SB623 Phase II clinical trial for traumatic brain injury
First written in FY2017-Q1. 14 of 24 entries say "Cited as achieved", first in FY2019. Latest entry: FY2027-H1.
No other company in this theme has enough history to compare yet.
- FY2027-H1Cited as achievedAnnual report
「For the SB623 chronic-phase traumatic brain injury program (the “Program”), the primary endpoint was achieved in the international Phase II clinical trial, including Japan, in November 2018, and the program was designated as a product eligible for the SAKIGAKE designation system in April 2019.」
The achievement of the primary endpoint in the international Phase II trial, including Japan, and the April 2019 SAKIGAKE designation were cited as past developments. - FY2024-Q3Cited as achievedAnnual report
「For the SB623 chronic-phase traumatic brain injury program, the international Phase II clinical trial, including Japan and involving 61 subjects, produced favorable results in November 2018, stating that “The SB623-treated group showed a statistically significant improvement in motor function compared with the control group and achieved the primary endpoint.” In April 2019, the program was designated by the Ministry of Health, Labour and Welfare as a product eligible for the SAKIGAKE designation system for regenerative medical products.」
The November 2018 achievement of the primary endpoint in the international Phase II trial involving 61 subjects and the April 2019 SAKIGAKE designation have again been cited as past developments. - FY2024-Q2Cited as achievedAnnual report
「For the SB623 chronic-phase traumatic brain injury program, the international Phase II clinical trial, including Japan and involving 61 subjects, produced favorable results in November 2018, stating that “The SB623-treated group showed a statistically significant improvement in motor function compared with the control group and achieved the primary endpoint,”」
The achievement of the primary endpoint in November 2018 in the international Phase II trial, including Japan and involving 61 subjects, has again been cited as a past accomplishment. - FY2024-Q1Cited as achievedAnnual report
「For the SB623 chronic-phase traumatic brain injury program, the international Phase II clinical trial, including Japan and involving 61 subjects, produced favorable results in November 2018, stating that “The SB623-treated group showed a statistically significant improvement in motor function compared with the control group and achieved the primary endpoint,”」
The achievement of the primary endpoint in November 2018 in the international Phase II trial, including Japan and involving 61 subjects, has again been cited as a past accomplishment. - FY2023Cited as achievedAnnual report
「The international Phase II clinical trial, including Japan and involving 61 subjects, produced favorable results in November 2018, stating that “The SB623-treated group showed a statistically significant improvement in motor function compared with the control group and achieved the primary endpoint,”」
The November 2018 achievement of the primary endpoint in the international Phase II trial involving 61 subjects has also been cited in the annual report as a past accomplishment. - FY2023-Q3Cited as achievedAnnual report
「For the SB623 chronic-phase traumatic brain injury program, the international Phase II clinical trial, including Japan and involving 61 subjects, produced favorable results in November 2018, stating that “The SB623-treated group showed a statistically significant improvement in motor function compared with the control group and achieved the primary endpoint,”」
The November 2018 results from the international Phase II trial, including Japan and involving 61 subjects, in which the primary endpoint was achieved, have again been cited as a past achievement. - FY2023-Q2Cited as achievedAnnual report
「The international Phase II clinical trial, including Japan and involving 61 subjects, produced favorable results in November 2018, stating that “The SB623-treated group showed a statistically significant improvement in motor function compared with the control group and achieved the primary endpoint,”」
The November 2018 results from the international Phase II trial, including Japan and involving 61 subjects, in which the primary endpoint was achieved, have again been cited as a past achievement. - FY2023-Q1Cited as achievedAnnual report
「The international Phase II clinical trial, including Japan and involving 61 subjects, produced favorable results in November 2018, stating that “The SB623-treated group showed a statistically significant improvement in motor function compared with the control group and achieved the primary endpoint,”」
