Chiglitazar Sodium (Trade name: Bilessglu®), a new molecular entity with a novel mechanism exclusively discovered by the company, is the first PPAR Pan agonist worldwide and an insulin sensitizer. Chiglitazar Sodium is a special achievement of the National 863 Program and the New Drug Innovation Program.

Chiglitazar Sodium achieves a dynamic balance of glucose, lipid, and energy metabolism by moderately activating the three PPAR receptors and improves metabolic diseases through various mechanisms such as glucose-lowering and insulin sensitization, lipid regulation, anti-inflammation, and anti-fibrosis. Several clinical trials have shown the efficacy and safety of Chiglitazar Sodium in the treatment of type 2 diabetes and fatty liver. Chiglitazar Sodium has been included in the textbook Internal Medicine and the Guideline for the Prevention and Treatment of Diabetes Mellitus in China and is expected to become a basic drug for the comprehensive treatment of metabolic diseases.

Figure. Potential mechanisms of action of Chiglitazar

Commercialization in China

• In Oct. 2021, Chiglitazar Sodium was approved for the treatment of type 2 diabetes.
• In Mar. 2023, Chiglitazar Sodium was included in the National Drug Reimbursement List for the first time.
• In Jul. 2024, Chiglitazar Sodium was approved for use in combination with metformin for a new indication to treat patients with type 2 diabetes mellitus who are inadequately controlled by metformin alone, providing a new option for combination therapy.

Exploration of Other Indications

• In Mar. 2024, a randomized, double-blind, placebo-controlled phase 2 clinical trial (CGZ203 study) evaluating Chiglitazar Sodium monotherapy in the treatment of metabolic dysfunction-associated steatohepatitis (MASH) achieved the primary efficacy endpoints with good efficacy; in Nov. 2024, the results of this study were presented in the oral presentation at the 75th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which was made by Professor You Hong from Beijing Friendship Hospital, Capital Medical University. Given that no drug has been approved for the treatment of fatty liver in China, there is a huge demand for clinical treatment. Chiglitazar Sodium has been approved for the indication of type 2 diabetes mellitus, and rich experience in actual medication has been accumulated. More than half of the patients with diabetes mellitus also suffer from metabolic-related fatty liver disease, and most of the patients with MASH at clinical visits have complications with diabetes mellitus. Therefore, based on the existing clinical trials and real-world medication evidence, the company will give priority to promoting Chiglitazar Sodium to benefit the majority of patients with type 2 diabetes complicated by MASH/MAFLD. Meanwhile, the company will continue to cooperate with the investigators to improve the evidence of Chiglitazar Sodium in the treatment of fatty liver throughout the disease course.

For more information, please scan the QR code below by Wechat and follow the "Metabolic News" .