Linerixibat (GSK2330672) 40 mg ( DrugBank: GSK-2330672 )


1 disease
IDDisease name (Link within this page)Number of trials
93Primary biliary cholangitis3

93. Primary biliary cholangitis


Clinical trials : 298 Drugs : 252 - (DrugBank : 59) / Drug target genes : 35 - Drug target pathways : 115
No.TrialIDDate_
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PhaseCountries
1EUCTR2019-003158-10-GR
(EUCTR)
19/12/202225/10/2022Linerixibat Long-term Safety and Tolerability Study (LLSAT)Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants with Primary Biliary Cholangitis - Long-term safety&tolerability of GSK2330672 as a treatment for cholestatic pruritus participants PBC Moderate to Severe Pruritus (itching) caused by primary biliary cholangitis (PBC)
MedDRA version: 24.1;Level: PT;Classification code 10064190;Term: Cholestatic pruritus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 21.0;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: linerixibat (GSK2330672) 40 mg
Product Code: GSK2330672
INN or Proposed INN: Linerixibat
GlaxoSmithKline Research & Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
305Phase 3United States;Czechia;Greece;Israel;Russian Federation;Italy;United Kingdom;Switzerland;France;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Bulgaria;China;Japan
2EUCTR2019-003158-10-BE
(EUCTR)
31/01/202223/11/2021Linerixibat Long-term Safety and Tolerability Study (LLSAT)Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants with Primary Biliary Cholangitis - Long-term safety&tolerability of GSK2330672 as a treatment for cholestatic pruritus participants PBC Moderate to Severe Pruritus (itching) caused by primary biliary cholangitis (PBC)
MedDRA version: 24.1;Level: PT;Classification code 10064190;Term: Cholestatic pruritus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 21.0;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: linerixibat (GSK2330672) 40 mg
Product Code: GSK2330672
INN or Proposed INN: Linerixibat
GlaxoSmithKline Research & Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
305Phase 3United States;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Brazil;Poland;China;Japan
3EUCTR2019-003158-10-PL
(EUCTR)
22/06/202027/03/2020Linerixibat Long-term Safety and Tolerability Study (LLSAT)Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants with Primary Biliary Cholangitis - Long-term safety&tolerability of GSK2330672 as a treatment for cholestatic pruritus participants PBC Moderate to Severe Pruritus (itching) caused by primary biliary cholangitis (PBC)
MedDRA version: 21.1;Level: PT;Classification code 10064190;Term: Cholestatic pruritus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 21.0;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: linerixibat (GSK2330672) 45mg
Product Code: GSK2330672
INN or Proposed INN: Linerixibat
Product Name: linerixibat (GSK2330672) 40 mg
Product Code: GSK2330672
INN or Proposed INN: Linerixibat
Product Name: linerixibat (GSK2330672) 45 mg
Product Code: GSK2330672
INN or Proposed INN: Linerixibat
GlaxoSmithKline Research & Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 3France;United States;Canada;Poland;Italy;United Kingdom;Japan