Long Development Timelines, High Costs and Low Success Rates for New Drugs
First written in FY2016. 8 of 17 entries say "Materialised", first in FY2017-Q2. Latest entry: 2026-09-10.
Seikagaku moved to the "Worse" side of this theme in 2016, 4 years before the typical company in this theme (2020).
The whole theme swung hardest in 2022: 20 of 40 companies on the "Worse" side.
22 other companies' latest entry also says "Materialised".
- 2026-09-10MaterialisedOccurring Fact
「No concerns were expressed regarding the clinical trial results, including the efficacy and safety of the product, and no additional clinical trials were requested.」
The risk associated with uncertainty in new drug development materialized in the form of a CRL for SI-6603's U.S. approval application. The reasons this time concerned deficiencies identified in inspections of manufacturing facilities and other sites, not the clinical trials. - FY2025MaterialisedAnnual report
「In March 2025, the company received a notice from the U.S. Food and Drug Administration (FDA) that its review had been completed, but approval was not obtained.」
The risk related to uncertainty and success rates in new drug development materialized when FDA approval for SI-6603 was not obtained. - FY2024-Q2MaterialisedAnnual report
「In the primary endpoint of the Phase III clinical trial conducted from May 2022, no statistically significant improvement was observed.」
In connection with the risk of low success rates and development uncertainty in new drug development, the risk materialized when the Phase III clinical trial of SI-614 failed to demonstrate a significant improvement in the primary endpoint. - FY2023-Q1MitigatedAnnual report
「Operating profit fell 74.7% to ¥1,126 million. R&D expenses declined following completion of subject enrollment in the additional US clinical trial of SI-6603, a treatment for lumbar disc herniation, but the impact of lower revenue more than offset the reduction.」
R&D expenses declined following completion of subject enrollment in the additional US trial of SI-6603, reducing part of the cost burden associated with new-drug development. - FY2022MitigatedAnnual report
「In March 2022, subject enrollment was completed for an additional trial in the Phase III clinical program. The plan is to conduct data analysis and prepare an approval application after a 1-year follow-up period.」
Regarding the delay risk in the additional US trial of SI-6603, subject enrollment was completed and the trial progressed to the follow-up stage. However, the disclosure does not state that the risk had been eliminated, as the trial was still before the filing for approval. - FY2022-Q2MaterialisedAnnual report
「Operating profit rose 665.0% to ¥6,038 million. Although SG&A expenses, including R&D expenses, increased as the additional US clinical trial of SI-6603, a treatment for lumbar disc herniation, progressed, the benefit of higher revenue more than offset the increase.」
Higher R&D expenses and other costs associated with the progress of the additional SI-6603 clinical trial are reflected in SG&A expenses. - FY2021RestatedAnnual report
「Follow-up for the additional Phase III clinical trial was scheduled for completion in November 2022, but the trial schedule has been delayed as the spread of COVID-19 led to more trial interruptions at some medical institutions and more subjects refraining from visiting trial sites.」
As a risk related to the long development timeline, high cost, and low probability of success for new drugs, the disclosure continues to cite delays in the additional US trial of SI-6603 and measures to promote subject enrollment. - FY2021-Q3RestatedAnnual report
「An additional Phase III clinical trial in the US began in February 2018, with follow-up scheduled for completion in November 2022. However, the spread of COVID-19 in the US caused more trial interruptions at some medical institutions and more subjects to refrain from visiting trial sites, resulting in delays to the trial schedule. As of the end of December 2020, with trial-site operations showing signs of recovery, measures including advertising to facilitate subject enrollment and the early launch of new sites in coordination with local clinical research organizations were being implemented to promote steady enrollment and minimize delays.」
Although delays in the additional US trial of SI-6603 continued, measures including the recovery of trial-site operations, advertising, and the early launch of new sites were being taken to promote subject enrollment and minimize delays. - FY2021-Q2MitigatedAnnual 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.」
Although delays due to COVID-19 continued in the additional US trial of SI-6603, the recovery of trial-site operations, advertising, and the launch of new sites were proving effective, and the trial was progressing steadily. The disclosure does not state that the risk itself had been eliminated. - FY2021-Q1WorsenedAnnual report
「An additional Phase III clinical trial in the US began in February 2018, with follow-up scheduled for completion in November 2022. However, the spread of COVID-19 in the US led to more trial interruptions at some medical institutions and more subjects refraining from visiting trial sites, and as of the end of June 2020, a delay of approximately 6 months was expected.」
The additional US trial of SI-6603 was expected to be delayed by approximately 6 months relative to the planned completion in November 2022 due to trial interruptions and missed visits by subjects associated with the spread of COVID-19. - FY2020WorsenedAnnual report
「In addition, the spread of COVID-19 in the U.S. has led to an increase in trial suspensions at some medical institutions and in subjects not attending visits, causing delays in the trial's progress.」
Regarding the risk of prolonged new-drug development, the additional SI-6603 trial experienced interruptions and missed visits by subjects due to COVID-19, in addition to the existing schedule delays. - FY2020-Q2WorsenedAnnual report
「Progress has been slower than expected because the eligibility criteria for subjects were made stricter to improve the likelihood of success and it has taken time to bring clinical trial sites online. Accordingly, the original trial plan was reviewed and the completion date was extended by 2 years, with follow-up scheduled to end in November 2022.」
The risk of prolonged new-drug development materialized in the form of delayed progress in the additional US trial of SI-6603 and a 2-year extension of its completion date. - FY2018-Q2MaterialisedAnnual report
「Although pharmacological effects were observed in the Phase III clinical trial of SI-6603 conducted in the US, no statistically significant improvement was observed in the primary endpoint of reduced leg pain 13 weeks after administration.」
In relation to the probability of success and risk of prolonged new-drug development, the US Phase III clinical trial of SI-6603 in fact failed to demonstrate a statistically significant improvement in its primary endpoint. - FY2017MaterialisedAnnual report
「For SI-6603 in Japan, for which we filed an application for marketing approval with the Ministry of Health, Labour and Welfare in January 2014, the review of quality control in the manufacturing process is continuing. We will continue working toward early approval.」
Quality-control review for domestic SI-6603 remains ongoing, and the prolonged approval process continues. The risk section also states that development takes 9 to 17 years and has an approximately 1-in-30,000 success rate. - FY2017-Q3MaterialisedAnnual report
「Operating profit fell 67.9% to ¥881 million, due mainly to higher R&D expenses as the US open-label trial of SI-6603, a treatment for lumbar disc herniation, progressed, in addition to a higher cost ratio resulting from drug-price reductions and the stronger yen.」
Higher R&D expenses associated with the progress of the US open-label trial of SI-6603 continue to appear in the results as a factor behind the decline in operating profit. - FY2017-Q2MaterialisedAnnual report
「Regulatory review related to quality control is taking longer than expected, making approval during the current fiscal year difficult.」
The domestic approval review for SI-6603 has taken longer than expected, demonstrating the risk of prolonged new-drug development through a delay in the timing of approval. - FY2016First statedAnnual report
「It takes 9 to 17 years from basic research to approval, and the probability of obtaining approval from the Ministry of Health, Labour and Welfare for a new drug from the creation of a novel compound is said to be approximately 1 in 30,000.」
The risk disclosure states that substantial R&D expenses may be incurred over an extended period without a product reaching the market, and that R&D expenses may fluctuate as development progresses.