Wednesday, July 8, 2026

Drug profile · INN

cholic acid

cholic acid (ORPHACOL) is a unknown. Associated with Mirum Pharmaceuticals International B.V.. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved Alimentary tract and metabolism (A05) A05AA03
US status approved
Patents linked 1
Pipeline programs 10
News articles 0
Drug details — cholic acid
US status
approved
Class
Alimentary tract and metabolism (A05)
Route
ORAL
Patents
1
Programs
10
Data quality
0.89

Quick answer

cholic acid (ORPHACOL) is a unknown. Associated with Mirum Pharmaceuticals International B.V.. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN cholic acid
Brand ORPHACOL
Mechanism Unknown
Therapeutic class Alimentary tract and metabolism (A05)
Route ORAL
Formulation CAPSULE
ATC code A05AA03

Mechanism of action

Unknown

Approval history

Authority Status Date
FDA approved
EMA approved

Pipeline programs

  1. Cholic Acid Phase 3 · Mirum Pharmaceuticals International · Bile Acid Synthesis Defect
  2. Cholic Acids Phase 3 · Mirum Pharmaceuticals International · Infantile Refsum's Disease
  3. Cholic acid Phase 3 · Mirum Pharmaceuticals International · Inborn Errors of Bile Acid Synthesis
  4. 747-213 Phase 2 · Anaxis Pharma · Primary Biliary Cholangitis (PBC)
  5. URSODEOXYCHOLIC ACID Phase 2 · George Institute for · Hepatorenal polycystic diseases
  6. Ursodeoxycholic acid Phase 2 · Hospital Authority · Hepatitis D
  7. Ursodeoxycholic acid Phase 2 · Chinese Academy of · COVID-19
  8. tauroursodeoxycholic acid (TUDCA) Phase 2 · First People's Hospital · Metabolic Dysfunction-Associated Steatotic Liver Disease Inf

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)
  1. US 11833160

    Ursodeoxycholic acid derivatives as HDAC inhibitors for the treatment of polycystic diseases

    Expires Mon Nov 30 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is cholic acid?

cholic acid (ORPHACOL) is a unknown. Associated with Mirum Pharmaceuticals International B.V.. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for cholic acid?

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

What is the US approval status of cholic acid?

cholic 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.