Phase III Study of SB623 in Chronic Traumatic Brain Injury in Europe
First written in FY2020-Q1. 7 of 19 entries say "Restated". Latest entry: 2026-09-17.
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- 2026-09-17AdvancedFinancial Results Presentation
「FDAと試験デザイン合意済み 来期の臨床試験開始に向けて準備中」
米国慢性期外傷性脳損傷プログラムについて、FDAとの試験デザイン合意後の準備段階から、来期の臨床試験開始を見据えた準備段階であることが具体化した。 - FY2027-H1RestatedAnnual report
「In the US, regarding development for traumatic brain injury, we have reached agreement with the US Food and Drug Administration (FDA) on the design of the Phase 3 trial and are preparing to begin the clinical trial.」
For the U.S. SB623 chronic-stage traumatic brain injury program, the status of preparations to begin the clinical trial following agreement with the FDA on the Phase III trial design has been reconfirmed. - FY2026AdvancedAnnual report
「In the U.S. market, the largest market, discussions are under way with the U.S. Food and Drug Administration (FDA) regarding the conduct of clinical trials for chronic-stage traumatic brain injury, based on Acugo®'s track record in Japan, and agreement has been reached on the design of the Phase 3 clinical trial. Preparations for the clinical trial are scheduled to begin from the following fiscal year.」
The U.S. chronic-stage traumatic brain injury program progressed from discussions with the FDA to agreement on the Phase III trial design, and a plan was established to begin trial preparations from the following fiscal year. - FY2025AdvancedAnnual report
「With the United States as the primary focus given its position as the largest market, discussions with U.S. regulators on clinical trials for chronic-stage traumatic brain injury have resumed based on Acugo®'s track record in Japan.」
The global development of SB623 for chronic-stage traumatic brain injury has progressed from the previous preparation policy to the stage of resuming discussions with U.S. regulators on clinical trials based on Acugo®'s domestic track record. - FY2023RestatedAnnual report
「For the global expansion of the SB623 chronic-stage traumatic brain injury program, preparations to begin clinical trials will also be advanced, including options such as partnering with other companies.」
The policy of advancing preparations for a global clinical trial for chronic-stage traumatic brain injury without specifying a start deadline, including options such as partnering with other companies, has been reconfirmed. - FY2022ReframedAnnual report
「For the global expansion of the SB623 chronic-stage traumatic brain injury program, preparations to begin clinical trials will also be advanced, including options such as partnering with other companies.」
While the filing no longer states a specific start date for the Phase III trial, it describes preparations to begin global clinical trials, including options such as partnering with other companies, indicating that the plan has been restructured as a flexible preparation phase. - FY2021DroppedAnnual report
「The company also plans to advance regional expansion overseas for the chronic-stage traumatic brain injury, chronic-stage ischemic stroke and intracerebral hemorrhage programs.」
Although a policy of regional expansion overseas is described, this filing does not state a specific start plan or deadline for the previously described global Phase III trial for chronic-stage traumatic brain injury, including in the United States and Europe. - FY2021-Q2SoftenedAnnual report
「The global Phase 3 trial for SB623 traumatic brain injury that had been scheduled to begin during the current fiscal year has been postponed until the following fiscal year or later.」
The start of the global Phase III trial for SB623 traumatic brain injury, which had been scheduled during the fiscal year under review, was postponed until the following fiscal year or later. - FY2021-Q1RestatedAnnual report
「The group planned to make effective use of these programs and begin a global Phase 3 clinical trial for the chronic-stage traumatic brain injury program, including in the United States and Europe, by the end of the fiscal year ending January 2021 (February 2020 to January 2021).」
The plan to begin a global Phase III trial for chronic-stage traumatic brain injury, including in the United States and Europe, by the end of the fiscal year ending January 2021 has been reconfirmed. - FY2020RestatedAnnual report
「The group planned to make effective use of these programs and begin a global Phase 3 clinical trial for the chronic-stage traumatic brain injury program, including in the United States and Europe, by the end of the fiscal year ending January 2021 (February 2020 to January 2021).」
The plan to begin a global Phase III trial for chronic-stage traumatic brain injury, including in the United States and Europe, by the end of the fiscal year ending January 2021 has been reconfirmed. - FY2020-Q3ReframedAnnual report
「The group planned to make effective use of these programs and begin a global Phase 3 clinical trial for the chronic-stage traumatic brain injury program, including in the United States and Europe, by the end of the fiscal year ending January 2021 (February 2020 to January 2021).」
The plan was expanded from a Europe-centered plan to a global Phase III trial plan including the United States and Europe, and the deadline for starting the trial was changed to the end of the fiscal year ending January 2021. - FY2020-Q2ReframedAnnual report
「In April 2019, SB623 was designated as an Advanced Therapy Medicinal Product (ATMP) by the European Medicines Agency (EMA), and the group planned to begin a global Phase 3 clinical trial for the chronic-stage traumatic brain injury program, including in Europe as well as the United States.」
While the wording expanded from the previous plan to begin a Phase III trial in Europe to a plan for a global Phase III trial for chronic-stage traumatic brain injury, including in the United States and Europe, the filing does not state the previously indicated deadline for starting the trial. - FY2020-Q1First statedAnnual report
「This designation was the first step toward global expansion, and the group planned to begin a Phase 3 clinical trial for the chronic-stage traumatic brain injury program in Europe by the end of the fiscal year ending January 2020.」
The EMA's ATMP designation was positioned as the first step toward expansion in Europe, and a plan to begin a Phase III trial for chronic-stage traumatic brain injury in Europe by the end of the fiscal year ending January 2020 was indicated for the first time.