Mt-7117 (DrugBank: -)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 51 | 全身性強皮症 | 2 |
| 254 | ポルフィリン症 | 6 |
| 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 | NCT04440592 (ClinicalTrials.gov) | December 31, 2020 | 17/6/2020 | Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis | Diffuse Cutaneous Systemic Sclerosis | Drug: MT-7117;Drug: Placebo | Mitsubishi Tanabe Pharma Development America, Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 72 | Phase 2 | United States |
| 2 | EUCTR2020-000134-17-GB (EUCTR) | 23/12/2020 | 05/08/2020 | A Phase 2, Multicenter, Randomised, Double-Blind, Placebo-Controlled-Parallel-Group study to determine how safe, effective and tolerable MT-7117 is in subjects with Diffuse Cutaneous Systemic Sclerosis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects with Diffuse Cutaneous Systemic Sclerosis | Diffuse Cutaneous Systemic Sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Dersimelagon Product Code: MT-7117 INN or Proposed INN: Dersimelagon Other descriptive name: MT-7117 | Mitsubishi Tanabe Pharma Development America (MTDA), Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;Canada;Spain;Belgium;Germany;Italy;United Kingdom |
| 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 | EUCTR2019-004226-16-GB (EUCTR) | 04/11/2020 | 29/05/2020 | A phase 3 trial to determine how safe, tolerable and effective MT-7117 is in adults and adolescents with Erythropoietic Protoporphyria or x-linked Protoporphyria | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Adults and Adolescents with Erythropoietic Protoporphyria or X-Linked Protoporphyria - RESPITE | Erythropoietic Protoporphyria or X-Linked Protoporphyria MedDRA version: 21.1;Level: LLT;Classification code 10015289;Term: Erythropoietic protoporphyria;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Dersimelagon Product Code: MT-7117 INN or Proposed INN: Dersimelagon Other descriptive name: MT-7117 | Mitsubishi Tanabe Pharma Development America (MTDA), Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 159 | Phase 3 | United States;Canada;Finland;Spain;Australia;Norway;Germany;Japan;Italy;United Kingdom;Sweden | ||
| 2 | EUCTR2019-004226-16-IT (EUCTR) | 08/10/2020 | 21/10/2020 | Study to Evaluate Efficacy, Safety, and Tolerability of MT 7117 in Adults and Adolescents with Erythropoietic Protoporphyria or X-Linked Protoporphyria | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Tolerability of MT 7117 in Adults and Adolescents with Erythropoietic Protoporphyria or X-Linked Protoporphyria - RESPITE | Erythropoietic Protoporphyria or X-Linked Protoporphyria MedDRA version: 21.1;Level: LLT;Classification code 10015289;Term: Erythropoietic protoporphyria;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Dersimelagon Product Code: [MT-7117] Other descriptive name: A novel synthetic, orally-administered, non-peptide small molecule, which acts as | Mitsubishi Tanabe Development America Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 159 | Phase 3 | United States;Canada;Finland;Spain;Australia;Norway;Germany;United Kingdom;Japan;Italy;Sweden | ||
| 3 | EUCTR2019-004226-16-SE (EUCTR) | 06/07/2020 | 26/05/2020 | A phase 3 trial to determine how safe, tolerable and effective MT-7117 is in adults and adolescents with Erythropoietic Protoporphyria or x-linked Protoporphyria | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Adults and Adolescents with Erythropoietic Protoporphyria or X-Linked Protoporphyria - RESPITE | Erythropoietic Protoporphyria or X-Linked Protoporphyria MedDRA version: 21.1;Level: LLT;Classification code 10015289;Term: Erythropoietic protoporphyria;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Dersimelagon Product Code: MT-7117 INN or Proposed INN: Dersimelagon Other descriptive name: MT-7117 | Mitsubishi Tanabe Pharma Development America (MTDA), Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 159 | Phase 3 | United States;Canada;Finland;Spain;Australia;Norway;Germany;United Kingdom;Japan;Italy;Sweden | ||
| 4 | NCT04402489 (ClinicalTrials.gov) | June 1, 2020 | 20/5/2020 | Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Erythropoetic Protoporphyria or X-Linked Protoporphyria | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Adults and Adolescents With Erythropoietic Protoporphyria or X-Linked Protoporphyria | EPP;XLP | Drug: Placebo;Drug: MT-7117 Low Dose;Drug: MT-7117 High Dose | Mitsubishi Tanabe Pharma Development America, Inc. | NULL | Recruiting | 12 Years | 75 Years | All | 159 | Phase 3 | United States;Australia;Canada;Finland;Germany;Italy;Japan;Norway;Spain;Sweden;United Kingdom |
| 5 | NCT03520036 (ClinicalTrials.gov) | July 5, 2018 | 23/4/2018 | Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Erythropoietic Protoporphyria | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Erythropoietic Protoporphyria | Erythropoietic Protoporphyria (EPP) | Drug: MT-7117 low dose;Drug: MT-7117 high dose;Drug: Placebo | Mitsubishi Tanabe Pharma Development America, Inc. | NULL | Completed | 18 Years | 75 Years | All | 102 | Phase 2 | United States |
| 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 |
| 6 | EUCTR2019-004226-16-NO (EUCTR) | 20/05/2020 | A phase 3 trial to determine how safe, tolerable and effective MT-7117 is in adults and adolescents with Erythropoietic Protoporphyria or x-linked Protoporphyria | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Adults and Adolescents with Erythropoietic Protoporphyria or X-Linked Protoporphyria - RESPITE | Erythropoietic Protoporphyria or X-Linked Protoporphyria MedDRA version: 21.1;Level: LLT;Classification code 10015289;Term: Erythropoietic protoporphyria;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Dersimelagon Product Code: MT-7117 INN or Proposed INN: Dersimelagon Other descriptive name: MT-7117 | Mitsubishi Tanabe Pharma Development America (MTDA), Inc. | NULL | NA | Female: yes Male: yes | 159 | Phase 3 | United States;Canada;Finland;Spain;Australia;Germany;Norway;Japan;Italy;United Kingdom;Sweden |