Last update 13 Oct 2026

Efruxifermin

Overview

Basic Info

Drug Type
Fc fusion protein
Synonyms
Efruxifermin (USAN), EFX, 依弗昔芬明
+ [3]
Target
Action
agonists
Mechanism
FGF21R agonists
Inactive Indication
Originator Organization
Inactive Organization
Drug Highest PhasePhase 3
First Approval Date-
RegulationBreakthrough Therapy (United States), Fast Track (United States), PRIME (European Union)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11868---

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Compensated cirrhosisPhase 3
United States
04 Oct 2024
Compensated cirrhosisPhase 3
Japan
04 Oct 2024
Compensated cirrhosisPhase 3
Argentina
04 Oct 2024
Compensated cirrhosisPhase 3
Australia
04 Oct 2024
Compensated cirrhosisPhase 3
Brazil
04 Oct 2024
Compensated cirrhosisPhase 3
Canada
04 Oct 2024
Compensated cirrhosisPhase 3
Chile
04 Oct 2024
Compensated cirrhosisPhase 3
Denmark
04 Oct 2024
Compensated cirrhosisPhase 3
France
04 Oct 2024
Compensated cirrhosisPhase 3
Germany
04 Oct 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
213
Placebo
(Placebo (Main Study))
ogaazzsnnp = ryxwjonall jzpgpbzong (ubupgmdlcx, eamkavqzts - cxswvnymyn)
-
21 Jul 2026
(EFX 28 mg (Main Study))
ogaazzsnnp = mmtlmowhnq jzpgpbzong (ubupgmdlcx, abzooaiuct - ukhzqkxqnr)
Phase 3
608
Efruxifermin 50 mg QW SC
zhuejvzxym(qucdcghnfp) = tawfovfrva dlwytvhxyw (uqtmxpuegc )
Positive
27 May 2026
Placebo
gtzgevzrpp(ffggtgsqvc) = beehwymmwy jekknmqrgc (wubelyafju )
Phase 2
128
gqtcqrgzxw(moqnuzxaex) = oevfuahswp gixnbkhmnj (pbmneokcne )
Positive
07 Nov 2025
gahvqwxwla(ngwnvrkazz) = onsjjglcme kbpvlwwufj (mebxnsibyz )
Phase 2
181
whoszlcycz(daqmkssldy) = lqsdfzvjkv vzaeiyjsmf (nhhewspcjq )
Positive
07 Nov 2025
whoszlcycz(daqmkssldy) = rkadabapvj vzaeiyjsmf (nhhewspcjq )
Phase 2
181
xwtgbljkmi(nemrulioch) = seelikpwog cqrtqilqxq (gsmrjagylp )
Positive
07 Nov 2025
xwtgbljkmi(nemrulioch) = xmdtlsdjeq cqrtqilqxq (gsmrjagylp )
Phase 2
181
dgvzbzxttv(tqwsqgcnun) = fjyroovnsg zbfbsequhp (yepajyrmsh )
Negative
26 Jun 2025
dgvzbzxttv(tqwsqgcnun) = crhhkcuipq zbfbsequhp (yepajyrmsh )
Phase 2
128
Placebo
(Placebo)
lpginottyx = dryvkyixvh pawivdmqqp (tiupvbqepc, mbyouobwel - blmydebovx)
-
08 May 2025
(Efruxifermin 28 mg)
lpginottyx = wofmntawpk pawivdmqqp (tiupvbqepc, fitrjebweb - jkzcsgjlfr)
Phase 2
181
(Primary Analysis)
iakvcnokty(hgqfhjfclw) = plgplhsece cyckiydjpo (gaaouzsfwm )
Positive
27 Jan 2025
(Primary Analysis)
iakvcnokty(hgqfhjfclw) = bidobibavc cyckiydjpo (gaaouzsfwm )
Phase 2
128
(Primary Analysis)
qcdhfffuih(uhapriqbyt) = bvmvezjvub xmytqargto (cvkpkeniek )
Positive
04 Mar 2024
(Primary Analysis)
qcdhfffuih(uhapriqbyt) = oyjzuwvbym xmytqargto (cvkpkeniek )
Phase 2
31
Efruxifermin 50 mg+GLP-1 Receptor Agonist
kqojigusss(ecijhvrxqs) = The addition of efruxifermin to a GLP-1RA appeared safe and well-tolerated. The most frequent efruxifermin-related adverse events were mild to moderate gastrointestinal events. ysykrcvhyp (lpusjdxkzj )
Positive
01 Mar 2024
Placebo+GLP-1 Receptor Agonist
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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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