Dersimelagon ( 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4
254ポルフィリン症12

51. 全身性強皮症


臨床試験数 : 525 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-000134-17-PL
(EUCTR)
14/09/202118/08/2021A 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 SclerosisA 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, Inc. (MTDA)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;Canada;Belgium;Spain;Poland;Germany;United Kingdom;Italy
2EUCTR2020-000134-17-DE
(EUCTR)
27/01/202106/10/2020A 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 SclerosisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;Canada;Poland;Spain;Belgium;Germany;United Kingdom;Italy
3EUCTR2020-000134-17-GB
(EUCTR)
23/12/202005/08/2020A 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 SclerosisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;Canada;Spain;Belgium;Germany;Italy;United Kingdom
4EUCTR2020-000134-17-IT
(EUCTR)
18/12/202015/06/2021A Phase 2, Multicenter, Randomised, Double-Blind, Placebo-ControlledParallel-Group study to determine how safe, effective and tolerable MT7117 is in subjects with Diffuse Cutaneous Systemic SclerosisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, and Tolerability of MT7117 in Subjects with Diffuse Cutaneous Systemic Sclerosis - NA 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]
Other descriptive name: A novel synthetic, orally-administered, non-peptide small molecule, which acts as an agonist of the melanocortin-1 receptor (MC1R)
Mitsubishi Tanabe Development America Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;Canada;Spain;Belgium;Germany;United Kingdom;Italy

254. ポルフィリン症


臨床試験数 : 72 薬物数 : 53 - (DrugBank : 16) / 標的遺伝子数 : 19 - 標的パスウェイ数 : 35
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-001831-17-DE
(EUCTR)
07/04/202222/11/2021An open label, long-term extension study to determine how safe and tolerable oral Dersimelagon is in subjects with Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)A Phase 3, Multicenter, Open-label, Long-term, Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects with Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP) Erythropoietic Protoporphyria or X-Linked Protoporphyria
MedDRA version: 24.0;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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
184Phase 3United States;Canada;Spain;Australia;Norway;Germany;United Kingdom;Japan;Italy;Sweden
2EUCTR2021-001831-17-ES
(EUCTR)
01/03/202216/12/2021An open label, long-term extension study to determine how safe and tolerable oral Dersimelagon is in subjects with Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)A Phase 3, Multicenter, Open-label, Long-term, Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects with Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP) Erythropoietic Protoporphyria or X-Linked Protoporphyria
MedDRA version: 24.0;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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
184Phase 3United States;Canada;Spain;Germany;United Kingdom;Japan
3NCT05005975
(ClinicalTrials.gov)
August 10, 202128/7/2021Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects With Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)A Phase 3, Multicenter, Open-label, Long-term, Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects With Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)EPP;XLPDrug: MT-7117Mitsubishi Tanabe Pharma Development America, Inc.NULLActive, not recruiting12 Years75 YearsAll175Phase 3United States;Australia;Canada;Germany;Italy;Japan;Norway;Spain;Sweden;United Kingdom
4EUCTR2019-004226-16-FI
(EUCTR)
29/04/202105/10/2020A phase 3 trial to determine how safe, tolerable and effective MT-7117 is in adults and adolescents with Erythropoietic Protoporphyria or x-linked ProtoporphyriaA 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.NULLNot RecruitingFemale: yes
Male: yes
159Phase 3United States;Canada;Finland;Spain;Australia;Norway;Germany;United Kingdom;Japan;Italy;Sweden
5EUCTR2019-004226-16-DE
(EUCTR)
20/04/202115/09/2020A phase 3 trial to determine how safe, tolerable and effective MT-7117 is in adults and adolescents with Erythropoietic Protoporphyria or x-linked ProtoporphyriaA 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: 24.0;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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
184Phase 3United States;Canada;Finland;Spain;Australia;Norway;Germany;United Kingdom;Italy;Japan;Sweden
6EUCTR2019-004226-16-GB
(EUCTR)
04/11/202029/05/2020A phase 3 trial to determine how safe, tolerable and effective MT-7117 is in adults and adolescents with Erythropoietic Protoporphyria or x-linked ProtoporphyriaA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
159Phase 3United States;Canada;Finland;Spain;Australia;Norway;Germany;Japan;Italy;United Kingdom;Sweden
7EUCTR2019-004226-16-IT
(EUCTR)
08/10/202021/10/2020Study to Evaluate Efficacy, Safety, and Tolerability of MT 7117 in Adults and Adolescents with Erythropoietic Protoporphyria or X-Linked ProtoporphyriaA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
159Phase 3United States;Canada;Finland;Spain;Australia;Norway;Germany;United Kingdom;Japan;Italy;Sweden
8EUCTR2019-004226-16-SE
(EUCTR)
06/07/202026/05/2020A phase 3 trial to determine how safe, tolerable and effective MT-7117 is in adults and adolescents with Erythropoietic Protoporphyria or x-linked ProtoporphyriaA 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: 24.0;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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
184Phase 3United States;Canada;Finland;Spain;Australia;Norway;Germany;United Kingdom;Italy;Japan;Sweden
9EUCTR2021-001831-17-IT
(EUCTR)
06/12/2021An open label, long-term extension study to determine how safe and tolerable oral Dersimelagon is in subjects with Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)A Phase 3, Multicenter, Open-label, Long-term, Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects with Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP) - NA Erythropoietic Protoporphyria or X-Linked Protoporphyria
MedDRA version: 24.0;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 Development America Inc.NULLNAFemale: yes
Male: yes
184Phase 3United States;Canada;Spain;Australia;Norway;Germany;United Kingdom;Japan;Italy;Sweden
10EUCTR2021-001831-17-NO
(EUCTR)
11/01/2022An open label, long-term extension study to determine how safe and tolerable oral Dersimelagon is in subjects with Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)A Phase 3, Multicenter, Open-label, Long-term, Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects with Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP) Erythropoietic Protoporphyria or X-Linked Protoporphyria
MedDRA version: 24.0;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.NULLNAFemale: yes
Male: yes
184Phase 3United States;Canada;Spain;Australia;Germany;Norway;United Kingdom;Japan;Italy;Sweden
11EUCTR2021-001831-17-SE
(EUCTR)
11/01/2022An open label, long-term extension study to determine how safe and tolerable oral Dersimelagon is in subjects with Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)A Phase 3, Multicenter, Open-label, Long-term, Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects with Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP) Erythropoietic Protoporphyria or X-Linked Protoporphyria
MedDRA version: 24.0;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, Inc.NULLNAFemale: yes
Male: yes
184Phase 3United States;Canada;Spain;Australia;Norway;Germany;United Kingdom;Italy;Japan;Sweden
12EUCTR2019-004226-16-NO
(EUCTR)
20/05/2020A phase 3 trial to determine how safe, tolerable and effective MT-7117 is in adults and adolescents with Erythropoietic Protoporphyria or x-linked ProtoporphyriaA 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: 24.0;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.NULLNAFemale: yes
Male: yes
184Phase 3United States;Canada;Finland;Spain;Australia;Germany;Norway;United Kingdom;Italy;Japan;Sweden