VILTOLARSEN ( DrugBank: Viltolarsen )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 113 | 筋ジストロフィー | 18 |
113. 筋ジストロフィー
臨床試験数 : 622 / 薬物数 : 485 - (DrugBank : 99) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 168
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2021-000122-10-GR (EUCTR) | 25/11/2021 | 13/10/2021 | A Phase 3 study of Viltolarsen in boys with Duchenne Muscular Dystrophy (DMD) | A Phase 3, Multi-center, Open-label Extension Study to Assess the Safety and Efficacy of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - RACER-53X | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Viltolarsen Product Code: NS-065/NCNP-01 INN or Proposed INN: VILTOLARSEN | NS Pharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 74 | Phase 3 | United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Turkey;Chile;Russian Federation;United Kingdom;Italy;Mexico;Canada;Australia;Norway;Netherlands;China;Japan;New Zealand;Korea, Republic of | ||
| 2 | EUCTR2019-002076-13-NO (EUCTR) | 08/09/2021 | 18/02/2021 | This is a randomized, double-blind, Placebo-controlled sudy to evaluate the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - RACER-53 | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Viltolarsen Product Code: NS-065/NCNP-01 INN or Proposed INN: VILTOLARSEN | NS Pharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 74 | Phase 3 | United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Turkey;Chile;Russian Federation;United Kingdom;Italy;Mexico;Canada;Australia;Netherlands;Norway;China;Japan;New Zealand;Sweden;Korea, Republic of | ||
| 3 | EUCTR2020-003653-30-ES (EUCTR) | 26/07/2021 | 15/12/2021 | A Phase 2 Open-label Study to Assess the Safety, Tolerability, and Efficacy of Viltolarsen in Ambulant and Non-Ambulant Boys with Duchenne Muscular Dystrophy (DMD) Compared to Natural History Controls - Galactic-53 | A Phase 2 Open-label Study to Assess the Safety, Tolerability, and Efficacy of Viltolarsen in Ambulant and Non-Ambulant Boys with Duchenne Muscular Dystrophy (DMD) Compared to Natural History Controls - Galactic-53 | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Viltolarsen Product Code: NS-065/NCNP-01 INN or Proposed INN: VILTOLARSEN | NS Pharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 20 | Phase 2 | United States;Spain;Turkey;Russian Federation;Italy;China | ||
| 4 | NCT04956289 (ClinicalTrials.gov) | July 1, 2021 | 30/6/2021 | Study to Assess the Safety, Tolerability, and Efficacy of Viltolarsen in Ambulant and Non-Ambulant Boys With DMD | A Phase 2 Open-label Study to Assess the Safety, Tolerability, and Efficacy of Viltolarsen in Ambulant and Non-Ambulant Boys With Duchenne Muscular Dystrophy (DMD) Compared to Natural History Controls | Duchenne Muscular Dystrophy | Drug: Viltolarsen | NS Pharma, Inc. | Nippon Shinyaku Co., Ltd. | Recruiting | 8 Years | N/A | Male | 20 | Phase 2 | United States;Italy;Russian Federation;Spain;Turkey |
| 5 | EUCTR2021-000122-10-NL (EUCTR) | 30/06/2021 | 08/04/2021 | A Phase 3 study of Viltolarsen in boys with Duchenne Muscular Dystrophy (DMD) | A Phase 3, Multi-center, Open-label Extension Study to Assess the Safety and Efficacy of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - RACER-53X | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Viltolarsen Product Code: NS-065/NCNP-01 INN or Proposed INN: VILTOLARSEN | NS Pharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 74 | Phase 3 | United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Turkey;Chile;Russian Federation;United Kingdom;Italy;Mexico;Canada;Australia;Norway;Netherlands;China;Japan;New Zealand;Korea, Republic of | ||
