Clinical Trials

Obeticholic acid is evaluated in numerous clinical trials from Early Phase 1 through Phase 4, focusing on indications such as nonalcoholic steatohepatitis (NASH), primary biliary cholangitis, cholestasis, compensated cirrhosis, obesity, and Barrett's esophagus. Sponsored by pharmaceutical entities like Intercept Pharmaceuticals and GlaxoSmithKline alongside academic institutions such as the National Cancer Institute and Universitaire Ziekenhuizen KU Leuven, these studies encompass completed, actively recruiting, terminated, and withdrawn trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04939051 RECRUITING
Barrett Esophagus; Esophageal Adenocarcinoma
National Cancer Institute (NCI)
 2024-01-03 PHASE2
NCT05573204 ACTIVE_NOT_RECRUITING
Non-alcoholic Steatohepatitis
Tanta University
 2021-09-01 PHASE2
NCT05223036 TERMINATED
Attenuated Familial Adenomatous Polyposis; Colorectal Carcinoma; Duodenal Carcinoma; Familial Adenomatous Polyposis
National Cancer Institute (NCI)
 2023-01-19 PHASE2
NCT06691412 NOT_YET_RECRUITING
Hepatitis B Virus; Steatosis
Assiut University
 2024-11-15 PHASE3
NCT06121375 TERMINATED
Biliary Atresia
Intercept Pharmaceuticals
 2024-09-02 PHASE2; PHASE3
NCT06488911 TERMINATED
Primary Biliary Cholangitis
Intercept Pharmaceuticals
 2024-07-01 PHASE3
NCT04594694 TERMINATED
Primary Biliary Cholangitis
Intercept Pharmaceuticals
 2019-10-02 PHASE2
NCT05239468 COMPLETED
Primary Biliary Cholangitis
Intercept Pharmaceuticals
 2022-03-21 PHASE2
NCT06247735 COMPLETED
Primary Biliary Cholangitis
Kowa Research Institute, Inc.
 2024-02-07 PHASE2
NCT05450887 COMPLETED
Primary Biliary Cholangitis
Nanjing Chia-tai Tianqing Pharmaceutical
 2021-09-23 PHASE3
NCT07104786 COMPLETED
Non Alcoholic Fatty Liver Disease
King Edward Medical University
 2023-08-24 PHASE2
NCT04956328 UNKNOWN
Primary Biliary Cirrhosis
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
 2021-07-22 PHASE3
NCT02548351 TERMINATED
Non Alcoholic Steatohepatitis (NASH)
Intercept Pharmaceuticals
 2015-09-22 PHASE3
NCT05740631 UNKNOWN
Healthy
Universitaire Ziekenhuizen KU Leuven
 2022-08-22
NCT05321524 TERMINATED
Biliary Atresia
Intercept Pharmaceuticals
 2015-07-01 PHASE2
NCT02430077 COMPLETED
Familial Partial Lipodystrophy
Abhimanyu Garg
 2016-06 PHASE2
NCT03439254 COMPLETED
Compensated Cirrhosis; Nonalcoholic Steatohepatitis
Intercept Pharmaceuticals
 2017-08-30 PHASE3
NCT05740631 Recruiting
Healthy
Universitaire Ziekenhuizen KU Leuven|Intercept Pharmaceuticals
 2022-08-22 Not Applicable
NCT05133830 COMPLETED
Pruritus
GlaxoSmithKline
 2021-11-23 PHASE1
NCT02308111 TERMINATED
Liver Cirrhosis, Biliary
Intercept Pharmaceuticals
 2014-12-26 PHASE4
NCT03633227 TERMINATED
Liver Cirrhosis, Biliary
Intercept Pharmaceuticals
 2018-06-22 PHASE4
NCT02532335 UNKNOWN
Obesity
Sahlgrenska University Hospital
 2015-08 PHASE1
NCT03836937 COMPLETED
Non-Alcoholic Fatty Liver Disease
Sir Salimullah Medical College Mitford Hospital
 2019-03-05
NCT04053023 COMPLETED
Cholestasis
GlaxoSmithKline
 2019-08-27 PHASE1
NCT02654236 COMPLETED
Alcohol Consumption
Suthat Liangpunsakul
 2016-04
NCT03253276 COMPLETED
Primary Biliary Cirrhosis
University of Aarhus
 2016-05-19 EARLY_PHASE1
NCT02039219 TERMINATED
Alcoholic Hepatitis
Naga P. Chalasani
 2014-11-03 PHASE2
NCT02633956 COMPLETED
Nonalcoholic Steatohepatitis
Intercept Pharmaceuticals
 2015-12-04 PHASE2
NCT02177136 COMPLETED
Primary Sclerosing Cholangitis (PSC)
Intercept Pharmaceuticals
 2015-02-09 PHASE2
NCT01625026 COMPLETED
Obesity; Gallstones
Sahlgrenska University Hospital
 2013-09 PHASE2
NCT02633956 Completed
Nonalcoholic Steatohepatitis
Intercept Pharmaceuticals
 2015-12-04 Phase 2
NCT02548351 Terminated
Non Alcoholic Steatohepatitis (NASH)
Intercept Pharmaceuticals
 2015-09-22 Phase 3
NCT01865812 COMPLETED
Primary Biliary Cirrhosis
Intercept Pharmaceuticals
 2013-12-03 PHASE2
NCT01585025 COMPLETED
Primary Bile Acid Malabsorption; Secondary Bile Acid Malabsorption; Chronic Diarrhoea
Imperial College Healthcare NHS Trust
 2012-04 PHASE2
NCT01265498 COMPLETED
Nonalcoholic Fatty Liver Disease (NAFLD); Nonalcoholic Steatohepatitis (NASH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2011-03 PHASE2
NCT01473524 COMPLETED
Primary Biliary Cirrhosis
Intercept Pharmaceuticals
 2012-01 PHASE3
NCT01933503 COMPLETED
Healthy
Intercept Pharmaceuticals
 2013-10 PHASE1
NCT01914562 COMPLETED
Healthy
Intercept Pharmaceuticals
 2013-08 PHASE1
NCT01904539 COMPLETED
Hepatic Impairment
Intercept Pharmaceuticals
 2013-06 PHASE1
NCT00570765 COMPLETED
Liver Cirrhosis, Biliary
Intercept Pharmaceuticals
 2008-01-17 PHASE2
NCT00550862 TERMINATED
Liver Cirrhosis, Biliary
Intercept Pharmaceuticals
 2007-10 PHASE2
NCT00501592 COMPLETED
Diabetes Mellitus, Type II; Fatty Liver
Intercept Pharmaceuticals
 2007-07 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-11)

Check the Obeticholic Acid (INT-747) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Obeticholic acid selectively binds to and activates the farnesoid X receptor (FXR) with an EC50 of 99 nM, modulating downstream gene transcription involved in bile acid regulation, lipid homeostasis, and autophagy. By suppressing hepatic bile acid synthesis and attenuating intracellular lipid accumulation, this agonist activity reduces liver inflammation and tissue damage, directly underpinning its clinical evaluation for nonalcoholic steatohepatitis and cholestasis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Jump to

Note: Technical data last updated: Sep 1, 2026.