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Drug

Teduglutide

Approved · EMA
Emerging researchLate-stage developmentRising momentum
Also known as (Gly2)GLP-2, Gattex, Glucagon-like peptide II (2-glycine) (human), Gly(2)-GLP-2+2 more

(Gly2)GLP-2, Gattex, Glucagon-like peptide II (2-glycine) (human), Gly(2)-GLP-2, Teduglutida, Teduglutide Recombinant.

RxNorm1364468UNII7M19191IKG
3
Research papers
2
Active clinical trials
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

An Open-label, Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of 0.05 mg/kg/Day Subcutaneous Teduglutide Following Treatment of Short Bowel Syndrome for 24 Weeks in Chinese Adults Who Are Dependent on Parenteral Support

Clinical trial2026-06-24Results expected Q1 2027 · ClinicalTrials.gov

Short Bowel Syndrome: Human Intestinal Organoids to Investigate the Different Efficacy of the GLP-2 Analogue Teduglutide in Pediatric Patients With Short Bowel Syndrome

Clinical trial2026-03-01Primary completion · ClinicalTrials.gov

Approval: Teduglutide Viatris (EMA)

Regulatory2026-01-08EMA

A Retrospective and Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed TED-C13-003

Clinical trial2025-03-19Results posted · ClinicalTrials.gov

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

Clinical trial2024-05-16Results posted · ClinicalTrials.gov

A Study to Investigate Gastrointestinal Epithelial Integrity and Arterial Inflammation in Individuals With and Without HIV

Clinical trial2023-06-12Results posted · ClinicalTrials.gov

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

Clinical trial2023-03-15Results posted · ClinicalTrials.gov

Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications

Clinical trial2022-12-29Withdrawn · ClinicalTrials.gov

Reduction of Parenteral Nutrition and Hydration Support and Safety With Long-Term Teduglutide Treatment in Patients With Short Bowel Syndrome-Associated Intestinal Failure: STEPS-3 Study.

Research2018-05-15Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition

Acute Effects of a Glucagon-Like Peptide 2 Analogue, Teduglutide, on Gastrointestinal Motor Function and Permeability in Adult Patients With Short Bowel Syndrome on Home Parenteral Nutrition.

Research2015-07-28JPEN. Journal of parenteral and enteral nutrition

Approval: Revestive (EMA)

Regulatory2012-08-30EMA

Teduglutide (ALX-0600), a dipeptidyl peptidase IV resistant glucagon-like peptide 2 analogue, improves intestinal function in short bowel syndrome patients.

Research2005-09-01Gut

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Teduglutide
Aliases & brands
(Gly2)GLP-2GattexGlucagon-like peptide II (2-glycine) (human)Gly(2)-GLP-2TeduglutidaTeduglutide Recombinant
RxNorm CUI
1364468
UNII
7M19191IKG
Regulatory jurisdictions
ema

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2012-08-30
Latest approval
2026-01-08
Authorities
EMA
Total events
2
emaEuropean Medicines Agency· 2 events
2026-01-08Approval
Approval: Teduglutide Viatris (EMA)
Indication: Teduglutide Viatris is indicated for the treatment of patients 4 months corrected gestational age and above with Short Bowel Syndrome (SBS). Patients should be stable following a… Show full indication

Teduglutide Viatris is indicated for the treatment of patients 4 months corrected gestational age and above with Short Bowel Syndrome (SBS). Patients should be stable following a period of intestinal adaptation after surgery.

Evidence ↗
2012-08-30Approval
Approval: Revestive (EMA)
Indication: Revestive is indicated for the treatment of patients aged 1 year and above with Short Bowel Syndrome (SBS). Patients should be stable following a period of intestinal adaptation… Show full indication

Revestive is indicated for the treatment of patients aged 1 year and above with Short Bowel Syndrome (SBS). Patients should be stable following a period of intestinal adaptation after surgery. Revestive is indicated for the treatment of patients aged 1 year and above with Short Bowel Syndrome. Patients should be stable following a period of intestinal adaptation after surgery.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

31 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
31
registered trials across all phases
LATEST COMPLETION 2023
2
Active studies
2
Recruiting
19
Late-stage (III+)
28
Completed
1
Discontinued
PHASE DISTRIBUTIONn = 31
Early Phase 11Phase 16Phase 25Phase 2 / 32Phase 314Phase 42Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Monocentric Single-arm Study to Characterize the Long-term Safety, Efficacy, and Pharmacodynamic of GLP-2 Analog (Revestive®) in the Management of Short Bowel Syndrome Pediatric Patients on Home-parenteral Nutrition (HPN)

CompletedPH IVAssistance Publique - Hôpitaux de Parisn=252020

Acute Effects of a Glucagon-like Peptide 2 Analog, Teduglutide, on Gastrointestinal Motor Function and Permeability in Patients With Short Bowel Syndrome on Home Parenteral Nutrition

CompletedPH IVMayo Clinicn=82015

An Open-label, Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of 0.05 mg/kg/Day Subcutaneous Teduglutide Following Treatment of Short Bowel Syndrome for 24 Weeks in Chinese Adults Who Are Dependent on Parenteral Support

RecruitingPH IIITakedan=132027

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

CompletedPH IIITakedan=32023

Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications

WithdrawnPH IIIAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)2022

Recent completions

Trials that read out recently, adding to the completed evidence base.

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

CompletedPH IIITakedan=32023

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

CompletedPH IIITakedan=112022

Investigating the Plasma Lipoprotein Response to a Single Subcutaneous Dose of Analogue Glucagon-like Peptide-2 in Humans

CompletedPH II/IIIUniversity Health Network, Toronton=102021

Investigating the Release of Stored Enteral Lipids in Response to a Single Subcutaneous Dose of Analogue Glucagon-like Peptide-2 in Humans

CompletedPH II/IIIUniversity Health Network, Toronton=212021

A Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Japanese Pediatric Subjects With Short Bowel Syndrome Who Completed SHP633-302

CompletedPH IIIShiren=92021

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

CompletedPH IShiren=642021

Research activity

3 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20052018
Major research themes4
Fluid Therapy1Intestines1Parenteral Nutrition1Parenteral Nutrition, Home1
Journals, researchers & institutions
Top journals
  • Gut1
  • JPEN. Journal of parenteral and enteral nutrition1
  • Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition1
Leading researchers
  • Ziegler TR2
  • Acosta A1
  • Boullata JI1
  • Buchman A1
  • Burton D1
  • Camilleri M1
  • Carlson PJ1
  • Edakkanambeth Varayil J1
Leading institutions
free-text, unnormalised
  • Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.)1
  • Emory University School of Medicine1
  • Hospital of the University of Pennsylvania and Drexel University1
  • Mayo Clinic1
  • Mount Sinai Medical Center1
  • Rigshospitalet1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.