| 6 | EUCTR2021-000122-10-ES (EUCTR) | 15/06/2021 | 30/07/2021 | A Phase 3 study of Viltolarsen in boys with Duchenne Muscular Dystrophy (DMD) | A Phase 3, Multi-center, Open-label Extension Study to Assess the Safety and Efficacy of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - RACER-53X | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Viltolarsen Product Code: NS-065/NCNP-01 INN or Proposed INN: VILTOLARSEN | NS Pharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 74 | Phase 3 | United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Turkey;Chile;Russian Federation;United Kingdom;Italy;Mexico;Canada;Australia;Norway;Netherlands;China;Japan;New Zealand;Korea, Republic of | ||
| 7 | NCT04687020 (ClinicalTrials.gov) | June 10, 2021 | 16/12/2020 | Long-term Use of Viltolarsen in Boys With Duchenne Muscular Dystrophy in Clinical Practice (VILT-502) | Long-term Use of Viltolarsen in Boys With Duchenne Muscular Dystrophy in Clinical Practice (VILT-502) | Duchenne Muscular Dystrophy | Drug: Viltolarsen | NS Pharma, Inc. | NULL | Enrolling by invitation | N/A | N/A | Male | 16 | Phase 4 | United States;Canada |
| 8 | EUCTR2020-003653-30-IT (EUCTR) | 08/06/2021 | 08/06/2021 | This is an Open-label Study to evaluate the Safety, Tolerability, and Efficacy of Viltolarsen in Ambulant and Non-Ambulant Boys with Duchenne Muscular Dystrophy (DMD) | A Phase 2 Open-label Study to Assess the Safety, Tolerability, and Efficacy of Viltolarsen in Ambulant and Non-Ambulant Boys with Duchenne Muscular Dystrophy (DMD) Compared to Natural History Controls - Galactic-53 | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Viltolarsen Product Code: [NS-065/NCNP-01] INN or Proposed INN: VILTOLARSEN | NS Pharma, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 20 | Phase 2 | United States;Spain;Turkey;Russian Federation;China;Italy | ||
| 9 | EUCTR2021-000122-10-IT (EUCTR) | 26/04/2021 | 08/06/2021 | A Phase 3 study of Viltolarsen in boys with Duchenne Muscular Dystrophy (DMD) | A Phase 3, Multi-center, Open-label Extension Study to Assess the Safety and Efficacy of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - RACER-53X | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Viltolarsen Product Code: [NS-065/NCNP-01] INN or Proposed INN: VILTOLARSEN | NS Pharma, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 74 | Phase 3 | United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Turkey;Chile;Russian Federation;United Kingdom;Italy;Mexico;Canada;Australia;Norway;Netherlands;China;Japan;New Zealand;Korea, Republic of | ||
| 10 | NCT04768062 (ClinicalTrials.gov) | April 13, 2021 | 19/2/2021 | Study to Assess the Safety and Efficacy of Viltolarsen in Ambulant Boys With DMD (RACER53-X) | A Phase 3, Multi-center, Open-label Extension Study to Assess the Safety and Efficacy of Viltolarsen in Ambulant Boys With Duchenne Muscular Dystrophy (DMD) | Duchenne Muscular Dystrophy | Drug: Viltolarsen | NS Pharma, Inc. | Nippon Shinyaku Co., Ltd. | Enrolling by invitation | N/A | N/A | Male | 74 | Phase 3 | Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Russian Federation;Spain;Turkey |
| 11 | EUCTR2019-002076-13-GR (EUCTR) | 12/11/2020 | 24/09/2020 | This is a randomized, double-blind, Placebo-controlled sudy to evaluate the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - RACER-53 | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Viltolarsen Product Code: NS-065/NCNP-01 INN or Proposed INN: VILTOLARSEN | NS Pharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 74 | Phase 3 | United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Turkey;Chile;Russian Federation;United Kingdom;Italy;Mexico;Canada;Australia;Norway;Netherlands;China;Japan;New Zealand;Sweden;Korea, Republic of | ||
