Pegbelfermin
Also known as: BMS-986036, BMS‑986036, pegbelfermin, PEGylated FGF21
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Summary
Pegbelfermin (BMS‑986036) is a PEGylated recombinant human FGF21 analogue under clinical investigation for the treatment of non‑alcoholic steatohepatitis (NASH) and related metabolic disorders.
Mechanism of Action
Activates the FGFR1c/KLB receptor complex, mimicking endogenous fibroblast growth factor 21 to increase lipid oxidation, improve insulin sensitivity, and reduce hepatic steatosis.
Routes of Administration
Goals & Uses
- Treatment of primary biliary cholangitis (PBC)Liver DiseaseLow
- Reduction of hepatic fibrosis in NASHLiver DiseaseModerate
- Reduce hepatic steatosisLiver DiseaseModerate
- Improvement of dyslipidemiaMetabolicModerate
- Improve insulin sensitivityMetabolic DisorderModerate
- Improvement of insulin sensitivityMetabolicLow
- Reduction of hepatic steatosis in NASHMetabolic / HepatologyModerate
Contraindications
- Severe renal impairment (eGFR <30 mL/min/1.73 m²)RenalModerate
- PregnancyPopulationHighPotential fetal risk or insufficient safety data
- Known hypersensitivity to pegbelfermin or PEG-containing productsAllergyHigh
Adverse Effects
- Injection site reactionsLocalCommon
- AlopeciaDermatologicUncommonHair loss
- HeadacheNeurologicUncommonPain in the head or upper neck
- NauseaGastrointestinalUncommonFeeling of sickness or urge to vomit
- Injection‑site erythemaLocalCommon
- Anti-drug antibodies (ADA)ImmunologicalUncommon
- DiarrheaGastrointestinalUncommonLoose or frequent stools
Drug Interactions
- Cytochrome P450 substratesLow
- Insulin / insulin secretagoguesModerate
- Lipid-lowering agents (statins, fibrates)Low
Population Constraints
- Severe renal impairmentOrgan ImpairmentRelative
- Pediatric patientsAgeRelative
- Lactating womenReproductiveRelative
- Severe hepatic impairment (Child-Pugh C)Organ ImpairmentRelative
- Pediatric patients (<12 years)PediatricRelative
- Elderly (>75 years)GeriatricRelative
Regulatory Status
- European UnionUnknownNo EMA marketing authorization; clinical studies in Europe.
- United StatesInvestigationalIND active; Phase 2b/3 trials ongoing.
- United KingdomInvestigationalNo MHRA approval; investigational use only in clinical trials.
Not approved; completed Phase 2 trials with encouraging biomarker data; ongoing Phase 2b/3 studies in NASH.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Pegbelfermin?
Pegbelfermin (BMS‑986036) is a PEGylated recombinant human FGF21 analogue under clinical investigation for the treatment of non‑alcoholic steatohepatitis (NASH) and related metabolic disorders.
What is Pegbelfermin used for?
Pegbelfermin is educationally associated with: Treatment of primary biliary cholangitis (PBC), Reduction of hepatic fibrosis in NASH, Reduce hepatic steatosis, Improvement of dyslipidemia, Improve insulin sensitivity, Improvement of insulin sensitivity, Reduction of hepatic steatosis in NASH. Educational only — not medical advice.
How is Pegbelfermin administered?
Recorded routes of administration: Subcutaneous.
What are the potential side effects of Pegbelfermin?
Reported adverse effects include: Injection site reactions, Alopecia, Headache, Nausea, Injection‑site erythema, Anti-drug antibodies (ADA), Diarrhea. This list is not exhaustive — consult a qualified clinician.
Who should avoid Pegbelfermin?
Recorded contraindications: Severe renal impairment (eGFR <30 mL/min/1.73 m²), Pregnancy, Known hypersensitivity to pegbelfermin or PEG-containing products. Consult a qualified clinician before use.