Drug intelligence / Profile preview

HEC169584

Development stage
Phase 1
Lead developer
Sunshine Lake Pharma
Modality
Small Molecules
Administration
Oral
01

Overview

**HEC169584** is a small molecule **thyroid hormone receptor beta (THR-β) agonist** developed by **Sunshine Lake Pharma** for the treatment of **non-alcoholic steatohepatitis (NASH)**, also known as metabolic dysfunction-associated steatohepatitis (MASH). This is the **first Class 1 innovative drug** independently developed using Sunshine Lake Pharma's **AI-driven small molecule drug design platform**, specifically utilizing the **HEC-GEN model** - a molecular fragment generation model based on sparse graph attention neural networks. Preclinical studies demonstrate that HEC169584 has **superior in vitro activity** against THR-β cells compared to Resmetirom (the first FDA-approved NASH drug), exhibits **strong liver targeting** with a liver-to-blood ratio of 24.5, and shows efficacy in improving liver function, blood lipids, hepatic lipids, liver inflammation, NAFLD activity score, and fibrosis in NASH mouse models with liver fibrosis. The drug received **clinical trial approval from NMPA in December 2024** and entered **Phase I clinical trials in August 2025**.

Other names
东健可
02

Targets

THRB (Thyroid hormone receptor beta)

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