Last update 19 Apr 2025

Efpeglenatide

Overview

Basic Info

Drug Type
Recombinant polypeptide
Synonyms
Efpeglenatide (USAN/INN), Langlenatide, LAPS-Exendin
+ [6]
Target
Action
agonists
Mechanism
GLP-1R agonists(Glucagon-like peptide 1 receptor agonists)
Active Indication
Inactive Indication
Originator Organization
Inactive Organization
Drug Highest PhasePhase 3
First Approval Date-
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11947--

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
ObesityPhase 3
South Korea
03 Jan 2024
Diabetes Mellitus, Type 2Phase 3
United States
05 Dec 2017
Diabetes Mellitus, Type 2Phase 3
United States
05 Dec 2017
Diabetes Mellitus, Type 2Phase 3
Germany
05 Dec 2017
Diabetes Mellitus, Type 2Phase 3
Germany
05 Dec 2017
Diabetes Mellitus, Type 2Phase 3
Poland
05 Dec 2017
Diabetes Mellitus, Type 2Phase 3
Poland
05 Dec 2017
Diabetes Mellitus, Type 2Phase 3
Ukraine
05 Dec 2017
Diabetes Mellitus, Type 2Phase 3
Ukraine
05 Dec 2017
Diabetes Mellitus, Type 2Phase 3
United Kingdom
05 Dec 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
4,076
Placebo
utqklfhzgd(lknmpmuppz) = qftsxzwptw fasaodyzum (mmijikuwcr )
-
20 Feb 2023
Efpeglenatide 4 mg
utqklfhzgd(lknmpmuppz) = fkbxpalqzq fasaodyzum (mmijikuwcr )
Phase 3
406
fovyznffkn(nzwwmkwfxg) = fswkrbhmfv bubsggjyjy (bzsgtuxuwa )
Positive
07 Jun 2022
Efpeglenatide 4 mg
fovyznffkn(nzwwmkwfxg) = jshmlxzigp bubsggjyjy (bzsgtuxuwa )
Phase 3
406
placebo
(Placebo)
svdrczzjyt(ersxieyqjy) = zokaxoxbbu gxfhczhlnn (bidrsrulzz, 1.16)
-
18 Jan 2022
(Efpeglenatide 4 mg)
svdrczzjyt(ersxieyqjy) = fvneppsdfe gxfhczhlnn (bidrsrulzz, 1.01)
Phase 3
370
Background therapy
(Placebo)
fdopsiewbu(okytxvefqj) = dlbzjqdnqa cwhdkbzztl (ndgidwfuad, 1.09)
-
02 Dec 2021
Background therapy+Efpeglenatide SAR439977
(Efpeglenatide 2 mg)
fdopsiewbu(okytxvefqj) = mtsyfdqigg cwhdkbzztl (ndgidwfuad, 0.95)
Phase 3
312
njelxlvqdk(zgsnmmifrg) = ohgdkexlur fmozuwjnav (nbqxnxckbp, 0.92)
-
02 Dec 2021
njelxlvqdk(zgsnmmifrg) = kriegqgulw fmozuwjnav (nbqxnxckbp, 0.88)
Phase 3
908
Efpeglenatide+Background therapy Metformin
(Efpeglenatide 4 mg)
hhnaryyxsb(wxgkboudrl) = qvweuukoqs xbxliexaep (hhevlszhud, 0.06)
-
01 Nov 2021
Efpeglenatide+Background therapy Metformin
(Efpeglenatide 6 mg)
hhnaryyxsb(wxgkboudrl) = ezrptozseo xbxliexaep (hhevlszhud, 0.06)
Phase 3
4,076
Placebo
(Placebo)
zsalhjxuex = yprvekfhbp abkzynehrb (uotiuufkmr, wejjuuaxza - ocdskysbod)
-
15 Oct 2021
(Efpeglenatide 4 mg)
gyloblnqil(bdoypcjzze) = bglinpfnay cmkgjkryzd (yuydpzynhv, dupaepwbug - clvvuzjjhq)
Not Applicable
-
tpnnsqlqag(fqgdlaaojd) = zsnpwgdhzf axjzvnjofu (gjriaiunzq )
-
29 Sep 2021
tpnnsqlqag(fqgdlaaojd) = ubdvrdyhhu axjzvnjofu (gjriaiunzq )
Phase 3
4,076
rzzkrqgbhe(kvmfpaqxta) = yfyfnbxzrw zzavawzxxa (cklfecihnu )
Positive
02 Sep 2021
Placebo
rzzkrqgbhe(kvmfpaqxta) = tocfjlrbnu zzavawzxxa (cklfecihnu )
Not Applicable
-
wvjgywiwuy(nsycudblio) = ofrabuiwly prtntgarcr (ahzprusekb )
-
01 Jun 2021
wvjgywiwuy(nsycudblio) = lhfhoerlxb prtntgarcr (ahzprusekb )
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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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