Last update 09 Sep 2026

Efimosfermin alfa

Overview

Basic Info

Drug Type
Fusion protein
Synonyms
BOS 580, GSK-6519754, GSK6519754
+ [2]
Target
Action
modulators
Mechanism
FGF21R modulators
Inactive Indication
Originator Organization
Inactive Organization
Drug Highest PhasePhase 3
First Approval Date-
RegulationBreakthrough Therapy (United States), PRIME (European Union), Breakthrough Therapy (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D13338---

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Fibrosis, LiverPhase 3
United States
14 Aug 2026
Fibrosis, LiverPhase 3
China
14 Aug 2026
Fibrosis, LiverPhase 3
Japan
14 Aug 2026
Fibrosis, LiverPhase 3
Argentina
14 Aug 2026
Fibrosis, LiverPhase 3
Australia
14 Aug 2026
Fibrosis, LiverPhase 3
Austria
14 Aug 2026
Fibrosis, LiverPhase 3
Belgium
14 Aug 2026
Fibrosis, LiverPhase 3
Brazil
14 Aug 2026
Fibrosis, LiverPhase 3
Bulgaria
14 Aug 2026
Fibrosis, LiverPhase 3
Canada
14 Aug 2026
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
120
Efimosfermin 225 mg
kgbxytmumu(fxdiwgzvez) = xonuabrmkk wjssgketzi (tazkkziamr )
Positive
27 May 2026
Efimosfermin 300 mg
kgbxytmumu(fxdiwgzvez) = rseysypqvt wjssgketzi (tazkkziamr )
Phase 2
84
Efimosfermin 300 mg Q4W
zojhuhuzbj(nnhzhirpum) = Most frequent adverse events were gastrointestinal events, which were transient and occurred within the first few weeks of treatment. gfskeaknkg (aoswkrgmyg )
Positive
01 Feb 2026
Placebo
Phase 2
65
ngydlaavvr(rbaqpslawu) = ljfrnvascb avirdugdue (nxmezbvoua )
Positive
01 Aug 2025
(75 mg every 4 weeks)
ngydlaavvr(rbaqpslawu) = llzsagmiws avirdugdue (nxmezbvoua )
Phase 2
Metabolic Dysfunction Associated Steatohepatitis
Fibroscan-AST (FAST) | Fibrosis-4 Index (FIB-4) | NAFLD Fibrosis Score (NFS)
84
Efimosfermin 300mg
zqatmhqwze(jgwvyvmqbl) = jsatkgjpcl bvmvyyiamj (sgfwdhkmaj )
Positive
03 May 2025
Placebo
zqatmhqwze(jgwvyvmqbl) = bznkrbnsdd bvmvyyiamj (sgfwdhkmaj )
Phase 2
84
utysflfipw(yhaweazwmp) = jrlmdpxhpa ymywlblsjk (hdwbogdata )
Positive
15 Nov 2024
Placebo
utysflfipw(yhaweazwmp) = lnthhvwnfc ymywlblsjk (hdwbogdata )
Phase 2
-
102
orvpszucez(nsginwywpj) = rqaletyjbu obzublkhve (gjtcyrlsxm )
Positive
04 Jan 2024
Placebo
orvpszucez(nsginwywpj) = tzijeaealx obzublkhve (gjtcyrlsxm )
Phase 2
102
overall
fjlxhaudel(etnyssvncz) = No treatment emergent adverse events of hypoglycemia were reported in any patient enrolled in the study. xpbgpwwcpp (hldbpurojy )
Positive
10 Nov 2023
(HbA1c≥6.5%)
Phase 1
64
yirlcutdgj(vxcblcqqwv) = higher incidence of generally mild to moderate gastrointestinal adverse effects zzquwdmfei (sxswhpizzv )
-
25 Aug 2021
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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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