Norucholic acid ( DrugBank: Norucholic acid )
2 diseases
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 93 | Primary biliary cholangitis | 2 |
| 94 | Primary sclerosing cholangitis | 8 |
93. Primary biliary cholangitis
Clinical trials : 298 / Drugs : 252 - (DrugBank : 59) / Drug target genes : 35 - Drug target pathways : 115
| 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 | EUCTR2021-001431-56-FI (EUCTR) | 04/05/2022 | 10/03/2022 | Clinical study comparing two doses of norucholic acid against placebo in the treatment of a liver disease called primary biliary cholangitis in patients without sufficient response to ursodeoxycholic acid | Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of norucholic acid tablets with placebo in the treatment of primary biliary cholangitis in patients with an inadequate response to ursodeoxycholic acid - NCA vs. placebo in PBC | primary biliary cholangitis 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: Norucholic acid (NCA) 500 mg Product Code: NCA 500mg INN or Proposed INN: Norucholic acid Other descriptive name: norucholic acid | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | France;Finland;Poland;Belgium;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland | ||
| 2 | EUCTR2021-001431-56-DE (EUCTR) | 07/03/2022 | 03/11/2021 | Clinical study comparing two doses of norucholic acid against placebo in the treatment of a liver disease called primary biliary cholangitis in patients without sufficient response to ursodeoxycholic acid | Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of norucholic acid tablets with placebo in the treatment of primary biliary cholangitis in patients with an inadequate response to ursodeoxycholic acid - NCA vs. placebo in PBC | primary biliary cholangitis 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: Norucholic acid (NCA) 500 mg Product Code: NCA 500mg INN or Proposed INN: Norucholic acid Other descriptive name: norucholic acid | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Finland;Spain;Lithuania;Austria;Switzerland;United Kingdom;France;Belgium;Poland;Denmark;Germany;Netherlands;Norway |
94. Primary sclerosing cholangitis
Clinical trials : 148 / Drugs : 118 - (DrugBank : 39) / Drug target genes : 18 - Drug target pathways : 141
| 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 | EUCTR2016-003367-19-SE (EUCTR) | 25/04/2018 | 12/02/2018 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis | Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of assumed autoimmune, but finally unidentified etiology, characterized by a chronic inflammatory and fibro-obliterative destruction of extra-, and intrahepatic bile ducts. The disease is characterized by diffuse inflammation, fibrosis, and strictures of the intra- and/or extrahepatic bile ducts with an impaired biliary secretion of potentially aggressive bile fluid often leading to cirrhosis. 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: Norursodeoxycholic acid INN or Proposed INN: Norucholic acid Other descriptive name: Norursodeoxycholic acid, NCA | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | ||
| 2 | EUCTR2016-003367-19-CZ (EUCTR) | 09/04/2018 | 08/01/2018 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis | Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of assumed autoimmune, but finally unidentified etiology, characterized by a chronic inflammatory and fibro-obliterative destruction of extra-, and intrahepatic bile ducts. The disease is characterized by diffuse inflammation, fibrosis, and strictures of the intra- and/or extrahepatic bile ducts with an impaired biliary secretion of potentially aggressive bile fluid often leading to cirrhosis. 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: Norursodeoxycholic acid INN or Proposed INN: Norucholic acid Other descriptive name: Norursodeoxycholic acid, NCA | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 3 | EUCTR2016-003367-19-BE (EUCTR) | 30/03/2018 | 09/01/2018 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis | Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of assumed autoimmune, but finally unidentified etiology, characterized by a chronic inflammatory and fibro-obliterative destruction of extra-, and intrahepatic bile ducts. The disease is characterized by diffuse inflammation, fibrosis, and strictures of the intra- and/or extrahepatic bile ducts with an impaired biliary secretion of potentially aggressive bile fluid often leading to cirrhosis. 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: Norursodeoxycholic acid INN or Proposed INN: Norucholic acid Other descriptive name: Norursodeoxycholic acid, NCA | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 4 | EUCTR2016-003367-19-DK (EUCTR) | 20/03/2018 | 01/02/2018 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis | Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of assumed autoimmune, but finally unidentified etiology, characterized by a chronic inflammatory and fibro-obliterative destruction of extra-, and intrahepatic bile ducts. The disease is characterized by diffuse inflammation, fibrosis, and strictures of the intra- and/or extrahepatic bile ducts with an impaired biliary secretion of potentially aggressive bile fluid often leading to cirrhosis. 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: Norursodeoxycholic acid INN or Proposed INN: Norucholic acid Other descriptive name: Norursodeoxycholic acid, NCA | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 5 | EUCTR2016-003367-19-FI (EUCTR) | 09/01/2018 | 11/12/2017 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis | Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of assumed autoimmune, but finally unidentified etiology, characterized by a chronic inflammatory and fibro-obliterative destruction of extra-, and intrahepatic bile ducts. The disease is characterized by diffuse inflammation, fibrosis, and strictures of the intra- and/or extrahepatic bile ducts with an impaired biliary secretion of potentially aggressive bile fluid often leading to cirrhosis. 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: Norursodeoxycholic acid INN or Proposed INN: Norucholic acid Other descriptive name: Norursodeoxycholic acid, NCA | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Netherlands;Germany;Norway;Sweden | ||
| 6 | EUCTR2016-003367-19-DE (EUCTR) | 28/09/2017 | 19/06/2017 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis | Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of assumed autoimmune, but finally unidentified etiology, characterized by a chronic inflammatory and fibro-obliterative destruction of extra-, and intrahepatic bile ducts. The disease is characterized by diffuse inflammation, fibrosis, and strictures of the intra- and/or extrahepatic bile ducts with an impaired biliary secretion of potentially aggressive bile fluid often leading to cirrhosis. 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: Norursodeoxycholic acid INN or Proposed INN: Norucholic acid Other descriptive name: Norursodeoxycholic acid, NCA | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 7 | EUCTR2016-003367-19-AT (EUCTR) | 01/08/2017 | 27/06/2017 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis | Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of assumed autoimmune, but finally unidentified etiology, characterized by a chronic inflammatory and fibro-obliterative destruction of extra-, and intrahepatic bile ducts. The disease is characterized by diffuse inflammation, fibrosis, and strictures of the intra- and/or extrahepatic bile ducts with an impaired biliary secretion of potentially aggressive bile fluid often leading to cirrhosis. 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: Norursodeoxycholic acid INN or Proposed INN: Norucholic acid Other descriptive name: Norursodeoxycholic acid, NCA | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 8 | EUCTR2016-003367-19-NO (EUCTR) | 07/03/2018 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis | Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of assumed autoimmune, but finally unidentified etiology, characterized by a chronic inflammatory and fibro-obliterative destruction of extra-, and intrahepatic bile ducts. The disease is characterized by diffuse inflammation, fibrosis, and strictures of the intra- and/or extrahepatic bile ducts with an impaired biliary secretion of potentially aggressive bile fluid often leading to cirrhosis. 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: Norursodeoxycholic acid INN or Proposed INN: Norucholic acid Other descriptive name: Norursodeoxycholic acid, NCA | Dr. Falk Pharma GmbH | NULL | NA | Female: yes Male: yes | 300 | Phase 3 | Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden |