RELDESEMTIV ( DrugBank: Reldesemtiv )
2 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 2 | 筋萎縮性側索硬化症 | 14 |
| 3 | 脊髄性筋萎縮症 | 1 |
2. 筋萎縮性側索硬化症
臨床試験数 : 624 / 薬物数 : 611 - (DrugBank : 160) / 標的遺伝子数 : 172 - 標的パスウェイ数 : 225
| 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 | EUCTR2020-004040-29-PT (EUCTR) | 14/01/2022 | 20/05/2021 | A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be tested. | A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS). - COURAGE-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: reldesemtiv Product Code: CK-2127107 INN or Proposed INN: reldesemtiv Other descriptive name: RELDESEMTIV | Cytokinetics Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 555 | Phase 3 | Portugal;United States;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 2 | EUCTR2020-004040-29-NL (EUCTR) | 25/11/2021 | 01/09/2021 | A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be tested. | A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS). - COURAGE-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: reldesemtiv Product Code: CK-2127107 INN or Proposed INN: reldesemtiv Other descriptive name: RELDESEMTIV | Cytokinetics Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 555 | Phase 3 | United States;Portugal;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Netherlands;Germany;Sweden | ||
| 3 | EUCTR2020-004040-29-ES (EUCTR) | 05/10/2021 | 21/06/2021 | A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be tested. | A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS). - COURAGE-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: reldesemtiv Product Code: CK-2127107 INN or Proposed INN: reldesemtiv Other descriptive name: RELDESEMTIV | Cytokinetics Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 555 | Phase 3 | United States;Portugal;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 4 | EUCTR2020-004040-29-IT (EUCTR) | 20/09/2021 | 30/08/2021 | A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be tested | A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) - COURAGE-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: reldesemtiv Product Code: [CK-2127107] INN or Proposed INN: reldesemtiv | CYTOKINETICS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 555 | Phase 3 | United States;Portugal;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 5 | EUCTR2020-004040-29-SE (EUCTR) | 07/09/2021 | 01/06/2021 | A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be tested. | A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS). - COURAGE-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: reldesemtiv Product Code: CK-2127107 INN or Proposed INN: reldesemtiv Other descriptive name: RELDESEMTIV | Cytokinetics Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 555 | Phase 3 | United States;Portugal;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 6 | NCT04944784 (ClinicalTrials.gov) | August 16, 2021 | 16/6/2021 | A Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS) | A Phase 3, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Reldesemtiv;Drug: Placebo | Cytokinetics | NULL | Recruiting | 18 Years | 80 Years | All | 555 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Ireland;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom |
| 7 | EUCTR2020-004040-29-IE (EUCTR) | 02/07/2021 | 09/04/2021 | A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be tested. | A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS). - COURAGE-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: reldesemtiv Product Code: CK-2127107 INN or Proposed INN: reldesemtiv Other descriptive name: RELDESEMTIV | Cytokinetics Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 555 | Phase 3 | United States;Portugal;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 8 | EUCTR2018-000586-37-IE (EUCTR) | 13/09/2018 | 08/05/2018 | A Study to Evaluate the Efficacy, Safety and Tolerability of CK-2127107 In Patients with Amyotrophic Lateral Sclerosis (ALS) | A Phase 2, Multi-Center, Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability Of CK-2127107 In Patients with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Reldesemtiv Product Code: CK-2127107 INN or Proposed INN: Reldesemtiv Other descriptive name: Reldesemtiv | Cytokinetics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 445 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Spain;Ireland;Australia;Netherlands | ||
| 9 | EUCTR2018-000586-37-NL (EUCTR) | 15/08/2018 | 04/06/2018 | A Study to Evaluate the Efficacy, Safety and Tolerability of CK-2127107 In Patients with Amyotrophic Lateral Sclerosis (ALS) | A Phase 2, Multi-Center, Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability Of CK-2127107 In Patients with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Reldesemtiv Product Code: CK-2127107 INN or Proposed INN: Reldesemtiv Other descriptive name: Reldesemtiv | Cytokinetics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 445 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Spain;Ireland;Australia;Netherlands | ||
| 10 | EUCTR2018-000586-37-ES (EUCTR) | 19/07/2018 | 23/05/2018 | A Study to Evaluate the Efficacy, Safety and Tolerability of CK-2127107 In Patients with Amyotrophic Lateral Sclerosis (ALS) | A Phase 2, Multi-Center, Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability Of CK-2127107 In Patients with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Reldesemtiv Product Code: CK-2127107 INN or Proposed INN: Reldesemtiv Other descriptive name: Reldesemtiv | Cytokinetics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 445 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Spain;Ireland;Australia;Netherlands | ||
| 11 | NCT03160898 (ClinicalTrials.gov) | July 24, 2017 | 12/5/2017 | A Study to Evaluate Efficacy, Safety and Tolerability of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis (ALS) | A Phase 2, Multi-Center, Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Reldesemtiv;Drug: Placebo | Cytokinetics | Astellas Pharma Inc | Completed | 18 Years | 80 Years | All | 458 | Phase 2 | United States;Australia;Canada;Ireland;Netherlands;Spain |
| 12 | EUCTR2020-004040-29-BE (EUCTR) | 28/05/2021 | A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be tested. | A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS). - COURAGE-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: reldesemtiv Product Code: CK-2127107 INN or Proposed INN: reldesemtiv Other descriptive name: RELDESEMTIV | Cytokinetics Inc | NULL | NA | Female: yes Male: yes | 555 | Phase 3 | United States;Portugal;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | |||
| 13 | EUCTR2020-004040-29-FR (EUCTR) | 19/04/2021 | A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be tested. | A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS). - COURAGE-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: reldesemtiv Product Code: CK-2127107 INN or Proposed INN: reldesemtiv Other descriptive name: RELDESEMTIV | Cytokinetics Inc | NULL | NA | Female: yes Male: yes | 555 | Phase 3 | United States;Portugal;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | |||
| 14 | EUCTR2020-004040-29-DE (EUCTR) | 09/04/2021 | A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be tested. | A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS). - COURAGE-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: reldesemtiv Product Code: CK-2127107 INN or Proposed INN: reldesemtiv Other descriptive name: RELDESEMTIV | Cytokinetics Inc | NULL | NA | Female: yes Male: yes | 555 | Phase 3 | United States;Portugal;Spain;Ireland;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden |
3. 脊髄性筋萎縮症
臨床試験数 : 217 / 薬物数 : 149 - (DrugBank : 33) / 標的遺伝子数 : 54 - 標的パスウェイ数 : 80
| 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 | NCT02644668 (ClinicalTrials.gov) | January 14, 2016 | 23/12/2015 | A Study of CK-2127107 in Patients With Spinal Muscular Atrophy | A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multiple Dose Study of CK-2127107 in Two Ascending Dose Cohorts of Patients With Spinal Muscular Atrophy | Spinal Muscular Atrophy | Drug: Placebo;Drug: Reldesemtiv 150 mg;Drug: Reldesemtiv 450 mg | Cytokinetics | Astellas Pharma Global Development, Inc. | Completed | 12 Years | N/A | All | 70 | Phase 2 | United States;Canada |