Phase II clinical trial of an HMGB1 peptide treatment for cerebral infarction
First written in FY2019. 10 of 26 entries say "Advanced", first in FY2020-Q1. Latest entry: FY2026.
No other company in this theme has enough history to compare yet.
- FY2026Failure to meet the primary endpointAnnual report
「In the cohort that did not undergo endovascular reperfusion therapy, the trial evaluated the modified Rankin Scale (mRS) 90 days after treatment initiation as the primary endpoint, measuring prognosis with regard to return to social activities. The razecemtide group did not show a statistically significant improvement over the placebo group, and the trial failed to achieve its primary endpoint.」
The global late Phase II trial in acute ischemic stroke ended in September 2026 but failed to achieve its primary endpoint. Exploratory analyses including severely ill patients suggested a trend toward improvement, and no new safety concerns were identified. - FY2025AdvancedAnnual report
「Based on the interim analysis, the evaluation committee recommended continuing the trial for the high-dose redasemtide group and discontinuing the trial for the low-dose redasemtide group.」
An interim analysis was conducted in April 2025 in the global late Phase 2 trial for acute cerebral infarction, resulting in a dose-group-specific recommendation to continue the high-dose group and discontinue the low-dose group. - FY2024RestatedAnnual report
「The global late Phase 2 clinical trial began in Japan on 10 April 2023, in the United States on 28 April 2023, and in Europe and China on 25 July 2023.」
It has been reaffirmed that the global late Phase 2 trial for cerebral infarction is being conducted in Japan, the United States, Europe, and China. - FY2024-Q3RestatedAnnual report
「Based on the favorable results of this trial, Shionogi & Co., Ltd. began a global late Phase 2 clinical trial in Japan on 10 April 2023, in the United States on 28 April 2023, and in Europe and China on 25 July 2023. Clinical trials are also scheduled to be conducted in 20 countries worldwide. The original plan was to proceed with the start of a global Phase 3 trial, but following consultations with the relevant regulatory authorities, it was decided to conduct a global late Phase 2 trial to determine the dose.」
The change in plan to a global late Phase 2 trial, its launch in Japan, the United States, Europe, and China, and the planned conduct of the trial in 20 countries worldwide have been reaffirmed. - FY2024-Q1RestatedAnnual report
「Based on the favorable results of this trial, Shionogi & Co., Ltd. began a global late Phase 2 clinical trial in Japan on 10 April 2023, in the United States on 28 April 2023, and in Europe and China on 25 July 2023. Clinical trials are also scheduled to be conducted in 20 countries worldwide. The original plan was to proceed with the start of a global Phase 3 trial, but following consultations with the relevant regulatory authorities, it was decided to conduct a global late Phase 2 trial to determine the dose.」
The change in plan to a global late Phase 2 trial, its launch in Japan, the United States, Europe, and China, and the planned conduct of the trial in 20 countries worldwide have been reaffirmed as previously reported. - FY2023AdvancedAnnual report
「Based on the favorable results of this trial, Shionogi & Co.,Ltd. began a global late-stage Phase II clinical trial in Japan on 10 April 2023, in the United States on 28 April 2023, and in Europe and China on 25 July 2023. Clinical trials are also planned in 20 countries worldwide.」
The plan changed from the previously planned global Phase 3 trial to a global late Phase 2 trial intended to determine the dose, and trial starts have been achieved in Japan, the United States, Europe, and China. - FY2023-Q3ReframedAnnual report
「Based on the favorable results of this trial, Shionogi & Co., Ltd. began a global late Phase 2 clinical trial in Japan on 10 April 2023 and in the United States on 28 April 2023. In Europe, a CTR (Clinical Trial Application) was submitted on 31 March 2023, and the clinical trial is scheduled to begin shortly. Clinical trials are also scheduled to be conducted in 20 countries worldwide, including China. The original plan was to proceed with the start of a global Phase 3 trial, but following consultations with the relevant regulatory authorities, it was decided to conduct a global late Phase 2 trial to determine the dose.」
Following consultations with the regulatory authorities, the plan changed from the previously anticipated start of a global Phase 3 trial to a global late Phase 2 trial intended to determine the dose. The trial began in Japan and the United States, with expansion to Europe and 20 countries worldwide planned. - FY2023-Q1AdvancedAnnual report
「Based on the results of evaluating mRS 90 days after treatment initiation, the proportion of patients who required assistance on the day after completing 5 days of dosing (mRS ≥3) but no longer required assistance 90 days after treatment initiation (mRS ≤2), indicating improvement in symptoms, was 18% in the placebo group versus 34% in the redasemtide group. mRS is a 7-point scale for assessing the severity of diseases causing impaired neuromotor function, including cerebrovascular disorders such as cerebral hemorrhage and cerebral infarction and neurological diseases such as Parkinson’s disease, ranging from 0 (no symptoms) to 6 (death). These results suggested the efficacy of redasemtide in patients with acute cerebral infarction.」
