Initiating clinical trials for osteoarthritis of the knee, cardiomyopathy and cirrhosis
First written in FY2019. 17 of 24 entries say "Advanced", first in FY2020. Latest entry: FY2026.
No other company in this theme has enough history to compare yet.
- FY2026AdvancedAnnual report
「A Phase II investigator-initiated clinical trial began in March 2024 at multiple institutions, led by Osaka University Hospital. Dosing of the first patient was completed in December 2024, and dosing of the final patient was completed in April 2026.」
Dosing of the final patient in the Phase II investigator-initiated clinical trial for ischemic cardiomyopathy was completed. The Phase II investigator-initiated clinical trials for osteoarthritis of the knee and chronic liver disease have also been completed, advancing multiple disease programmes from their trial-initiation targets to the stages of completion and final-patient dosing. - FY2025AdvancedAnnual report
「A Phase II investigator-initiated clinical trial began in March 2024 at multiple sites centered on Osaka University Hospital, and dosing of the first patient was completed in December 2024.」
For ischemic cardiomyopathy, development progressed from the start of the Phase II investigator-initiated clinical trial to completion of dosing of the first patient. - FY2024RestatedAnnual report
「The investigator-initiated Phase II clinical trials for osteoarthritis of the knee and chronic liver disease have been completed, while the Phase II investigator-initiated clinical trial for ischemic cardiomyopathy began in March 2024.」
The development stage for multiple diseases was reconfirmed as either completion or commencement of Phase II trials. - FY2024-Q3RestatedAnnual report
「A Phase II investigator-initiated clinical trial began in March 2024 at multiple sites centered on Osaka University Hospital. The primary objective of this trial is to evaluate the efficacy and safety of Redasemtide in patients with ischemic cardiomyopathy who have undergone coronary artery bypass surgery, with Redasemtide or placebo administered for 5 days to 10 patients in each group.」
For cardiomyopathy, a Phase II investigator-initiated clinical trial began at multiple sites, with efficacy and safety to be evaluated following 5 days of dosing in 10 patients in each group, as reconfirmed. - FY2024-Q2AdvancedAnnual report
「Since March 2024, an investigator-initiated Phase II clinical trial has been under way at multiple institutions, led by Osaka University Hospital.」
For cardiomyopathy, development progressed from the previous planned start to the actual commencement of the Phase II investigator-initiated clinical trial. - FY2024-Q1AdvancedAnnual report
「The start of a Phase II investigator-initiated trial at multiple institutions, centered on Osaka University Hospital, is planned for the first half of 2024.」
A specific plan was presented to begin the Phase II investigator-initiated clinical trial for cardiomyopathy during the first half of 2024. - FY2023AdvancedAnnual report
「In addition to improvement in liver stiffness measured by MR elastography, multiple cases also showed a tendency toward improvement in other fibrosis indicators, including the fibrosis index, fibrosis markers and the modified HAI fibrosis stage. Based on a comprehensive assessment by the principal investigator incorporating the results of these efficacy measures, the investigator concluded that a tendency toward improvement in liver fibrosis was suggested in 3 of 5 patients (60%) who received retasemtiv at 1.5 mg/kg based on body weight once weekly for 4 weeks, for a total of 4 doses, and in 2 of 5 patients (40%) who received 4 consecutive days of dosing in Week 1 followed by once-weekly dosing in Weeks 2 to 4, for a total of 7 doses.」
For chronic liver disease, development progressed from achieving the primary endpoint in the Phase II trial to the stage of examining efficacy trends by dosing method and future development policies. - FY2023-Q3AdvancedAnnual report
「Regarding development of the chronic liver disease treatment (PJ1-05), we were informed in April 2023 that the investigator-initiated clinical trial conducted by Niigata University Medical and Dental Hospital (Phase II; 10 patients in the Redasemtide group) had achieved its primary endpoint. Regarding the primary objective, the safety evaluation of Redasemtide administration, adverse events for which a causal relationship with the investigational drug could not be ruled out occurred in 2 of the 10 patients, namely dysphonia and fever. Both events were mild and resolved.」
The primary endpoint was achieved in the Phase II investigator-initiated clinical trial for chronic liver disease, and tolerability was described as good apart from mild adverse events that resolved. - FY2023-Q2AdvancedAnnual report
