Obeticholic acid

Overview

Primary biliary cirrhosis, or PBC, is a progressive and chronic condition that leads to hepatic injury often resulting in end-stage liver failure that requires liver transplantation. Obeticholic acid is a farnesoid-X receptor (FXR) agonist used to treat this condition, possibly allowing for increased survival. In 2016, it was granted approval to treat primary biliary cholangitis in combination with ursodeoxycholic acid, which was previously the mainstay treatment for this condition. In May 2021, the FDA updated its prescribing information to contraindicate the use of obeticholic acid in patients with PBC and advanced cirrhosis (e.g. those with portal hypertension or hepatic decompensation) due to a risk of liver failure, in some cases requiring liver transplantation. Obeticholic acid is currently being considered for FDA approval to treat fibrosis caused by non-alcoholic liver steatohepatitis (NASH). The NDA from Intercept Pharmaceuticals was approved in November 2019 and obeticholic acid is expected to be granted full approval for this indication in 2020.

Indication

用于治疗原发性胆汁性胆管炎(PBC)或用于治疗原发性胆汁性肝硬化（PBC）。

Associated Conditions

Primary Biliary Cholangitis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Obeticholic Acid Versus Placebo, in Combination with Ursodeoxycholic Acid in Patients with Primary Biliary Cirrhosis	2024/12/04	NCT06715319	Phase 3	Completed	Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Obeticholic Acid (OCA) Compared to Placebo in Pediatric Participants With Biliary Atresia, Post-hepatoportoenterostomy	2023/11/07	NCT06121375	Phase 2	Recruiting	Intercept Pharmaceuticals
The Effect of Obeticholic Acid in Healthy Volunteers	2023/02/23	NCT05740631	Not Applicable	Recruiting	Universitaire Ziekenhuizen KU Leuven
Comparative Study Between Obeticholic Acid Versus Vitamin E in Patients with Non-alcoholic Steatohepatitis	2022/10/10	NCT05573204	Phase 2	Active, not recruiting	Tanta University
Testing Obeticholic Acid for Familial Adenomatous Polyposis	2022/02/03	NCT05223036	Phase 2	Recruiting	National Cancer Institute (NCI)
Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Adult Participants	2021/11/24	NCT05133830	Phase 1	Completed	GlaxoSmithKline
Study of Obeticholic Acid（OCA） Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC)	2021/07/09	NCT04956328	Phase 3	UNKNOWN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Obeticholic Acid for Prevention in Barrett's Esophagus	2021/06/25	NCT04939051	Phase 2	Recruiting	National Cancer Institute (NCI)
Study of OCA in Combination with BZF Evaluating Efficacy, Safety, and Tolerability in Participants with PBC	2020/10/20	NCT04594694	Phase 2	Active, not recruiting	Intercept Pharmaceuticals
Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis	2019/09/03	NCT04076527	N/A	Recruiting	University of Leipzig

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Ocaliva	Intercept Pharmaceuticals Inc	69516-010	ORAL	10 mg in 1 1	10/18/2022
Ocaliva	Intercept Pharmaceuticals Inc	69516-005	ORAL	5 mg in 1 1	10/18/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Ocaliva	Advanz Pharma Limited,Unit 17,Northwood House,Northwood Crescent,Dublin 9,D09 V504,Ireland	Revoked	12/12/2016

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
OCALIVA obeticholic acid 5 mg tablet bottle	293379	Chiesi Australia Pty Ltd	Medicine	A	9/21/2018
OCALIVA obeticholic acid 10 mg tablet bottle	293378	Chiesi Australia Pty Ltd	Medicine	A	9/21/2018

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
OCALIVA	advanz pharma canada inc.	02463121	Tablet - Oral	5 MG	5/26/2017
OCALIVA	advanz pharma canada inc.	02463148	Tablet - Oral	10 MG	5/26/2017

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

GSK's Linerixibat Shows Significant Improvement in Cholestatic Pruritus for Primary Biliary Cholangitis Patients

4 months ago

GSK's phase III GLISTEN trial demonstrates linerixibat significantly improves cholestatic pruritus (relentless itch) in patients with primary biliary cholangitis, addressing a major quality of life concern.

Ipsen Secures Dual CHMP Approvals for Rare Liver Disease Treatments Following Regulatory Strategy Shift

4 months ago

Ipsen received CHMP approval for odevixibat under the new brand name Kayfanda for Alagille syndrome, marking the second approval for the same drug after rebranding due to orphan status complications.

Madrigal's Resmetirom Shows Promise in NASH Treatment Where Others Have Failed

5 months ago

Madrigal Pharmaceuticals' resmetirom demonstrated significant efficacy in the Phase 3 MAESTRO-NASH trial, achieving both primary endpoints of NASH resolution and liver fibrosis improvement.

Eli Lilly Acquires Organovo's FXR Agonist Program for IBD in $60M Deal

6 months ago

• Eli Lilly has secured worldwide rights to Organovo's FXR agonist program, including lead candidate FXR314, with a $10M upfront payment and potential milestone payments of up to $50M. • FXR314 demonstrated promising Phase II results in MASH trials, achieving a significant 22.8% mean reduction in liver fat content compared to 6.1% in the placebo group. • The development focus will shift to inflammatory bowel disease (IBD), with a Phase II trial planned for Q4 2025, despite earlier success in MASH indications.

FDA Grants Accelerated Approval to Ipsen's Iqirvo, First Dual PPAR Agonist for Primary Biliary Cholangitis

7 months ago

Ipsen's Iqirvo (elafibranor) receives FDA accelerated approval as the first dual PPAR alpha/delta agonist and first new therapy in over a decade for primary biliary cholangitis treatment.

Help Us Improve

Your feedback helps us provide better drug information and insights.

AI-Powered Research

Premium Access