# CureGene Completes First‑Participant Dose in Phase I Trial of CG‑0416, Advancing Clinical Development of Novel Oral Liver-Targeting THR-β Agonist

- Link: https://www.thailand-business-news.com/pr-news/curegene-completes-first-participant-dose-in-phase-i-trial-of-cg-0416-advancing-clinical-development-of-novel-oral-liver-targeting-thr-%ce%b2-agonist
- Published: 2026-08-21T19:08:00+07:00
- Author: PR Newswire

SHANGHAI, Aug. 21, 2026 /PRNewswire/ — CureGene recently announced that the first
subject has been dosed in its Phase I clinical trial of CG-0416, a novel oral liver-
targeting THR-β agonist developed in-house, in Australia. Subject enrollment is 
progressing smoothly.

CG-0416 is designed based on CureGene’s proprietary prodrug platform, incorporating
precise design and structural optimization to achieve several key differentiators:

 ◦ Liver-targeting delivery: High intrahepatic release of active moiety to achieve
   low systemic exposures and minimize off-target effects in the tissues other than
   liver;
 ◦ Improving metabolic parameters: Significant reduction of liver fat along with
   favorable changes in lipid profile and glucose tolerance;
 ◦ Fat loss with muscle preservation: As a monotherapy, CG-0416 demonstrates weight-
   loss efficacy comparable to current GLP-1 receptor agonists (RA) (e.g., semaglutide)
   while preserving muscle mass. In combination with GLP-1 RA agents, CG-0416 exhibits
   strong synergistic effects for additional weight reduction with high quality 
   muscle preservation.
 ◦ Non-CYP metabolism pathway: Hydrolysis-mediated activation avoids CYP450 oxidative
   metabolism, minimizing drug–drug interaction (DDI) and individual variability;
 ◦ High oral bioavailability: Up to 92% bioavailability with a favorable safety 
   and tolerability profile, supporting long-term daily use.

These characteristics position CG-0416 as a promising oral therapy for chronic metabolic
diseases, including obesity, metabolic dysfunction-associated steatohepatitis (MASH),
etc.

Preclinical data demonstrated that CG-0416 potently activates lipid metabolism in
the liver, markedly reduces liver fat accumulation, and consequently ameliorates
inflammation and fibrosis. As a monotherapy, CG-0416 has a weight-loss efficacy 
comparable to that of mainstream GLP-1 receptor agonists but shows minimum muscle
loss. When combined with GLP-1 RAs, CG-0416 exhibits a strong synergistic effect
for reducing weight and improving metabolic parameters.

The FIH Phase I trial in Australia is a randomized, double-blind, placebo-controlled
study in healthy participants, designed to evaluate the safety, tolerability, pharmacokinetics(
PK) and pharmacodynamics (PD) of CG-0416 following single and multiple ascending
doses. Leveraging Australia’s well-established Phase I clinical infrastructure, 
this trial will generate critical data to support subsequent global development 
and indication expansion of CG-0416.

"The first subject dosed in our Phase I trial marks another solid step forward in
CureGene’s strategic expansion into cardiovascular and metabolism disease," said
Dr. Gongxin He, Founder and Chief Executive Officer of CureGene. "Through continuous
innovation using the prodrug technology, we are dedicated to bring safer, clinically
valuable, and more convenient therapies to the patients worldwide."

**About CG-0416****‌**

CG-0416 is a novel liver-targeted THR-β prodrug in development for MASH & obesity-
related complications. Its tissue-selective activation mechanism simultaneously 
addresses hepatic lipid accumulation, inflammation, and fibrosis, while demonstrating
superior metabolic control to resmetirom and VK-2809 in preclinical studies. As 
a potential oral adjunct to GLP-1 therapies, CG-0416 combines rapid fat reduction
with muscle preservation, positioning it as a next-generation metabolic modulator.

**About CureGene Pharmaceutical**

Founded in 2018, CureGene Pharmaceutical possesses proprietary core platform technologies
and independent high-efficiency innovation capabilities. The Company primarily focuses
on therapeutic areas including cardiovascular & cerebrovascular diseases and antiviral
therapies, striving to become a China-rooted, globally oriented innovative pharmaceutical
enterprise.

Leveraging its proprietary platforms, CureGene has built a robust pipeline of innovative
assets with broad market value and global independent intellectual property rights,
with multiple candidates actively progressing through clinical development. Driven
by its corporate mission and vision, the Company has assembled a high-caliber team
of globally minded scientists and overseas returnees. Under its integrated strategic
layout, CureGene achieves rapid and efficient R&D translation, with all pipeline
candidates demonstrating strong potential to become first-in-class or best-in-class
therapies.

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