SB623 Traumatic Brain Injury Clinical Trial in Japan
First written in FY2017-Q1. 18 of 39 entries say "Advanced", first in FY2017-Q3. Latest entry: FY2027-H1.
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- FY2027-H1Cited as achievedAnnual report
「Development proceeded under this framework. In July 2024, we obtained conditional and time-limited marketing authorization for “Akuugo® Intracerebral Implantation Injection” (hereinafter, “Akuugo®”), and in December 2025 approval was granted for partial changes to Akuugo®’s marketing authorization particulars to remove the condition restricting shipments.」
For the domestic chronic-phase traumatic brain injury program, the historical progress cited includes obtaining conditional and time-limited approval and approval for partial changes related to removing the shipment restriction. - FY2026AdvancedAnnual report
「Subsequently, in June 2025, we applied for partial changes to Acugo®’s manufacturing and marketing approval with the aim of lifting the conditions restricting shipments, and those changes were approved in December 2025.」
Following the application for partial changes to the marketing authorization particulars, the domestic chronic-phase traumatic brain injury program advanced to the stage of removing the shipment restriction after approval was obtained in December 2025. - FY2026-H1AdvancedAnnual report
「Subsequently, manufacturing was conducted to obtain conformity for approximately 2 commercial-scale production runs to confirm comparability and consistency, one of the approval conditions. The 2 production runs completed to date have met all acceptance criteria in specification testing and characterization and have been judged to conform. In response, in June 2025 we completed an application for partial changes to the marketing authorization particulars for Akuugo®.」
The domestic chronic-phase traumatic brain injury program advanced to the stage of completing the application for partial changes to the marketing authorization particulars after the 2 commercial-scale production runs following conditional and time-limited approval were judged to conform. - FY2025AdvancedAnnual report
「Manufacturing was conducted on the assumption that conformity would need to be demonstrated for approximately 2 commercial-scale production runs to confirm comparability and consistency, one of the approval conditions. As of today, a single production run has met all acceptance criteria in specification testing and characterization, and has been judged to conform.」
After obtaining conditional and time-limited approval, the domestic chronic-phase traumatic brain injury program advanced to the stage at which the first commercial-scale production run was judged to conform for purposes of confirming comparability and consistency. - FY2025-H1AdvancedAnnual report
「On 31 July of the following month, the Ministry of Health, Labour and Welfare granted Acugo® conditional, time-limited marketing approval in Japan for the indication of improving motor paralysis in the chronic phase following traumatic brain injury.」
The domestic chronic-phase traumatic brain injury program advanced from the application and deliberation stages to the stage of obtaining conditional and time-limited marketing authorization. - FY2025-Q1AdvancedAnnual report
「This application had been designated for continued deliberation at the meeting of the Regenerative Medical Products and Biotechnology Committee of the Pharmaceutical Affairs and Food Sanitation Council held on 25 March 2024. Accordingly, on 12 June, the Ministry of Health, Labour and Welfare announced that the committee would meet on 19 June. The agenda includes deliberation of “whether to grant marketing authorization for the regenerative medical product Akuugo Intracerebral Implantation Injection, developed by the company as SB623, and whether conditions and a time limit are required, as well as whether a re-examination period should be designated.” The committee will therefore deliberate whether to approve the company’s SB623 product.」
Following continued deliberation in March 2024, the domestic SB623 chronic-phase traumatic brain injury program advanced to the stage at which approval and related matters would be deliberated by the Pharmaceutical Affairs Council on 19 June 2024. - FY2024AdvancedAnnual report
「This application was reviewed at the meeting of the Regenerative Medical Products and Biotechnology Committee of the Pharmaceutical Affairs and Food Sanitation Council held on 25 March 2024. As a result of the review, the clinical issues were assessed as having significance for providing the product to clinical practice. Accordingly, we understand that the remaining issues for obtaining approval have been narrowed to quality-related matters. Going forward, we will consult with the authorities and submit additional quality-related data and other materials.」
The marketing authorization application for the domestic SB623 chronic-phase traumatic brain injury program was reviewed by the Pharmaceutical Affairs Council. While the clinical issues were assessed as meaningful, the remaining issues for obtaining approval were narrowed to quality-related matters, and the company proceeded to submit additional data. - FY2024-Q3SoftenedAnnual report
