TMS Co., Ltd.
Notice of Completion of Investigation of Clinical Trial Notification for Initiation of Early Phase II Clinical Trial of TMS-008 for Acute Kidney Injury
Following completion of the PMDA 14-day investigation, the clinical trial notification for the early Phase II clinical trial of TMS-008 has been cleared and the trial can be formally conducted. The study is a randomized, double-blind, placebo-controlled, multi-center, dose-escalation trial targeting AKI patients. The trial costs are included within the R&D expense range for fiscal 2026 and will not affect the financial results for the fiscal year ending December 2026.
Key Figures
- Completion of investigation of the clinical trial notification for initiation of the early Phase II clinical trial of TMS-008
- R&D expense range for the current period announced on February 13, 2026
- No impact on financial results for the fiscal year ending December 2026
AI要約
Formal Announcement of Trial Initiation and Study Design
Regarding the early Phase II clinical trial of TMS-008 targeting patients at risk of acute kidney injury following cardiovascular surgery, the PMDA completed its 14-day investigation and the company is now formally authorized to conduct the clinical trial. The study is randomized, double-blind, placebo-controlled, dose-escalation and multi-center, aiming to evaluate safety and efficacy.
Impact on Financial Results and Outlook
The costs required for this trial are included within the R&D expense range for the current fiscal year, and the company discloses that there will be no impact on the financial results for the fiscal year ending December 2026. The company will promptly disclose any new material developments. TMS Co., Ltd. will continue discovery and development of the pipeline leveraging collaboration with academic institutions.
TMS Co., Ltd.
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