Domestic approval application and overseas approval and sales launch for NS-304
First written in FY2016. 17 of 32 entries say "Restated". Latest entry: FY2026.
10 other companies' latest entry also says "Advanced".
- FY2026AdvancedAnnual report
「・A Phase 3 trial for NS-304 (generic name: selexipag) in arteriosclerosis obliterans was initiated in April 2026.」
For NS-304, development for arteriosclerosis obliterans progressed from the late Phase 2 trial stage to the initiation of a Phase 3 trial. - 2026-05-15AdvancedRevision to earnings forecast
「・A Phase 3 trial for NS-304 (generic name: selexipag) in arteriosclerosis obliterans was initiated in April 2026.」
NS-304について、閉塞性動脈硬化症向け開発が第三相試験の開始段階へ進んだ。 - FY2025AdvancedAnnual report
「For NS-304 (generic name: selexipag), approval was obtained in December 2024 for pediatric pulmonary arterial hypertension, and a pediatric formulation was launched in March 2025. A late Phase 2 trial for arteriosclerosis obliterans has also been under way since February 2022.」
The program for pediatric pulmonary arterial hypertension progressed to approval in December 2024 and the launch of a pediatric formulation in March 2025. - FY2025-H1RestatedAnnual report
「・For NS-304 (generic name: selexipag), a Phase 2 trial in pediatric patients with pulmonary arterial hypertension has been under way since November 2020, and an application for approval was filed in April 2024. A late Phase 2 trial for arteriosclerosis obliterans has also been under way since February 2022.」
This restates the status of the approval application filed for NS-304 in pediatric pulmonary arterial hypertension and the late Phase 2 trial for arteriosclerosis obliterans. - FY2024AdvancedAnnual report
「For NS-304 (generic name: selexipag), a Phase 2 trial for pediatric pulmonary arterial hypertension was conducted from November 2020, and an approval application was submitted in April 2024. A late Phase 2 trial for arteriosclerosis obliterans has also been under way since February 2022.」
For NS-304, the Phase 2 trial for pediatric pulmonary arterial hypertension progressed to the approval application stage in April 2024. The late Phase 2 trial for arteriosclerosis obliterans has continued. - FY2024-Q3RestatedAnnual report
「For NS-304 (generic name: selexipag), a Phase 2 trial for pediatric pulmonary arterial hypertension has been under way jointly with Janssen Pharmaceutical K.K. since November 2020. A late Phase 2 trial for arteriosclerosis obliterans has also been under way since February 2022.」
For NS-304, the Phase 2 trial for pediatric pulmonary arterial hypertension and the late Phase 2 trial for arteriosclerosis obliterans have continued. - FY2024-Q2RestatedAnnual report
「For NS-304 (generic name: selexipag), a Phase 2 trial for pediatric pulmonary arterial hypertension has been under way jointly with Janssen Pharmaceutical K.K. since November 2020. A late Phase 2 trial for arteriosclerosis obliterans has also been under way since February 2022.」
The Phase 2 trial for the pediatric indication of NS-304 and the late Phase 2 trial for arteriosclerosis obliterans have continued. - FY2024-Q1RestatedAnnual report
「For NS-304 (generic name: selexipag), a Phase 2 trial for pediatric pulmonary arterial hypertension has been under way jointly with Janssen Pharmaceutical K.K. since November 2020. A late Phase 2 trial for arteriosclerosis obliterans has also been under way since February 2022.」
The Phase 2 trial for the pediatric indication of NS-304 and the late Phase 2 trial for arteriosclerosis obliterans have continued. - FY2023RestatedAnnual report
「For NS-304 (generic name: selexipag), a Phase 2 trial for pediatric pulmonary arterial hypertension has been under way jointly with Janssen Pharmaceutical K.K. since November 2020. A late Phase 2 trial for arteriosclerosis obliterans has also been under way since February 2022.」
The Phase 2 trial for the pediatric indication of NS-304 and the late Phase 2 trial for arteriosclerosis obliterans have continued. - FY2023-Q2RestatedAnnual report
「For NS-304 (generic name: selexipag), a Phase 2 trial for pediatric pulmonary arterial hypertension has been under way jointly with Janssen Pharmaceutical K.K. since November 2020. A late Phase 2 trial for arteriosclerosis obliterans has also been under way since February 2022.」
For NS-304, the Phase 2 trial for the pediatric indication and the late Phase 2 trial for arteriosclerosis obliterans have continued. - FY2023-Q1AdvancedAnnual report
「For NS-304 (generic name: selexipag), a Phase 2 trial for pediatric pulmonary arterial hypertension has been under way jointly with Janssen Pharmaceutical K.K. since November 2020. A late Phase 2 trial for arteriosclerosis obliterans has also been under way since February 2022.」
For NS-304, the next confirmatory trial for arteriosclerosis obliterans progressed from the preparation stage to the late Phase 2 trial stage in February 2022. The Phase 2 trial for the pediatric indication has also continued. - FY2022-Q3RestatedAnnual report
