GLEPAGLUTIDE

Investigational

Description
Sources: https://www.ncbi.nlm.nih.gov/pubmed/30880176 | https://clinicaltrials.gov/ct2/show/NCT03905707 | https://www.zealandpharma.com/glepaglutide | https://www.globenewswire.com/news-release/2017/10/24/1152210/0/en/U-S-FDA-grants-orphan-drug-designation-to-glepaglutide-for-the-treatment-of-short-bowel-syndrome.html

Glepaglutide (also known as ZP 1848), a long-acting glucagon-like peptide-2 (GLP-2) analog that was developed for patients with reduced or complete loss of intestinal function. In October 2017 - The U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) has granted an orphan drug designation to glepaglutide for the treatment of the rare disease short bowel syndrome (SBS). Many people with SBS are dependent on the frequent intake of intravenous fluids and nutrition delivered through a central catheter. Currently, glepaglutide is participating in a phase III clinical trial to determine the safety and efficacy of subcutaneous injection of the drug for the treatment of SBS.

Originator

Approval Year

PubMed

Title	Date	PubMed
Glepaglutide, a novel long-acting glucagon-like peptide-2 analogue, for patients with short bowel syndrome: a randomised phase 2 trial.	2019-05	30880176

Sample Use Guides

In Vivo Use Guide

Glucagon-Like Peptide-2 (GLP-2) analog, 10 mg subcutaneous injection twice weekly.

Route of Administration: Other

Substance Class	Protein Created by `admin` on `Mon Mar 31 20:06:47 GMT 2025` Edited by `admin` on `Mon Mar 31 20:06:47 GMT 2025`
Protein Type	PEPTIDE
Protein Sub Type
Sequence Type	COMPLETE
Record UNII	4M3C1913N6
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

GLEPAGLUTIDE

Official Name

English

ZP-1848

Preferred Name

English

MUTATED HUMAN GLUCAGON LIKE PEPTIDE-2 (GLP-2) ANALOGUE WITH A C-TERMINAL HEXA-LYSINE ADDITION(2-GLYCINE(A>G),3-GLUTAMIC ACID(D>E),5-THREONINE(S>T),8-SERINE(D>S),10-LEUCINE(M>L),11-ALANINE(N>A),16-ALANINE(N>A),24-ALANINE(N>A),28-ALANINE(Q>A))HUMAN GLUCAGO

Systematic Name

English

HIS-GLY-GLU-GLY-THR-PHE-SER-SER-GLU-LEU-ALA-THR-ILE-LEU-ASP-ALA-LEU-ALA-ALA-ARG-ASP-PHE-ILE-ALA-TRP-LEU-ILE-ALA-THR-LYS-ILE-THR-ASP-LYS-LYS-LYS-LYS-LYS-LYS-NH2

Common Name

English

Glepaglutide [WHO-DD]

Common Name

English

ZP1848

Code

English

L-LYSINAMIDE, L-HISTIDYLGLYCYL-L-.ALPHA.-GLUTAMYLGLYCYL-L-THREONYL-L-PHENYLALANYL-L-SERYL-L-SERYL-L-.ALPHA.-GLUTAMYL-L-LEUCYL-L-ALANYL-L-THREONYL-L-ISOLEUCYL-L-LEUCYL-L-.ALPHA.-ASPARTYL-L-ALANYL-L-LEUCYL-L-ALANYL-L-ALANYL-L-ARGINYL-L-.ALPHA.-ASPARTYL-L-P

Systematic Name

English

glepaglutide [INN]

Common Name

English

GLEPAGLUTIDE [USAN]

Common Name

English

Classification Tree Code System Code

FDA ORPHAN DRUG

539216