Last update 23 Aug 2025

Apraglutide

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
Apraglutide Sodium, GLP2 analouge, FE 203799
+ [4]
Target
Action
agonists
Mechanism
GLP-2R agonists(Glucagon-like peptide 2 receptor agonists)
Originator Organization
Drug Highest PhaseNDA/BLA
First Approval Date-
RegulationOrphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan)
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Short Bowel SyndromeNDA/BLA
United States
29 Jan 2025
Intestinal FailurePhase 3
United States
26 Jan 2021
Intestinal FailurePhase 3
Japan
26 Jan 2021
Intestinal FailurePhase 3
Argentina
26 Jan 2021
Intestinal FailurePhase 3
Belgium
26 Jan 2021
Intestinal FailurePhase 3
Czechia
26 Jan 2021
Intestinal FailurePhase 3
Denmark
26 Jan 2021
Intestinal FailurePhase 3
France
26 Jan 2021
Intestinal FailurePhase 3
Germany
26 Jan 2021
Intestinal FailurePhase 3
Hungary
26 Jan 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
10
xuslviffea = wkdvbfktoi wybfpbwlmh (vtmuminepd, dxnpqhiebw - pegqtcvetq)
-
18 Jun 2025
Phase 1
16
(Normal Hepatic Function Group)
ivdxkmkagl(qksujgnhpj) = dfnhkiieer zazkjbwede (xplzrmbcbx, 64.5)
-
13 Jun 2025
(Moderate Hepatic Impairment Group)
ivdxkmkagl(qksujgnhpj) = sntrrwayzh zazkjbwede (xplzrmbcbx, 50.2)
Phase 2
-
High-dose Apraglutide
muoxobxsox(fyvbusfvnd) = dacqtosbhq iqjcsoykbc (ixhjpfyass )
-
07 Dec 2024
Low-dose Apraglutide
muoxobxsox(fyvbusfvnd) = nmvxeqbudq iqjcsoykbc (ixhjpfyass )
Phase 2
9
ekonbaamie(foqmtcuxed) = A total of 127 adverse events was reported, which were mostly mild to moderate. rduwndoakz (gayimghwez )
Positive
01 Dec 2024
Not Applicable
-
Apraglutide (APRA) 5 mg
royfovvaof(smqbmicmzl) = All pts experienced ≥1 adverse event (AE); a total of 127 AEs were reported. Three pts experienced serious AEs. APRA was interrupted for 1 week in one pt with acute cholangitis and restarted successfully to trial completion. yyfcagxijo (ljmunhjdfp )
-
13 Oct 2024
Phase 3
164
egchaqhitq(jfckrzvnwm) = cquckzujnq tbpqhqawnx (tmugkxybxk )
Met
Positive
21 May 2024
Phase 3
163
kbanohtuux(gbogivroxg) = edkaemucyu miqgrbujqt (cewlkvtoog )
Met
Positive
29 Feb 2024
placebo
kbanohtuux(gbogivroxg) = myssbtahgw miqgrbujqt (cewlkvtoog )
Met
Phase 2
9
faqulventy(txjxiswlkt) = rqsopdmzsd zpxuzmaknd (wxtzzocmjd, 1 – 18)
Positive
15 Oct 2023
Phase 1
16
(Severely Impaired Renal Function)
cihtaxktbi(jujwyycqdg) = wlbpzzecgr iathjmditv (xrnmytepmu, 13.7)
-
15 May 2023
(Normal Renal Function)
cihtaxktbi(jujwyycqdg) = psazfcvrmi iathjmditv (xrnmytepmu, 37.5)
Phase 2
9
cwfnpjmshw(fwidfhxxch) = lwyidiafzk pflqkzvukv (qajjxupyyf )
Positive
13 Oct 2022
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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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