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Gan Lai Pharmaceuticals today announced that ASC41 oral tablets have been approved by the U.
The approval of the US clinical trial application (IND) is based on a randomized, double-blind, placebo-controlled, single-dose and multi-dose escalation phase I clinical trial with 65 subjects completed in China Efficacy and safety data, as well as the process data of oral tablets developed by Ganlai’s proprietary formulation technology that can be produced commercially.
In May 2020, the company announced that the first non-alcoholic steatohepatitis clinical trial application for ASC41 was approved by the China National Medical Products Administration.
In January 2021, the company announced the completion of a randomized, double-blind, placebo-controlled, single-dose and multi-dose escalation phase I clinical trial.
In February 2021, the company announced that during the 28-day oral administration treatment of overweight and obese subjects, compared with the placebo group, subjects in the ASC41 group had low-density lipoprotein cholesterol (LDL-C) and triglycerides ( TG) and total cholesterol (TC) showed continuous, clinically significant and statistically significant decreases.
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