Last update 09 May 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)
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Structure/Sequence

R&D Status

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IndicationHighest PhaseCountry/LocationOrganizationDate
Metabolic Dysfunction Associated SteatohepatitisPhase 3
United States
24 Oct 2025
Compensated cirrhosisPhase 2
United States
09 Apr 2025
Metabolic dysfunction-associated steatotic liver diseasePhase 1
New Zealand
05 Mar 2026
ObesityPhase 1
United States
26 Feb 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
84
Efimosfermin 300 mg Q4W
gvbjmxuwnt(iwbifzjknm) = Most frequent adverse events were gastrointestinal events, which were transient and occurred within the first few weeks of treatment. omxjkoqheo (wkoawojqqn )
Positive
01 Feb 2026
Placebo
Phase 2
65
uxiadwqezu(fmloaqizsr) = wochkhxazd fpojoagkfg (bzxhyxavme )
Positive
01 Aug 2025
(75 mg every 4 weeks)
uxiadwqezu(fmloaqizsr) = zjpcdgzfbq fpojoagkfg (bzxhyxavme )
Phase 2
84
wadzdonwqs(jzlflonbhr) = qqsmlajcgs pzxyatxbbd (wnjsujqmah )
Positive
15 Nov 2024
Placebo
wadzdonwqs(jzlflonbhr) = wkqlsevddg pzxyatxbbd (wnjsujqmah )
Phase 2
-
102
jejuvtulqc(dbysoeunun) = jjslujltdf xezbezstic (wqdijuaeex )
Positive
04 Jan 2024
Placebo
jejuvtulqc(dbysoeunun) = xevabvyhkq xezbezstic (wqdijuaeex )
Phase 2
102
overall
nlogkdiuat(bfgegcrlmo) = No treatment emergent adverse events of hypoglycemia were reported in any patient enrolled in the study. pyggkcrzzg (gitntzuxaz )
Positive
10 Nov 2023
(HbA1c≥6.5%)
Phase 1
64
ditpyroolj(wwxfqctuvd) = higher incidence of generally mild to moderate gastrointestinal adverse effects hrlvkcsxfh (ewfhfqimqh )
-
25 Aug 2021
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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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