「We are currently responding to the PMDA’s review to obtain approval and steadily preparing our sales infrastructure so that we can promptly begin sales after approval. The timing of approval is not something we can determine, but we aim to obtain approval in March 2024.」
The target for approval of the domestic SB623 chronic-phase traumatic brain injury program changed from “during the current fiscal year,” as stated previously, to March 2024. Responses to the PMDA’s review and preparations to establish the sales infrastructure are continuing. - FY2024-Q2RestatedAnnual report
「We are currently responding to the PMDA’s review and addressing the yield-related issue, namely, that yield has declined compared with the time of filing, in order to obtain approval. We are also steadily preparing our sales infrastructure so that we can promptly begin sales after approval. The timing of approval is not something we can determine, but we aim to obtain approval during the current fiscal year.」
For the domestic SB623 chronic-phase traumatic brain injury program, the plan to respond to the PMDA’s review, address the yield issue and establish the sales infrastructure, with the aim of obtaining approval during the current fiscal year, has been reconfirmed. - FY2024-Q1RestatedAnnual report
「We are currently responding to the PMDA’s review and addressing the yield-related issue, namely, that yield has declined compared with the time of filing, in order to obtain approval. We are also steadily preparing our sales infrastructure so that we can promptly begin sales after approval. The timing of approval is not something we can determine, but we aim to obtain approval during the current fiscal year.」
For the domestic SB623 chronic-phase traumatic brain injury program, the plan to respond to the PMDA’s review, address the yield issue and establish the sales infrastructure, with the aim of obtaining approval during the current fiscal year, has been reconfirmed. - FY2023AdvancedAnnual report
「The timing of approval is not something we can determine, but to obtain approval we are addressing the regulatory authorities’ review and the yield-related issue, namely, that yield has declined compared with the time of filing, with the aim of obtaining approval during the current fiscal year.」
For the domestic SB623 chronic-phase traumatic brain injury program, the company indicated a target of obtaining approval during the current fiscal year, while addressing the PMDA’s review following the application and the issue of lower yield compared with the time of filing. - FY2023-Q3RestatedAnnual report
「To obtain approval, we will respond to the PMDA’s review while steadily preparing our sales infrastructure so that we can promptly begin sales after approval.」
For the domestic SB623 chronic-phase traumatic brain injury program, preparations are under way to respond to the PMDA’s review following completion of the marketing authorization application and to establish the sales infrastructure required after approval. - FY2023-Q2RestatedAnnual report
「To obtain approval, we will respond to the PMDA’s review while steadily preparing our sales infrastructure so that we can promptly begin sales after approval.」
For the domestic SB623 chronic-phase traumatic brain injury program, preparations are under way to respond to the PMDA’s review following completion of the marketing authorization application and to establish the sales infrastructure required after approval. - FY2023-Q1RestatedAnnual report
「Since the designation, we have continued consultations with the Pharmaceuticals and Medical Devices Agency (PMDA) under the Sakigake Designation System, completed the Sakigake Comprehensive Evaluation Consultation in January 2022, and in March 2022 completed our first domestic marketing authorization application for a regenerative medical product (the “Marketing Authorization Application”). To obtain approval, we will respond to the PMDA’s review while steadily preparing our sales infrastructure so that we can promptly begin sales after approval.」
For the domestic SB623 chronic-phase traumatic brain injury program, preparations are under way to respond to the PMDA’s review following completion of the marketing authorization application and to establish the sales infrastructure required after approval. - FY2022AdvancedAnnual report
「By the end of January 2022, we had completed the Sakigake Comprehensive Evaluation Consultation, and in March 2022 we filed an application with the Ministry of Health, Labour and Welfare for marketing authorization of a regenerative medical product indicated for the improvement of motor dysfunction following traumatic brain injury.」
For the domestic chronic-phase traumatic brain injury program, the Sakigake Comprehensive Evaluation Consultation was completed, followed by the completion of the marketing authorization application for a regenerative medical product in March 2022. - FY2022-Q3AdvancedAnnual report
「The SB623 chronic-phase traumatic brain injury program is currently in the phase of the Sakigake Comprehensive Evaluation Consultation. This consultation is divided into five parts: clinical, nonclinical, quality, reliability and GCTP, and authorization to file is obtained for each part.」
