TheraRadar
Data updated: May 26, 2026

OBETICHOLIC ACID

Hepatology Approved 2023-05-30
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
2
Years on Market

Details

Status
Discontinued
First Approved
2023-05-30
Routes
ORAL
Dosage Forms
TABLET

Companies

Apotex MSN Lupin OPTIMUS PHARMA PRIVATE LTD
Active Ingredient: OBETICHOLIC ACID

OBETICHOLIC ACID Approval History

2024
2025
2026
Original
New Indication
New Form
Label Update
6 FDA actions from 2023 to 2023
May 2023 ORIGINAL
Update
FDA Letter

What OBETICHOLIC ACID Treats

1 FDA approvals

Originally approved for its first indication in 2023 .

  • Other (1)
📋

Clinical Trial Registry

12 trials
Trial Sponsor ID Phase Status Title
NCT05223036 NCI-2022-00341 NCI-2022-00341, 2021-0286 Ph 2 terminated Testing Obeticholic Acid for Familial Adenomatous Polyposis
NCT04939051 NCI-2021-06441 NCI-2021-06441, UMCC 2022.048 Ph 2 recruiting Obeticholic Acid for Prevention in Barrett's Esophagus
NCT04594694 747-213 Ph 2 terminated Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC
NCT02548351 REGENERATE results posted 747-303 Ph 3 terminated Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment
NCT02430077 results posted STU 062014-033 Ph 2 completed Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients
NCT01585025 OBADIAH1 results posted CRO1909 2011-003777-28 Ph 2 completed Obeticholic Acid in Bile Acid Diarrhoea
NCT05133830 213688 Ph 1 completed Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Adult Participants
NCT01865812 results posted 747-205 Ph 2 completed Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis
NCT04053023 results posted 206224 Ph 1 completed Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Subjects
NCT02633956 CONTROL results posted 747-209 Ph 2 completed Combination Obeticholic Acid (OCA) and Statins for Monitoring of Lipids (CONTROL)
NCT01265498 FLINT results posted NASH-FLINT (IND) U01DK061730 Ph 2 completed The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in NASH Treatment Trial(FLINT)
NCT01625026 OCABSGS OCABSGS Ph 2 completed Obeticholic Acid in Bariatric and Gallstone Disease
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

OBETICHOLIC ACID FDA Label Details

Looking for the branded version?

OCALIVA

Full clinical data, patents, trials, and competitive landscape for obeticholic acid.

See OCALIVA

Data Sources

FDA Approval: ANDA214862 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.