The achievement of the primary endpoint in the Phase II trial for chronic-phase traumatic brain injury in the US and Japan, involving 61 subjects, has again been cited as an achievement in November 2018. - FY2022-Q2Cited as achievedAnnual report
「For the SB623 chronic-phase traumatic brain injury program, the Phase II clinical trial in the US and Japan, involving 61 subjects, produced favorable results in November 2018, stating that “The SB623-treated group showed a statistically significant improvement in motor function compared with the control group and achieved the primary endpoint,”」
The achievement of the primary endpoint in the Phase II trial for chronic-phase traumatic brain injury in the US and Japan, involving 61 subjects, has again been cited. - FY2021-Q1Cited as achievedAnnual report
「For the SB623 chronic-phase traumatic brain injury program, the Phase II clinical trial in the US and Japan, involving 61 subjects, produced favorable results in November 2018, stating that “The SB623-treated group showed a statistically significant improvement in motor function compared with the control group and achieved the primary endpoint,”」
The achievement of the primary endpoint in the Phase II trial for chronic-phase traumatic brain injury in the US and Japan, involving 61 subjects, has again been cited as a past achievement. - FY2020Cited as achievedAnnual report
「Our group's independently conducted Phase II clinical trial for the chronic-phase traumatic brain injury program in the US and Japan, involving 61 subjects, produced favorable results in November 2018, stating that “The SB623-treated group showed a statistically significant improvement in motor function compared with the control group and achieved the primary endpoint.”」
The achievement of the primary endpoint in the Phase II trial for chronic-phase traumatic brain injury in the US and Japan, involving 61 subjects, was also cited in the annual report. - FY2020-Q3Cited as achievedAnnual report
「Our group's independently conducted Phase II clinical trial for the SB623 chronic-phase traumatic brain injury program in the US and Japan, involving 61 subjects, produced favorable results in November 2018, stating that “The SB623-treated group showed a statistically significant improvement in motor function compared with the control group and achieved the primary endpoint,”」
The achievement of the primary endpoint in the Phase II trial for chronic-phase traumatic brain injury in the US and Japan, involving 61 subjects, has been cited again. - FY2020-Q1Cited as achievedAnnual report
「Our group's independently conducted Phase II clinical trial for the SB623 chronic-phase traumatic brain injury program in the US and Japan, involving 61 subjects, produced favorable results in November 2018, stating that “The SB623-treated group showed a statistically significant improvement in motor function compared with the control group and achieved the primary endpoint,”」
The achievement of the primary endpoint in the Phase II trial for chronic-phase traumatic brain injury in the US and Japan, involving 61 subjects, has been cited again. - FY2019Cited as achievedAnnual report
「Our group's independently conducted Phase II clinical trial for the chronic-phase traumatic brain injury program in the US and Japan completed enrollment of 61 subjects in April 2018 and produced favorable results in November of the same year, stating that “The SB623-treated group showed a statistically significant improvement in motor function compared with the control group and achieved the primary endpoint.”」
The completion of enrollment of 61 subjects and achievement of the primary endpoint in the Phase II trial for chronic-phase traumatic brain injury in the US and Japan were also cited as achievements in the annual report. - FY2019-Q3AchievedAnnual report
「Our group's independently conducted Phase II clinical trial for the chronic-phase traumatic brain injury program in the US and Japan completed enrollment of all subjects (61) in April 2018. On 1 November 2018, we announced favorable results stating that “The SB623-treated group showed a statistically significant improvement in motor function compared with the control group and achieved the primary endpoint.”」
In the Phase II trial for chronic-phase traumatic brain injury in the US and Japan, favorable results were announced after enrollment of 61 subjects was completed, showing a statistically significant improvement in motor function and achievement of the primary endpoint. - FY2019-Q2RestatedAnnual report
「Our group's independently conducted chronic-phase traumatic brain injury program in the US and Japan is in Phase II clinical trials. Enrollment of all subjects (61) was completed in April 2018, and the trial is currently in a 6-month follow-up period. The trial results are scheduled to be announced during the fiscal year ending January 2019 (February 2018 to January 2019).」