「For NS-304 (generic name: selexipag), a Phase 2 trial for pediatric pulmonary arterial hypertension has been under way jointly with Janssen Pharmaceutical K.K. since November 2020. The late Phase 2 trial for arteriosclerosis obliterans has also been completed, and preparations are under way for another confirmatory trial.」
The company is reiterating the status of the Phase 2 trial for the pediatric indication of NS-304 and preparations for the next confirmatory trial for arteriosclerosis obliterans. - FY2022-Q2AdvancedAnnual report
「For NS-304 (generic name: selexipag), a Phase 3 trial for chronic thromboembolic pulmonary hypertension was conducted jointly with Janssen Pharmaceutical K.K., and approval for the addition of chronic thromboembolic pulmonary hypertension as an indication was obtained in August 2021. A Phase 2 trial for pediatric pulmonary arterial hypertension has been under way jointly with Janssen Pharmaceutical K.K. since November 2020. The late Phase 2 trial for arteriosclerosis obliterans has been completed, and preparations are under way for another confirmatory trial. Nippon Shinyaku is conducting a standalone early Phase 2 trial for lumbar spinal canal stenosis.」
For NS-304, approval for the additional indication of chronic thromboembolic pulmonary hypertension was obtained in August 2021. The Phase 2 trial for the pediatric indication, preparations for the next confirmatory trial for arteriosclerosis obliterans, and the early Phase 2 trial for lumbar spinal canal stenosis have also continued. - FY2022-Q1RestatedAnnual report
「For NS-304 (generic name: selexipag), a Phase 3 trial for chronic thromboembolic pulmonary hypertension was conducted jointly with Janssen Pharmaceutical K.K., and an approval application was submitted in November 2020. The indication received orphan-drug designation from the Ministry of Health, Labour and Welfare in 2016. A Phase 2 trial for pediatric pulmonary arterial hypertension has been under way jointly with Janssen Pharmaceutical K.K. since November 2020. The late Phase 2 trial for arteriosclerosis obliterans has been completed, and preparations are under way for another confirmatory trial. Nippon Shinyaku is conducting a standalone early Phase 2 trial for lumbar spinal canal stenosis.」
The company is reiterating the previous status of NS-304: the Phase 3 trial for which an approval application has been submitted, the Phase 2 trial for the pediatric indication, preparations for the next confirmatory trial for arteriosclerosis obliterans, and the early Phase 2 trial for lumbar spinal canal stenosis. - FY2021AdvancedAnnual report
「For NS-304 (generic name: selexipag), a Phase 3 trial for chronic thromboembolic pulmonary hypertension was conducted jointly with Janssen Pharmaceutical K.K., and an approval application was submitted in November 2020. The indication received orphan-drug designation from the Ministry of Health, Labour and Welfare in 2016. A Phase 2 trial for pediatric pulmonary arterial hypertension has been under way jointly with Janssen Pharmaceutical K.K. since November 2020. The late Phase 2 trial for arteriosclerosis obliterans has been completed, and preparations are under way for another confirmatory trial. Nippon Shinyaku is conducting the trial independently. In addition, Nippon Shinyaku is conducting a standalone early Phase 2 trial for lumbar spinal canal stenosis.」
For NS-304, in addition to the approval application for chronic thromboembolic pulmonary hypertension, the company describes completion of the late Phase 2 trial for arteriosclerosis obliterans and progress to the preparation stage for the next confirmatory trial. - FY2021-Q3AdvancedAnnual report
「For NS-304 (generic name: selexipag), a Phase 3 trial for chronic thromboembolic pulmonary hypertension was conducted jointly with Janssen Pharmaceutical K.K., and an approval application was submitted in November 2020. The indication received orphan-drug designation from the Ministry of Health, Labour and Welfare in 2016. A Phase 2 trial for pediatric pulmonary arterial hypertension was begun jointly with Janssen Pharmaceutical K.K. in November 2020. Nippon Shinyaku is also conducting standalone late Phase 2 and early Phase 2 trials for arteriosclerosis obliterans and lumbar spinal canal stenosis, respectively.」
For NS-304, an approval application for the Phase 3 trial for chronic thromboembolic pulmonary hypertension was submitted in November 2020, and a Phase 2 trial for pediatric pulmonary arterial hypertension was also initiated. - FY2021-Q2AdvancedAnnual report
