SAKIGAKE designation and initiation of clinical trials for NS-065
First written in FY2016. 18 of 29 entries say "Restated". Latest entry: 2026-11-13.
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- 2026-11-13AchievedRevision to earnings forecast
「ＮＳ－０６５／ＮＣＮＰ－０１：グローバル第Ⅲ相継続試験（302試験）が終了し、追加グローバル第Ⅲ相試験（303試験）を検討中である。」
グローバル第Ⅲ相継続試験が終了し、治験総括報告書をFDAに提出した一方、追加試験は検討段階となった。 - FY2026RestatedAnnual report
「The Duchenne muscular dystrophy treatment NS-065/NCNP-01 (brand name: Viltepso® intravenous infusion 250 mg, generic name: viltolarsen) was approved in Japan in March 2020 and launched in May, while in the United States it was approved in August 2020 and launched the same month. A global Phase 3 continuation trial is currently under way.」
This restates the status of Viltepso's approval and launch in Japan and the United States and the global Phase 3 continuation trial. - FY2025-H1RestatedAnnual report
「・The Duchenne muscular dystrophy treatment NS-065/NCNP-01 (brand name: Viltepso® intravenous infusion 250 mg, generic name: viltolarsen) was approved in Japan in March 2020 and launched in May. A global Phase 3 continuation trial is currently under way.」
This restates the ongoing global Phase 3 continuation trial following Viltepso's approval and launch in Japan. - FY2024-Q3RestatedAnnual report
「・The Duchenne muscular dystrophy treatment NS-065/NCNP-01 (brand name: Viltepso® intravenous infusion 250 mg, generic name: viltolarsen) was approved in Japan in March 2020 and launched in May. A global Phase 3 trial is currently under way.」
This restates the continuation of the global Phase 3 trial following Viltepso's approval and launch in Japan. - FY2024-Q2RestatedAnnual report
「・The Duchenne muscular dystrophy treatment NS-065/NCNP-01 (brand name: Viltepso® intravenous infusion 250 mg, generic name: viltolarsen) was approved in Japan in March 2020 and launched in May. A global Phase 3 trial is currently under way.」
This restates the continuation of the global Phase 3 trial following Viltepso's approval and launch in Japan. - FY2024-Q1RestatedAnnual report
「・The Duchenne muscular dystrophy treatment NS-065/NCNP-01 (brand name: Viltepso® intravenous infusion 250 mg, generic name: viltolarsen) was approved in Japan in March 2020 and launched in May. A global Phase 3 trial is currently under way.」
This restates the continuation of the global Phase 3 trial following Viltepso's approval and launch in Japan. - FY2023RestatedAnnual report
「・The Duchenne muscular dystrophy treatment NS-065/NCNP-01 (brand name: Viltepso® intravenous infusion 250 mg, generic name: viltolarsen) was approved in Japan in March 2020 and launched in May. A global Phase 3 trial is currently under way.」
This restates the continuation of the global Phase 3 trial following Viltepso's approval and launch in Japan. - FY2023-Q2RestatedAnnual report
「・The Duchenne muscular dystrophy treatment NS-065/NCNP-01 (brand name: Viltepso® intravenous infusion 250 mg, generic name: viltolarsen) was approved in Japan in March 2020 and launched in May. A global Phase 3 trial is currently under way.」
This restates the continuation of the global Phase 3 trial following Viltepso's approval and launch in Japan. - FY2022-Q3RestatedAnnual report
「For NS-065／NCNP-01 (generic name: viltolarsen), approval was obtained and sales began in the United States in August 2020. In Europe, the product received orphan drug designation from the EMA in June 2020. An application for approval was filed in China in June 2021. A global Phase 3 trial is currently under way.」
This restates the status of viltolarsen's U.S. sales, European designation, application for approval in China and global Phase 3 trial. - FY2022-Q2RestatedAnnual report
「• For NS-065／NCNP-01 (generic name: viltolarsen), approval was obtained and sales began in the United States in August 2020. In Europe, the product received orphan drug designation from the EMA in June 2020. An application for approval was filed in China in June 2021. A global Phase 3 trial is currently under way.」
This restates the status of viltolarsen's U.S. sales, European orphan drug designation, application for approval in China and global Phase 3 trial. - FY2022-Q1AdvancedAnnual report
「For NS-065／NCNP-01 (generic name: viltolarsen), approval was obtained and sales began in the United States in August 2020. In Europe, the product received orphan drug designation from the EMA in June 2020. An application for approval was filed in China in June 2021. A global Phase 3 trial is currently under way.」
This describes the application for approval in China as a new overseas development milestone for viltolarsen. - FY2021RestatedAnnual report
「For NS-065／NCNP-01 (generic name: viltolarsen), approval was obtained and sales began in the United States in August 2020. In Europe, the product received orphan drug designation from the EMA in June 2020. A global Phase 3 trial is currently under way.」
This restates the status of U.S. approval and launch, the European designation and the global Phase 3 trial. - FY2021-Q3RestatedAnnual report