「We were informed in March 2023 that the investigator-initiated clinical trial (Phase II) conducted at Hirosaki University had achieved its primary endpoint. Regarding the primary objective, the safety evaluation of Redasemtide administration, no serious adverse events or adverse drug reactions determined to be related to the drug were observed, confirming the safety of the drug when administered for osteoarthritis of the knee. The efficacy of the drug, established as a secondary endpoint, is currently being analyzed. At 52 weeks after dosing began, the median change in the percentage area of cartilage defects in the medial femoral condyle was -3.5% in the placebo group, compared with -7.5% in the Redasemtide group, indicating a trend toward greater reduction in the defect area in the Redasemtide group.」
The primary endpoint was achieved in the Phase II trial for osteoarthritis of the knee, and safety was confirmed. Efficacy is still being analyzed, but the percentage area of cartilage defects at 52 weeks was -3.5% in the placebo group versus -7.5% in the Redasemtide group. - FY2023-Q1RestatedAnnual report
「Since November 2020, an investigator-initiated Phase II clinical trial in patients with chronic liver disease has been conducted at Niigata University, and patient enrollment was completed in June 2022. Data analysis and evaluation are scheduled to follow a 6-month follow-up period.」
It was reconfirmed that patient enrollment had been completed in the Phase II clinical trial for chronic liver disease and that the trial was at the follow-up and analysis stage. - FY2022RestatedAnnual report
「Since November 2020, an investigator-initiated Phase II clinical trial in patients with chronic liver disease has been conducted at Niigata University, and patient enrollment was completed in June 2022. Data analysis and evaluation are scheduled to follow a 6-month follow-up period.」
It was reconfirmed that patient enrollment had been completed in the Phase II clinical trial for chronic liver disease, which had progressed to the follow-up and analysis stages. - FY2022-Q3AdvancedAnnual report
「Since November 2020, an investigator-initiated Phase II clinical trial in patients with chronic liver disease has been conducted at Niigata University, and patient enrollment was completed in June 2022. Data analysis and evaluation are scheduled to follow a 6-month follow-up period.」
Patient enrollment was completed in the Phase II clinical trial for chronic liver disease, progressing from the target of starting treatment to the follow-up and analysis stages. Following osteoarthritis of the knee, specific clinical development milestones were presented for multiple diseases. - FY2022-Q1AdvancedAnnual report
「An investigator-initiated clinical trial (Phase II) in patients with osteoarthritis of the knee has been conducted at Hirosaki University since November 2020, and patient enrollment was completed in December 2021. Data analysis and evaluation are scheduled to follow a 4-week treatment period and a 48-week follow-up period.」
Patient enrollment was completed in the Phase II investigator-initiated clinical trial for osteoarthritis of the knee, which progressed to the treatment, follow-up and data analysis stages. Preparations were also reported to be under way for a Phase II clinical trial for cardiomyopathy. - FY2021-Q3AdvancedAnnual report
「In November 2020, a Phase II investigator-initiated trial in patients with chronic liver disease was started at Niigata University, and dosing of the first subject began in March 2021.」
Progressed from the initiation of the Phase II clinical trial for chronic liver disease to dosing of the first patient in March 2021. - FY2021-Q2AdvancedAnnual report
「In November 2020, a Phase 2 investigator-initiated clinical trial began at Hirosaki University, a national university corporation, in patients with knee osteoarthritis, and dosing of the first subject began in February 2021. In November 2020, a Phase 2 investigator-initiated clinical trial also began at Niigata University, a national university corporation, in patients with chronic liver disease.」
Phase 2 trials began for knee osteoarthritis and chronic liver disease, and the knee osteoarthritis trial advanced to dosing of the first subject. - FY2021-Q1AdvancedAnnual report
「In November 2020, a Phase 2 investigator-initiated clinical trial began at Niigata University, a national university corporation, in patients with chronic liver disease.」
A Phase 2 investigator-initiated clinical trial began for chronic liver disease, and a trial for knee osteoarthritis also began in the same month. Nonclinical research findings were reported for cardiomyopathy. - FY2020AdvancedAnnual report
「In June 2020, the company entered into an agreement with Hirosaki University and Shionogi & Co., Ltd. concerning the conduct of a Phase 2 investigator-initiated clinical trial for knee osteoarthritis. The trial is planned to begin at Hirosaki University during 2020 to evaluate the efficacy and safety of redasemtide in patients with knee osteoarthritis.」
An agreement to conduct a Phase 2 investigator-initiated clinical trial for knee osteoarthritis was signed, advancing the plan to begin the trial during 2020. An agreement to conduct a similar trial and a plan to begin it during the year were also reported for chronic liver disease. - FY2019First statedAnnual report
「The company also aims to begin clinical trials for knee osteoarthritis, cardiomyopathy, and cirrhosis during 2020.」
The target of beginning trials for 3 diseases during 2020 was explicitly stated.