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Nippon Shinyaku’s R&D Activities
We focus our drug discovery research on strategic fields such as urology and hematology, and on the elucidation of the causes of new diseases. By doing so, we are speedily developing original and unique products.
- April 18, 2025
- FDA Grants Orphan Drug Designation to NS-229 for the Treatment of Eosinophilic Granulomatosis with Polyangiitis
- March 19, 2025
- Launch of Uptravi® Tablets for Pediatric 0.05 mg for the Treatment of Pulmonary Arterial Hypertension in Japan
- March 05, 2025
- CAP-1002: The U.S. FDA has accepted the Biologics License Application for Duchenne Muscular Dystrophy Cardiomyopathy
- December 27, 2024
- MHLW approval of Uptravi® tablets 0.2 mg and 0.4 mg for the Treatment of Pediatric PAH and Uptravi® tablets for pediatric 0.05 mg
- December 02, 2024
- Senkuteki Iyakuhin (Pioneering Drug) Designation and Orphan Drug Designation granted to NS-089/NCNP-02 for the Treatment of Duchenne Muscular Dystrophy
- November 20, 2024
- YUVANCI® Combination Tablets for the Treatment of Pulmonary Arterial Hypertension : Start of co-promotion activities with Johnson & Johnson
- November 13, 2024
- Nippon Shinyaku and Atsena Therapeutics enter into an Exclusive Strategic Collaboration for ATSN-101 in the U.S. and Japan
- October 11, 2024
- VILTEPSO® (viltolarsen) injection: Phase II study (Galactic53 trial) Data Published in Scientific Reports
- September 24, 2024
- Johnson & Johnson Obtains Approval for YUVANCI ® Combination Tablet for the Treatment of Pulmonary Arterial Hypertension
- September 06, 2024
- FDA Grants Rare Pediatric Disease Designation to NS-050/NCNP-03 for the Treatment of Duchenne Muscular Dystrophy
- May 22, 2024
- Launch of VyxeosⓇ Combination for I.V. Injection for the Treatment of High-risk AML in Japan
- April 04, 2024
- Announcement of Research Alliance with MiNA Therapeutics in the Field of Central Nervous System
- March 26, 2024
- Vyxeos® Combination for I.V. Injection Receives Approval for the Treatment of High-risk AML in Japan
- December 21, 2023
- The European Commission Grants Orphan Drug Designation to NS-089/NCNP-02 for the Treatment of Duchenne Muscular Dystrophy
- August 28, 2023
- Orphan Drug Designation granted to NS-401
- August 08, 2023
- NS-018, Treatment for Myelofibrosis under development in overseas received Orphan Drug Designation from EC
- August 07, 2023
- FDA Grants Orphan Drug Designation to NS-089/NCNP-02 for the Treatment of Duchenne Muscular Dystrophy
- July 28, 2023
- FDA Grants Breakthrough Therapy Designation to NS-089/NCNP-02 for the Treatment of Duchenne Muscular Dystrophy
- July 04, 2023
- FDA Grants Rare Pediatric Disease Designation to NS-089/NCNP-02 for the Treatment of Duchenne Muscular Dystrophy
- June 21, 2023
- Submission of New Drug Application for NS-87 (daunorubicin and cytarabine liposome injection) in Japan
- May 09, 2023
- VILTEPSO® (viltolarsen): Four-Year Clinical Trial Data Published in the Journal of Neuromuscular Diseases
- April 14, 2023
- Agreement with the U.S. FDA for a Global Phase II Study Plan of NS-089/NCNP-02 for the Treatment of Duchenne Muscular Dystrophy
- December 23, 2022
- Humanized Anti-CD20 Monoclonal Antibody Gazyva Approved for Additional Indication of Chronic Lymphocytic Leukemia
- December 20, 2022
- NS-018, Treatment for Myelofibrosis under development in overseas received Orphan Drug Designation from the U.S. FDA
- November 16, 2022
- Launch of Fintepla® (fenfluramine) for the Treatment of Seizures Associated with Dravet syndrome in Japan
- October 24, 2022
- VILTEPSO® (viltolarsen) injection: Four-Year Clinical Trial Data Presented at the World Muscle Society 2022 Conference
- October 03, 2022
- VILTEPSO® (viltolarsen) injection Four-Year Clinical Trial Data to be Presented at the World Muscle Society 2022 Conference
- September 26, 2022
- Fintepla® (fenfluramine) Approved in Japan for the Treatment of Seizures Associated with Dravet syndrome
- May 31, 2022
- VILTEPSO® (viltolarsen): Long-Term Efficacy and Safety Data Published in the Journal of Neuromuscular Diseases
- May 30, 2022
- Orphan Drug Designation granted to NS-87
- March 28, 2022
- Marketing approval of MonoVer for I.V. injection 500mg/1000mg by MHLW for the treatment of iron deficiency anemia
- December 22, 2021
- Zogenix Submission of New Drug Application for ZX008 (Fenfluramine Hydrochloride) in Japan
- December 10, 2021
- Coverage in NHI Drug Price Listing and Launch Date of TADALAFIL Tablets 2.5 mg/5 mg ZA "SIOE"
- November 29, 2021
- Nippon Shinyaku Implements VILTEPSO Managed Access Program
- November 25, 2021
- Addition of Viltepso to the List of Injection Drugs That Physicians Providing Health Insurance Treatment Can Administer
- November 10, 2021
- Nippon Shinyaku enter into an Option Agreement for DYN101 in Japan
- September 22, 2021
- VILTEPSO® (viltolarsen) injection Interim Long-Term Clinical Trial Data Scheduled for Presentation at the Child Neurology Society Annual Meeting
- September 17, 2021
- VILTEPSO® (viltolarsen) injection Interim Long-Term Clinical Trial Data Scheduled for Presentation at the World Muscle Society 2021 Virtual Conference
- July 01, 2021
- VILTEPSO® (viltolarsen) injection: Long-Term Efficacy and Safety Data Presented at the PPMD 2021 Virtual Annual Conference
Therapeutic Areas
We are focusing our R&D on these five priority.