| 12 | NCT04060199 (ClinicalTrials.gov) | April 14, 2020 | 15/8/2019 | Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys With DMD (RACER53) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys With Duchenne Muscular Dystrophy (DMD) | Duchenne Muscular Dystrophy | Drug: Viltolarsen;Drug: Placebo | NS Pharma, Inc. | Nippon Shinyaku Co., Ltd. | Recruiting | 4 Years | 7 Years | Male | 74 | Phase 3 | United States;Australia;Canada;Chile;Greece;Hong Kong;Italy;Japan;Korea, Republic of;Mexico;Netherlands;New Zealand;Norway;Russian Federation;Spain;Taiwan;Turkey;Ukraine;United Kingdom;Sweden |
| 13 | EUCTR2019-002076-13-NL (EUCTR) | 03/03/2020 | 25/11/2019 | This is a randomized, double-blind, Placebo-controlled sudy to evaluate the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - RACER-53 | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Viltolarsen Product Code: NS-065/NCNP-01 INN or Proposed INN: VILTOLARSEN | NS Pharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 74 | Phase 3 | United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Turkey;Chile;Russian Federation;United Kingdom;Italy;Mexico;Canada;Australia;Norway;Netherlands;China;Japan;New Zealand;Sweden;Korea, Republic of | ||
| 14 | EUCTR2019-002076-13-GB (EUCTR) | 02/03/2020 | 16/09/2019 | This is a randomized, double-blind, Placebo-controlled sudy to evaluate the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - RACER-53 | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Viltolarsen Product Code: NS-065/NCNP-01 INN or Proposed INN: VILTOLARSEN | NS Pharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 74 | Phase 3 | Korea, Republic of;Sweden;Japan;Netherlands;Australia;Poland;Brazil;Belgium;Canada;France;Italy;United Kingdom;Russian Federation;Chile;Turkey;Spain;Taiwan;United States | ||
| 15 | EUCTR2019-002076-13-IT (EUCTR) | 27/01/2020 | 05/01/2021 | This is a randomized, double-blind, Placebo-controlled sudy to evaluate the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - RACER-53 | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Viltolarsen Product Code: [NS-065/NCNP-01] INN or Proposed INN: VILTOLARSEN | NS Pharma, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 74 | Phase 3 | United States;Taiwan;Greece;Spain;Turkey;Chile;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Brazil;Belgium;Australia;Netherlands;Japan;Sweden;Korea, Republic of | ||
| 16 | EUCTR2019-002076-13-ES (EUCTR) | 16/12/2019 | 06/11/2019 | This is a randomized, double-blind, Placebo-controlled sudy to evaluate the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - RACER-53 | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Viltolarsen Product Code: NS-065/NCNP-01 INN or Proposed INN: VILTOLARSEN | NS Pharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 74 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Spain;Turkey;Russian Federation;Chile;United Kingdom;Italy;France;Canada;Poland;Belgium;Brazil;Australia;Netherlands;Japan;Sweden;Korea, Republic of | ||
| 17 | NCT04337112 (ClinicalTrials.gov) | January 23, 2008 | 2/4/2020 | The Expanded Access Use of Viltolarsen in Duchenne Muscular Dystrophy With Confirmed Exon 53 Amenable Mutation | The Expanded Access Use of Viltolarsen for the Treatment of Duchenne Muscular Dystrophy (DMD) Amenable to Exon 53 Skipping | Muscular Dystrophy, Duchenne;DMD | Drug: viltolarsen | NS Pharma, Inc. | NULL | Approved for marketing | 3 Years | 12 Years | Male | NULL | ||
| 18 | EUCTR2019-002076-13-SE (EUCTR) | 17/10/2019 | This is a randomized, double-blind, Placebo-controlled sudy to evaluate the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - RACER-53 | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Viltolarsen Product Code: NS-065/NCNP-01 INN or Proposed INN: VILTOLARSEN | NS Pharma, Inc. | NULL | Not Recruiting | Female: no Male: yes | 74 | Phase 3 | United States;Taiwan;Spain;Turkey;Chile;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Poland;Australia;Netherlands;Japan;Sweden;Korea, Republic of |