Aldafermin

Fibroblast Growth Factor 19 (FGF19) AnalogueRx: InvestigationalCompound: Investigational

Also known as: FGF19 analogue, NGM282

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

Summary

Aldafermin (NGM282) is a non-tumorigenic analogue of FGF19 developed by NGM Biopharmaceuticals for the treatment of non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC). It reduces hepatic steatosis, inflammation, and fibrosis in clinical trials, although Phase 2b studies did not meet the primary fibrosis endpoint, leading to re-evaluation of its development.

Mechanism of Action

Engineered FGF19 analogue that activates FGFR4/β-Klotho signalling in the liver, suppressing de novo lipogenesis and bile acid synthesis, reducing hepatic fat accumulation and fibrosis without the mitogenic activity associated with native FGF19.

Routes of Administration

Subcutaneous

Goals & Uses

  • 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

Contraindications

  • Known hypersensitivity to aldafermin or excipientsAllergyHigh
  • 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
  • DiarrhoeaGastrointestinalCommon
  • Hepatic enzyme elevationsHepaticUncommon

Drug Interactions

  • Bile acid sequestrants (e.g., cholestyramine)Moderate
  • StatinsLow

Population Constraints

  • PregnancyReproductive SafetyRelative
  • Paediatric patientsAgeRelative
  • Decompensated cirrhosisHepatic ImpairmentRelative

Regulatory Status

  • European UnionInvestigationalNo marketing authorisation; clinical trials conducted under national CTAs.
  • United StatesInvestigationalStudied under IND; no NDA filed as of 2024; Phase 2b results did not support advancement in NASH.
  • United KingdomInvestigationalNo MHRA approval; investigational use only.

No approved indication in any jurisdiction as of 2024. Investigated under IND in the US; Phase 2 trials completed; development status uncertain following Phase 2b results in NASH.

Evidence & Sources

No sources recorded yet.

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