Table 1.
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.