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Last Updated: March 28, 2024

CLINICAL TRIALS PROFILE FOR VILTOLARSEN


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All Clinical Trials for viltolarsen

Trial ID Title Status Sponsor Phase Start Date Summary
NCT04060199 ↗ Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys With DMD (RACER53) Recruiting Nippon Shinyaku Co., Ltd. Phase 3 2020-04-14 The main objective of this study is to evaluate the efficacy of Viltolarsen compared to placebo in Duchenne muscular dystrophy (DMD) patients amenable to exon 53 skipping.
NCT04060199 ↗ Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys With DMD (RACER53) Recruiting NS Pharma, Inc. Phase 3 2020-04-14 The main objective of this study is to evaluate the efficacy of Viltolarsen compared to placebo in Duchenne muscular dystrophy (DMD) patients amenable to exon 53 skipping.
NCT04687020 ↗ Long-term Use of Viltolarsen in Boys With Duchenne Muscular Dystrophy in Clinical Practice (VILT-502) Recruiting NS Pharma, Inc. Phase 4 2021-06-10 The VILT-502 study is Non-interventional Study(United States)/Low-intervention Clinical Trial (Canada) of Viltolarsen administered intravenously once weekly for 10 years to boys with DMD who complete the NS-065/NCNP-01-202 study.
NCT04768062 ↗ Study to Assess the Safety and Efficacy of Viltolarsen in Ambulant Boys With DMD (RACER53-X) Recruiting Nippon Shinyaku Co., Ltd. Phase 3 2021-04-13 This is a Phase 3, multi-center, open-label extension study in ambulant boys with DMD who have completed the 48-week treatment period of either viltolarsen or placebo in Study NS-065/NCNP-01-301.
NCT04768062 ↗ Study to Assess the Safety and Efficacy of Viltolarsen in Ambulant Boys With DMD (RACER53-X) Recruiting NS Pharma, Inc. Phase 3 2021-04-13 This is a Phase 3, multi-center, open-label extension study in ambulant boys with DMD who have completed the 48-week treatment period of either viltolarsen or placebo in Study NS-065/NCNP-01-301.
NCT04956289 ↗ Study to Assess the Safety, Tolerability, and Efficacy of Viltolarsen in Ambulant and Non-Ambulant Boys With DMD Recruiting Nippon Shinyaku Co., Ltd. Phase 2 2021-07-01 This is a phase II, open-label study where weekly doses of 80 mg/kg viltolarsen is administered intravenously over a 48-week treatment period to ambulant and non-ambulant DMD patients over the age of 8 years.
NCT04956289 ↗ Study to Assess the Safety, Tolerability, and Efficacy of Viltolarsen in Ambulant and Non-Ambulant Boys With DMD Recruiting NS Pharma, Inc. Phase 2 2021-07-01 This is a phase II, open-label study where weekly doses of 80 mg/kg viltolarsen is administered intravenously over a 48-week treatment period to ambulant and non-ambulant DMD patients over the age of 8 years.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for viltolarsen

Condition Name

Condition Name for viltolarsen
Intervention Trials
Duchenne Muscular Dystrophy 4
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Condition MeSH

Condition MeSH for viltolarsen
Intervention Trials
Muscular Dystrophy, Duchenne 4
Muscular Dystrophies 4
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Clinical Trial Locations for viltolarsen

Trials by Country

Trials by Country for viltolarsen
Location Trials
United States 5
Spain 3
Italy 3
Turkey 3
Japan 2
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Trials by US State

Trials by US State for viltolarsen
Location Trials
Virginia 2
Oregon 1
Illinois 1
California 1
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Clinical Trial Progress for viltolarsen

Clinical Trial Phase

Clinical Trial Phase for viltolarsen
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for viltolarsen
Clinical Trial Phase Trials
Recruiting 4
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Clinical Trial Sponsors for viltolarsen

Sponsor Name

Sponsor Name for viltolarsen
Sponsor Trials
NS Pharma, Inc. 4
Nippon Shinyaku Co., Ltd. 3
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Sponsor Type

Sponsor Type for viltolarsen
Sponsor Trials
Industry 7
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