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Cholbam (CHOLIC ACID)
Cholbam works by binding to the G-protein coupled bile acid receptor 1, which helps regulate bile acid levels in the body.
Cholbam (Cholic Acid) is a bile acid medication originally developed by RTRX and currently owned by Mirum. It targets the G-protein coupled bile acid receptor 1 and is classified as a bile acid modality. Cholbam is FDA-approved to treat various conditions, including inborn errors of bile acid metabolism, disorders of the biliary tract, and incomplete passage of stool. The medication is off-patent, with no active Orange Book patents. As a bile acid, Cholbam works by regulating the levels of bile acids in the body.
At a glance
| Generic name | CHOLIC ACID |
|---|---|
| Sponsor | Mirum |
| Drug class | Bile Acid [EPC] |
| Target | G-protein coupled bile acid receptor 1 |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2015 |
Mechanism of action
Cholic acid is primary bileacid synthesized from cholesterol in the liver. In bile acid synthesisdisorders due to SEDs in the biosynthetic pathway, and in PDs includingZellweger spectrum disorders, deficiency of primary bile acids leadsto unregulated accumulation of intermediate bile acids and cholestasis. Bile acids facilitate fat digestion and absorption by forming mixedmicelles and facilitate absorption of fat-soluble vitamins in theintestine.Endogenousbile acids including cholic acid enhance bile flow and provide thephysiologic feedback inhibition of bile acid synthesis. The mechanismof action of cholic acid has not been fully established; however,it is known that cholic acid and its conjugates are endogenous ligandsof the nuclear receptor, farnesoid receptor (FXR). FXR regulatesenzymes and transporters that are involved in bile acid synthesisand in the enterohepatic circulation to maintain bile acid homeostasisunder normal physiologic conditions.
Approved indications
- Bile Acid Synthesis Disorders Due to SEDs
- Adjunctive Treatment of Peroxisomal Disorders
Common side effects
- Diarrhea
- Reflux Esophagitis
- Malaise
- Jaundice
- Skin lesion
- Nausea
- Abdominal Pain
- Intestinal Polyp
- Urinary Tract Infection
- Peripheral Neuropathy
Drug interactions
- cyclosporine
- bile acid binding resins (cholestyramine, colestipol, colesevelam)
- aluminum-based antacids
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)
- Deciphering the Mechanisms Involved in Microbial Translocation Across the Spectrum of HCV Associated Liver Fibrosis
- Efficacy & Safety of Oral Adjuvants to Phototherapy in Neonatal Hyperbilirubinemia (PHASE4)
- Validation of Different Methods for HepQuant DuO® Blood Sample Collection
- 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)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Cholbam CI brief — competitive landscape report
- Cholbam updates RSS · CI watch RSS
- Mirum portfolio CI