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Glepaglutide

Generic Name: Glepaglutide

Drug Type: Biotech

CAS Number: 914009-86-2

Unique Ingredient Identifier: 4M3C1913N6

Overview

Glepaglutide is under investigation in clinical trial NCT00868660 (Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending Dose).

Background

Glepaglutide is under investigation in clinical trial NCT00868660 (Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending Dose).

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

The Long-term Effect on Intestinal Absorption and Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome

Phase 3

Completed

Posted: 2021/08/05

Sponsor:Zealand Pharma

Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial

Phase 3

Posted: 2021/05/11

Sponsor:Zealand Pharma

A Bridging Trial to Compare the PK Profile When Glepaglutide is Administered Via Vial/Syringe Versus Autoinjector.

Phase 1

Completed

Posted: 2020/03/24

Sponsor:Zealand Pharma

Pharmacokinetic Profile of Glepaglutide After a Single Injection in Subjects With Varying Degrees of Renal Function

Phase 1

Completed

Posted: 2019/11/26

Sponsor:Zealand Pharma

Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS

Phase 3

Recruiting

Posted: 2019/04/05

Sponsor:Zealand Pharma

FDA Approved Products

No FDA products found for this drug

Singapore Approved Products

No Singapore products found for this drug

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FDA Issues Complete Response Letter for Zealand Pharma's Glepaglutide in Short Bowel Syndrome

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The FDA issued a Complete Response Letter for Zealand Pharma's glepaglutide, a GLP-2 analog, intended for short bowel syndrome (SBS) treatment, citing insufficient evidence of efficacy and safety.

Drug Development Updates

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