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Other Disclosures4891TMS Co.,Ltd.Pharmaceuticals

Notice of Submission of Clinical Trial Notification for the Early Phase II Clinical Trial of TMS-008 in Acute Kidney Injury

To prepare for the launch of a domestic early Phase II clinical trial of TMS-008 for acute kidney injury following cardiovascular surgery, a clinical trial notification was submitted to PMDA. The trial is a multicenter study evaluating safety and efficacy.

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Announced details

TMS-008
Applicable field (uses covered by this announcement)

Treatment of acute kidney injury (AKI) following cardiovascular surgery

Launch dateThe clinical trial notification was submitted on 30 September 2026. The planned start date for the trial is Not disclosed
What the company reported numerically
Usage history

Results from a Phase I trial in healthy adults suggesting good tolerability and safety

Relationship between the counterparty and the company
TMS Co.,Ltd.4891
Relationship with the Company

Recipient of the clinical trial notification

CounterpartyPharmaceuticals and Medical Devices Agency (PMDA)

An independent administrative agency responsible for the approval review and safety measures for pharmaceuticals, medical devices and other products

Impact on Business Performance

No impact on earnings for the fiscal year ending December 2026

The company does not address Contract Value / Offering price.

Source (materials cited by the company)

Machado MN, et al. Rev Bras Cir Cardiovasc. 29: 299–307 (2014)

Announced details
ItemDetails
Names of Products / Services CoveredTMS-008
CounterpartyPharmaceuticals and Medical Devices Agency (PMDA)
Counterparty overviewAn independent administrative agency responsible for the approval review and safety measures for pharmaceuticals, medical devices and other products
Relationship with the CompanyRecipient of the clinical trial notification
Launch dateThe clinical trial notification was submitted on 30 September 2026. The planned start date for the trial is Not disclosed
Applicable areaTreatment of acute kidney injury (AKI) following cardiovascular surgery
Usage historyResults from a Phase I trial in healthy adults suggesting good tolerability and safety
Impact on Business PerformanceNo impact on earnings for the fiscal year ending December 2026
SourceMachado MN, et al. Rev Bras Cir Cardiovasc. 29: 299–307 (2014)
Items this document does not state (9)
Contract ValueOffering priceContract DateAward/certification nameAwarding / certifying bodyRegistration number and expiry dateLocationLocation scaleQuantitative Effects

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.

The costs of this trial for the fiscal year ending December 2026 are included in the previously disclosed range of research and development expenses for the current fiscal year, so there will be no impact on earnings.

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Corrections happenIf the company reissues this disclosure, the page is rebuilt from the corrected version and the revision number moves up.
Notice of Submission of Clinical Trial Notification for the Early Phase II Clinical Trial of TMS-008 in Acute Kidney Injury | TMS Co.,Ltd. (4891) timely disclosure | Komori