GLP-2 analogue

Teduglutide updates

Answer

3 changes for Teduglutide in the last 12 months. Latest: 2026-04-17.

DateTypeWhat changedSource
2026-04-17TrialNew trial registered: Glucagon-like Peptide 2 (GLP-2) in Undernourished Women Improving From Histology-Confirmed Environmental Enteric Dysfunction (EED)Trial register ClinicalTrials.gov
2026-02-10TrialNew trial registered: TED_ORG: Study on Short Bowel SyndromeTrial register ClinicalTrials.gov
2026-01-06TrialNew trial registered: A Study of Teduglutide in Chinese Children and Teenagers With Short Bowel SyndromeTrial register ClinicalTrials.gov
2025-09-05LabelFDA label revised: Gattex (NDA203441)Regulator FDA drug label register
2025-05-15TrialNew trial registered: A Study of Teduglutide in Chinese Adults With Short Bowel SyndromeTrial register ClinicalTrials.gov
2024-07-29Federal RegisterFederal Register notice: Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for CommentsRegulator Federal Register
2024-05-16ResultsResults posted: A Study of Teduglutide in Japanese Children With Short Bowel Syndrome Aged 4 Months or OlderTrial register ClinicalTrials.gov
2023-06-12ResultsResults posted: A Study of the Gut Barrier and Blood Vessel Inflammation in Individuals With and Without HIVTrial register ClinicalTrials.gov
2023-03-15ResultsResults posted: An Extension Study of Teduglutide in Japanese Participants With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004Trial register ClinicalTrials.gov
2022-10-04ResultsResults posted: A Study to Evaluate the Bioavailability of Teduglutide Administered Subcutaneously by Syringe Injection Versus Pen Injector in Healthy Adult ParticipantsTrial register ClinicalTrials.gov
2022-09-28TrialNew trial registered: A Survey to Assess Participants' and Physicians' Knowledge When Using GATTEX (Knowledge Assessment Survey)Trial register ClinicalTrials.gov
2022-05-24ResultsResults posted: A Study in Japanese Children With Short Bowel Syndrome Who Completed SHP633-302Trial register ClinicalTrials.gov
2022-05-12TrialNew trial registered: A Study of Teduglutide (Revestive®) in Participants With Short Bowel Syndrome (SBS) in CanadaTrial register ClinicalTrials.gov
2021-10-13ResultsResults posted: Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)Trial register ClinicalTrials.gov
2021-10-06ResultsResults posted: Teduglutide for Enterocutaneous Fistula (ECF)Trial register ClinicalTrials.gov
2021-08-30TrialNew trial registered: A Study of Teduglutide in Japanese Children With Short Bowel Syndrome Aged 4 Months or OlderTrial register ClinicalTrials.gov
2021-08-26TrialNew trial registered: A Study of Teduglutide in Japanese People With Short Bowel SyndromeTrial register ClinicalTrials.gov
2021-06-14ResultsResults posted: Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 StudyTrial register ClinicalTrials.gov
2021-06-07TrialNew trial registered: Bridging Intestinal Failure With Teduglutide - a Case ReportTrial register ClinicalTrials.gov
2021-05-12TrialNew trial registered: A Study With Teduglutide (Revestive®) in Adults With Short Bowl SyndromeTrial register ClinicalTrials.gov
2021-05-07TrialNew trial registered: A Study of Teduglutide (Revestive®) in Children, Teenagers and Adults With Short Bowel DiseaseTrial register ClinicalTrials.gov
2021-04-23TrialNew trial registered: Teduglutide in Short Bowel Syndrome PatientsTrial register ClinicalTrials.gov
2021-04-08ResultsResults posted: Safety, Efficacy and Pharmacokinetic Study of Teduglutide in Infants 4 to 12 Months of Age With Short Bowel SyndromeTrial register ClinicalTrials.gov
2021-04-05TrialNew trial registered: Pediatric Teduglutide RegistryTrial register ClinicalTrials.gov
2021-02-10ResultsResults posted: Study in Japanese Pediatric Subjects With Short Bowel Syndrome (SBS) Who Are Dependent on Parenteral SupportTrial register ClinicalTrials.gov
2021-02-01TrialNew trial registered: Quality of Life in Patients With Short Bowel Syndrome Treated Without and With Teduglutide - a Prospective Nested Matched Pair AnalysisTrial register ClinicalTrials.gov
2020-08-04ResultsResults posted: Study of Teduglutide in Japanese Participants With Short Bowel SyndromeTrial register ClinicalTrials.gov
2020-07-10TrialNew trial registered: A Study to Evaluate the Bioavailability of Teduglutide Administered Subcutaneously by Syringe Injection Versus Pen Injector in Healthy Adult ParticiTrial register ClinicalTrials.gov
2020-04-03TrialNew trial registered: Pharmacokinetics of Apixaban in Patients With Short Bowel Syndrome Requiring Long Term Parenteral NutritionTrial register ClinicalTrials.gov
2020-03-02TrialNew trial registered: Treatment of Patients With Teduglutide (GLP-2) for GVHD and Analysis of Paneth Cells of GVHD PatientsTrial register ClinicalTrials.gov
2019-11-20ResultsResults posted: Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome (SBS)Trial register ClinicalTrials.gov
2019-05-16TrialNew trial registered: Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and ComplicationsTrial register ClinicalTrials.gov
2019-03-04TrialNew trial registered: Effects of Oral Glucose and Teduglutide on Plasma LipoproteinsTrial register ClinicalTrials.gov
2018-10-23TrialNew trial registered: Therapeutic Approaches to Malnutrition EnteropathyTrial register ClinicalTrials.gov
2018-10-16ResultsResults posted: Short Bowel Syndrome Research Study for Children Up To 17 Years of Age on Parenteral NutritionTrial register ClinicalTrials.gov
2018-09-10TrialNew trial registered: Study of Teduglutide in Japanese Participants With Short Bowel SyndromeTrial register ClinicalTrials.gov
2018-07-23TrialNew trial registered: An Extension Study of Teduglutide in Japanese Participants With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-00Trial register ClinicalTrials.gov
