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FDA Approved PEGylated Drugs 2019

What is PEGylateion? What are the PEGylated drugs used for? PEGylation is the process of the strands attachment of the polymer PEG to molecules and macrostructures, such as a drug, therapeutic protein or vesicle, that can improve the safety and efficiency of many therapeutics. The chain binds to the drugs covalently and build it sterically stable. Thus, the PEGylated proteins or peptides are non-toxic, non-antigenic, non-immunogenic, and highly water soluble. In addition, it further increases half-life of the PEGylated drugs and reduces dose frequency by preventing renal excretion of drugs.

PEGylation products consists of various reagents including linkerscross-linkers, and labels. Different reagents include AMINE, CARBOXYL, and CARBOXYL PEGylation. The PEGylated drugs currently are used in the treatment of cancer, chronic kidney diseases, hepatitis, multiple sclerosis, hemophilia, and gastrointestinal disorders.  ADAGEN manufactured by Enzon Pharmaceuticals, Inc., US was the first PEGylated protein approved by the U.S. Food and Drug Administration (FDA) in March 1990, to enter the market. Since the introduction of ADAGEN, a mass of PEGylated protein and peptide drugs have kept up the footsteps and many others are under clinical trial or under development stages. Among the FDA approved drugs, Pegasys and Neulasta, exceeded $5 billion in 2011. It’s worth mentioning that all of the FDA approved drugs containmethoxypoly (ethylene glycol) or mPEG. Below, we lists all of the FDA Approved PEGylated Drugs on the market.


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