「For NS-065／NCNP-01 (generic name: viltolarsen), approval was obtained and sales began in the United States in August 2020. In Europe, the product received orphan drug designation from the EMA in June 2020. A global Phase 3 trial is currently under way.」
Global Phase 3 trials of viltolarsen remain under way following its approval and launch in the United States. - FY2021-Q2AdvancedAnnual report
「• For NS-065／NCNP-01 (generic name: viltolarsen), approval was obtained and sales began in the United States in August 2020. In Europe, the product received orphan drug designation from the EMA in June 2020. A global Phase 3 trial is currently under way.」
NS-065/NCNP-01 progressed to launch in the United States after approval of the rolling application for approval. The European orphan drug designation and global Phase 3 trial are also continuing. - FY2021-Q1AdvancedAnnual report
「・The Duchenne muscular dystrophy treatment NS-065/NCNP-01 (brand name: Viltepso® intravenous infusion 250 mg, generic name: viltolarsen) was approved on 25 March 2020 and launched on 20 May. A global Phase 3 trial is currently under way. ・For NS-065/NCNP-01 (generic name: viltolarsen), a rolling application for approval was filed in the United States and approved on 13 August. The product received orphan drug designation from the EMA in Europe in June 2020. A global Phase 3 trial is currently under way.」
NS-065/NCNP-01 progressed from approval in Japan in March 2020 to launch in May, and the rolling application for approval was also approved in the United States. It received orphan drug designation from the EMA in Europe, and the global Phase 3 trial is continuing. - FY2020AdvancedAnnual report
「The Duchenne muscular dystrophy treatment NS-065/NCNP-01 (brand name: Viltepso®, generic name: viltolarsen) was submitted for approval in September 2019 and approved on 25 March 2020. The product was designated by the Ministry of Health, Labour and Welfare in October 2015 as a product eligible for Japan's SAKIGAKE designation system, designated as an orphan drug in August 2019, and designated in October 2019 as a product eligible for the conditional early approval system. A global Phase 3 trial is currently under way. ・For NS-065/NCNP-01 (generic name: viltolarsen), a Phase 2 trial was conducted in the United States, and a rolling application for approval was filed from February 2019, completed in September and accepted in February 2020.」
NS-065/NCNP-01 progressed from the application for approval following completion of the domestic Phase 1/2 trial to approval in March 2020, and is currently undergoing a global Phase 3 trial. The rolling application for approval was also accepted in the United States. - FY2020-Q3AdvancedAnnual report
「The Phase 1/2 trial of the Duchenne muscular dystrophy treatment NS-065/NCNP-01 (generic name: viltolarsen) was completed, and an application for approval was filed in September 2019. The product was designated by the Ministry of Health, Labour and Welfare in October 2015 as a product eligible for Japan's SAKIGAKE designation system, designated as an orphan drug in August 2019, and designated in October 2019 as a product eligible for the conditional early approval system.」
Following the domestic application for approval, NS-065/NCNP-01 was designated in October 2019 as a product eligible for the conditional early approval system. - FY2020-Q2AdvancedAnnual report
「・The Phase 1/2 trial of the Duchenne muscular dystrophy treatment NS-065/NCNP-01 (generic name: viltolarsen) was completed, and an application for approval was filed in September of the current year. The product was designated by the Ministry of Health, Labour and Welfare in October 2015 as a product eligible for Japan's SAKIGAKE designation system, and designated as an orphan drug in August of the current year. ・The Phase 2 trial of NS-065/NCNP-01 (generic name: viltolarsen) was conducted in the United States, and a rolling application for approval had been under way since February of the current year, but was completed in September. The product received Fast Track designation from the FDA in October 2016, followed by orphan drug and rare pediatric disease designations in January 2017.」
For NS-065/NCNP-01, the domestic Phase 1/2 trial was completed, followed by an application for approval in September, while the rolling application for approval in the United States was completed in September. - FY2020-Q1RestatedAnnual report
「・The Phase 2 trial of NS-065/NCNP-01 (generic name: viltolarsen) was conducted in the United States, and a rolling application for approval was initiated in February of the current year. The product received Fast Track designation from the FDA in October 2016, followed by orphan drug and rare pediatric disease designations in January 2017.」
This restates the status of the U.S. Phase 2 trial, the rolling application for approval initiated in February 2019 and the various FDA designations for NS-065/NCNP-01. - FY2019-Q3AdvancedAnnual report
「・The Phase 1/2 trial of the Duchenne muscular dystrophy treatment NS-065/NCNP-01 has been completed. The product was designated by the Ministry of Health, Labour and Welfare in October 2015 as a product eligible for Japan's SAKIGAKE designation system.」
