MedPath

Teduglutide

Generic Name
Teduglutide
Brand Names
Gattex, Revestive
Drug Type
Biotech
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 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)

A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome

Phase 3
Not yet recruiting
Conditions
Short Bowel Syndrome
Interventions
First Posted Date
2025-05-15
Last Posted Date
2025-05-15
Lead Sponsor
Takeda
Target Recruit Count
13
Registration Number
NCT06973304
Locations
🇨🇳

Beijing Tsinghua Changgung Hospital, Changping, Beijing, China

🇨🇳

Peking Union Medical College Hospital, Dongcheng, Beijing, China

🇨🇳

The General Hospital of Eastern Theater Command, Nanjing, Jiangsu, China

and more 1 locations

A Study of PJ009 in Healthy Adult Volunteers

Phase 1
Completed
Conditions
Short Bowel Syndrome
Interventions
Drug: Placebo
First Posted Date
2024-07-26
Last Posted Date
2024-07-29
Lead Sponsor
Chongqing Peg-Bio Biopharm Co., Ltd.
Target Recruit Count
24
Registration Number
NCT06523101
Locations
🇨🇳

The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China

Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition

Phase 3
Recruiting
Conditions
Short Bowel Syndrome
Interventions
Drug: PJ009 Placebo
First Posted Date
2024-07-22
Last Posted Date
2024-08-21
Lead Sponsor
Chongqing Peg-Bio Biopharm Co., Ltd.
Target Recruit Count
72
Registration Number
NCT06512584
Locations
🇨🇳

Beijing Tsinghua Changgung Hospital, Beijing, Beijing, China

🇨🇳

Chongqing General Hospital, Chongqing, Chongqing, China

🇨🇳

The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

and more 5 locations

A Study of Teduglutide in Japanese Children With Short Bowel Syndrome Aged 4 Months or Older

Phase 3
Completed
Conditions
Short Bowel Syndrome
Interventions
First Posted Date
2021-08-30
Last Posted Date
2024-05-16
Lead Sponsor
Takeda
Target Recruit Count
3
Registration Number
NCT05027308
Locations
🇯🇵

University of Tsukuba Hospital, Tsukuba, Ibaraki, Japan

🇯🇵

Kagoshiha University Hospital, Kagoshima, Japan

🇯🇵

Tohoku University Hospital, Sendai, Miyagi, Japan

and more 3 locations

A Study of Teduglutide in Japanese People With Short Bowel Syndrome

Recruiting
Conditions
Short Bowel Syndrome
Interventions
First Posted Date
2021-08-26
Last Posted Date
2025-05-11
Lead Sponsor
Takeda
Target Recruit Count
120
Registration Number
NCT05023382
Locations
🇯🇵

Takeda selected site, Tokyo, Japan

🇯🇵

Takeda Selected Site, Tokyo, Japan

Bridging Intestinal Failure With Teduglutide - a Case Report

Completed
Conditions
Short Bowel Syndrome
First Posted Date
2021-06-07
Last Posted Date
2021-06-07
Lead Sponsor
Medical University of Vienna
Target Recruit Count
1
Registration Number
NCT04916665
Locations
🇦🇹

Medical University of Vienna, Vienna, Austria

Teduglutide in Short Bowel Syndrome Patients

Completed
Conditions
Short Bowel Syndrome
First Posted Date
2021-04-23
Last Posted Date
2021-04-26
Lead Sponsor
Medical University of Vienna
Target Recruit Count
17
Registration Number
NCT04857801

Pediatric Teduglutide Registry

Completed
Conditions
Short Bowel Syndrome
Interventions
First Posted Date
2021-04-05
Last Posted Date
2023-12-11
Lead Sponsor
Boston Children's Hospital
Target Recruit Count
142
Registration Number
NCT04832087
Locations
🇺🇸

Boston Children's Hospital, Boston, Massachusetts, United States

Quality of Life in Patients With Short Bowel Syndrome Treated Without and With Teduglutide - a Prospective Nested Matched Pair Analysis

Conditions
Intestinal Failure
Short Bowel Syndrome
Interventions
First Posted Date
2021-02-01
Last Posted Date
2021-02-01
Lead Sponsor
Charite University, Berlin, Germany
Target Recruit Count
40
Registration Number
NCT04733066
Locations
🇩🇪

Charite University, Berlin, Germany, Berlin, Germany

A Study to Evaluate the Bioavailability of Teduglutide Administered Subcutaneously by Syringe Injection Versus Pen Injector in Healthy Adult Participants

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Device: Syringe Injection
Device: Pen injector
First Posted Date
2020-07-10
Last Posted Date
2022-10-04
Lead Sponsor
Shire
Target Recruit Count
64
Registration Number
NCT04465396
Locations
🇺🇸

Celerion, Phoenix, Arizona, United States

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