Efruxifermin

FGF21 Analogue (Fc Fusion Protein)Rx: InvestigationalCompound: Investigational

Also known as: AKR-001, EFX, Fc-FGF21

Educational Only — Not medical advice. Consult a qualified clinician before using any peptide.

Summary

Efruxifermin (EFX) is an investigational Fc-FGF21 fusion protein developed by Akero Therapeutics for the treatment of metabolic dysfunction-associated steatohepatitis (MASH, formerly NASH) and metabolic dysfunction-associated steatotic liver disease (MASLD). It has demonstrated significant histological improvements in liver fibrosis and steatosis in Phase 2 clinical trials, with Phase 3 trials ongoing.

Mechanism of Action

Efruxifermin is a long-acting Fc-fusion analogue of fibroblast growth factor 21 (FGF21) that activates FGF receptors (primarily FGFR1c and FGFR3c) in complex with the co-receptor beta-klotho, leading to improved insulin sensitivity, reduced hepatic lipogenesis, increased fatty acid oxidation, and anti-fibrotic effects in the liver.

Routes of Administration

Subcutaneous

Goals & Uses

  • MASH/NASH fibrosis improvementHepatologyModerate
  • Treatment of compensated cirrhosis due to MASHHepatologyLow
  • Reduction of hepatic steatosisMetabolicModerate
  • Improvement of metabolic parametersMetabolicModerate
  • Body weight reductionMetabolicLow
  • MASH resolutionHepatologyModerate

Contraindications

  • PregnancyPopulationHighPotential fetal risk or insufficient safety data
  • Decompensated cirrhosisHepatic ImpairmentModerate
  • Hypersensitivity to efruxifermin or excipientsAllergy/immunologyHigh

Adverse Effects

  • Hair loss (alopecia)DermatologicalUncommon
  • Injection site reactionsLocalCommon
  • NauseaGastrointestinalCommonFeeling of sickness or urge to vomit
  • HypophosphatemiaMetabolic/electrolyteUncommon
  • VomitingGastrointestinalUncommonForceful expulsion of stomach contents
  • DiarrheaGastrointestinalCommonLoose or frequent stools

Drug Interactions

  • Insulin and insulin secretagoguesModerate
  • Lipid-lowering agents (statins, fibrates)Low

Population Constraints

  • Severe renal impairmentOrgan ImpairmentRelative
  • Pediatric patientsAgeRelative
  • Pregnant or lactating womenReproductiveRelative
  • Decompensated cirrhosis (Child-Pugh C)HepaticRelative

Regulatory Status

  • European UnionInvestigationalUnder clinical investigation; no marketing authorization granted by EMA.
  • United StatesInvestigationalFDA Breakthrough Therapy Designation granted for MASH with liver fibrosis (F2-F3). Phase 3 SYNCHRONY trials ongoing. NDA not yet filed.
  • United KingdomInvestigationalUnder clinical investigation; not approved by MHRA.

Efruxifermin has received Breakthrough Therapy Designation from the US FDA for the treatment of MASH with liver fibrosis (stages F2-F3). It is currently under Phase 3 clinical investigation (SYNCHRONY program). Not yet approved in any jurisdiction.

Evidence & Sources

No sources recorded yet.

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