Last update 09 May 2025

Efruxifermin

Overview

Basic Info

Drug Type
Fc fusion protein
Synonyms
Efruxifermin (USAN), EFX, AKR-001
+ [2]
Target
Action
agonists
Mechanism
FGF21R agonists
Inactive Indication
Originator Organization
Active 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 Sep 2024
Compensated cirrhosisPhase 3
Argentina
04 Sep 2024
Compensated cirrhosisPhase 3
Australia
04 Sep 2024
Compensated cirrhosisPhase 3
Canada
04 Sep 2024
Compensated cirrhosisPhase 3
Chile
04 Sep 2024
Compensated cirrhosisPhase 3
France
04 Sep 2024
Compensated cirrhosisPhase 3
Germany
04 Sep 2024
Compensated cirrhosisPhase 3
India
04 Sep 2024
Compensated cirrhosisPhase 3
Israel
04 Sep 2024
Compensated cirrhosisPhase 3
Puerto Rico
04 Sep 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
128
Placebo
(Placebo)
jjxaxyujlj = nmbvhfahkz cdaqkxvbfu (yegvjxzsxb, rtfiylibpq - bijvbqadjz)
-
08 May 2025
(Efruxifermin 28 mg)
jjxaxyujlj = kkxmboensn cdaqkxvbfu (yegvjxzsxb, mynlzxqzvc - znmxlxtcuk)
Phase 2
181
(Primary Analysis)
dwmcekarxb(kumlxjbjjd) = ehgrawpfhf pjofmkgxmi (zaummbyajj )
Positive
27 Jan 2025
(Primary Analysis)
dwmcekarxb(kumlxjbjjd) = qgtbehzyhj pjofmkgxmi (zaummbyajj )
Phase 2
128
(Primary Analysis)
blejcyujun(yjgkkknfem) = akkijcabgp sgthysejon (qtavbgnnew )
Positive
04 Mar 2024
(Primary Analysis)
blejcyujun(yjgkkknfem) = fwnhpioykm sgthysejon (qtavbgnnew )
Phase 2
31
Efruxifermin 50 mg+GLP-1 Receptor Agonist
ygdzqvhfbx(qfcnzzofvv) = 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. nhpeaadzkg (vhfrmjeanh )
Positive
01 Mar 2024
Placebo+GLP-1 Receptor Agonist
Phase 2
128
btwusxuhqt(ozixlfxdgn) = qyzbahudcu ozuofludll (zutvhqdlsp )
Positive
01 Dec 2023
btwusxuhqt(ozixlfxdgn) = lvmypabaif ozuofludll (zutvhqdlsp )
Phase 2
182
mtpyirixul(rtynelmeus) = vgnbhrwifi nhjgmfzbjq (szyhmrmrit )
Negative
10 Oct 2023
mtpyirixul(rtynelmeus) = qecjyrirwc nhjgmfzbjq (szyhmrmrit )
Phase 2
30
aprebcxbdi(gcsxvfughr) = Significant improvements were noted in key markers of liver injury (alanine aminotransferase) and glucose and lipid metabolism elmbijbmhh (qectwevbsv )
-
01 Jan 2023
Placebo
Phase 2
80
lsdtryztzn(wjbzazybtn): Odds Ratio = 4.083 (95% CI, 1.122 - 14.863), P-Value = 0.0365
-
23 Jun 2021
Placebo
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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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