[drug report] sofosbuvir Drug Report

It was developed by Gilead and approved by FDA on December 6, 2013, EMA on January 16, 2014, and PMDA on March 26, 2015 Catalog 1) summary information 2) drug overview 3) API information 4) pharmacological action 5) listing in the United States (1 article) 6) listing in the European Union (1 article) 7) listing in Japan (2 articles) 8) registration and application in China (45 articles) 9) drug description (2 articles) 10) global clinical trials (212 articles) 11) patent status in the United States (8 articles) 12) more global R & D information (4 articles) 1) summary information 2) drug overview It was developed by Gilead and approved by FDA on December 6, 2013, EMA on January 16, 2014, and PMDA on March 26, 2015 Sophobuvir is a HCV ns5brna dependent RNA polymerase inhibitor, which plays an important role in virus replication As part of the combined antiviral therapy, the drug is used in the treatment of chronic hepatitis C (CHC) infection Sovaldi is an oral film coated tablet, each tablet contains 400mg of sophosfovir The recommended dose is 400mg every time, once a day, either with meal or on an empty stomach 3) API information chemistry Name: propan-2-yln - [(s) -{[(2R, 3R, 4R, 5R) - 5 - (2,4-dioxo-3, 4-dihydropyrimidin-1 (2H) - YL) - 4-fluoro-3-hydroxy-4-methylolan-2-yl] methoxy} phenoxyphosphoryl] - L-alanine CAS Registration No.: 119037-88-0 molecular formula: c22h29fn3o9p molecular weight: 529.454) pharmacological category: systemic anti infective drugs > systemic anti viral drugs > Direct anti viral drugs > other anti viral mechanisms: sofosbuvir is nucleolide analog inhibitor, Which specifically invests in HCV NS5B polymer Softbuvir prevents HCV virtual replication by binding to the two Mg2 + ions present in HCV NS5B polymer's GDD active sitemotif 5) us listing (1 article) EU listing (1 article) Japan listing (2 articles) 8) China registration declaration (45 articles) Note: due to the huge data space, only 10 articles are listed here 9) Drug instructions (2 items) 10) global clinical trials (212 items) Note: due to the huge data space, only 5 items are listed here 11) US patent status (8 items) Note: due to the huge data space, only 5 items are listed here 12) More global R & D information (4 data sources): due to the huge length of the report, we will not go over them one by one here If you want to get the full text of the report, you can click "Pharma global drug R & D database" to view it Original statement: This article is the original manuscript of yaozhi.com, welcome to reprint, reprint please indicate the source, thank you!