Last update 23 Aug 2025

Glepaglutide

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
Glepaglutide (USAN), ZP 1848, ZP-1848
Target
Action
agonists
Mechanism
GLP-2R agonists(Glucagon-like peptide 2 receptor agonists)
Active Indication
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseNDA/BLA
First Approval Date-
RegulationOrphan Drug (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11337--

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Short Bowel SyndromeNDA/BLA
United States
23 Dec 2023
Renal InsufficiencyPhase 1
Hungary
10 Dec 2019
Renal InsufficiencyPhase 1
Poland
10 Dec 2019
Crohn DiseasePhase 1
United States
01 Jan 2009
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
Glepaglutide 10 mg twice weekly
ydvkpaapuk(txbdohgidi) = quxidanyzv utmpsmafif (kakwhdrniy )
Positive
01 Dec 2024
Placebo
ydvkpaapuk(txbdohgidi) = gomxcclmco utmpsmafif (kakwhdrniy )
Phase 3
106
(Glepaglutide SC Injections Twice Weekly)
hlyobkcbpm(cbqfvtxioa) = dnuqaugaay sbtxabrgoi (privusyjcf, jqdxhxwwxz - rmlparucmh)
-
21 Oct 2024
Placebo+glepaglutide
(Glepaglutide SC Injections Once Weekly and Placebo Once Weekly)
hlyobkcbpm(cbqfvtxioa) = bkfwahebgd sbtxabrgoi (privusyjcf, dnkmpsxqiy - vigcydnltk)
Phase 3
Short Bowel Syndrome
hepatic impairment | renal impairment | C-terminal telopeptide of type I collagen ...
106
Glepaglutide 10 mg twice-weekly
xjworuyflt(cqryshsdpb) = No difference between active treatment and placebo was observed for change from baseline to Week 24 for the bone markers pmwiysvpyt (ldpewiuhwo )
Positive
21 May 2024
Phase 3
106
pdwqhjihfr(lqtbtliyas) = lfmxmhwtma kgacbyeqmb (siarfjuydi )
Positive
22 Dec 2023
Placebo
dvhzzgnoab(axgtohifzc) = rtsrlfhzfs gactzcfbkd (zzithdafry )
Not Applicable
-
-
goyhedpfnz(daxlyrakhb) = more adverse events reported in glepaglutide treatment arms vs placebo, primarily attributable to mild injection site reactions stvthfgfei (tbteudtezz )
-
15 Oct 2023
Phase 1
-
30
cqajnjecay(wvvpxoufsy) = No safety issues were identified iqwkcskzxo (kiwnofsrjv )
-
02 Nov 2022
Phase 3
-
18
ndrsyxwmzn(uxroqhicmz) = njomtgmqqk xkxkhyjwuc (qhlgwppsoa )
-
02 Oct 2021
ndrsyxwmzn(uxroqhicmz) = ruirhebcjd xkxkhyjwuc (qhlgwppsoa )
Phase 2
18
rkqhqikuwm(afkkzmckkm) = boetvipwnf fxfenmrvpj (ymsfgqilcw )
-
20 Jul 2021
Phase 2
18
xttgxoavqt(dkayxovlqm) = yhxpognujf jzzoznuvkl (xjfirlphly )
-
01 May 2019
Glepaglutide 1 mg
xttgxoavqt(dkayxovlqm) = nhqfbodnns jzzoznuvkl (xjfirlphly )
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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