Drug

Obeticholic acid

Regulatory activity · EMA / MHRA

Late-stage development

Also known as 6-ECDCA, 6-Ethyl-CDCA, 6-alpha-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid+2 more

6-ECDCA, 6-Ethyl-CDCA, 6-alpha-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 6alpha-Ethyl-chenodeoxycholic acid, Ocaliva.

RxNorm1798288 ChEMBLCHEMBL566315UNII0462Z4S4OZ

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Obeticholic Acid for Prevention in Barrett's Esophagus

Clinical trial2026-05-13Results expected Q3 2027 · ClinicalTrials.gov

A Phase IIa, Placebo-Controlled, Randomized Study of Daily Obeticholic Acid (OCA) to Reduce Intestinal Polyp Burden in Familial Adenomatous Polyposis (FAP)

Clinical trial2026-04-17Terminated · ClinicalTrials.gov

Obeticholic Acid Among Chronic HBV Patients with Hepatic Steatosis : Clinical and Portal Doppler Outcomes

Clinical trial2026-01-01Primary completion · ClinicalTrials.gov

A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination With Bezafibrate in Subjects With Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid

Clinical trial2025-10-14Terminated · ClinicalTrials.gov

A Phase 2a, Double-Blind, Randomized, Active Controlled, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Bezafibrate Administered in Combination With Obeticholic Acid in Subjects With Primary Biliary Cholangitis

Clinical trial2025-09-01Completed · ClinicalTrials.gov

Comparative Study Evaluating the Outcome of Obeticholic Acid Versus Vitamin E in Patients with Non-alcoholic Steatohepatitis Without Cirrhosis

Clinical trial2025-01-10Results expected Q4 2026 · ClinicalTrials.gov

Market withdrawal: Ocaliva (EMA)

Regulatory2024-08-30EMA

Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients

Clinical trial2024-08-27Results posted · ClinicalTrials.gov

Effectiveness of Obeticholic Acid Versus Vitamin E in Patients of Non-alcoholic Fatty Liver Disease

Clinical trial2024-05-23Completed · ClinicalTrials.gov

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis

Clinical trial2023-10-23Results posted · ClinicalTrials.gov

A Multi-center, Randomized, Double-blind Trail Evaluating the Efficacy and Safety of Combination of Obecholic Acid and UDCA Compared With UDCA Monotherapy in PBC Patients With an Inadequate Response to UDCA .

Clinical trial2023-09-20Primary completion · ClinicalTrials.gov

Drug Safety Update: Obeticholic acid (Ocaliva▼): risk of serious liver injury in patients with pre-existing moderate or severe hepatic impairment; reminder to adjust dosing according to liver function monitoring

Regulatory2018-04-24MHRA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Obeticholic acid

Aliases & brands

6-ECDCA6-Ethyl-CDCA6-alpha-ethylchenodeoxycholic acid6-ethylchenodeoxycholic acid6alpha-Ethyl-chenodeoxycholic acidOcaliva

RxNorm CUI

1798288

ChEMBL ID

CHEMBL566315

UNII

0462Z4S4OZ

Regulatory jurisdictions

emamhra

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities

EMA · MHRA

Total events

emaEuropean Medicines Agency· 1 event

2024-08-30Market withdrawalMarket

Market withdrawal: Ocaliva (EMA)

Indication: Ocaliva is indicated for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an… Show full indication

Ocaliva is indicated for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.

Evidence ↗

mhraMedicines and Healthcare products Regulatory Agency· 1 event

2018-04-24Safety communicationSafety

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).