2018-06-27TrialNew trial registered: Safety, Efficacy and Pharmacokinetic Study of Teduglutide in Infants 4 to 12 Months of Age With Short Bowel SyndromeTrial register ClinicalTrials.gov
2018-06-19TrialNew trial registered: Characterization of the Long-term Safety, Efficacy, and Pharmacodynamics Revestive® in the Management of Short Bowel Syndrome Pediatric PatientsTrial register ClinicalTrials.gov
2018-05-23TrialNew trial registered: L-NMMA on GLP-2 Mediated Intestinal Lipoprotein ReleaseTrial register ClinicalTrials.gov
2018-02-22TrialNew trial registered: Glucagon-like Peptide-2 Mediated Secretion of Stored Enteral LipidsTrial register ClinicalTrials.gov
2018-02-06TrialNew trial registered: Plasma Lipoprotein Response to Glucagon-like Peptide-2Trial register ClinicalTrials.gov
2017-10-03Federal RegisterFederal Register notice: Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant DeoxyriboRegulator Federal Register
2017-08-31TrialNew trial registered: A Study in Japanese Children With Short Bowel Syndrome Who Completed SHP633-302Trial register ClinicalTrials.gov
2016-12-02TrialNew trial registered: Study in Japanese Pediatric Subjects With Short Bowel Syndrome (SBS) Who Are Dependent on Parenteral SupportTrial register ClinicalTrials.gov
2016-11-03TrialNew trial registered: Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)Trial register ClinicalTrials.gov
2016-10-31TrialNew trial registered: Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 StudyTrial register ClinicalTrials.gov
2016-09-05TrialNew trial registered: Teduglutide for Enterocutaneous Fistula (ECF)Trial register ClinicalTrials.gov
2016-02-22ResultsResults posted: Short Bowel Syndrome and Teduglutide Versus PlaceboTrial register ClinicalTrials.gov
2016-02-15TrialNew trial registered: Short Bowel Syndrome Research Study for Children Up To 17 Years of Age on Parenteral NutritionTrial register ClinicalTrials.gov
2015-09-14ResultsResults posted: A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel SyndromeTrial register ClinicalTrials.gov
2015-05-07Federal RegisterFederal Register notice: Determination of Regulatory Review Period for Purposes of Patent Extension; GATTEXRegulator Federal Register
2015-05-01TrialNew trial registered: A Study of the Gut Barrier and Blood Vessel Inflammation in Individuals With and Without HIVTrial register ClinicalTrials.gov
2015-01-19TrialNew trial registered: Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome (SBS)Trial register ClinicalTrials.gov
2014-12-25ResultsResults posted: A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021Trial register ClinicalTrials.gov
2014-12-24ResultsResults posted: Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)Trial register ClinicalTrials.gov
2014-03-28TrialNew trial registered: Short Bowel Syndrome and Teduglutide Versus PlaceboTrial register ClinicalTrials.gov
2013-11-11TrialNew trial registered: Registry for Participants With Short Bowel SyndromeTrial register ClinicalTrials.gov
2013-09-27TrialNew trial registered: A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel SyndromeTrial register ClinicalTrials.gov
2013-07-15ResultsResults posted: Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel SyndromeTrial register ClinicalTrials.gov
2013-04-23ResultsResults posted: Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)Trial register ClinicalTrials.gov
2012-08-22Federal RegisterFederal Register notice: Gastrointestinal Drugs Advisory Committee; Notice of MeetingRegulator Federal Register
2012-03-22TrialNew trial registered: A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021Trial register ClinicalTrials.gov
2012-02-01ResultsResults posted: Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) SubjectsTrial register ClinicalTrials.gov
2010-09-27TrialNew trial registered: Effect of Teduglutide on Gastric Emptying in Healthy SubjectsTrial register ClinicalTrials.gov
2009-12-09TrialNew trial registered: Pharmacokinetics of 10 mg Teduglutide in Subjects With Renal Impairment Compared to Healthy Subjects With Normal Renal FunctionTrial register ClinicalTrials.gov
2009-12-09TrialNew trial registered: Effects of Teduglutide on Cardiac Repolarisation and Conduction in Healthy Male and Female VolunteersTrial register ClinicalTrials.gov
2009-06-30TrialNew trial registered: Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)Trial register ClinicalTrials.gov
2009-01-12TrialNew trial registered: A Double-Blind Multi-Dose Tolerability and Pharmacokinetic Study of TeduglutideTrial register ClinicalTrials.gov
2009-01-09TrialNew trial registered: Pharmacokinetics (PK) of 20 mg Teduglutide in Participants With Moderately Impaired Hepatic Function Compared to Healthy ParticipantsTrial register ClinicalTrials.gov
2008-11-27TrialNew trial registered: Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) SubjectsTrial register ClinicalTrials.gov
2006-03-29TrialNew trial registered: Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008Trial register ClinicalTrials.gov
2005-09-15TrialNew trial registered: Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)Trial register ClinicalTrials.gov
2004-04-14TrialNew trial registered: Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel SyndromeTrial register ClinicalTrials.gov
2003-11-13TrialNew trial registered: Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's DiseaseTrial register ClinicalTrials.gov

From ClinicalTrials.gov, EU CTIS, FDA labels, recalls, shortages and warning letters, the Federal Register, and regulators' published actions. Not medical advice.

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