Preclinical development and preparation for Phase I clinical trials of TMS-008
First written in FY2023-Q3. 15 of 17 entries say "Advanced", first in FY2023. Latest entry: 2026-10-15.
No other company in this theme has enough history to compare yet.
- FY2027-H1AdvancedAnnual report
「During the interim accounting period, the Company designed a trial and developed the implementation structure for an early Phase II clinical trial targeting cardiac surgery-associated acute kidney injury (CSA-AKI). Following two preliminary consultations with PMDA, a face-to-face advice meeting was scheduled for August 2026.」
For TMS-008, the Company advanced to designing an early Phase II trial for acute kidney injury after cardiac surgery and establishing the implementation structure. A face-to-face PMDA advice meeting was scheduled for August 2026 after two preliminary consultations. - FY2026-H1AchievedAnnual report
「During the interim accounting period, the data readout from the Phase I clinical trial in healthy subjects was conducted in April 2025, the clinical study report (CSR) was completed in June, and the Phase I trial was completed. Preparations for the next trial are underway.」
The TMS-008 Phase I trial in healthy subjects was completed after the data readout and completion of the CSR, and preparations for the next trial began. - FY2025AdvancedAnnual report
「During the fiscal year, the Company began the Phase I first-in-human clinical trial. The first patient, a healthy adult man, was dosed on 19 June 2024, and dosing and observation of all subjects in the five-step dose-escalation study were completed in December. Analysis and evaluation of pharmacokinetics, pharmacodynamics and safety were completed in March 2025 after fiscal year-end, and the data readout was announced in April. Preparations for the next trial have now begun.」
In the TMS-008 Phase I first-in-human trial, dosing of the first patient began in June 2024, dosing and observation of all subjects were completed in December, and preparations for the next trial began. - FY2025-H1AdvancedAnnual report
「During the interim accounting period, the Company proceeded with preparations to begin dosing in the Phase I clinical trial. The first patient was dosed on 19 June, and dosing in Cohort 2 was completed in August. No concerns had arisen as of that time, and the Phase I trial was progressing smoothly.」
The first patient in the TMS-008 Phase I trial was dosed on 19 June, and dosing in Cohort 2 was completed in August. No concerns arose and the trial was progressing smoothly. - FY2025-Q1AdvancedAnnual report
「During the first quarter, the Company proceeded with preparations to begin dosing in the Phase I clinical trial. As a first-in-human study of TMS-008, the trial will administer ascending doses to healthy adult men to evaluate pharmacokinetics, pharmacodynamics and safety. The first patient had completed dosing after the end of the quarter.」
Preparations for the TMS-008 Phase I trial progressed, and the first patient completed dosing after quarter-end, making the transition into Phase I concrete. - FY2024-Q3AdvancedAnnual report
「For TMS-008, the Company continued CMC preparations for the Phase I clinical trial and GLP-based safety studies. Manufacture of the clinical-trial drug substance was completed and formulation manufacturing is underway. In relation to the approval application, the Company held its second preliminary consultation with PMDA in November 2023 and is preparing to proceed to face-to-face advice after a third preliminary consultation. It also completed the selection of the CRO, clinical trial sites and testing laboratory.」
Manufacture of the clinical-trial drug substance was completed and formulation manufacturing began. The Company held its second preliminary PMDA consultation and completed selection of the CRO, trial sites and testing laboratory. Patents were also granted in Japan and China. - FY2024-Q2AdvancedAnnual report
「For TMS-008, the Company continued CMC preparations for the Phase I clinical trial and GLP-based safety studies. Manufacturing and shipment of the clinical-trial drug substance were completed in the second quarter. The Company also held a preliminary consultation with PMDA in June 2023 and began selecting a CRO.」
Manufacture and shipment of the Phase I drug substance were completed, and the Company held a preliminary consultation with PMDA. It also began selecting a CRO, marking further progress in trial preparations. - FY2024-Q1AdvancedAnnual report
「For TMS-008, which is being developed for potential indications including acute kidney injury and cancer cachexia, the Company continued CMC preparations for the Phase I clinical trial and safety studies based on GLP. It decided to begin manufacturing the clinical-trial drug substance in the second quarter. It also completed its application for a preliminary consultation with PMDA, with the meeting scheduled for June 2023.」
The Company decided to begin manufacturing drug substance for the Phase I trial in the second quarter and completed its application for a preliminary PMDA consultation. The consultation was scheduled for June 2023, making the preparations for clinical entry more concrete. - FY2023AdvancedAnnual report
「During the fiscal year, the Company began GLP toxicology studies, including preliminary studies to optimize the formulation. In parallel, it began preparing the implementation plan and establishing the structure for starting clinical trials.」
The Company began GLP toxicology studies and preparations for clinical trials, targeting entry into a Phase I clinical trial in the fiscal year ending February 2024. - FY2023-Q3First statedAnnual report
「For TMS-008, being developed for potential indications including acute kidney injury and cancer cachexia, the Company continued CMC work on formulation manufacturing following manufacture of the drug substance. It completed manufacture of the formulation for GLP toxicology studies and manufacture of the drug substance for pilot-scale production. GLP toxicology studies for the Phase I clinical trial are continuing.」
The Company is advancing CMC work, GLP toxicology studies and Phase I preparations for TMS-008, targeting acute kidney injury and cancer cachexia. Manufacture of the formulation for GLP toxicology studies and drug substance for pilot-scale production has been completed.