Drugs / Efimosfermin
last change Apr 2026 re-read 3 minutes ago

Efimosfermin

also known as Efimosfermin alfa

Protein / enzyme biologic

Developed for
metabolic dysfunction-associated steatohepatitis · NAFLD1
Investigated by
GlaxoSmithKline

Trials 2

2022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT06920043 Apr 2025 → Jul 2028 expected NAFLD1, metabolic dysfunction-associated steatohepatitis GlaxoSmithKline Recruiting No outcome recorded
Phase 2 NCT04880031 Sep 2021 → Oct 2025 metabolic dysfunction-associated steatohepatitis GlaxoSmithKline Completed No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2026-04-27 GlaxoSmithKline Regulatory GSK’s investigational liver therapy, efimosfermin, receives US FDA Breakthrough Therapy and EMA Priority Medicines (PRIME) designations for MASH gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that efimosfermin, a once-monthly investigational liver therapy, has been granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) and Priority Medicines (PRIME) Designation by the European Medicines Agency (EMA) for the treatment of MASH.
2025-11-07 GlaxoSmithKline Results GSK presents data from its advancing liver pipeline at AASLD 2025 gsk.com ↗
Late breaking results for once-monthly efimosfermin in metabolic dysfunction-associated steatohepatitis (MASH), supporting the start of phase III clinical trials

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 3 sources stand behind the page.

FieldValueCited text
Known as Efimosfermin ClinicalTrials.gov intervention name — accepted as the source's own label NCT06920043 ↗
1

NCT04880031 ↗

Known as Efimosfermin alfa “Efimosfermin alfa (efimosfermin, formerly BOS-580) is a long-acting, engineered variant of FGF21 designed to have a prolonged half-life.” PMID 40484014 ↗ Jun 2025
Modality Protein / enzyme biologic “Efimosfermin alfa (efimosfermin, formerly BOS-580) is a long-acting, engineered variant of FGF21 designed to have a prolonged half-life.” PMID 40484014 ↗ Jun 2025
Route Subcutaneous “Efimosfermin will be administered by subcutaneous injection” NCT04880031 ↗