KRP-114V Marketing Authorization Application
First written in FY2018-Q2. 6 of 10 entries say "Advanced", first in FY2018. Latest entry: FY2026.
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- FY2026AdvancedAnnual report
「For KRP-114VP, an overactive bladder treatment for the pediatric indication of Beova, we began a Phase III clinical trial,」
The pediatric indication expansion of Beova progressed from the start of the Phase I trial to the start of the Phase III clinical trial. - FY2023-Q2AdvancedAnnual report
「In addition, in August 2022 we began a Phase I clinical trial of KRP-114VP in pediatric patients with overactive bladder. The trial is intended to expand the indication of the overactive bladder treatment Beova to pediatric patients.」
For the pediatric indication expansion of Beova (KRP-114V), a Phase I clinical trial of KRP-114VP began in August 2022. - FY2020-Q1Cited as achievedAnnual report
「Sales also increased for Beova, a selective β3-adrenergic receptor agonist for the treatment of overactive bladder, which was launched in November 2018.」
For KRP-114V, the company recorded increased sales following the acquisition of approval and the product launch. - FY2019AchievedAnnual report
「We obtained marketing approval from the Ministry of Health, Labour and Welfare for Beova, a selective β3-adrenergic receptor agonist for the treatment of overactive bladder (generic name: vibegron; development code: KRP-114V), and launched it in November of the same year.」
Following the acquisition of marketing approval, KRP-114V reached its new-product launch in November 2018. - FY2019-Q3AdvancedAnnual report
「Beova, a selective β3-adrenergic receptor agonist for overactive bladder for which marketing approval had been obtained in September 2018, was launched in November.」
KRP-114V progressed from obtaining marketing approval to its new-product launch in November 2018. - FY2019-Q2AchievedAnnual report
「In September of that year, we obtained marketing approval from the Ministry of Health, Labour and Welfare for Beova, a selective β3-adrenergic receptor agonist for the treatment of overactive bladder (generic name: vibegron; development code: KRP-114V).」
Following the marketing authorization application, KRP-114V proceeded to obtain marketing approval. - FY2018AdvancedAnnual report
「In fiscal 2018, we will begin marketing Nasonex, an allergic rhinitis treatment for which we acquired exclusive distribution rights from MSD Co., Ltd., while aiming to launch the overactive bladder treatment KRP-114V within the fiscal year.」
The company set a target of launching KRP-114V within the fiscal year following submission of the marketing authorization application and specified its sales rollout alongside Nasonex. - FY2018-Q2First statedAnnual report
「In September 2017, we submitted a marketing authorization application to the Ministry of Health, Labour and Welfare for KRP-114V, a treatment for overactive bladder.」
A marketing authorization application for KRP-114V was submitted to the Ministry of Health, Labour and Welfare in September 2017.