CAS number：881681-00-1
molecular formula：C17H16FN3O2S
molecular weight：345.39

English synonyms

Vonoprazan;1-[5-(2-Fluorophenyl)-1-[(pyridin-3-yl)sulfonyl]-1H-pyrrol-3-yl]-N-methylmethanamine;1H-Pyrrole-3-methanamine,5-(2-fluorophenyl)-N-methyl-1-(3-pyridinylsulfonyl);TAK-438 (free base);Vonoprazan-025;Voronazan interfluoroisomer;Vonoprazan related Impuirty 29;Vonoprazan m-Fluoro Isomer

Related categories

Impurities; reference substances-impurity reference substances; pharmaceutical intermediates; pharmaceutical raw materials; impurity reference substances; Vonoprazan intermediates; chemical intermediates; API/intermediates; product

Introduction

Vonoprazan fumarate (TAK-438, Vonoprazan fumarate) is a new oral anti-gastric drug jointly launched by Takeda Pharmaceutical and Otsuka Pharmaceutical.
【Registration Classification】Chemical Drug Class 3.1
【Indications】For the treatment of erosive esophagitis, gastric ulcer and duodenal ulcer.
On February 28, 2014, Takeda Pharmaceuticals submitted a new drug application (NDA) for vonoprazan (TAK-438) to the Japanese Ministry of Labor, Health and Welfare (MHLW). The submission of this new drug application is based on good data from phase III clinical trials. Takeda Pharmaceutical has launched several Phase III clinical trials in Japan to investigate the efficacy of TAK-438 for indications of erosive esophagitis, gastric ulcer, duodenal ulcer, and Helicobacter pylori eradication. In clinical trials, compared with the current proton pump inhibitors (PPIs), Vonorazan (TAK-438) does not have CYP2C19 metabolism, so it has shown better efficacy in clinical trials: treatment of gastric ulcer/10 The curative effect of duodenal ulcer, reflux esophagitis, and eradication of Helicobacter pylorus is better than that of lansoprazole, and it has good tolerance and safety.

Active Pharmaceutical Ingredients

API, also known as active pharmaceutical ingredients, refers to any substance or mixture of substances used in the manufacture of drugs. Such substances are used in the diagnosis, treatment, symptom relief, treatment or prevention of diseases. It has pharmacological activity or other direct effects or can affect the function or structure of the body. API meaning pharma.

API Active Pharmaceutical Ingredients

Obtained from natural medicine. Natural medicine is an important part of medicine. For example, artemisinin, an effective antimalarial ingredient isolated from the traditional Chinese medicine Artemisia annua.
Take existing drugs as first-comers.
1) Discover the active ingredients of the drug from the side effects of the drug. For example, the phenothiazine antipsychotic chlorpromazine and its analogs are developed from the sedative side effects of the similarly structured antihistamine promethazine.
2) Obtained through drug metabolism research. For example, the metabolites of antidepressants imipramine and amitriptyline, norimipramine and noramitriptyline, have stronger antidepressant effects than the original drug; oxazepam is the active metabolite of diazepam.
3) Leading with existing breakthrough drugs. For example, the research on lansoprazole and other prazols is based on omeprazole, which is more active than omeprazole.
Obtained by screening with pharmacological model. Through combinatorial chemistry, a large number of chemical libraries with different structures are constructed without separation of mixtures. Through high-throughput screening, the components are found to have pharmaceutical activity and then separated, and the structure of the active compound is determined.
Designed according to physiological and pathological mechanisms. For example: the study of fluorouracil takes the nucleotide uracil synthesized from DNA or RNA as the lead compound, and replaces the hydrogen at position 5 with fluorine, making it a metabolic antagonist of the normal metabolites of the organism, and is used as an antitumor drug

Team Presentation