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Cholic Acids
Cholic acid is a primary bile acid that restores bile acid-dependent signaling pathways to improve cholestasis and fat malabsorption in patients with bile acid synthesis disorders.
Cholic acid is a primary bile acid that restores bile acid-dependent signaling pathways to improve cholestasis and fat malabsorption in patients with bile acid synthesis disorders. Used for Cerebrotendinous xanthomatosis (CTX), Progressive familial intrahepatic cholestasis (PFIC), Bile acid synthesis disorders.
At a glance
| Generic name | Cholic Acids |
|---|---|
| Also known as | Cholic, Cholic Acid, Cholic Acid Capsules |
| Sponsor | Mirum Pharmaceuticals, Inc. |
| Drug class | Bile acid replacement therapy |
| Target | Farnesoid X receptor (FXR) and TGR5 signaling pathways |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology / Metabolic Disorders |
| Phase | Phase 3 |
Mechanism of action
Cholic acid functions as a replacement therapy for patients with deficient endogenous bile acid synthesis, particularly in cerebrotendinous xanthomatosis (CTX) and other inborn errors of bile acid metabolism. By supplementing the deficient primary bile acid pool, it restores normal enterohepatic circulation, improves fat-soluble vitamin absorption, and reduces accumulation of toxic bile acid precursors. This mechanism addresses the underlying metabolic defect rather than treating symptoms alone.
Approved indications
- Cerebrotendinous xanthomatosis (CTX)
- Progressive familial intrahepatic cholestasis (PFIC)
- Bile acid synthesis disorders
Common side effects
- Diarrhea
- Abdominal pain
- Pruritus
- Fatigue
Key clinical trials
- A Study to Evaluate Patient Satisfaction With the Overall Face and Neck Appearance After Combined Treatment of OnabotulinumtoxinA, JUVÉDERM® Products, KYBELLA, CoolSculpting Elite and SkinMedica Products (PHASE4)
- Efficacy & Safety of Oral Adjuvants to Phototherapy in Neonatal Hyperbilirubinemia (PHASE4)
- The Role of Secondary Bile Acids in Intestinal Inflammation (PHASE2, PHASE3)
- Quantitative Liver Function Tests Using Cholates (PHASE2)
- Comparing UDCA and Corticosteroids in Immunotherapy Induced Cholestatic Hepatitis (PHASE2)
- Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis (PHASE3)
- Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis: a Real World Study (PHASE3)
- Efficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Cholic Acids CI brief — competitive landscape report
- Cholic Acids updates RSS · CI watch RSS
- Mirum Pharmaceuticals, Inc. portfolio CI