Obeticholic Acid

Phase 2

Intercept Pharmaceuticals, Inc. (ICPT)

Phase 2

Development Phase

Upcoming Catalysts

Historical Events

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape

0 competitors in Primary Biliary Cirrhosis

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Drug Information

Target Indication

Primary Biliary Cirrhosis

Clinical Trial

NCT01865812

Last updated: 1/2/2026

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Source: FDA Orange Book

Regulatory Approvals

EMAPending

Zektayos - Hepjuvo

Improvement of liver fibrosis and resolution of steatohepatitis in adult patients with significant liver fibrosis due to nonalcoholic steatohepatitis (NASH)

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EMA12/12/2016

Ocaliva

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.

Conditional

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Drug Science

Mechanism of action & safety profile

Developer

ICPT

Intercept Pharmaceuticals, Inc.

Biotechnology•North America•NASDAQ

Related Pipeline

Obeticholic Acid (OCA)Phase 3

Primary Biliary Cirrhosis

INT-747Phase 2