Aldafermin
Also known as: Aldafermin, FGF19 analog, FGF19 analogue, NGM282
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Summary
Aldafermin (NGM282) is a recombinant, engineered analogue of human fibroblast growth factor‑19 designed for subcutaneous injection. It is being evaluated in clinical trials for non‑alcoholic steatohepatitis (NASH) and other metabolic liver disorders.
Mechanism of Action
Activates FGFR4/β‑Klotho signaling in hepatocytes, suppressing CYP7A1‑mediated bile‑acid synthesis and improving hepatic lipid metabolism.
Routes of Administration
Goals & Uses
- Non‑alcoholic steatohepatitis (NASH) treatmentLiver DiseaseModerate
- Primary biliary cholangitisAutoimmune Liver DiseaseLow
- Treatment of primary sclerosing cholangitis (PSC)Hepatology / Cholestatic DiseaseLow
- Reduction of bile acid synthesisMetabolicHigh
- Reduction of hepatic steatosis in NASHMetabolic / HepatologyModerate
- Improvement of liver fibrosis in NASHHepatologyModerate
- Non‑alcoholic steatohepatitis (NASH)IndicationModerate
Contraindications
- Known hypersensitivity to aldafermin or excipientsAllergyHigh
- Severe hepatic impairmentOrganHighLiver function concerns
- PregnancyPopulationModeratePotential fetal risk or insufficient safety data
- Known hypersensitivity to Aldafermin or any excipientAllergyModerate
- Hepatocellular carcinoma or high risk of hepatic malignancyOncologyHigh
Adverse Effects
- Injection site reactionsLocalCommon
- NauseaGastrointestinalCommonFeeling of sickness or urge to vomit
- Elevations in low-density lipoprotein (LDL) cholesterolMetabolic / LipidCommon
- Injection‑site reactionsLocalCommon
- Elevated LDL‑cholesterolLipidCommon
- DiarrhoeaGastrointestinalCommon
- DiarrheaGastrointestinalCommonLoose or frequent stools
- Hepatic enzyme elevationsHepaticUncommon
- Injection‑site reactionLocalCommon
- Elevated serum lipaseLaboratoryUncommon
- Abdominal painGastrointestinalUncommonPain or discomfort in the abdomen
Drug Interactions
- Bile acid sequestrants (e.g., cholestyramine)Moderate
- StatinsModerate
Population Constraints
- PregnancyReproductive SafetyRelative
- Pediatric patientsAgeAbsolute
- Paediatric patientsAgeRelative
- Decompensated cirrhosisHepatic ImpairmentRelative
Regulatory Status
- European UnionInvestigationalClinical trials authorized under EU Clinical Trial Regulation.
- United StatesInvestigationalPhase 2/3 trials ongoing for NASH.
- United KingdomInvestigationalBeing evaluated in UK clinical sites.
Not approved in any major jurisdiction; currently in Phase 2/3 clinical development.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Aldafermin?
Aldafermin (NGM282) is a recombinant, engineered analogue of human fibroblast growth factor‑19 designed for subcutaneous injection. It is being evaluated in clinical trials for non‑alcoholic steatohepatitis (NASH) and other metabolic liver disorders.
What is Aldafermin used for?
Aldafermin is educationally associated with: Non‑alcoholic steatohepatitis (NASH) treatment, Primary biliary cholangitis, Treatment of primary sclerosing cholangitis (PSC), Reduction of bile acid synthesis, Reduction of hepatic steatosis in NASH, Improvement of liver fibrosis in NASH, Non‑alcoholic steatohepatitis (NASH). Educational only — not medical advice.
How is Aldafermin administered?
Recorded routes of administration: Subcutaneous.
What are the potential side effects of Aldafermin?
Reported adverse effects include: Injection site reactions, Nausea, Elevations in low-density lipoprotein (LDL) cholesterol, Injection‑site reactions, Elevated LDL‑cholesterol, Diarrhoea, Diarrhea, Hepatic enzyme elevations, Injection‑site reaction, Elevated serum lipase, Abdominal pain. This list is not exhaustive — consult a qualified clinician.
Who should avoid Aldafermin?
Recorded contraindications: Known hypersensitivity to aldafermin or excipients, Severe hepatic impairment, Pregnancy, Known hypersensitivity to Aldafermin or any excipient, Hepatocellular carcinoma or high risk of hepatic malignancy. Consult a qualified clinician before use.