For the Phase II trial for chronic-phase traumatic brain injury in the US and Japan, the previously reported progress has been reconfirmed: enrollment of 61 subjects was completed, the 6-month follow-up is under way, and the results are scheduled to be announced during the fiscal year ending January 2019. - FY2018AdvancedAnnual report
「For this program, although 52 subjects had been planned, enrollment of 61 subjects was ultimately completed in April 2018. Going forward, after a 6-month follow-up period, we aim to achieve the earliest launch among our SB623 programs by using Japan's conditional and time-limited early approval system. Specifically, we aim to announce the results during the fiscal year ending January 2019 and submit the application for approval during the fiscal year ending January 2020.」
The SB623 Phase II trial for chronic-phase traumatic brain injury completed enrollment of 61 subjects against the planned 52, and the timing of follow-up, results disclosure and the application for approval was specified. - FY2018-Q3RestatedAnnual report
「The Phase II clinical trial for SB623 chronic-phase traumatic brain injury being conducted in the US and Japan, planned to enroll 52 subjects and designed as a double-blind trial, began enrolling its first subject in the US in July 2016 and in Japan in October 2016, respectively, and enrollment progressed smoothly during the period.」
For the 52-subject SB623 Phase II trial for chronic-phase traumatic brain injury being conducted in the US and Japan, enrollment continued smoothly after the initial enrollment, a status that has been reconfirmed. - FY2018-Q2RestatedAnnual report
「The Phase II clinical trial for SB623 chronic-phase traumatic brain injury being conducted in the US and Japan, planned to enroll 52 subjects and designed as a double-blind trial, began enrolling its first subject in the US in July 2016 and in Japan in October 2016, respectively, and enrollment has proceeded sequentially since then.」
For the 52-subject SB623 Phase II trial for chronic-phase traumatic brain injury being conducted in the US and Japan, sequential enrollment has continued after the initial enrollment, a status that has been reconfirmed. - FY2018-Q1AdvancedAnnual report
「For the traumatic brain injury program, based on the results of the previously conducted Phase I/IIa clinical trial for chronic-phase cerebral infarction, approval was obtained from the US Food and Drug Administration (FDA) and the Pharmaceuticals and Medical Devices Agency (PMDA) to omit Phase I, and the program began with Phase II.」
The SB623 traumatic brain injury program obtained approval from the FDA and PMDA to omit Phase I and begin with Phase II. - FY2017RestatedAnnual report
「For the SB623 chronic-phase traumatic brain injury program, the first subject was enrolled in the Phase II clinical trial in July 2016, which was planned to enroll 52 subjects and was a double-blind trial, and subject enrollment has continued sequentially since then.」
The US Phase II trial has continued enrolling subjects, planned at 52, since the initial enrollment in July 2016. - FY2017-Q3RestatedAnnual report
「In the United States, the first subject was enrolled in March 2016 in the Phase IIb clinical trial for the SB623 chronic stroke programme, which was planned to involve 156 subjects. Subsequently, in July 2016, the first subject was enrolled in the Phase II clinical trial for the SB623 chronic traumatic brain injury programme, which was planned to involve 52 subjects. Subject enrolment is currently proceeding sequentially in the 2 development programmes in the United States.」
After the first subject was enrolled in the US in July 2016, subjects have continued to be enrolled sequentially, a status that has been reconfirmed. - FY2017-Q2AdvancedAnnual report
「Subsequently, in July 2016, the first subject was enrolled in the Phase II clinical trial for the SB623 chronic-phase traumatic brain injury program, which was planned to enroll 52 subjects. In the US, subjects are currently being enrolled sequentially in the 2 development programs.」
The program progressed from recruitment and preparations for enrollment in the US to enrollment of the first subject in July 2016. - FY2017-Q1First statedAnnual report
「For the SB623 Phase II clinical trial for traumatic brain injury (52 subjects), recruitment began in the US in October 2015, and preparations are being advanced toward enrolling the first subject.」
Recruitment began in the US in October 2015, and a Phase II trial with 52 subjects is under way.