Mbx-8025 (DrugBank: MBX-8025)
3 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 79 | 家族性高コレステロール血症（ホモ接合体） | 4 |
| 93 | 原発性胆汁性胆管炎［原発性胆汁性肝硬変 (~2017.3)］ | 10 |
| 94 | 原発性硬化性胆管炎 | 2 |
| 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 | EUCTR2014-004856-68-NO (EUCTR) | 29/04/2015 | 26/01/2015 | A 12-week, open-label , all subjects will first receive 2 weeks of placebo drug and then active medication in a dose escalating manner: each patient will first receive 50 mg, after evaluation the option exists to increase the dose to to 100 mg and after another evaluation to 200 mg active study drug, phase 2 study to evaluate the effects of MBX-8025 in patients with Homozygous Familial Hypercholesterolemia (HoFH) | A 12-week, open-label, dose-escalating, phase 2 study to evaluate the effects of MBX-8025 in patients with Homozygous Familial Hypercholesterolemia (HoFH) | Homozygous Familial Hypercholesterolemia;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: MBX-8025 Product Code: MBX-8025 INN or Proposed INN: MBX-8025 | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 8 | Phase 2 | France;Netherlands;Norway | ||
| 2 | EUCTR2014-004856-68-NL (EUCTR) | 23/04/2015 | 28/01/2015 | A 12-week, open-label , all subjects will first receive 2 weeks of placebo drug and then active medication in a dose escalating manner: each patient will first receive 50 mg, after evaluation the option exists to increase the dose to to 100 mg and after another evaluation to 200 mg active study drug, phase 2 study to evaluate the effects of MBX-8025 in patients with Homozygous Familial Hypercholesterolemia (HoFH) | A 12-week, open-label, dose-escalating, phase 2 study to evaluate the effects of MBX-8025 in patients with Homozygous Familial Hypercholesterolemia (HoFH) | Homozygous Familial Hypercholesterolemia;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: MBX-8025 Product Code: MBX-8025 INN or Proposed INN: MBX-8025 | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 8 | Phase 2 | France;Norway;Netherlands | ||
| 3 | NCT02472535 (ClinicalTrials.gov) | April 2015 | 22/5/2015 | Study to Evaluate the Effects of MBX-8025 in Patients With HoFH | A 12-week, Open-label, Dose-escalating, Phase 2 Study to Evaluate the Effects of MBX-8025 in Patients With Homozygous Familial Hypercholesterolemia (HoFH) | Homozygous Familial Hypercholesterolemia | Other: Run-In Period: Placebo;Drug: MBX-8025 50 mg (Dose Escalation Period 1);Drug: MBX-8025 50 mg or 100 mg (Dose Escalation Period 2);Drug: MBX-8025 50 mg, 100 mg or 200 mg (Dose Escalation Period 3) | CymaBay Therapeutics, Inc. | NULL | Completed | 18 Years | N/A | Both | 13 | Phase 2 | Canada;France;Netherlands;Norway |
| 4 | EUCTR2014-004856-68-FR (EUCTR) | 13/03/2015 | 19/05/2015 | A 12-week, open-label , all subjects will first receive 2 weeks of placebo drug and then active medication in a dose escalating manner: each patient will first receive 50 mg, after evaluation the option exists to increase the dose to to 100 mg and after another evaluation to 200 mg active study drug, phase 2 study to evaluate the effects of MBX-8025 in patients with Homozygous Familial Hypercholesterolemia (HoFH) | A 12-week, open-label, dose-escalating, phase 2 study to evaluate the effects of MBX-8025 in patients with Homozygous Familial Hypercholesterolemia (HoFH) | Homozygous Familial Hypercholesterolemia;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: MBX-8025 Product Code: MBX-8025 INN or Proposed INN: MBX-8025 | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 8 | Phase 2 | France;Norway;Netherlands |
| 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 | EUCTR2018-001171-20-NL (EUCTR) | 18/04/2019 | 16/11/2018 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United 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 | ||
| 2 | EUCTR2018-001171-20-PL (EUCTR) | 27/12/2018 | 06/11/2018 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United 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 | ||
