Announced details
Treatment for patients at risk of acute kidney injury following cardiovascular surgery
Completion of PMDA's 14-day investigation
The company submitted a clinical trial notification to PMDA, which conducted the investigation.
An independent administrative agency responsible for the approval review and safety measures of pharmaceuticals and medical devices. The document does not state its location, representative, capital, or year of establishment.
There will be no impact on results for the fiscal year ending December 2026. The costs for this trial in the current fiscal year are included in the research and development expense range announced on 13 February 2026.
The company does not address Contract Value / Offering price.
Machado MN, et al. Rev Bras Cir Cardiovasc. 29: 299-307 (2014)
| Item | Details |
|---|---|
| Names of Products / Services Covered | TMS-008 |
| Counterparty | Pharmaceuticals and Medical Devices Agency (PMDA) |
| Counterparty overview | An independent administrative agency responsible for the approval review and safety measures of pharmaceuticals and medical devices. The document does not state its location, representative, capital, or year of establishment. |
| Relationship with the Company | The company submitted a clinical trial notification to PMDA, which conducted the investigation. |
| Launch date | 15 October 2026 (announced as the date on which the clinical trial became officially eligible to proceed; the actual trial start date is not disclosed) |
| Applicable area | Treatment for patients at risk of acute kidney injury following cardiovascular surgery |
| Quantitative Effects | Completion of PMDA's 14-day investigation |
| Impact on Business Performance | There will be no impact on results for the fiscal year ending December 2026. The costs for this trial in the current fiscal year are included in the research and development expense range announced on 13 February 2026. |
| Source | Machado MN, et al. Rev Bras Cir Cardiovasc. 29: 299-307 (2014) |
Items this document does not state (9)
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 PMDA completed its 14-day investigation.