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Ocaliva

(Obeticholic acid)

ApprovedSmall molecule

IIntercept Pharmaceuticals

Obeticholic acid is used to treat primary biliary cholangitis (PBC), a rare liver disease where the immune system damages bile ducts, causing bile to build up in the liver and damage it over time.[2] Ocaliva is currently approved and in use across 13 indications[4].[1]

Ocaliva is one of 179 small molecule programs targeting NASH/MASH. It is currently in Approved.

13

Indications

30

Total Trials

3

Active Trials

178

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

7

Patents

Pipeline

Status by Indication[4][1]

Indication

NASH/MASHApproved

Fatty Liver DiseaseActive, not recruiting

ObesityApproved

Liver DiseaseApproved

Hepatitis, AlcoholicApproved

InsomniaActive, not recruiting

Biliary Liver CirrhosisActive, not recruiting

Alcohol DrinkingActive, not recruiting

CholangitisActive, not recruiting

Familial Partial LipodystrophyApproved

NASH/MASHApproved

Approved

Fatty Liver DiseasePreclinical

Active, not recruiting

ObesityApproved

Approved

Liver DiseaseApproved

Approved

Hepatitis, AlcoholicApproved

Approved

InsomniaPreclinical

Active, not recruiting

Biliary Liver CirrhosisApproved

Active, not recruiting

Alcohol DrinkingPreclinical

Active, not recruiting

CholangitisApproved

Active, not recruiting

Familial Partial LipodystrophyApproved

Approved

Showing 10 of 13 indications

Competition

Competitive Landscape

190 competitors in Obesity

#DrugCompanyPhaseTrials

Ocaliva

IIntercept Pharmaceuticals

Maridebart Cafraglutide

NNC0487-0111

Gemtesa

Sumitomo Pharma America, Inc.

Zenagamtide

Berobenatide

Ribupatide

Elecoglipron

PF-08653944

Survodutide

Boehringer Ingelheim

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Non-Alcoholic Steatohepatitis

NCT05573204

Q3 2027

Phase 2Recruiting

Barrett Esophagus

NCT04939051

Clinical

Trials by Indication[1]

Primary Biliary Cholangitis4 trials

Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis

Terminated·IIntercept Pharmaceuticals·Phase 4·NCT02308111·334 enrolled

Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment

Terminated·IIntercept Pharmaceuticals·Phase 4·NCT03633227·22 enrolled

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

Completed·IIntercept Pharmaceuticals·Phase 2·NCT05239468·72 enrolled

Show 1 more trial

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

Terminated·IIntercept Pharmaceuticals·Phase 2·NCT04594694·75 enrolled

Primary Biliary Cirrhosis3 trials

Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC)

Completed·IIntercept Pharmaceuticals·Phase 2·NCT00570765·60 enrolled

Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis

Completed·IIntercept Pharmaceuticals·Phase 3·NCT01473524·217 enrolled

Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis

Completed·IIntercept Pharmaceuticals·Phase 2·NCT01865812·27 enrolled

Interaction2 trials

Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Adult Participants

Completed· GSK logo

GSK·Phase 1·NCT05133830·52 enrolled

Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Subjects

Completed· GSK logo

GSK·Phase 1·NCT04053023·19 enrolled

Cirrhosis2 trials

Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis

Completed·IIntercept Pharmaceuticals·Phase 3·NCT03439254·919 enrolled

Study of Obeticholic Acid（OCA） Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC)

Unknown status· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 3·NCT04956328·120 enrolled

Acute Lymphoblastic Leukemia1 trial

Obeticholic Acid in Bariatric and Gallstone Disease

Completed·SSahlgrenska University Hospital·Phase 2·NCT01625026·40 enrolled

18 more indications

Obese Patients1 trial

Obeticholic Acid in Morbidly Obese Patients and Healthy Volunteers

Unknown status·SSahlgrenska University Hospital·Phase 1·NCT02532335·40 enrolled

Statins1 trial

Combination Obeticholic Acid (OCA) and Statins for Monitoring of Lipids (CONTROL)

