Xofluza is under clinical development by Shionogi and currently in Pre-Registration for Unspecified Influenza Virus Infections. According to GlobalData, Pre-Registration drugs for Unspecified Influenza Virus Infections does not have sufficient historical data to build an indication benchmark PTSR for Pre-Registration. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Xofluza LoA Report. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Xofluza overview
Baloxavir marboxil (Xofluza) is an anti-viral agent. It is formulated as film coated tablets, tablets, coated tablets, granules for oral route of administration. Xofluza is indicated for the treatment of type A and type B influenza virus infections and for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours and who are at high risk of developing flu-related complications or otherwise healthy. Xofluza is indicated for the treatment of uncomplicated influenza in patients 12 years of age and older. Xofluza is indicated for the treatment of acute uncomplicated influenza in otherwise healthy children aged five to less than 12 years of age who have been symptomatic for no more than 48 hours.
It is under development for the treatment of influenza caused by seasonal influenza A and B virus strains in both adults and pediatrics. It is under development for the prophylaxis of influenza infections, avian influenza subtypes H5N1 infections, H7N9 infections. It is a prodrug of baloxavir acid.
It was also under development for the treatment of influenza caused by seasonal influenza A and B virus and also for Coronavirus infections.
Shionogi overview
Shionogi focuses on the research, development, manufacturing, and marketing of pharmaceutical products, diagnostic reagents, and medical devices. It develops innovative products and services in collaboration with its partners. The company offers prescription drugs, over-the-counter (OTC) drugs, and diagnostic products for therapeutic areas including metabolic disorders, pain/central nervous system (CNS), infectious diseases and cancer. It offers contract development and manufacturing facilities including all stages from drug development to commercial manufacturing. The company operates a network of subsidiaries, branches, sales offices manufacturing plants, and research laboratories across Japan, China, Taiwan, North America and Europe. Shionogi is headquartered in Osaka, Japan.
For a complete picture of Xofluza’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
