TMS Co., Ltd.
Notification of Submission of Clinical Trial Notification for Early Phase II Clinical Trial of TMS-008 for Acute Kidney Injury
Submitted a clinical trial notification to PMDA to initiate the domestic early Phase II clinical trial of TMS-008. The target population is patients at risk of acute kidney injury after cardiac surgery. The trial is double-blind, randomized, placebo-controlled, dose-escalation, and multicenter. Impact on this fiscal period's results is unknown.
Key Figures
- Clinical trial notification submission date: Unknown
- TMS-008 trial type: Early Phase II clinical trial
- Target indication: Patients at risk of acute kidney injury after cardiac surgery
AI要約
Business and R&D Developments
TMS Co., Ltd. has submitted a clinical trial notification to the Pharmaceuticals and Medical Devices Agency (PMDA) to initiate the early Phase II clinical trial of TMS-008. This trial is a double-blind, randomized, placebo-controlled, dose-escalation, multicenter study targeting patients at risk of acute kidney injury following cardiovascular surgery, and aims to evaluate safety and efficacy. At this time, the impact of this trial on the current fiscal period's results is unknown.
Future Schedule and Risks
Costs associated with initiating this trial are included in the R&D expense range disclosed on February 13, 2026, and no direct impact on the fiscal year ending December 2026 is expected at this time. The company will promptly disclose any new developments. Risk factors include future clinical trial progress, regulatory decisions, and uncertainties inherent in drug development.
TMS Co., Ltd.
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