The Phase 2 cerebral infarction trial disclosed that the proportion of patients requiring no assistance after 90 days was 34% in the redasemtide group versus 18% in the placebo group, and preparations are proceeding to begin a global Phase 3 trial. - FY2022RestatedAnnual report
「Based on the favorable results of this trial, Shionogi & Co., Ltd. is proceeding with preparations to transition to a global Phase 3 clinical trial.」
The company has reaffirmed its policy of proceeding with preparations to transition to a global Phase 3 trial after confirming efficacy in the Phase 2 cerebral infarction trial. - FY2022-Q2AdvancedAnnual report
「The primary endpoint, mRS 90 days after treatment initiation, was achieved, confirming the efficacy of redasemtide in patients with acute cerebral infarction. Based on the favorable results of this trial, Shionogi & Co., Ltd. plans to proceed with preparations to transition to a global Phase 3 clinical trial.」
The primary endpoint of mRS 90 days after treatment initiation was achieved in the Phase 2 cerebral infarction trial, confirming efficacy. Preparations to transition to a global Phase 3 trial are scheduled to proceed. - FY2022-Q1RestatedAnnual report
「This trial is comparing the efficacy of redasemtide in patients with acute cerebral infarction under double-blind conditions, using the mRS (modified Rankin Scale, a scale for assessing the severity of cerebrovascular disorders such as cerebral hemorrhage and cerebral infarction) 90 days after treatment initiation as the measure. The trial is currently at the stage of data analysis and evaluation following the follow-up period for enrolled patients.」
It has been reaffirmed that, following completion of enrollment of the target 150 subjects, the trial is at the stage of follow-up and data analysis and evaluation. - FY2021AdvancedAnnual report
「Patient enrollment reached and completed the target of 150 subjects in July 2021. Data analysis and evaluation are scheduled to be conducted after the follow-up period for enrolled patients.」
In the Phase 2 trial of the cerebral infarction treatment, the study has advanced from completion of enrollment of the target 150 subjects to follow-up and data analysis. - FY2021-Q3RestatedAnnual report
「The Phase 2 clinical trial being conducted by Shionogi & Co., Ltd., the licensee for the drug, is ongoing. Dosing of the first subject at a clinical trial site was conducted in November 2019. Subject enrollment and safety confirmation have progressed smoothly to date, and dosing of additional subjects is expected to continue.」
The company has reaffirmed that dosing of the first subject, subject enrollment, and safety confirmation are progressing smoothly in the Phase 2 company-sponsored trial of the cerebral infarction treatment. - FY2021-Q2RestatedAnnual report
「The Phase 2 clinical trial being conducted by Shionogi & Co., Ltd., the licensee for the drug, is ongoing. Dosing of the first subject at a clinical trial site was conducted in November 2019. Subject enrollment and safety confirmation have progressed smoothly to date, and dosing of additional subjects is expected to continue.」
The company has reaffirmed that dosing of the first subject, subject enrollment, and safety confirmation are progressing smoothly in the Phase 2 company-sponsored trial of the cerebral infarction treatment. - FY2021-Q1RestatedAnnual report
「The Phase 2 clinical trial being conducted by Shionogi & Co., Ltd., the licensee for the drug, is ongoing. Dosing of the first subject at a clinical trial site was conducted in November 2019. Subject enrollment and safety confirmation have progressed smoothly to date, and dosing of additional subjects is expected to continue.」
The previous explanation has been reaffirmed that dosing of the first subject, subject enrollment, and safety confirmation are progressing smoothly in the Phase 2 company-sponsored trial of the cerebral infarction treatment. - FY2020-Q3RestatedAnnual report
「The Phase 2 company-sponsored clinical trial for cerebral infarction, led by Shionogi & Co., Ltd. since April 2019, began dosing subjects in November of the same year. Subject enrollment and safety confirmation have progressed steadily.」
The company has reaffirmed that dosing, subject enrollment, and safety confirmation are progressing steadily in the Phase 2 company-sponsored trial for cerebral infarction. - FY2020-Q2RestatedAnnual report
「In addition, dosing of the first subject was conducted at a clinical trial site on 4 November 2019, and dosing of subjects is expected to continue.」
The same information as previously reported has been reaffirmed for the Phase 2 company-sponsored trial of the cerebral infarction treatment, including dosing of the first subject and progress in subject enrollment and safety confirmation. - FY2020-Q1AdvancedAnnual report
「In addition, dosing of the first subject was conducted at a clinical trial site on 4 November 2019, and dosing of subjects is expected to continue.」
A specific clinical milestone was reported for the cerebral infarction treatment: dosing of the first subject was conducted on 4 November 2019. - FY2019First statedAnnual report
「For the development of the cerebral infarction treatment (PJ1-02), Shionogi & Co., Ltd., the licensee for the drug, has begun a Phase 2 clinical trial, with subject enrollment and safety confirmation progressing smoothly to date.」
The company reported that Shionogi & Co., Ltd., as the lead developer, had begun the Phase 2 trial in the cerebral infarction indication, with enrollment and safety confirmation progressing.