TISA-818 (EnliTISA)

TISA-818 is a long-acting fibroblast growth factor 21 (FGF21) analog being developed by EnliTISA (Shanghai) Pharmaceutical Co., Ltd. for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). FGF21 is an endogenous metabolic hormone that plays a critical role in regulating lipid and glucose metabolism, insulin sensitivity, and energy expenditure. TISA-818 functions as an agonist of the FGF receptor complex (specifically FGFR1c, FGFR2c, and FGFR3c) in the presence of the obligate co-receptor beta-Klotho. By activating these pathways, the drug aims to reduce hepatic fat accumulation, decrease liver inflammation, and reverse or prevent the progression of hepatic fibrosis. It is currently being evaluated in Phase 1 clinical trials to determine its safety, tolerability, and pharmacokinetic profile following subcutaneous administration.