Completion of Patient Enrollment in a Phase 1/2 Physician-Initiated Clinical Trial in Patients with Ischemic Cardiomyopathy
Osaka University Hospital, Osaka University
A total of 5 facilities, centered on Osaka University Hospital / Peptide drug created from redasemtide (development code: S-00515)
Because 14 cases are sufficient to conduct a meaningful assessment of the primary objectives, safety and tolerability, and after comprehensively considering the status of the clinical trial and other factors
No impact (no impact on full-year results for the fiscal year ending July 2026)
As of now, this matter is not expected to affect full-year results for the fiscal year ending July 2026.
Efficacy is scheduled to be assessed through various cardiac function tests and other evaluations conducted 52 weeks after administration.
| Item | Details |
|---|---|
| Event name | Completion of Patient Enrollment in a Phase 1/2 Physician-Initiated Clinical Trial in Patients with Ischemic Cardiomyopathy |
| Subject Entity | Osaka University Hospital, Osaka University |
| Target Locations / Products | A total of 5 facilities, centered on Osaka University Hospital / Peptide drug created from redasemtide (development code: S-00515) |
| Cause | Because 14 cases are sufficient to conduct a meaningful assessment of the primary objectives, safety and tolerability, and after comprehensively considering the status of the clinical trial and other factors |
| Amount of Impact on Business Performance | No impact (no impact on full-year results for the fiscal year ending July 2026) |
| Impact on Earnings Forecast | As of now, this matter is not expected to affect full-year results for the fiscal year ending July 2026. |
| Outlook | Efficacy is scheduled to be assessed through various cardiac function tests and other evaluations conducted 52 weeks after administration. |
Items this document does not state (18)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.Because 14 cases are sufficient to conduct a meaningful assessment of the primary objectives, safety and tolerability, and after comprehensively considering the status of the clinical trial and other factors.