Preparing to Repeat the U.S. Phase III Clinical Trial of SI-6603
First written in FY2018-Q2. 6 of 17 entries say "Advanced", first in FY2019. Latest entry: 2026-09-10.
No other company in this theme has enough history to compare yet.
- 2026-09-10WorsenedOccurring Fact
「We will continue to work closely with the FDA and Ferring Pharmaceuticals, with which we have entered into a license agreement, and consider an early resubmission toward obtaining approval.」
Following resubmission, the review process resulted in receipt of a CRL. The company has moved to the stage of considering an early resubmission after addressing manufacturing issues, rather than obtaining approval. - FY2026AdvancedAnnual report
「We subsequently completed our response to the FDA's additional observations and resubmitted the application to the FDA in March 2026.」
The response to the marketing application following the SI-6603 additional Phase III trial in the United States progressed to completion of the FDA's additional requirements and resubmission in March 2026. - 2026-05-21AdvancedGeneral Meetings of Shareholders
「We resubmitted the application to the FDA in March 2026.」
SI-6603 progressed to resubmission after the company completed its response to the issues raised by the FDA. Approval has not yet been obtained. - FY2025ReframedAnnual report
「The FDA did not express concerns related to the clinical trial results, including the efficacy and safety of the product, and did not require any additional clinical trials. However, it raised additional issues mainly concerning the manufacturing facilities and the control of the active pharmaceutical ingredient and finished product. Going forward, we will address these issues toward early approval and aim to resubmit within one year of receiving this notice.」
SI-6603 moved to the stage of addressing issues concerning the manufacturing facilities and control of the active pharmaceutical ingredient and finished product and preparing for resubmission, rather than conducting additional clinical trials. - FY2025-H1AchievedAnnual report
「In March 2024, we filed a Biologics License Application (BLA) for SI-6603, and in May of the same year the BLA was accepted by the U.S. Food and Drug Administration (FDA). We are currently responding to the review toward approval.」
Preparation for the marketing application following the rerun of the Phase III clinical trial in the United States culminated in the submission of a BLA in March 2024 and its acceptance by the FDA in May of the same year. The application is currently under review. - FY2024-Q3RestatedAnnual report
「Follow-up in the additional Phase III clinical trial was completed in March 2023, and in May of the same year we obtained topline results showing a statistically significant improvement in the primary endpoint. We are currently preparing for an early filing for approval.」
For the SI-6603 additional Phase III trial in the United States, preparation for an early marketing application has continued following receipt of the topline results. No new completion of a marketing application has been reported. - FY2024-Q1AdvancedAnnual report
「Follow-up in the additional Phase III clinical trial was completed in March 2023, and in May of the same year we obtained topline results showing a statistically significant improvement in the primary endpoint. We will now prepare for an early filing for approval.」
Following completion of follow-up in the SI-6603 additional Phase III trial in the United States, the company obtained topline results showing a statistically significant improvement in the primary endpoint and progressed to the preparation stage for an early marketing application. - FY2023-Q3RestatedAnnual report
「To obtain approval and launch SI-6603, a treatment for lumbar disc herniation, in the United States, we will make full use of Seikagaku North America Corporation, established in Canada, to file the marketing application promptly and reliably and respond to the review process. We will also prepare for sales in close cooperation with our sales partner, seeking to maximize the product's value through its early adoption in clinical practice.」
For SI-6603's approval and launch in the United States, the medium-term management plan specified concrete execution measures, including use of the Canadian subsidiary, the marketing application and review-process responses, and sales preparation with the sales partner. Approval itself had not yet been achieved. - FY2022AdvancedAnnual report
「Although the trial schedule had been delayed by the spread of COVID-19, patient enrollment in the additional Phase III clinical trial was completed in March 2022. Following a 1-year follow-up period, we plan to analyze the results and prepare the approval application.」
The SI-6603 additional Phase III trial in the United States completed subject enrollment despite delays and the impact of infectious disease, and moved to follow-up and preparation for the marketing application. - FY2021RestatedAnnual report
「We will continue implementing measures to reduce the risk of COVID-19 infection and other measures, while seeking to minimize delays.」
For the SI-6603 additional trial in the United States, the company continues its policy of seeking to minimize ongoing delays through measures to reduce infection risk and promote subject enrollment. - FY2021-Q3RestatedAnnual report
「As of the end of December 2020, with trial-site operations showing signs of recovery, we implemented measures including effective advertising to promote subject enrollment and the early launch of new sites in cooperation with local contract research organizations, seeking to steadily promote enrollment and minimize delays. We will continue conducting the trial while implementing measures to reduce the risk of COVID-19 infection and other measures.」
In the SI-6603 additional trial in the United States, advertising activities, the early launch of new trial sites and measures to reduce infection risk are continuing amid ongoing delays. - FY2021-Q2AdvancedAnnual report
「As of the end of September 2020, the trial was progressing steadily. Trial-site operations were recovering, and measures such as advertising to facilitate subject enrollment and the early launch of new sites in coordination with local clinical research organizations were proving effective.」
The SI-6603 additional Phase III trial in the United States progressed steadily despite delays, supported by the recovery of trial-site operations, advertising activities and the early launch of new sites. - FY2021-Q1SoftenedAnnual report
「We began an additional Phase III clinical trial in the United States in February 2018 and had been proceeding with a plan to complete follow-up in November 2022. However, the spread of COVID-19 in the United States led to an increase in trial suspensions at some medical institutions and in subjects postponing visits, and as of the end of June 2020, we expected a delay of approximately 6 months. While giving top priority to conditions at medical sites and preventing infection among patients and healthcare professionals, we are steadily implementing measures such as effective advertising to promote subject enrollment and the early launch of new sites in cooperation with local contract research organizations.」
Although the SI-6603 additional trial in the United States is expected to be delayed by approximately 6 months, the company is conducting advertising activities to promote subject enrollment and working to launch new trial sites promptly. - FY2020SoftenedAnnual report
「In addition, the spread of COVID-19 in the United States has led to an increase in trial suspensions at some medical institutions and in subjects postponing visits, resulting in delays to the trial's progress. We are currently collecting and reviewing local information and, once the situation has subsided, plan to focus on subject enrollment while reconsidering the trial plan.」
The SI-6603 additional trial in the United States was extended by two years in November 2019, moving the expected completion date to November 2022, and was subsequently delayed further by COVID-19. - FY2020-Q3RestatedAnnual report
「For SI-6603, a treatment for lumbar disc herniation, we will focus on accelerating the additional Phase III clinical trial and make every effort toward its launch in the United States.」
The medium-term management plan continues to target acceleration of the SI-6603 additional trial in the United States and its launch there. - FY2019AdvancedAnnual report
「We began an additional Phase III clinical trial in February 2018. We are currently focusing on various measures to improve the probability of success of the additional trial.」
For the SI-6603 Phase III trial in the United States, the company progressed from examining and preparing for a rerun to conducting an additional trial, enrolling subjects and implementing measures to improve the probability of success. - FY2018-Q2First statedAnnual report
「Going forward, we will continue discussions with the U.S. Food and Drug Administration (FDA) and Ferring Pharmaceuticals, our license partner, while examining and preparing for an early rerun of the Phase III clinical trial in the United States.」
Following the failure to observe a statistically significant improvement in the primary endpoint of the Phase III clinical trial in the United States, the company has for the first time described measures to examine and prepare for an early rerun of the trial while consulting with the FDA and its license partner.