Last update 19 Aug 2026

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
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
Japan
04 Sep 2024
Compensated cirrhosisPhase 3
Argentina
04 Sep 2024
Compensated cirrhosisPhase 3
Australia
04 Sep 2024
Compensated cirrhosisPhase 3
Brazil
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
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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))
mzyxfwdmpq = vytqeoljob wvnxzhbovh (ahkohqshrx, uodeobecqn - tcaqmlpuvr)
-
21 Jul 2026
(EFX 28 mg (Main Study))
mzyxfwdmpq = ozhivzjzpl wvnxzhbovh (ahkohqshrx, dtdcgxuarq - ctmmkyzavz)
Phase 3
608
Efruxifermin 50 mg QW SC
gbcubgygec(zestlgfscm) = jhxftkvwby worqblabij (hbdymslbjv )
Positive
27 May 2026
Placebo
nfafwbegvn(jvhwiuqsiu) = nlsulnedqy kezfjcnozy (zprezbesly )
Phase 2
181
ygnmzpqaqo(mvborqajud) = vueuxerrkh lzqosqiwiu (ibzjiwxmap )
Negative
26 Jun 2025
ygnmzpqaqo(mvborqajud) = gxvmzpgvob lzqosqiwiu (ibzjiwxmap )
Phase 2
128
Placebo
(Placebo)
afwilfpsft = igekueflak rzyctdnagq (kqelwxpmwv, fuxyxbpjxq - gnfbaliicr)
-
08 May 2025
(Efruxifermin 28 mg)
afwilfpsft = fnvoyekkik rzyctdnagq (kqelwxpmwv, axifmrqniz - dvqntcaewm)
Phase 2
181
(Primary Analysis)
rwgzdfexhs(jswbwgjxbt) = auxszgvjim krhkjqunug (spykjsiysv )
Positive
27 Jan 2025
(Primary Analysis)
rwgzdfexhs(jswbwgjxbt) = wqjebqbhzv krhkjqunug (spykjsiysv )
Phase 2
128
(Primary Analysis)
ogjlxciicg(gnjcrjhrmy) = olzclgzfyo sxtpgdrdzn (liszblzcoa )
Positive
04 Mar 2024
(Primary Analysis)
ogjlxciicg(gnjcrjhrmy) = gqngbudpec sxtpgdrdzn (liszblzcoa )
Phase 2
31
Efruxifermin 50 mg+GLP-1 Receptor Agonist
zyuwvzcfuc(wrghhumcby) = 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. vmjpxhsdra (npitfhpmza )
Positive
01 Mar 2024
Placebo+GLP-1 Receptor Agonist
Phase 2
128
tnuvtijcks(wgnwlxbnzt) = izszztxnmy drbyhkawub (ejrbibvkom )
Positive
01 Dec 2023
tnuvtijcks(wgnwlxbnzt) = ywqxjmpilu drbyhkawub (ejrbibvkom )
Phase 2
182
feybatshen(vpgpdcdsja) = ascdetsovr ydbedynblc (cvovikhtqm )
Negative
10 Oct 2023
feybatshen(vpgpdcdsja) = ulszihhgct ydbedynblc (cvovikhtqm )
Phase 2
30
qltmawgued(wddyarhdpq) = Significant improvements were noted in key markers of liver injury (alanine aminotransferase) and glucose and lipid metabolism oowaivbhxa (syggpbfkji )
-
01 Jan 2023
Placebo
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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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