The domestic chronic-phase traumatic brain injury program has advanced from the consultation stage with the PMDA to the Sakigake Comprehensive Evaluation Consultation phase, and the process of obtaining authorization to file for each of the five parts, clinical, nonclinical, quality, reliability and GCTP, is taking concrete shape. - FY2022-Q2RestatedAnnual report
「In Japan, we are actively consulting with the Pharmaceuticals and Medical Devices Agency (PMDA) under the Sakigake Designation System, with the aim of filing a marketing authorization application at an early stage.」
The policy of pursuing a marketing authorization application for the domestic chronic-phase traumatic brain injury program while continuing consultations with the PMDA has been reconfirmed. - FY2021SoftenedAnnual report
「In Japan, we are actively consulting with the Pharmaceuticals and Medical Devices Agency (PMDA) under the SAKIGAKE designation system, aiming to submit an application for marketing approval.」
Consultations with the PMDA toward domestic approval are continuing, but the specific application timing previously indicated as the fiscal year ending January 2021 is no longer stated, and the wording has reverted to aiming for an “early” application. - FY2021-Q3SoftenedAnnual report
「In Japan, we are actively consulting with the Pharmaceuticals and Medical Devices Agency (PMDA) under the SAKIGAKE designation system, aiming to submit an application for marketing approval during the fiscal year ending January 2021. However, we currently expect that the application is highly likely to be delayed beyond the fiscal year ending January 2021.」
For the domestic chronic-phase traumatic brain injury program, consultations with the PMDA are continuing, but it was indicated that the application for approval, previously planned for the fiscal year ending January 2021, is highly likely to be delayed. - FY2021-Q1RestatedAnnual report
「We are currently consulting with the Pharmaceuticals and Medical Devices Agency (PMDA) and plan to submit an application for marketing approval as a regenerative medical product during the fiscal year ending January 2021 (February 2020 to January 2021).」
For the domestic chronic-phase traumatic brain injury program, consultations with the PMDA are under way, and the plan to submit an application for approval during the fiscal year ending January 2021 has been reconfirmed. - FY2020AdvancedAnnual report
「We are currently conducting face-to-face consultations and preliminary meetings with the PMDA. We plan to complete the SAKIGAKE comprehensive evaluation consultation and submit an application for marketing approval as a regenerative medical product during the fiscal year ending January 2021 (February 2020 to January 2021).」
For the domestic chronic-phase traumatic brain injury program, face-to-face consultations and preliminary meetings with the PMDA are under way, and the plan to submit an application for approval during the fiscal year ending January 2021 after the SAKIGAKE comprehensive evaluation consultation has taken shape. - FY2020-Q3SoftenedAnnual report
「The planned timing of the application for approval was reviewed and changed to the fiscal year ending January 2021 (February 2020 to January 2021) to allow sufficient time to prepare for commercial production and fulfill the responsibility of ensuring a stable post-launch supply.」
The timing of the application for approval for the domestic chronic-phase traumatic brain injury program was changed to the fiscal year ending January 2021 to prioritize preparations for commercial production and a stable supply. - FY2020-Q1AdvancedAnnual report
「In April 2019, the domestic chronic-phase traumatic brain injury program was designated by the Ministry of Health, Labour and Welfare as a product eligible for the SAKIGAKE designation system for regenerative medical products. This designation makes it possible to receive priority consultations and reviews from the Pharmaceuticals and Medical Devices Agency (PMDA) concerning regulatory approval. We aim to use this benefit and Japan's conditional and time-limited approval system for regenerative medical products to submit an application for marketing approval as a regenerative medical product during the fiscal year ending January 2020 (February 2019 to January 2020).」
The domestic chronic-phase traumatic brain injury program was designated as a product eligible for the SAKIGAKE designation system, and the plan advanced to submit an application for approval during the fiscal year ending January 2020 by using priority consultations and reviews. - FY2019RestatedAnnual report
「Accordingly, for the chronic-phase traumatic brain injury program in Japan, we aim to use the conditional and time-limited approval system for regenerative medical products in Japan and submit an application for marketing approval as a regenerative medical product during the fiscal year ending January 2020.」
