Drug updated on 12/11/2024
| Dosage Form | Capsule (oral; 50 mg, 250 mg) |
| Drug Class | Bile acids |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of bile acid synthesis disorders due to single enzyme defects (SEDs)
- Indicated for adjunctive treatment of peroxisomal disorders (PDs) including Zellweger spectrum disorders in patients who exhibit manifestations of liver disease, steatorrhea or complications from decreased fat-soluble vitamin absorption.
Latest News
Summary
- This summary is based on the review of one systematic review/meta-analysis. [1]
- Association with Gestational Diabetes Mellitus (GDM) Risk: Cholic acid (CA) is identified as one of eight plasma bile acid metabolites associated with the risk of GDM during pregnancy. Taurocholic acid (TCA) is positively associated with GDM (odds ratio (OR) 2.07, 95% confidence interval (CI) [1.05, 3.96], P = 0.030), while lithocholic acid (LCA) shows a negative association (OR 0.83, 95% CI [0.68, 1.01], P = 0.065).
- Population Focus: The study exclusively involves pregnant women, investigating the association of specific bile acids with the risk of developing GDM but does not provide information on cholic acid’s effectiveness as a treatment.
- There is no safety information available in the reviewed studies.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Cholbam (cholic acid) Prescribing Information. | 2024 | Mirum Pharmaceuticals, Inc., Foster City, CA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Bile acid metabolites in early pregnancy and risk of gestational diabetes mellitus: Results from a prospective cohort study | 2023 | Diabetes, Obesity & Metabolism |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| EASL Clinical Practice Guidelines on genetic cholestatic liver diseases | 2024 | Journal of Hepatology |