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Shanghai Chengyi Biotechnology Co.
, Ltd.
recently announced that the US Food and Drug Administration (FDA) has approved its application
for a clinical trial of the glucagon-like peptide 1 (GLP-1) receptor agonist ECC5004 in the United States for the treatment of type 2 diabetes mellitus (T2DM).
This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ECC5004 in healthy subjects and T2DM subjects
.
GLP-1 is secreted by enteroendocrine cells and regulates postprandial blood glucose fluctuations
by increasing glucose-dependent insulin secretion, reducing glucagon secretion, and delaying gastric emptying.
It also suppresses appetite and reduces weight
by activating GLP-1 receptors in the brain.
Therefore, GLP-1 receptor agonists have been approved for the treatment of type 2 diabetes and obesity and are recommended on a metformin basis as the initial treatment
of patients with type 2 diabetes who are at high risk of atherosclerotic cardiovascular disease or chronic renal disease.
In addition, ongoing clinical trials have shown that GLP-1 receptor agonists are promising for the treatment of other diseases, including nonalcoholic steatohepatitis and Alzheimer's disease
.
However, almost all currently approved GLP-1 agonist drugs require subcutaneous injection
.
ECC5004 is a novel oral small molecule GLP-1 receptor agonist, discovered by Chengyi's internal drug discovery platform, which has proven its efficacy and safety
in preclinical studies.
Dr.
Jingye Zhou, CEO of Chengyi Biologics, said, "We are very excited
that the FDA has approved IND for our small molecule GLP-1 receptor agonist, ECC5004.
Small molecule GLP-1 receptor agonists have the potential to be the cornerstone of
many metabolic indications.
This approval brings our carefully designed small molecule GLP-1 receptor agonist ECC5004 closer to providing clinical benefits
to hundreds of millions of patients affected by type 2 diabetes and obesity worldwide.
" We are committed to advancing this project so that we can help our patients
as early as possible.
”