GKT137831 ( DrugBank: - )


2 diseases
IDDisease name (Link within this page)Number of trials
85Idiopathic interstitial pneumonia1
93Primary biliary cholangitis14

85. Idiopathic interstitial pneumonia


Clinical trials : 627 Drugs : 443 - (DrugBank : 120) / Drug target genes : 99 - Drug target pathways : 212
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03865927
(ClinicalTrials.gov)
September 7, 20201/3/2019GKT137831 in IPF Patients With Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of GKT137831 in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisOther: Placebo Oral Tablet;Drug: GKT137831University of Alabama at BirminghamNULLRecruiting40 Years85 YearsAll60Phase 2United States

93. Primary biliary cholangitis


Clinical trials : 298 Drugs : 252 - (DrugBank : 59) / Drug target genes : 35 - Drug target pathways : 115
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-001810-13-SE
(EUCTR)
06/04/202230/11/2021A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness (TRANSFORM)TRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness
MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SETANAXIB
Product Code: GKT137831
INN or Proposed INN: Setanaxib
Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D
Calliditas Therapeutics Suisse SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
318Phase 2;Phase 3United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Canada;Belgium;Poland;Denmark;Australia;Germany;New Zealand;Sweden
2EUCTR2021-001810-13-DE
(EUCTR)
10/02/202207/10/2021A Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with PBC and Elevated Liver StiffnessTRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness
MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SETANAXIB
Product Code: GKT137831
INN or Proposed INN: Setanaxib
Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D
Genkyotex Suisse SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
318Phase 2;Phase 3United States;Czechia;Greece;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden
3EUCTR2021-001810-13-IT
(EUCTR)
18/01/202205/11/2021A Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with PBC and Elevated Liver StiffnessTRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness
MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SETANAXIB
Product Code: [GKT137831]
INN or Proposed INN: Setanaxib
Genkyotex Suisse SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
318Phase 2;Phase 3United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand;Sweden
4EUCTR2021-001810-13-ES
(EUCTR)
17/01/202219/10/2021A Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with PBC and Elevated Liver StiffnessTRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness
MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SETANAXIB
Product Code: GKT137831
INN or Proposed INN: Setanaxib
Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D
Genkyotex Suisse SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
318Phase 2;Phase 3United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden
5EUCTR2021-001810-13-AT
(EUCTR)
13/01/202211/10/2021A Trial of Setanaxib in Patients with Primary Biliary Cholangitis (PBC) and Liver Stiffness (TRANSFORM)TRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness
MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SETANAXIB
Product Code: GKT137831
INN or Proposed INN: Setanaxib
Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D
Calliditas Therapeutics Suisse SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
318Phase 2;Phase 3United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Canada;Belgium;Poland;Denmark;Australia;Germany;New Zealand;Sweden
6EUCTR2021-001810-13-PL
(EUCTR)
11/01/202228/10/2021A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness (TRANSFORM)TRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness
MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SETANAXIB
Product Code: GKT137831
INN or Proposed INN: Setanaxib
Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D
Calliditas Therapeutics Suisse SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
318Phase 2;Phase 3United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Canada;Belgium;Poland;Denmark;Australia;Germany;New Zealand;Sweden
7EUCTR2021-001810-13-HU
(EUCTR)
11/12/202130/09/2021A Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with PBC and Elevated Liver StiffnessTRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness
MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SETANAXIB
Product Code: GKT137831
INN or Proposed INN: Setanaxib
Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D
Genkyotex Suisse SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
318Phase 2;Phase 3United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand;Sweden
8EUCTR2021-001810-13-GR
(EUCTR)
07/12/202112/11/2021A Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with PBC and Elevated Liver StiffnessTRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness
MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SETANAXIB
Product Code: GKT137831
INN or Proposed INN: Setanaxib
Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D
Genkyotex Suisse SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
318Phase 2;Phase 3United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden
9EUCTR2016-004599-23-IT
(EUCTR)
26/02/201807/01/2021A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline PhosphataseA Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess theEfficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase - GSN00300 Primary Biliary Cholangitis
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: GKT137831
INN or Proposed INN: GKT137831
GENKYOTEX SANULLNot RecruitingFemale: yes
Male: yes
102Phase 2United States;Greece;Canada;Spain;Belgium;Israel;Germany;United Kingdom;Italy
10EUCTR2016-004599-23-GR
(EUCTR)
27/10/201706/07/2017A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline PhosphataseA Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase Primary Biliary Cholangitis
MedDRA version: 20.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000023866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: GKT137831
INN or Proposed INN: GKT137831
Other descriptive name: GKT137831
Genkyotex SANULLNot Recruiting Female: yes
Male: yes
102 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Greece;Belgium;Spain;Israel;Germany;Italy;United Kingdom
11EUCTR2016-004599-23-DE
(EUCTR)
19/09/201710/07/2017A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline PhosphataseA Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase Primary Biliary Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: GKT137831
INN or Proposed INN: GKT137831
Other descriptive name: GKT137831
Genkyotex SANULLNot Recruiting Female: yes
Male: yes
102 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom
12EUCTR2016-004599-23-BE
(EUCTR)
10/08/201710/04/2017A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline PhosphataseA Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase Primary Biliary Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: GKT137831
INN or Proposed INN: GKT137831
Other descriptive name: GKT137831
Genkyotex SANULLNot RecruitingFemale: yes
Male: yes
102Phase 2United States;Greece;Canada;Spain;Belgium;Israel;Germany;Italy;United Kingdom
13EUCTR2016-004599-23-ES
(EUCTR)
26/07/201704/07/2017A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline PhosphataseA Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase Primary Biliary Cholangitis
MedDRA version: 20.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000023866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: GKT137831
INN or Proposed INN: GKT137831
Other descriptive name: GKT137831
Genkyotex SANULLNot RecruitingFemale: yes
Male: yes
102Phase 2United States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom
14EUCTR2016-004599-23-GB
(EUCTR)
30/06/201717/05/2017A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline PhosphataseA Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase Primary Biliary Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: GKT137831
INN or Proposed INN: GKT137831
Other descriptive name: GKT137831
Genkyotex SANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
102 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom