China Inquirydetail - Semaglutide for Type 2 Diabetes – Gentolex

Product Detail

Synonyms

Sermaglutide; Semaglutide fandachem; Semaglutide impurity; Sermaglutide USP/EP; semaglutide; Sermaglutide CAS 910463 68 2; Ozempic, 

Description

Semaglutide is a new generation of GLP-1 (glucagon-like peptide-1) analogs, and semaglutide is a long-acting dosage form developed based on the basic structure of liraglutide, which has a better effect in the treatment of type 2 diabetes. 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 has a longer aliphatic chain and increased hydrophobicity, but semaglutide is modified with a short chain of PEG, and its hydrophilicity is greatly enhanced. After PEG modification, it can not only bind closely to albumin, cover the enzymatic hydrolysis site of DPP-4, but also reduce renal excretion, prolong the biological half-life, and achieve the effect of long circulation.

Application

Semaglutide is a long-acting dosage form developed based on the basic structure of liraglutide, which is more effective in treating type 2 diabetes.

Bioactivity

Semaglutide (Rybelsus, Ozempic, NN9535, OG217SC, NNC0113-0217) is a long-acting glucagon-like peptide 1 (GLP-1) analog, an agonist of GLP-1receptor, with a potential type 2 Therapeutic efficacy of diabetes mellitus (T2DM).

Quality System

In general, quality system and assurance is in place covering all stage of production of the finished product. Adequate manufacturing and control operations are performed in compliance with the approved procedures/ specifications. Change control and Deviation handling system is in place, and necessary impact assessment and investigation were conducted. Proper procedures are in place to ensure quality of product prior to release into the market.