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. Author manuscript; available in PMC: 2018 Apr 16.
Published in final edited form as: Nat Rev Gastroenterol Hepatol. 2017 Oct 11;15(2):111–128. doi: 10.1038/nrgastro.2017.119

Table 1.

Clinical trials and ongoing studies of targeting bile acid signalling in gastrointestinal diseases

Agent Gastrointestinal Condition Type of study Status Phase of development Reference
FXR agonist
OCA Patients with PBC who have inadequate response to UDCA Randomized, Double Blind, Placebo Controlled Still recruiting Phase III 217
Px-104 NAFLD Open label Complete phase II 218
OCA PSC Randomized, Double Blind, Placebo Controlled Ongoing, but not recruiting participants phase II 219
LJN452 PBC Randomized, Double-blind, Placebo-controlled Still recruiting phase II 220
OCA NASH and fibrosis Randomized, Double Blind, Placebo Controlled Still recruiting Phase III 221
OCA Moderately severe alcoholic hepatitis Randomized, Double Blind, Placebo Controlled Still recruiting phase II 222
OCA NAFLD, NASH Randomized, Double Blind, Placebo Controlled Complete Phase II 223
TGR5 agonist
INT-767 (23-sulphate derivative of OCA) PSC phase I 224
INT-777 (6α-ethyl-23(S)-methylcholic acid) NASH preclinical 225
VDR related
Vitamin D3 IBD and Hypovitaminosis D Randomized, Parallel Assignment, Double Blind Complete Phase III 226
Vitamin D3 IBD, Ulcerative Colitis, Crohn Disease Interventional, Single Group Assignment Not yet recruiting Phase III 227
UDCA related
norUDCA PSC Randomized, Parallel Assignment, Double Blind Complete Phase II 228
UDCA Polycystic Liver Disease Interventional, Single Group Assignment, Open Label Complete Phase III 229
UDCA Functional Dyspepsia Randomized, Double Blind, Placebo Controlled Not yet recruiting Phase IV 230
TUDCA PBC Randomized, Parallel Assignment, Double Blind Complete Phase III 231
UDCA FAP, Duodenal Neoplasms, Duodenal Polyps Randomized, Parallel Assignment, Double Blind Complete Phase III 232

Abbreviations:

CD, Crohn Disease; FAP, Familial Adenomatous Polyposis; FXR, farnesoid X receptor; IBD, inflammatory bowel disease; INT-767, 23-sulphate derivative of OCA; INT-777, 6α-ethyl-23(S)-methylcholic acid; NAFLD, nonalcoholic fatty liver disease; NASH, nonalcoholic steatohepatitis; Nor UDCA, norursodeoxycholic acid; OCA, obeticholic acid; UDCA, ursodeoxycholic acid; PBC, primary biliary cirrhosis; PSC, primary sclerosing cholangitis; TGR5, G-protein-coupled bile acid receptor 1; TUDCA, tauroursodeoxycholic acid; UC, Ulcerative Colitis; UDCA, ursodeoxycholic acid; VDR, Vitamin D receptor.