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Drug

Cholic Acid

Approved · EMA
Emerging researchLate-stage development

Also known as CA - Cholic acid, Cholbam, Tri-saturated bile acid, 3 alpha, 7 alpha, 12 alpha, Trihydroxycholanic acid.

RxNorm1440856ChEMBLCHEMBL205596ATCA05AA03UNIIG1JO7801AE
2
Research papers
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Phase II Study of Cholic Acid for Hepatic Steatosis in Lipodystrophy Patients

Clinical trial2025-08-06Results posted · ClinicalTrials.gov

Production of deoxycholic acid by low-abundant microbial species is associated with impaired glucose metabolism.

Research2024-05-20Nature communications

Smith-Lemli-Opitz Syndrome: A Pilot Study of Cholic Acid Supplementation

Clinical trial2024-04-30Results posted · ClinicalTrials.gov

An Open Label, Single Center, Nonrandomized Continuation Study of Cholic Acid Capsules to Treat Subjects With Inborn Errors of Bile Acid Synthesis

Clinical trial2023-10-03Results posted · ClinicalTrials.gov

Open Label, Single Center, Nonrandomized Study Comparing Efficacy of To Be Marketed Cholic Acid With That of the Currently Used Formulation of Cholic Acid Capsules Used to Treat Children With Inborn Errors of Bile Acid Synthesis

Clinical trial2023-10-03Results posted · ClinicalTrials.gov

Approval: Orphacol (EMA)

Regulatory2013-09-12EMA

Cholic acid for hepatic steatosis in patients with lipodystrophy: a randomized, controlled trial.

Research2013-04-15European journal of endocrinology

Study of Bile Acids in Patients With Peroxisomal Disorders

Clinical trial1999-04-01Terminated · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Cholic Acid
Aliases & brands
CA - Cholic acidCholbamTri-saturated bile acid3 alpha, 7 alpha, 12 alpha, Trihydroxycholanic acid
RxNorm CUI
1440856
ChEMBL ID
CHEMBL205596
ATC codes
A05AA03
UNII
G1JO7801AE
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2013-09-12
Latest approval
2013-09-12
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2013-09-12Approval
Approval: Orphacol (EMA)
Indication: Orphacol is indicated for the treatment of inborn errors in primary bile acid synthesis due to3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase… Show full indication

Orphacol is indicated for the treatment of inborn errors in primary bile acid synthesis due to3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase deficiency ininfants, children and adolescents aged 1 month to 18 years and adults.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

5 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
5
registered trials across all phases
LATEST COMPLETION 2023
3
Late-stage (III+)
4
Completed
1
Discontinued
PHASE DISTRIBUTIONn = 5
Phase 1 / 21Phase 21Phase 32Phase N / A1

Recent completions

Trials that read out recently, adding to the completed evidence base.

Smith-Lemli-Opitz Syndrome: A Pilot Study of Cholic Acid Supplementation

CompletedPH I/IIUniversity of Nebraskan=122023

An Open Label, Single Center, Nonrandomized Continuation Study of Cholic Acid Capsules to Treat Subjects With Inborn Errors of Bile Acid Synthesis

CompletedPH IIIMirum Pharmaceuticals, Inc.n=532016

Phase II Study of Cholic Acid for Hepatic Steatosis in Lipodystrophy Patients

CompletedPH IIUniversity of Texas Southwestern Medical Centern=182011

Open Label, Single Center, Nonrandomized Study Comparing Efficacy of To Be Marketed Cholic Acid With That of the Currently Used Formulation of Cholic Acid Capsules Used to Treat Children With Inborn Errors of Bile Acid Synthesis

CompletedPH IIIMirum Pharmaceuticals, Inc.n=162010

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20132024
Major research themes4
Deoxycholic Acid1Diabetes Mellitus, Type 21Gastrointestinal Microbiome1Glucose1
Journals, researchers & institutions
Top journals
  • European journal of endocrinology1
  • Nature communications1
Leading researchers
  • Adams-Huet B1
  • Ahmad Z1
  • Bäckhed F1
  • Bergström G1
  • Brumbaugh A1
  • Fischbach MA1
  • Garg A1
  • Hazen SL1
Leading institutions
free-text, unnormalised
  • Center for Human Nutrition1
  • Center for Microbiome and Human Health1
  • ChEM-H Institute1
  • Lerner Research Institute1
  • Novo Nordisk Foundation Center for Basic Metabolic Research1
  • Sahlgrenska University Hospital1

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Deoxycholic Acid

Studied across the same disease area as Cholic Acid in the shared literature.

1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.