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A few days ago, the marketing application of Zhaoke Pharmaceutical's 3 generic drug sodium phenylbutyrate powder (the relevant acceptance number is CYHS1800114) entered the administrative review stage, and it is expected that it will be formally approved soon for the adjuvant treatment of carbamoyl phosphate synthase ( CPS), ornithine transcarbamylase (OTC) or argininosuccinate synthetase (AS) deficiency caused by chronic urea cycle disorder (UCD) caused hyperammonemia.
Hyperammonemia, also known as hyperammonemia, is a metabolic disorder of the urea cycle, which is a group of metabolic disorders in the neonatal or childhood period characterized by increased blood ammonia.
The urea cycle can synthesize the "toxic" ammonia produced in various metabolic pathways of the body into "non-toxic" urea and excrete it in the urine.
The treatment of hyperammonemia needs to be combined with diet and drugs, and the intake of protein is strictly restricted in the diet.
Sodium phenylbutyrate is a prodrug, and its active metabolite, phenylacetate, mediates the excretion of nitrogen by combining with glutamic acid and ammonia to produce phenylacetylglutamine.
In February 2013, Hyperion Therapeutics (acquired by Horizon Pharma in March 2015) developed Glycerol phenylbutyrate (Glycerol phenylbutyrate) based on Buphenyl was approved by the FDA for the treatment of hyperammonemia caused by certain congenital urea cycle disorders.
It is worth mentioning that Ravicti ranked ninth in the "2021 Global Top 10 List of Expensive Drugs" compiled by the US drug price tracking website GoodRxGoodRx.
In China, no sodium phenylbutyrate product has been approved for marketing, but Boao Lecheng Weijian Rare Disease Clinical Medicine Center has introduced Ravicti for the treatment of urea cycle disorders.
According to the insight database, several companies such as Betta Pharmaceuticals and Zhaoke Pharmaceuticals have begun to deploy the sodium phenylbutyrate generic drug market.
In addition, in addition to sodium phenylbutyrate, the US FDA approved recordati's carbaglu (carglumic) for the treatment of hyperammonemia caused by N-acetylglutamate synthase (NAGS) deficiency in 2010.
In addition, Versantis’ VS-01 was granted the FDA’s qualification for the treatment of urea cycle disorders in pediatric rare diseases in October 2020.
