FGF19 and FGF21: In NASH we trust

Mol Metab. 2021 Apr:46:101152. doi: 10.1016/j.molmet.2020.101152. Epub 2020 Dec 29.


Objective: FGF19 and FGF21 have shown therapeutic promise since their discovery, attested by the fact there are at least 5 assets that activate the FGFR/KLB pathway and one FGF19 analog in clinical development.

Methods: We performed a detailed analyses of published preclinical and clinical data to offer insights into the mechanism of action, as well as PK/PD and efficacy data of the clinical assets.

Results: Scouring the literature, we offer mechanistic insights from preclinical data using rodents and non-human primates and pharmacodynamic data from clinical studies.

Conclusion: The basic and applied science around endocrine FGFs has evolved exponentially over the years with FGF19 and FGF21 analogs are now entering Phase 3 clinical research.

Keywords: Clinical trials; Drug development; FGF19; FGF21; Metabolism; NASH.

Publication types

  • Review

MeSH terms

  • Adipose Tissue
  • Central Nervous System
  • Drug Development
  • Fibroblast Growth Factors / analogs & derivatives*
  • Fibroblast Growth Factors / metabolism*
  • Homeostasis
  • Liver
  • Non-alcoholic Fatty Liver Disease / drug therapy*
  • Non-alcoholic Fatty Liver Disease / metabolism*


  • FGF19 protein, human
  • FGF21 protein, human
  • Fibroblast Growth Factors