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| Name | Semaglutide |
| CAS Number | 910463-68-2 |
| Molecular Formula | C187H291N45O59 |
| Molecular Weight | 4113.57754 |
| EINECS Number | 203-405-2 |
Semaglutide is a new generation of GLP-1 (glucagon-like peptide-1) analogs. It is a long-acting dosage form developed based on the basic structure of liraglutide, demonstrating enhanced therapeutic efficacy in the treatment of type 2 diabetes mellitus (T2DM). As a long-acting glucagon-like peptide 1 (GLP-1) analog and an agonist of the GLP-1 receptor, semaglutide exhibits strong potential in glycemic control and diabetes management.
Novo Nordisk has completed 6 Phase IIIa studies of semaglutide injection and submitted a new drug registration application for semaglutide weekly injection to the U.S. Food and Drug Administration (FDA) on December 5, 2016. A Marketing Authorization Application (MAA) was also submitted to the European Medicines Agency (EMA).
Compared with liraglutide, semaglutide features a longer aliphatic chain and increased hydrophobicity. It is modified with a short chain of PEG, which significantly enhances its overall hydrophilicity.
After PEG modification, semaglutide binds closely to albumin and covers the enzymatic hydrolysis site of DPP-4. This structural enhancement reduces renal excretion, prolongs biological half-life, and achieves a long-circulation effect.
A comprehensive quality system and assurance framework is in place covering all stages of production of the finished product. Adequate manufacturing and control operations are performed in strict compliance with approved procedures and specifications. Robust Change Control and Deviation handling systems are implemented, with necessary impact assessments and investigations conducted. Proper procedures ensure the highest quality of the product prior to market release.
