Wednesday, July 8, 2026

Drug profile · INN

obeticholic acid

obeticholic acid (OCALIVA) is a bile acid receptor fxr agonist. Associated with Amdipharm Mercury (Australia) Pty Limited. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: unknown TGA: approved Alimentary tract and metabolism (A05) A05AA04
US status approved
Patents linked 0
Pipeline programs 2
News articles 0
Drug details — obeticholic acid
US status
approved
Class
Alimentary tract and metabolism (A05)
Route
ORAL
Patents
0
Programs
2
Data quality
0.84

Quick answer

obeticholic acid (OCALIVA) is a bile acid receptor fxr agonist. Associated with Amdipharm Mercury (Australia) Pty Limited. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN obeticholic acid
Brand OCALIVA
Mechanism Bile acid receptor FXR agonist
Target Bile acid receptor
Therapeutic class Alimentary tract and metabolism (A05)
Route ORAL
Formulation TABLET
ATC code A05AA04

Mechanism of action

Bile acid receptor FXR agonist

Primary target: Bile acid receptor

Approval history

Authority Status Date
FDA approved
EMA unknown
TGA approved

Pipeline programs

  1. 747-213 Phase 2 · Anaxis Pharma · Primary Biliary Cholangitis (PBC)
  2. Ocaliva 5 mg film-coated tablets Phase 2 · Anaxis Pharma · Primary biliary cholangitis

Related & competitor drugs

  1. agalsidase alfa Alimentary tract and metabolism (A16)
  2. alogliptin Alimentary tract and metabolism (A10)
  3. alogliptin benzoate Alimentary tract and metabolism (A10)
  4. aprepitant Alimentary tract and metabolism (A04)
  5. budesonide Alimentary tract and metabolism (A07)
  6. canagliflozin Alimentary tract and metabolism (A10)

Frequently asked questions

What is obeticholic acid?

obeticholic acid (OCALIVA) is a bile acid receptor fxr agonist. Associated with Amdipharm Mercury (Australia) Pty Limited. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for obeticholic acid?

OCALIVA is a marketed brand name for obeticholic acid. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of obeticholic acid?

obeticholic acid has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.