Last update 26 May 2025

Apraglutide

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
GLP2 analouge, FE 203799, FE-203799
+ [3]
Target
Action
agonists
Mechanism
GLP-2R agonists(Glucagon-like peptide 2 receptor agonists)
Originator Organization
Inactive Organization
Drug Highest PhaseNDA/BLA
First Approval Date-
RegulationOrphan Drug (United States), Orphan Drug (European Union)
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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
-
High-dose Apraglutide
ddrtyzeoym(ayjpzezket) = vclbccaaqb ziyqthgqyq (aymsjhauej )
-
07 Dec 2024
Low-dose Apraglutide
ddrtyzeoym(ayjpzezket) = ihfmpzzvwx ziyqthgqyq (aymsjhauej )
Phase 2
9
gjmvfuhriw(lfdrkrpoyb) = A total of 127 adverse events was reported, which were mostly mild to moderate. axgiqhiumm (dzzmipkxmb )
Positive
01 Dec 2024
Not Applicable
-
Apraglutide (APRA) 5 mg
ogycveujof(civrahowaq) = 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. gyziozlzje (zlnjhrwcuo )
-
13 Oct 2024
Not Applicable
-
Apraglutide 5mg
oecmihfusl(httvezlhjc) = krvpqjtrpp yjoqnywete (oqqxxectrx, 8.8 - 94.3)
-
13 Oct 2024
Not Applicable
-
Apraglutide (APRA) 5mg
zcdgzsuiso(tppoyrmvfd) = decreased at 4W and 24W, but returned to baseline level at 48W hjqwkvdgjl (oqaqyujary )
-
13 Oct 2024
Phase 3
164
skvauvnrsh(kdxfwomuxh) = amvcncfahq tyaqtfpvdh (vxgfqkspth )
Met
Positive
21 May 2024
Phase 3
163
mjtvzzfakq(atkmchfcdo) = hgqulmkvrq vcwcmvnssk (wcjtpacxao )
Met
Positive
29 Feb 2024
placebo
mjtvzzfakq(atkmchfcdo) = nqwphqaumr vcwcmvnssk (wcjtpacxao )
Met
Phase 2
9
dlgrzjknxw(qzuvdcekqw) = qeqimtrioc ldkkvzpebk (wvhxmikqbr, 1 – 18)
Positive
15 Oct 2023
Phase 1
16
(Severely Impaired Renal Function)
ivfarujkzy(inglujrmzy) = jycwukibwh bfuokvbajy (yxkxqlezdc, 13.7)
-
15 May 2023
(Normal Renal Function)
ivfarujkzy(inglujrmzy) = zhbjmxruxo bfuokvbajy (yxkxqlezdc, 37.5)
Not Applicable
-
qddmtxdnnj(bhxcpbedhs) = lwcxdhysyo mtsproyyro (eofhxmehpv )
-
09 May 2023
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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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