CLINICAL TRIALS PROFILE FOR VILTOLARSEN

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.

Clinical Trial Conditions for VILTOLARSEN

Condition Name

Condition Name for VILTOLARSEN
Intervention	Trials
Duchenne Muscular Dystrophy	4

Condition MeSH

Condition MeSH for VILTOLARSEN
Intervention	Trials
Muscular Dystrophy, Duchenne	4
Muscular Dystrophies	4

Clinical Trial Locations for VILTOLARSEN

Trials by Country

Trials by Country for VILTOLARSEN
Location	Trials
United States	5
Spain	3
Italy	3
Turkey	3
Korea, Republic of	2

Trials by US State

Trials by US State for VILTOLARSEN
Location	Trials
Virginia	2
Oregon	1
Illinois	1
California	1

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

Clinical Trial Status

Clinical Trial Status for VILTOLARSEN
Clinical Trial Phase	Trials
Recruiting	4

Clinical Trial Sponsors for VILTOLARSEN

Sponsor Name

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

Sponsor Type

Sponsor Type for VILTOLARSEN
Sponsor	Trials
Industry	7