of PJ009 in Healthy Adult Volunteers	2024/07/26	NCT06523101	Phase 1	Completed	Chongqing Peg-Bio Biopharm Co., Ltd.
Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition	2024/07/22	NCT06512584	Phase 3	Recruiting	Chongqing Peg-Bio Biopharm Co., Ltd.
A Study of Teduglutide in Japanese Children With Short Bowel Syndrome Aged 4 Months or Older	2021/08/30	NCT05027308	Phase 3	Completed	Takeda
A Study of Teduglutide in Japanese People With Short Bowel Syndrome	2021/08/26	NCT05023382	N/A	Recruiting	Takeda
Bridging Intestinal Failure With Teduglutide - a Case Report	2021/06/07	NCT04916665	N/A	Completed	Medical University of Vienna
Teduglutide in Short Bowel Syndrome Patients	2021/04/23	NCT04857801	N/A	Completed	Medical University of Vienna
Pediatric Teduglutide Registry	2021/04/05	NCT04832087	N/A	Completed	Boston Children's Hospital
Quality of Life in Patients With Short Bowel Syndrome Treated Without and With Teduglutide - a Prospective Nested Matched Pair Analysis	2021/02/01	NCT04733066	N/A	UNKNOWN	Charite University, Berlin, Germany
A Study to Evaluate the Bioavailability of Teduglutide Administered Subcutaneously by Syringe Injection Versus Pen Injector in Healthy Adult Participants	2020/07/10	NCT04465396	Phase 1	Completed	Shire

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Gattex	Takeda Pharmaceuticals America, Inc.	68875-0101	SUBCUTANEOUS	5 mg in 0.5 mL	2/28/2024

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Revestive	Takeda Pharmaceuticals International AG Ireland,Branch,Block 2 Miesian Plaza,50 -58 Baggot Street Lower,Dublin 2,D02 HW68,Ireland	Authorised	8/30/2012

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
REVESTIVE teduglutide 5 mg powder for solution for injection vial with diluent pre-filled syringe	274911	Takeda Pharmaceuticals Australia Pty Ltd	Medicine	A	5/19/2017

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
REVESTIVE	takeda canada inc	02445727	Kit , Powder For Solution - Subcutaneous	5 MG / VIAL	10/28/2015

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
REVESTIVE 5 MG POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Takeda Pharmaceuticals International Ag Ireland Branch	12787001	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

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