Chiglitazar (Trade name: Bilessglu®), a new-generation insulin sensitizing candidate drug for the treatment of type 2 diabetes mellitus (T2DM), is a Class 1 innovative drug developed independently by Chipscreen Biosciences. Chiglitazar Sodium targets insulin resistance, a core mechanism in the occurrence and development of type 2 diabetes mellitus (T2DM). It moderately activates all three PPAR subtypes to achieve a dynamic balance of glucose, lipid, energy, and protein metabolism. Preliminary comprehensive clinical studies indicate that Chiglitazar Sodium has excellent safety, pharmacokinetic, and pharmacodynamic profiles, demonstratingefficacy in regulating blood glucose, blood lipids, and energy in patients with T2DM.
Chiglitazar can control blood glucose level and ameliorate the lipid and energy metabolic disorders that accompany T2DM, helping to prevent and control cardiovascular complications. This makes Chiglitazar a potentially more comprehensive treatment option for T2DM.
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.
- In Jul. 2024, Chiglitazar Sodium was approved for use in combination with metformin to treat patients with type 2 diabetes mellitus who are inadequately controlled by metformin alone, providing a new option for combination therapy.
Indication Exploration
- In Mar. 2024, a randomized, double-blind, placebo-controlled phase II clinical trial (CGZ203 study) evaluating Chiglitazar Sodium monotherapy for nonalcoholic steatohepatitis reached its primary efficacy endpoint, demonstrating good efficacy. The phase III protocol is currently being finalized.
- Exploratory studies on combination therapies with metformin and empagliflozin are ongoing.
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