Evaluation of a Phase III Trial and Selection of a Sales Partner for SI-614
First written in FY2017. 3 of 7 entries say "Advanced", first in FY2022. Latest entry: FY2025.
No other company in this theme has enough history to compare yet.
- FY2025DroppedAnnual report
「Because no statistically significant improvement was observed in the primary endpoint of the Phase III clinical trial conducted since May 2022, the company decided to discontinue development of this program.」
Development of SI-614 was discontinued after the Phase III clinical trial failed to meet its primary endpoint. - FY2024-Q3RestatedAnnual report
「No statistically significant improvement was observed in the primary endpoint of the Phase III clinical trial conducted since May 2022. The company is currently evaluating its future development policy based on the data obtained.」
Following the failure to meet the primary endpoint in the Phase III trial, SI-614 remains at the stage of evaluating its future development policy based on the data. - FY2024-Q2SoftenedAnnual report
「In the primary endpoint of the Phase III clinical trial conducted since May 2022, no statistically significant improvement was observed. In response, we are analyzing the data obtained and considering our future development policy.」
After SI-614 failed to demonstrate a significant improvement in the primary endpoint of the Phase III clinical trial, development regressed from the previous stage of trial progress to evaluating the data and future development policy. - FY2024-Q1AdvancedAnnual report
「Follow-up for the Phase III clinical trial intended to evaluate efficacy and safety ended in June 2023, and the company is currently analyzing the data obtained.」
For the U.S. Phase III clinical trial of SI-614 launched in May 2022, follow-up ended in June 2023 and the trial progressed to the data analysis stage. - FY2023-Q3AdvancedAnnual report
「Subject enrollment in the Phase III clinical trial conducted since May 2022 was completed in February 2023. The trial is intended to evaluate efficacy and safety. After obtaining data from the current trial, the company plans to select a commercialization partner and conduct a second Phase III clinical trial and a long-term administration trial.」
In the U.S. Phase III clinical trial of SI-614 launched in May 2022, subject enrollment was completed in February 2023. The company plans to select a commercialization partner after obtaining the data and conduct a second Phase III trial and a long-term administration trial. - FY2022AdvancedAnnual report
「Because clinically useful effects were confirmed in the Phase II/III clinical trial and other studies, the company began a Phase III clinical trial in May 2022. The trial is intended to evaluate efficacy and safety.」
Following the Phase II/III trial and other studies, SI-614 progressed to the stage of initiating a Phase III clinical trial in the United States in May 2022. - FY2017First statedAnnual report
「The Phase II/III clinical trial ended in January 2015. The company is currently evaluating a Phase III clinical trial based on the data obtained and proceeding with the selection of a commercialization partner.」
For SI-614, a treatment for dry eye disease, the company first reported evaluating a Phase III trial based on data obtained after completion of the Phase II/III trial and selecting a commercialization partner.