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Nippon Shinyaku Co., Ltd. (JP:4516)
:4516
Ns-863 Low Dose, Ns-863 High Dose
Pulmonary Arterial Hypertension
Phase II
Not Yet Recruiting
Clinical Trial of NS-863 in Participants With Pulmonary Arterial Hypertension (PAH)
Jan 30, 2026
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Ns-863 Low Dose, Ns-863 High Dose
Pulmonary Hypertension Associated With Interstitial Lung Disease (Ph-Ild)
Phase II
Not Yet Recruiting
A Clinical Trial of NS-863 in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Jan 30, 2026
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[14C] Ns-580
Healthy
Phase I
Completed
A Study of Absorption, Metabolism, Excretion of [14C]-NS-580 in Healthy Male Subjects
Oct 22, 2024
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Ns-089/Ncnp-02
Duchenne Muscular Dystrophy (Dmd)
Phase II
Active Not Recruiting
Extension Study of NS-089/NCNP-02 in DMD
Oct 05, 2021
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Ns-018, Best Available Therapy
Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis, Primary Myelofibrosis
Phase II
Terminated
Study to Assess Efficacy and Safety of NS-018 Compared to BAT in Patients With Myelofibrosis
Apr 09, 2021
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Viltolarsen
Duchenne Muscular Dystrophy
Phase III
Completed
Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys With DMD (RACER53)
Aug 15, 2019
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Nippon Shinyaku Co., Ltd. (4516) have in its pipeline
4516 is currently developing the following drugs: Ns-863 Low Dose, Ns-863 High Dose, Ns-863 Low Dose, Ns-863 High Dose, [14C] Ns-580. These drug candidates are in various stages of clinical development as the company works toward FDA approval.