Completed·IIntercept Pharmaceuticals·Phase 2·NCT02633956·84 enrolled

Effectiveness1 trial

A Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients

Withdrawn·IIntercept Pharmaceuticals··NCT05293938

Treatment1 trial

The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in NASH Treatment Trial(FLINT)

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT01265498·283 enrolled

Non-Alcoholic Fatty Liver Disease1 trial

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

Completed·KKing Edward Medical University·Phase 2·NCT07104786·90 enrolled

Sclerosing Cholangitis1 trial

Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC)

Completed·IIntercept Pharmaceuticals·Phase 2·NCT02177136·77 enrolled

Hepatitis1 trial

Trial of Obeticholic Acid in Patients With Moderately Severe Alcoholic Hepatitis (AH)

Terminated·NNaga P. Chalasani·Phase 2·NCT02039219·19 enrolled

Alcohol Consumption1 trial

Effect of Heavy Alcohol Consumption on Farnesoid X Receptor (FXR) Signaling

Completed·SSuthat Liangpunsakul·N/A·NCT02654236·30 enrolled

Hepatic Impairment1 trial

Hepatic Impairment Trial of Obeticholic Acid

Completed·IIntercept Pharmaceuticals·Phase 1·NCT01904539·32 enrolled

Hepatic steatosis1 trial

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

Not yet recruiting·—·Phase 3·NCT06691412·100 enrolled

Non-Alcoholic Steatohepatitis1 trial

Comparative Study Between Obeticholic Acid Versus Vitamin E in Patients with Non-alcoholic Steatohepatitis

Active, not recruiting·TTanta University·Phase 2·NCT05573204·59 enrolled

Diarrhoea1 trial

Obeticholic Acid in Bile Acid Diarrhoea

Completed·IImperial College Healthcare NHS Trust·Phase 2·NCT01585025·35 enrolled

Lipodystrophy1 trial

Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients

Completed·AAbhimanyu Garg·Phase 2·NCT02430077·10 enrolled

NAFLD1 trial

Role of Obeticholic Acid in the Patients of NAFLD With Raised ALT

Completed·—·N/A·NCT03836937·70 enrolled

PET/CT1 trial

Effect of Obeticholic Acid on Transport of Bile Acids in PBC Examined by 11C-cholyl-sarcosine PET/CT

Completed·UUniversity of Aarhus·Phase 1·NCT03253276·8 enrolled

Familial adenomatous polyposis1 trial

Testing Obeticholic Acid for Familial Adenomatous Polyposis

Suspended·NNational Cancer Institute (NCI)·Phase 2·NCT05223036·80 enrolled

Fibrosis1 trial

Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment

Terminated·IIntercept Pharmaceuticals·Phase 3·NCT02548351·2,477 enrolled

Barrett Esophagus1 trial

Obeticholic Acid for Prevention in Barrett's Esophagus

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04939051·30 enrolled

Regulatory

FDA Approval Timeline[5]

May 27, 2016

OCALIVA

NDA NDA207999

Sources

References

[1]
ClinicalTrials.gov — 30 trial records for Obeticholic acid. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Ocaliva drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Obeticholic acid compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Obeticholic acid. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA207999). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Ocaliva. U.S. Food & Drug Administration.
[7]
PubMed — 1 publication indexed for Obeticholic acid. U.S. National Library of Medicine.
[8]
SEC EDGAR — Intercept Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: FXR Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: IIntercept Pharmaceuticals

Patent Landscape[6]

Patent Cliff

Feb 21, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

RE48286Feb 21, 2027

10174073Jun 17, 2033

9238673Jun 17, 2033

10047117Sep 6, 2033

10751349Apr 26, 2036

2 more patents

10758549Apr 26, 2036

10052337Apr 26, 2036

Key Publications[7]

Obeticholic Acid in Primary Biliary Cholangitis: Long-Term Outcomes

HepatologyJun 22, 2023DOI: 10.1097/HEP.0000000000000425

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