The plan to use the conditional and time-limited approval system and aim to submit an application for approval during the fiscal year ending January 2020 for the chronic-phase traumatic brain injury program in Japan has been reconfirmed. - FY2019-Q3AdvancedAnnual report
「Accordingly, for the chronic-phase traumatic brain injury program in Japan, we aim to use the conditional and time-limited approval system for regenerative medical products in Japan and submit an application for marketing approval during the fiscal year ending January 2020.」
Following achievement of the primary endpoint in the chronic-phase traumatic brain injury trial, the plan advanced to using Japan's conditional and time-limited approval system and aiming to submit an application for approval during the fiscal year ending January 2020. - FY2019-Q2RestatedAnnual report
「In particular, for the chronic-phase traumatic brain injury program in Japan, we aim to submit an application for marketing approval by using Japan's conditional and time-limited approval system for regenerative medical products. The application is scheduled to be submitted during the fiscal year ending January 2020.」
The plan to use Japan's conditional and time-limited approval system and submit an application for approval during the fiscal year ending January 2020 for the chronic-phase traumatic brain injury program in Japan has been reconfirmed. - 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.」
Enrollment in the US-Japan global trial was completed with 61 subjects, exceeding the planned 52, and a schedule was presented for announcing the results and submitting an application for approval in preparation for using Japan's early approval system. - 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 US-Japan global trial, including Japan, enrollment has continued smoothly since the initial enrollment in Japan in October 2016, a status that has been reconfirmed. - FY2018-Q2RestatedAnnual report
「For 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, enrollment of the first subject began in the US in July 2016 and in Japan in October 2016, respectively, and subjects have continued to be enrolled sequentially since then.」
For the US-Japan global trial, sequential enrollment has continued after the initial enrollment in the US and Japan, a status that has been reconfirmed. - FY2018-Q1RestatedAnnual report
「For 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, enrollment of the first subject began in the US in July 2016 and in Japan in October 2016, respectively, and subjects have continued to be enrolled sequentially since then.」
For the SB623 global trial for traumatic brain injury, planned to enroll a total of 52 subjects in the US and Japan, sequential enrollment has continued after the initial enrollment in the US and Japan, a status that has been reconfirmed. - FY2017RestatedAnnual report
「In Japan, a clinical trial notification for chronic-phase traumatic brain injury was submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) in March 2016. Following the 30-day review period, it became possible to conduct the domestic clinical trial. The traumatic brain injury program is currently being conducted as a global trial in the US and Japan, and the first subject from Japan was enrolled in October 2016.」
The annual report reconfirms that the trial became eligible for implementation in Japan and that the first subject was enrolled in October 2016 in the US-Japan global trial. - FY2017-Q3AdvancedAnnual report
「The chronic-phase traumatic brain injury program is currently being conducted as a global trial in the US and Japan, with a total of 52 subjects, and enrollment of subjects from Japan began in October 2016.」
Specific progress has been reported for the global trial involving a total of 52 subjects in the US and Japan, with enrollment beginning in Japan. - FY2017-Q2RestatedAnnual report
「In Japan, we submitted a clinical trial notification for chronic-phase traumatic brain injury to the Pharmaceuticals and Medical Devices Agency (PMDA) on 7 March 2016. Following the 30-day review period, it became possible to conduct the domestic clinical trial. These chronic-phase traumatic brain injury programs in the US and Japan are currently being conducted as a global trial, and a total of 52 subjects from the US and Japan are scheduled to be enrolled going forward.」
The plan for conducting the trial in Japan and enrolling a total of 52 subjects in the US-Japan global trial has been reconfirmed with the same details as in the previous quarter. - FY2017-Q1First statedAnnual report
「Regarding the notification of the clinical trial for traumatic brain injury in Japan submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) on 7 March 2016, 30 days had elapsed for the review period, making it possible to conduct the clinical trial in Japan. The Phase II clinical trial for traumatic brain injury already under way in the US, involving 52 subjects, will serve as the global trial, and subjects from Japan are scheduled to be enrolled among these 52 subjects going forward.」
After the clinical trial notification was submitted to the PMDA, the trial became eligible for implementation in Japan upon the lapse of 30 days, and a plan was presented to enroll subjects from Japan in the US trial as a global trial.