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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.

December 21, 2023
The European Commission Grants Orphan Drug Designation to NS-089/NCNP-02 for the Treatment of Duchenne Muscular Dystrophy
October 17, 2023
NS-089/NCNP-02: Preclinical data published in Molecular Therapy Nucleic Acids
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 27, 2023
UCB Japan Submitted Additional Application of Fintepla® (fenfluramine) in Japan for the Treatment of Seizures Associated with Lennox-Gastaut Syndrome
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
March 15, 2023
Launch of MonoVer® for I.V. injection 500mg/1000mg for the treatment of iron deficiency anemia
February 16, 2023
Nippon Shinyaku and Capricor Therapeutics enter into an Exclusive Partnership for Commercialization and Distribution of CAP-1002 for the Treatment of Duchenne Muscular Dystrophy in Japan
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
March 17, 2022
The result of an Investigator-Initiated Clinical Trial (First In Human trial) of NS-089/NCNP-02 for the treatment of Duchenne muscular dystrophy
March 11, 2022
The result of an Investigator-Initiated Clinical Trial (First In Human trial) of NS-089/NCNP-02 for the treatment of Duchenne muscular dystrophy
March 07, 2022
Filing of Humanized Anti-CD20 Monoclonal Antibody Gazyva for Additional Indication of Chronic Lymphocytic Leukemia
January 25, 2022
Nippon Shinyaku and Capricor Therapeutics enter into an Exclusive Partnership for Commercialization and Distribution of CAP-1002 for the Treatment of Duchenne Muscular Dystrophy in US
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
August 25, 2021
MHLW approval of Uptravi® for the Treatment of inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) or persistent/recurrent CTEPH after surgery
July 01, 2021
VILTEPSO® (viltolarsen) injection: Long-Term Efficacy and Safety Data Presented at the PPMD 2021 Virtual Annual Conference
June 25, 2021
Submission of New Drug Application for NS-065/NCNP-01 (viltolarsen) in China
June 21, 2021
Webcast of VILTEPSO® (viltolarsen) injection: Long-Term Data Scheduled for Presentation at the PPMD 2021 Virtual Annual Conference
May 12, 2021
(Media)VILTEPSO injection Long-Term Clinical Trial Data to be Presented at the PPMD 2021 Virtual Annual Conference
March 23, 2021
(Media)MHLW approval of Vidaza(azacitidine) for the Treatment of Acute Myeloid Leukemia