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ALIMENTARY TRACT AND METABOLISM › BILE AND LIVER THERAPY › BILE THERAPY › Other drugs for bile therapy
linerixibat
A05AX08
Forms & Strengths
- Oral capsules under clinical investigation
- Typical studied strengths: 90 mg, 180 mg
Adult Dosing
- Investigational agent; no FDA-approved adult dosing
- Studied doses in clinical trials for cholestatic pruritus range from 90 mg to 180 mg orally twice daily
Pediatric Dosing
- Safety and efficacy not established in pediatric populations
- Not recommended for pediatric use outside of approved clinical trials
Indications
- Investigated for the treatment of pruritus associated with primary biliary cholangitis (PBC)
- Studied in other cholestatic liver diseases
Mechanism of Action
- Ileal bile acid transporter (IBAT) inhibitor
- Blocks the reabsorption of bile acids in the terminal ileum, increasing fecal bile acid excretion
- Reduces serum bile acid concentrations, mitigating bile acid-mediated pruritus
Contraindications
- Hypersensitivity to linerixibat or any of its excipients
- Complete biliary obstruction
- Severe hepatic impairment where clearance is severely compromised (per clinical protocol exclusions)
Adverse Reactions
- Diarrhea
- Abdominal pain
- Frequent bowel movements
- Elevated serum transaminases (transient)
Drug Interactions
- Bile acid sequestrants (e.g., cholestyramine, colestipol) may bind to linerixibat or interfere with its absorption; administer apart
- Potential interactions with OATP1B1/3 or other hepatic uptake transporters based on class pharmacology
Curated Content: Needs Vetting Before Put to Clinical Use