Dorzagliatin is the world’s first approved glucokinase activator (GKA). It restores the sensitivity of the body’s natural “glucose sensors” in the pancreas and liver, helping the body respond to sugar in a more physiological way. Since its effect depends on glucose levels, the risk of hypoglycemia is lower compared to drugs with a “fixed” or rigid action.

On September 30, 2022, Dorzagliatin was approved in China (NMPA) both as monotherapy and in combination with metformin — the first GKA drug approved worldwide.

In Phase III clinical trials (SEED — in drug-naïve patients, and DAWN — as an add-on to metformin), Dorzagliatin significantly reduced HbA1c and postprandial glucose compared with placebo. Its safety profile was comparable to control. A meta-analysis of clinical trials also confirmed efficacy and acceptable tolerability.

Observations suggest that in some patients who started therapy at an early stage of type 2 diabetes, normal blood glucose (so-called “remission”) could be achieved and maintained even after treatment was stopped. While this is not a cure, it signals the potential to restore glucose regulation in early-stage patients. Decisions, of course, must always be individualized and made together with a physician.

Adults with type 2 diabetes, especially those needing improved postprandial control or for whom other regimens are unsuitable. However, treatment decisions are made strictly by an endocrinologist, taking into account coexisting conditions and other medications.

⚠️ Important: Self-treatment is not an option. Always discuss therapy choices with your healthcare provider.

For questions about access and logistics, our partner MedPutnik can provide organizational guidance.

Sources: Hua Medicine / NMPA; Phase III SEED & DAWN trials; safety and efficacy meta-analysis.