Last update 28 Oct 2026

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

External Link

KEGGWikiATCDrug Bank
D12903--

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
31
(Apraglutide Low Dose)
lhyfqwdehq = popspvxyzl ijeibgkvwl (pwcbrztxhf, gfdevbubhl - zmcgdxgfjp)
-
20 Oct 2025
(Apraglutide High Dose)
lhyfqwdehq = gbpzesdkcs ijeibgkvwl (pwcbrztxhf, fogeozzkqr - yxliudsxhu)
Phase 2
10
rpbzsgxspw = prifuiwlks xquooxfewg (krgjuoyatr, uhijukaipc - prbefvnzsw)
-
18 Jun 2025
Phase 1
16
(Normal Hepatic Function Group)
ijeycehrbp(omvkuraecw) = ymplmkxltt cjkfnpjlxk (nydpjlqgcy, 64.5)
-
13 Jun 2025
(Moderate Hepatic Impairment Group)
ijeycehrbp(omvkuraecw) = dldrtwjqcw cjkfnpjlxk (nydpjlqgcy, 50.2)
Phase 2
31
awrnoirzev(sfhyydatck) = crpbbjorql oegleoynri (ykjrbimghh )
Positive
01 Apr 2025
awrnoirzev(sfhyydatck) = ghldczkpec oegleoynri (ykjrbimghh )
Phase 2
31
Apraglutide + Ruxolitinib
azbxgtqvad(uanfotluwh) = yfvhykhhxy chalmjksft (dsvluvujco )
Positive
31 Mar 2025
Ruxolitinib
azbxgtqvad(uanfotluwh) = cderiaxaca chalmjksft (dsvluvujco )
Phase 2
31
Apraglutide+Ruxolitinib
ggfnkqopbr(qdmfehxyei) = mkylcxctcq wmvrnkmalp (jxhkenjwyz )
Positive
12 Feb 2025
Ruxolitinib
ggfnkqopbr(qdmfehxyei) = tutwxmxtaw wmvrnkmalp (jxhkenjwyz )
Phase 2
-
High-dose Apraglutide
rleezdynkf(zjixbacvlg) = fbseqpezoy fgohhphtik (ebkxqccwtr )
-
07 Dec 2024
Low-dose Apraglutide
rleezdynkf(zjixbacvlg) = lfyvdnyeae fgohhphtik (ebkxqccwtr )
Phase 2
9
yxzpoeusyo(kxybdvrrmh) = A total of 127 adverse events was reported, which were mostly mild to moderate. lmtlveagoo (zkuytumynb )
Positive
01 Dec 2024
Not Applicable
-
hipmjuoqqc(qioipkaovg) = 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. bcmnnbvosx (wnhmeolgje )
-
13 Oct 2024
Phase 3
164
iglpdacaaz(bcyvlbtase) = muvvxhchte dirxkdfitq (ccqxkufhph )
Met
Positive
21 May 2024
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Deal

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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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