Drug intelligence / Profile preview

APL-18881

Development stage
Unknown
Lead developer
Sunshine Lake Pharma
Modality
Small Molecules, Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes
Administration
Subcutaneous Injection
01

Overview

APL-18881 (also known as HEC88473) is a bi-specific fusion protein that acts as a dual agonist of the fibroblast growth factor 21 receptor (FGF21R) and the glucagon-like peptide 1 receptor (GLP-1R). It is being developed for metabolic diseases, with primary indications including type 2 diabetes, nonalcoholic steatohepatitis (NASH), and obesity. The drug leverages the synergistic and complementary effects of FGF21 and GLP-1 pathways to provide comprehensive metabolic benefits. Clinical data from Phase 1 trials in healthy volunteers, obese subjects, and type 2 diabetics have shown acceptable safety/tolerability profiles and robust pharmacodynamic responses at both target receptors. As of June 2025, APL-18881 is in Phase 2 clinical trials for type 2 diabetes in China; an open US IND supports further development for cardiometabolic, liver, and related diseases internationally[1][5][6][7].

Other names
glucagon-like peptide-1/fibroblast growth factor 21 dual-target biologicGLP-1/FGF21 dual agonist
02

Targets

FGFR1 (Fibroblast growth factor receptor 1)GLP1R (GLP-1R)

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