「For NS-304 (generic name: selexipag), a Phase 3 trial for chronic thromboembolic pulmonary hypertension is being conducted jointly with Janssen Pharmaceutical K.K., and preparations are under way for an approval application. The indication received orphan-drug designation from the Ministry of Health, Labour and Welfare in 2016. Nippon Shinyaku is also conducting standalone late Phase 2 and early Phase 2 trials for arteriosclerosis obliterans and lumbar spinal canal stenosis, respectively.」
For NS-304, the Phase 3 trial for chronic thromboembolic pulmonary hypertension progressed to the approval application preparation stage. Trials for the other 2 indications have also continued. - FY2021-Q1RestatedAnnual report
「For NS-304 (generic name: selexipag), a Phase 3 trial for chronic thromboembolic pulmonary hypertension is under way jointly with Janssen Pharmaceutical K.K. The indication received orphan-drug designation from the Ministry of Health, Labour and Welfare in 2016. Nippon Shinyaku is also conducting a standalone late Phase 2 trial for arteriosclerosis obliterans and a standalone early Phase 2 trial for lumbar spinal canal stenosis.」
The Phase 3 trial for NS-304 for chronic thromboembolic pulmonary hypertension, the late Phase 2 trial for arteriosclerosis obliterans, and the early Phase 2 trial for lumbar spinal canal stenosis have continued. The joint development partner is identified as Janssen Pharmaceutical K.K. - FY2020-Q3RestatedAnnual report
「For NS-304 (generic name: selexipag), a Phase 3 trial for chronic thromboembolic pulmonary hypertension is under way jointly with Actelion Pharmaceuticals Japan Co., Ltd. The indication received orphan-drug designation from the Ministry of Health, Labour and Welfare in June 2016. Nippon Shinyaku is also conducting a standalone late Phase 2 trial for arteriosclerosis obliterans and a standalone early Phase 2 trial for lumbar spinal canal stenosis, which began in February 2018.」
For NS-304, the Phase 3 trial for chronic thromboembolic pulmonary hypertension, the late Phase 2 trial for arteriosclerosis obliterans, and the early Phase 2 trial for lumbar spinal canal stenosis have continued. - FY2020-Q2RestatedAnnual report
「For NS-304 (generic name: selexipag), a Phase 3 trial for chronic thromboembolic pulmonary hypertension is under way jointly with Actelion Pharmaceuticals Japan Co., Ltd. The indication received orphan-drug designation from the Ministry of Health, Labour and Welfare in June 2016. Nippon Shinyaku is also conducting a standalone late Phase 2 trial for arteriosclerosis obliterans and a standalone early Phase 2 trial for lumbar spinal canal stenosis, which began in February of the previous year.」
For NS-304, the Phase 3 trial for chronic thromboembolic pulmonary hypertension, the late Phase 2 trial for arteriosclerosis obliterans, and the early Phase 2 trial for lumbar spinal canal stenosis have continued. - FY2020-Q1RestatedAnnual report
「For NS-304, Johnson & Johnson, the licensee, began a Phase 3 trial for chronic thromboembolic pulmonary hypertension in March of that year.」
The company is reiterating the status of the Phase 3 trial for chronic thromboembolic pulmonary hypertension initiated by the licensee for NS-304. - FY2019AdvancedAnnual report
「For NS-304, Johnson & Johnson, the licensee, began a Phase 3 trial for chronic thromboembolic pulmonary hypertension in March of that year.」
For NS-304, the licensee began a Phase 3 trial for chronic thromboembolic pulmonary hypertension in March 2019. - FY2019-Q3RestatedAnnual report
「For NS-304 (generic name: selexipag), a Phase 3 trial for chronic thromboembolic pulmonary hypertension is under way jointly with Actelion Pharmaceuticals Japan Co., Ltd. The indication received orphan-drug designation from the Ministry of Health, Labour and Welfare in June 2016. Nippon Shinyaku is also conducting a standalone late Phase 2 trial for arteriosclerosis obliterans. In addition, Nippon Shinyaku began a standalone early Phase 2 trial for lumbar spinal canal stenosis in February of the previous year.」
For NS-304, the Phase 3 trial for chronic thromboembolic pulmonary hypertension, the late Phase 2 trial for arteriosclerosis obliterans, and the early Phase 2 trial for lumbar spinal canal stenosis have continued as before. - FY2019-Q2RestatedAnnual report
「For NS-304 (generic name: selexipag), a Phase 3 trial for chronic thromboembolic pulmonary hypertension is under way jointly with Actelion Pharmaceuticals Japan Co., Ltd. The indication received orphan-drug designation from the Ministry of Health, Labour and Welfare in June 2016. Nippon Shinyaku is also conducting a standalone late Phase 2 trial for arteriosclerosis obliterans. In addition, Nippon Shinyaku began a standalone early Phase 2 trial for lumbar spinal canal stenosis in February of that year.」
For NS-304, the Phase 3 trial for chronic thromboembolic pulmonary hypertension, the late Phase 2 trial for arteriosclerosis obliterans, and the early Phase 2 trial for lumbar spinal canal stenosis have continued as before. - FY2019-Q1AdvancedAnnual report
