Clinical trials
Full profile accessFollow clinical development from study design and recruitment through results.
- Trial phase
- Status
- Readouts
Drug intelligence / Profile preview
**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**.
Beyond the preview
Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.
Follow clinical development from study design and recruitment through results.
Explore development by indication, patient population, and geography.
Trace asset ownership, licensing agreements, and commercial partnerships.
Explore the patent landscape and regulatory exclusivity around an asset.
Compare development programs by target, modality, and indication.
Connect source evidence and development news to your research questions.
See how Gosset can support your research on HEC169584.