| 3 | EUCTR2017-003910-16-GB (EUCTR) | 08/02/2018 | 15/11/2017 | A study to evaluate the safety and tolerability of seladelpar in subjects with primary biliary cholangitis | An 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. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3;Phase 4 | Serbia;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 | ||
| 4 | EUCTR2016-002996-91-DE (EUCTR) | 21/02/2017 | 17/11/2016 | A study evaluating 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) | 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 Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 2 | United States;Canada;Germany;United Kingdom | |||
| 5 | EUCTR2016-002996-91-GB (EUCTR) | 12/01/2017 | 21/11/2016 | A study evaluating 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) | 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 Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 2 | United States;Canada;Germany;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 |
| 6 | NCT02955602 (ClinicalTrials.gov) | November 28, 2016 | 2/11/2016 | Seladelpar (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 Cirrhosis | Drug: MBX-8025 2 mg Capsule;Drug: MBX-8025 5 mg Capsule;Drug: MBX-8025 10 mg Capsule | CymaBay Therapeutics, Inc. | NULL | Completed | 18 Years | 75 Years | All | 119 | Phase 2 | United States;Canada;Germany;United Kingdom |
| 7 | EUCTR2015-002698-39-PL (EUCTR) | 03/03/2016 | 08/01/2016 | A Study Evaluating the Effects of Two Doses of MBX-8025 Compared to a Placebo in Patients with Primary Biliary Cirrhosis (PBC) who have not responded to previous treatment with ursodeoxycholic acid (UDCA). | 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 MedDRA version: 18.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MBX-8025 Product Code: MBX-8025 Other descriptive name: MBX-8025 Product Name: MBX 8025 Product Code: MBX 8025 Other descriptive name: MBX-8025 | CymaBay Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | United States;Canada;Poland;Germany;United Kingdom | ||
| 8 | EUCTR2015-002698-39-DE (EUCTR) | 18/12/2015 | 30/09/2015 | A Study Evaluating the Effects of Two Doses of MBX-8025 Compared to a Placebo in Patients with Primary Biliary Cirrhosis (PBC) who have not responded to previous treatment with ursodeoxycholic acid (UDCA). | 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 MedDRA version: 19.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MBX-8025 Product Code: MBX-8025 INN or Proposed INN: NA Other descriptive name: MBX-8025 Product Name: MBX 8025 Product Code: MBX 8025 INN or Proposed INN: NA Other descriptive name: MBX-8025 | CymaBay Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | United States;Canada;Poland;Germany;United Kingdom | ||
| 9 | EUCTR2015-002698-39-GB (EUCTR) | 11/11/2015 | 17/09/2015 | A Study Evaluating the Effects of Two Doses of MBX-8025 Compared to a Placebo in Patients with Primary Biliary Cirrhosis (PBC) who have not responded to previous treatment with ursodeoxycholic acid (UDCA). | 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 MedDRA version: 18.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MBX-8025 Product Code: MBX-8025 Other descriptive name: MBX-8025 Product Name: MBX 8025 Product Code: MBX 8025 Other descriptive name: MBX-8025 | CymaBay Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | United States;Canada;Poland;Germany;United Kingdom | ||
| 10 | NCT02609048 (ClinicalTrials.gov) | November 2015 | 13/11/2015 | Study 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 mg | CymaBay Therapeutics, Inc. | NULL | Terminated | 18 Years | 75 Years | All | 41 | Phase 2 | United States;Canada;Germany;Poland;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 | EUCTR2019-001760-30-GB (EUCTR) | 11/10/2019 | 27/06/2019 | The 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 Therapeutics | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Canada;Poland;Australia;Israel;Germany;United Kingdom | ||
| 2 | EUCTR2019-001760-30-PL (EUCTR) | 18/09/2019 | 18/07/2019 | The 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 Therapeutics | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Canada;Poland;Australia;Israel;Germany;United Kingdom |