TheraRadar
Data updated: May 26, 2026

OCALIVA (obeticholic acid)

Trial Activity: Declining 1 active trials
Orphan Drug Priority Review
Hepatology Approved 2016-05-27
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Intercept Pharmaceuticals conducting 4 trials (33%)
20 indications explored (Broad Platform)
→ attenuated familial adenomatous polyposis (1 trials)
→ colorectal carcinoma (1 trials)
→ duodenal carcinoma (1 trials)
1
Indication
--
Phase 3 Trials
1
Priority Reviews
9
Years on Market

Details

Status
Discontinued
First Approved
2016-05-27
Patent Cliff
2036

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET

Companies

INTERCEPT PHARMS INC
Active Ingredient: OBETICHOLIC ACID

OCALIVA Approval History

2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
10 FDA actions from 2016 to 2022
Feb 2022 SUPPL
Label · Labeling
FDA Letter Label
May 2021 SUPPL
Label · Labeling
FDA Letter Label
Feb 2018 SUPPL
Label · Labeling
FDA Letter Label

What OCALIVA Treats

1 FDA approvals

Originally approved for its first indication in 2016 .

  • 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
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

OCALIVA FDA Label Details

View full patent landscape →
7 OB patents · 3 families · 176 international docs across 40 countries

OCALIVA Patents & Exclusivity

Latest Patent: Apr 2036

Patents (7 active)

US10758549 Expires Apr 26, 2036
US10751349 Expires Apr 26, 2036
US10052337 Expires Apr 26, 2036
US10047117 Expires Sep 6, 2033
US10174073 Expires Jun 17, 2033
US9238673 Expires Jun 17, 2033
USRE48286 Expires Feb 21, 2027
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for OCALIVA

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2036
  • • 28 active patents

Trial Analysis

  • • 12 total trials
  • • Stage: Declining

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA207999 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment