Seladelpar    (DrugBank: -)

2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
93原発性胆汁性胆管炎[原発性胆汁性肝硬変 (~2017.3)]16
94原発性硬化性胆管炎3

93. 原発性胆汁性胆管炎[原発性胆汁性肝硬変 (~2017.3)] [臨床試験数:230,薬物数:215(DrugBank:51),標的遺伝子数:34,標的パスウェイ数:107
Searched query = "Primary biliary cholangitis", "Primary biliary cirrhosis", "PBC"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
16 / 230 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04620733
(ClinicalTrials.gov)
January 20214/11/2020RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)Primary Biliary CholangitisDrug: Seladelpar 10 mg;Drug: Placebo;Drug: Seladelpar 5 mgCymaBay Therapeutics, Inc.NULLNot yet recruiting18 Years75 YearsAll180Phase 3NULL
2EUCTR2018-001171-20-AT
(EUCTR)
29/04/201919/10/2018A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240Phase 3Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of
3EUCTR2018-001171-20-NL
(EUCTR)
18/04/201916/11/2018A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
CymaBay Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Serbia;Greece;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of
4EUCTR2018-001171-20-BE
(EUCTR)
06/03/201929/01/2019A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240Phase 3Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of
5EUCTR2018-001171-20-FR
(EUCTR)
23/01/201918/10/2018A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240Phase 3Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2018-001171-20-PL
(EUCTR)
27/12/201806/11/2018A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
CymaBay Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Serbia;Greece;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of
7EUCTR2018-001171-20-ES
(EUCTR)
21/12/201818/01/2019A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240Phase 3Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of
8EUCTR2018-001171-20-DE
(EUCTR)
20/12/201818/10/2018A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240Phase 3Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of
9NCT03602560
(ClinicalTrials.gov)
November 26, 201818/7/2018ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)A 52-week, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Safety and Efficacy of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)Primary Biliary CholangitisDrug: seladelpar 5-10 mg;Drug: seladelpar 10 mg;Drug: PlaceboCymaBay Therapeutics, Inc.NULLSuspended18 Years75 YearsAll240Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;Chile;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Spain;United Kingdom
10EUCTR2018-001171-20-HU
(EUCTR)
26/11/201818/10/2018A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240Phase 3Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2018-001171-20-GR
(EUCTR)
23/11/201818/10/2018A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA).A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240Phase 3Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of
12EUCTR2017-003910-16-GB
(EUCTR)
08/02/201815/11/2017A study to evaluate the safety and tolerability of seladelpar in subjects with primary biliary cholangitisAn Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC) Primary Biliary Cholangitis
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Seladelpar
Product Code: MBX-8025, DSIC
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025, DSIC
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025, Formulation 2
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025, Formulation 2
INN or Proposed INN: SELADELPAR
CymaBay Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
350Phase 3;Phase 4Serbia;United States;Greece;Spain;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of
13EUCTR2017-003910-16-DE
(EUCTR)
29/01/201804/12/2017A study to evaluate the safety and tolerability of seladelpar in subjects with primary biliary cholangitisAn Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC) Primary Biliary Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
CymaBay Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
128Phase 2;Phase 3United States;Canada;Germany;United Kingdom
14NCT03301506
(ClinicalTrials.gov)
December 12, 201726/9/2017Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)Primary Biliary CirrhosisDrug: Seladelpar 5 mg Capsule;Drug: Seladelpar 10 mg CapsuleCymaBay Therapeutics, Inc.NULLActive, not recruiting18 Years75 YearsAll500Phase 3United States;Canada;Germany;United Kingdom
15NCT02955602
(ClinicalTrials.gov)
November 28, 20162/11/2016Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)An 8-week, Dose Ranging, Open Label, Randomized, Phase 2 Study With a 44-week Extension, to Evaluate the Safety and Efficacy of MBX-8025 in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or Intolerance to Ursodeoxycholic Acid (UDCA)Primary Biliary CirrhosisDrug: MBX-8025 2 mg Capsule;Drug: MBX-8025 5 mg Capsule;Drug: MBX-8025 10 mg CapsuleCymaBay Therapeutics, Inc.NULLCompleted18 Years75 YearsAll119Phase 2United States;Canada;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT02609048
(ClinicalTrials.gov)
November 201513/11/2015Study to Evaluate the Effects of Two Doses of MBX-8025 in Subjects With Primary Biliary Cirrhosis (PBC)A 12-week, Double-blind, Randomized, Placebo-controlled, Phase 2 Study, to Evaluate the Effects of Two Doses of MBX-8025 in Subjects With Primary Biliary Cirrhosis (PBC) and an Inadequate Response to Ursodeoxycholic Acid (UDCA)Primary Biliary Cirrhosis (PBC)Drug: Placebo Comparator;Drug: Experimental: Seladelpar / MBX-8025 50 mg;Drug: Experimental: Seladelpar / MBX-8025 200 mgCymaBay Therapeutics, Inc.NULLTerminated18 Years75 YearsAll41Phase 2United States;Canada;Germany;Poland;United Kingdom

94. 原発性硬化性胆管炎 [臨床試験数:134,薬物数:105(DrugBank:37),標的遺伝子数:18,標的パスウェイ数:131
Searched query = "Primary sclerosing cholangitis", "PSC"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
3 / 134 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-001760-30-GB
(EUCTR)
11/10/201927/06/2019The aim of this study is to assess the safety, tolerability and efficacy of seladelpar in subjects with Primary Sclerosing Cholangitis (PSC)A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of Seladelpar Administered for 24 Weeks in Adult Patients with Primary Sclerosing Cholangitis (PSC) Primary Sclerosing Cholangitis (PSC) is a chronic cholestatic liver disease that is characterized by diffuse inflammation and fibrosis of the bile ducts. The intra and/or extrahepatic bile ducts can be affected with ongoing ductal destruction leading to cholestasis, advanced fibrosis, and cirrhosis. Disease progression will eventually lead to liver failure with its consequent complications such as portal hypertension and increased risk of malignancy, including HCC and cholangiocarcinoma.
MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
CymaBay TherapeuticsNULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Canada;Poland;Australia;Israel;Germany;United Kingdom
2EUCTR2019-001760-30-PL
(EUCTR)
18/09/201918/07/2019The aim of this study is to assess the safety, tolerability and efficacy of seladelpar in subjects with Primary Sclerosing Cholangitis (PSC)A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of Seladelpar Administered for 24 Weeks in Adult Patients with Primary Sclerosing Cholangitis (PSC) Primary Sclerosing Cholangitis (PSC) is a chronic cholestatic liver disease that is characterized by diffuse inflammation and fibrosis of the bile ducts. The intra and/or extrahepatic bile ducts can be affected with ongoing ductal destruction leading to cholestasis, advanced fibrosis, and cirrhosis. Disease progression will eventually lead to liver failure with its consequent complications such as portal hypertension and increased risk of malignancy, including HCC and cholangiocarcinoma.
MedDRA version: 20.0;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
CymaBay TherapeuticsNULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Canada;Poland;Australia;Israel;Germany;United Kingdom
3NCT04024813
(ClinicalTrials.gov)
August 15, 201920/6/2019A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSCA Phase 2, Randomized, Double Blind, Placebo Controlled, Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of Seladelpar Administered for 24 Weeks in Adult Patients With Primary Sclerosing Cholangitis (PSC)Primary Sclerosing CholangitisDrug: Seladelpar;Drug: Placebo to match SeladelparCymaBay Therapeutics, Inc.NULLSuspended18 YearsN/AAll1Phase 2United States;Canada;Poland