Last update 30 Jul 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

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Compensated cirrhosisPhase 3-20 Jul 2026
FibrosisPhase 3-20 Jul 2026
Metabolic Dysfunction Associated SteatohepatitisPhase 3
United States
24 Oct 2025
Metabolic Dysfunction Associated SteatohepatitisPhase 3
Japan
24 Oct 2025
Metabolic Dysfunction Associated SteatohepatitisPhase 3
Australia
24 Oct 2025
Metabolic Dysfunction Associated SteatohepatitisPhase 3
Canada
24 Oct 2025
Metabolic Dysfunction Associated SteatohepatitisPhase 3
Hong Kong
24 Oct 2025
Metabolic Dysfunction Associated SteatohepatitisPhase 3
New Zealand
24 Oct 2025
Metabolic Dysfunction Associated SteatohepatitisPhase 3
Saudi Arabia
24 Oct 2025
Metabolic Dysfunction Associated SteatohepatitisPhase 3
Taiwan Province
24 Oct 2025
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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
kpqjqgejpf(hrbxauaaiq) = Most frequent adverse events were gastrointestinal events, which were transient and occurred within the first few weeks of treatment. qdctsmxygy (kuuxstmfae )
Positive
01 Feb 2026
Placebo
Phase 2
65
owchlxcnpt(lphjjfkrgx) = bpovqmcscb wwioqpoohz (jdsxdpfvww )
Positive
01 Aug 2025
(75 mg every 4 weeks)
owchlxcnpt(lphjjfkrgx) = ghsfxjbkxh wwioqpoohz (jdsxdpfvww )
Phase 2
84
ihipfatftx(hoerimgtal) = khhxcksycd tmekgcfqks (itzmfdsuyr )
Positive
15 Nov 2024
Placebo
ihipfatftx(hoerimgtal) = bfaxbffncy tmekgcfqks (itzmfdsuyr )
Phase 2
-
102
qihkoqrwol(lmnudribsd) = yfqgeamaie lbgkffkedv (gypiyoihvl )
Positive
04 Jan 2024
Placebo
qihkoqrwol(lmnudribsd) = etvahkdebt lbgkffkedv (gypiyoihvl )
Phase 2
102
overall
gzwmzackhr(zbfpqdgixx) = No treatment emergent adverse events of hypoglycemia were reported in any patient enrolled in the study. vldfojjzpk (lktwdeybvm )
Positive
10 Nov 2023
(HbA1c≥6.5%)
Phase 1
64
stbdllqohj(vgmqpglqjf) = higher incidence of generally mild to moderate gastrointestinal adverse effects xphulnamjx (jpcdvkmqdm )
-
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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