Launch of the Phase III Clinical Trial for KRP-108P
First written in FY2018-Q1. 2 of 6 entries say "Restated". Latest entry: FY2021-Q1.
No other company in this theme has enough history to compare yet.
- FY2021-Q1AchievedAnnual report
「In June 2020, the company obtained a partial-change approval to add dosing and administration for pediatric indications for Flutiform, a combination treatment for asthma.」
The expansion of the pediatric indication for Flutiform being developed as KRP-108P reached completion with the acquisition of approval for partial changes to the approved information in June 2020. - FY2020-Q2AdvancedAnnual report
「For KRP-108P (expansion of the pediatric indication for Flutiform), the company filed an application for marketing approval in July of the same year.」
KRP-108P, which had entered Phase III clinical trials, progressed to the stage of filing an application for marketing approval in July 2019. - FY2020-Q1AdvancedAnnual report
「The company devoted maximum effort to preparing for regulatory applications for 3 development pipeline products that had moved into the application-preparation stage in the previous fiscal year: the combination asthma treatment KRP-108P, the quinolone synthetic antibacterial agent KRP-AM1977Y, and the interstitial cystitis treatment KRP-116D.」
It was stated that KRP-108P had moved to the application-preparation stage after the start of its Phase III trial. - FY2018RestatedAnnual report
「The Phase III clinical trial of KRP-108P, a combination asthma treatment, to expand the pediatric indication for Flutiform began in June 2017,」
The company continues to describe the launch of the KRP-108P Phase III trial to expand the pediatric indication for Flutiform. - FY2018-Q2RestatedAnnual report
「We began a Phase III clinical trial for KRP-108P, an asthma combination therapy, in June 2017. The trial was intended to expand the pediatric indication for Flutiform, which was marketed for adult asthma.」
The company continues to describe the launch of the KRP-108P Phase III trial to expand the pediatric indication for Flutiform. - FY2018-Q1First statedAnnual report
「We began a Phase III clinical trial for KRP-108P, an asthma combination therapy, in June 2017. The trial was intended to expand the pediatric indication for Flutiform, which was marketed for adult asthma.」
A Phase III trial of KRP-108P was launched to expand Flutiform’s indication to pediatric patients.