「For NS-304 (generic name: selexipag), a Phase 3 trial for chronic thromboembolic pulmonary hypertension is under way jointly with Actelion Pharmaceuticals Japan Co., Ltd. The indication received orphan-drug designation from the Ministry of Health, Labour and Welfare in June 2016. Nippon Shinyaku is also conducting a standalone late Phase 2 trial for arteriosclerosis obliterans. In addition, Nippon Shinyaku began a standalone early Phase 2 trial for lumbar spinal canal stenosis in February of that year.」
For NS-304, in addition to the existing Phase 3 trial for chronic thromboembolic pulmonary hypertension and late Phase 2 trial for arteriosclerosis obliterans, an early Phase 2 trial for lumbar spinal canal stenosis was initiated in February of that year. - FY2018-Q3RestatedAnnual report
「For NS-304 (generic name: selexipag), a Phase 3 trial for chronic thromboembolic pulmonary hypertension is under way jointly with Actelion Pharmaceuticals Japan Co., Ltd. The indication received orphan-drug designation from the Ministry of Health, Labour and Welfare in June 2016. Nippon Shinyaku is also conducting a standalone late Phase 2 trial for arteriosclerosis obliterans.」
For NS-304, the Phase 3 trial for chronic thromboembolic pulmonary hypertension and the late Phase 2 trial for arteriosclerosis obliterans have continued. - FY2018-Q2RestatedAnnual report
「For NS-304 (generic name: selexipag), a Phase 3 trial for chronic thromboembolic pulmonary hypertension is under way jointly with Actelion Pharmaceuticals Japan Co., Ltd. The indication received orphan-drug designation from the Ministry of Health, Labour and Welfare in June 2016. Nippon Shinyaku is also conducting a standalone late Phase 2 trial for arteriosclerosis obliterans.」
For NS-304, the Phase 3 trial for chronic thromboembolic pulmonary hypertension and the late Phase 2 trial for arteriosclerosis obliterans have continued. - FY2018-Q1RestatedAnnual report
「For NS-304 (generic name: selexipag), a Phase 3 trial for chronic thromboembolic pulmonary hypertension is under way jointly with Actelion Pharmaceuticals Japan Co., Ltd. The indication received orphan-drug designation from the Ministry of Health, Labour and Welfare in June 2016. Nippon Shinyaku is also conducting a standalone late Phase 2 trial for arteriosclerosis obliterans.」
For NS-304, the Phase 3 trial for chronic thromboembolic pulmonary hypertension and the late Phase 2 trial for arteriosclerosis obliterans have continued. - FY2017-Q3AdvancedAnnual report
「In addition, we began domestic sales in November 2016 of Uptravi tablets, our internally discovered treatment for pulmonary arterial hypertension (generic name: selexipag), which was jointly developed with Actelion Pharmaceuticals Japan Co., Ltd.」
The company progressed from domestic approval and launch preparations to beginning domestic sales of Uptravi tablets in November 2016. - FY2017-Q2AdvancedAnnual report
「For NS-304, a treatment for pulmonary hypertension (generic name: selexipag), a marketing authorization application for pulmonary arterial hypertension was submitted in January 2016, approval was obtained in September, and preparations are currently under way for its launch under the product name Uptravi tablets. In addition, a Phase 3 trial for chronic thromboembolic pulmonary hypertension was begun jointly with Actelion Pharmaceuticals Japan Co., Ltd. in June 2016. The indication received orphan-drug designation in June of that year. Nippon Shinyaku began a standalone late Phase 2 trial for arteriosclerosis obliterans in August 2016.」
NS-304 progressed from the domestic approval application stage to approval in September and preparations for launch, while Phase 3 and late Phase 2 trials for additional indications have also begun. - FY2017-Q1AdvancedAnnual report
「In addition, we began a Phase 3 trial in June 2016 with the company for chronic thromboembolic pulmonary hypertension. The indication received orphan-drug designation on 20 June of that year. Nippon Shinyaku began a standalone late Phase 2 trial for arteriosclerosis obliterans in August 2016.」
For NS-304, a Phase 3 trial for chronic thromboembolic pulmonary hypertension was initiated and orphan-drug designation was obtained for the indication. In addition, a late Phase 2 trial for arteriosclerosis obliterans was scheduled to begin in August 2016. - FY2016First statedAnnual report
「For NS-304, a treatment for pulmonary hypertension (generic name: selexipag), the efficacy assessment period of the Phase 2 trial for pulmonary arterial hypertension conducted jointly with Actelion Pharmaceuticals Japan Co., Ltd. was completed, and a marketing authorization application was submitted in January 2016.」
The company states that the product progressed to the approval application stage in Japan, received marketing approval in the United States in December 2015 and launched sales there in January 2016, and received a positive opinion in Europe in January 2016.