Efruxifermin
Also known as: AKR-001, BMS‑986089, EFX, Fc-FGF21
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Summary
Efruxifermin (BMS‑986089) is a long‑acting Fc‑fusion analog of fibroblast growth factor‑21 designed for metabolic diseases such as non‑alcoholic steatohepatitis (NASH) and type‑2 diabetes.
Mechanism of Action
Binds to the FGFR1c/KLB receptor complex, activating downstream signaling that improves insulin sensitivity, reduces hepatic lipogenesis, and enhances fatty‑acid oxidation.
Routes of Administration
Goals & Uses
- MASH/NASH fibrosis improvementHepatologyModerate
- Treatment of compensated cirrhosis due to MASHHepatologyLow
- Reduction of hepatic steatosisMetabolicModerate
- Type‑2 diabetes mellitusIndicationModerate
- Non‑alcoholic steatohepatitis (NASH)IndicationModerate
- Improvement of metabolic parametersMetabolicModerate
- Body weight reductionMetabolicLow
- MASH resolutionHepatologyModerate
Contraindications
- Known hypersensitivity to efruxifermin or any excipientAllergyHigh
- 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
- HypotensionCardiovascularUncommonLow blood pressure
- NauseaGastrointestinalCommonFeeling of sickness or urge to vomit
- HypophosphatemiaMetabolic/electrolyteUncommon
- VomitingGastrointestinalUncommonForceful expulsion of stomach contents
- Elevated LDL‑cholesterolLipidCommon
- Injection site reactionLocalCommonRedness, swelling, itching, bruising, or pain at the injection site
- DiarrheaGastrointestinalCommonLoose or frequent stools
Drug Interactions
- Insulin and insulin secretagoguesModerate
- StatinsLow
- Lipid-lowering agents (statins, fibrates)Low
Population Constraints
- PregnancyReproductive SafetyRelative
- Severe renal impairmentOrgan ImpairmentRelative
- Pediatric patientsAgeRelative
- Pediatric (<18 y)AgeRelative
- Pregnant or lactating womenReproductiveRelative
- Decompensated cirrhosis (Child-Pugh C)HepaticRelative
Regulatory Status
- European UnionInvestigationalUnder review in clinical programs.
- United StatesInvestigationalPhase 2/3 trials ongoing for NASH.
- United KingdomInvestigationalUnder clinical investigation; not approved by MHRA.
In Phase 2/3 clinical development for NASH and type‑2 diabetes; not approved in any jurisdiction as of 2024.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Efruxifermin?
Efruxifermin (BMS‑986089) is a long‑acting Fc‑fusion analog of fibroblast growth factor‑21 designed for metabolic diseases such as non‑alcoholic steatohepatitis (NASH) and type‑2 diabetes.
What is Efruxifermin used for?
Efruxifermin is educationally associated with: MASH/NASH fibrosis improvement, Treatment of compensated cirrhosis due to MASH, Reduction of hepatic steatosis, Type‑2 diabetes mellitus, Non‑alcoholic steatohepatitis (NASH), Improvement of metabolic parameters, Body weight reduction, MASH resolution. Educational only — not medical advice.
How is Efruxifermin administered?
Recorded routes of administration: Subcutaneous.
What are the potential side effects of Efruxifermin?
Reported adverse effects include: Hair loss (alopecia), Injection site reactions, Hypotension, Nausea, Hypophosphatemia, Vomiting, Elevated LDL‑cholesterol, Injection site reaction, Diarrhea. This list is not exhaustive — consult a qualified clinician.
Who should avoid Efruxifermin?
Recorded contraindications: Known hypersensitivity to efruxifermin or any excipient, Pregnancy, Decompensated cirrhosis, Hypersensitivity to efruxifermin or excipients. Consult a qualified clinician before use.