The domestic Phase 1/2 trial of NS-065/NCNP-01 was completed. It is also stated that the U.S. Phase 2 trial was conducted and a rolling application for approval was initiated, indicating progress from the trial stage to the application stage. - FY2019-Q2RestatedAnnual report
「・The Phase 1/2 trial of the Duchenne muscular dystrophy treatment NS-065/NCNP-01 is under way. The product was designated by the Ministry of Health, Labour and Welfare in October 2015 as a product eligible for Japan's SAKIGAKE designation system.」
This restates the previous status of the domestic Phase 1/2 trial and SAKIGAKE designation for NS-065/NCNP-01. The overseas Phase 2 trial and the various FDA designations also remain in place. - FY2019-Q1RestatedAnnual report
「・The Phase 1/2 trial of the Duchenne muscular dystrophy treatment NS-065/NCNP-01 is under way. The product was designated by the Ministry of Health, Labour and Welfare in October 2015 as a product eligible for Japan's SAKIGAKE designation system.」
This restates the previous status of the domestic Phase 1/2 trial and SAKIGAKE designation for NS-065/NCNP-01. - FY2018-Q3RestatedAnnual report
「・The Phase 1/2 trial of the Duchenne muscular dystrophy treatment NS-065/NCNP-01 is under way. The product was designated by the Ministry of Health, Labour and Welfare in October 2015 as a product eligible for Japan's SAKIGAKE designation system. ・A Phase 2 trial of NS-065/NCNP-01 is under way in the United States. The product received Fast Track designation from the FDA in October 2016, followed by orphan drug and rare pediatric disease designations in January 2017.」
This restates the status of the domestic Phase 1/2 trial, the U.S. Phase 2 trial and the various designations already obtained. - FY2018-Q2RestatedAnnual report
「The Phase 1/2 trial of the Duchenne muscular dystrophy treatment NS-065/NCNP-01 is under way. The product was designated by the Ministry of Health, Labour and Welfare in October 2015 as a product eligible for Japan's SAKIGAKE designation system. ・A Phase 2 trial of NS-065/NCNP-01 is under way in the United States. The product received Fast Track designation from the FDA in October 2016, followed by orphan drug and rare pediatric disease designations in January 2017.」
This restates the status of the domestic Phase 1/2 trial, the U.S. Phase 2 trial and the various designations already obtained. - FY2018-Q1RestatedAnnual report
「・The Phase 1/2 trial of the Duchenne muscular dystrophy treatment NS-065/NCNP-01 is under way. The product was designated by the Ministry of Health, Labour and Welfare in October 2015 as a product eligible for Japan's SAKIGAKE designation system. ・A Phase 2 trial of NS-065/NCNP-01 is under way in the United States. The product received Fast Track designation from the FDA in October 2016, followed by orphan drug and rare pediatric disease designations in January 2017.」
This restates the status of the domestic Phase 1/2 trial, the U.S. Phase 2 trial and the various designations already obtained. - FY2017-Q3AdvancedAnnual report
「・The Phase 1/2 trial of the Duchenne muscular dystrophy treatment NS-065/NCNP-01 is under way. It was designated by the Ministry of Health, Labour and Welfare in October 2015 as a product eligible for Japan's SAKIGAKE designation system. ・A Phase 2 trial of NS-065/NCNP-01 is under way in the United States. It received Fast Track designation from the FDA in October 2016, followed by orphan drug and rare pediatric disease designations in January 2017.」
In addition to the ongoing U.S. Phase 2 trial, the product received Fast Track, orphan drug and rare pediatric disease designations from the FDA. - FY2017-Q2AdvancedAnnual report
「The Duchenne muscular dystrophy treatment NS-065/NCNP-01 was designated by the Ministry of Health, Labour and Welfare in October 2015 as a product eligible for Japan's SAKIGAKE designation system. A clinical trial notification was filed in January 2016, and a Phase 1/2 trial was initiated. ・For NS-065/NCNP-01, a clinical trial notification was filed with the U.S. Food and Drug Administration (FDA) in March 2016, and a Phase 2 trial was initiated.」
In addition to the domestic Phase 1/2 trial, a Phase 2 trial was initiated in the United States after a clinical trial notification was filed with the FDA. - FY2017-Q1RestatedAnnual report
「The Duchenne muscular dystrophy treatment NS-065 was designated by the Ministry of Health, Labour and Welfare on 27 October 2015 as a product eligible for Japan's SAKIGAKE designation system. A clinical trial notification was filed in January 2016, and a Phase 1/2 trial was initiated.」
This restates the status of NS-065's SAKIGAKE designation and the initiation of its Phase 1/2 trial. - FY2016First statedAnnual report
「The Duchenne muscular dystrophy treatment NS-065 was designated by the Ministry of Health, Labour and Welfare on 27 October 2015 as a product eligible for Japan's SAKIGAKE designation system. A clinical trial notification was filed in January 2016, and a Phase 1/2 trial was initiated.」
It states that a Phase 1/2 trial was initiated in Japan, and that a clinical trial notification was filed in the United States in March 2016, followed by the initiation of an early Phase 2 trial.