What Was Approved?
On March 17, 2026, the U.S. Food and Drug Administration approved Lynavoy (linerixibat) for the treatment of cholestatic pruritus associated with primary biliary cholangitis, or PBC, in adults.
Lynavoy is intended to treat the itching associated with PBC. It should not be described as a cure for PBC itself.
How Does Lynavoy Work?
Lynavoy is an ileal bile acid transporter, or IBAT, inhibitor.
It reduces the reabsorption of bile acids in the terminal part of the small intestine, which increases their elimination through the stool. This mechanism is associated with reduced cholestatic itching in some patients.
How Is Lynavoy Taken?
The recommended dose is:
40 mg by mouth twice daily.
The tablets should be swallowed whole at least 30 minutes before food or beverages other than water.
Who Should Avoid Lynavoy?
The FDA label advises avoiding Lynavoy in patients with:
- Decompensated cirrhosis
- Previous or current hepatic decompensation events, such as ascites, variceal bleeding, or hepatic encephalopathy
What Are the Main Safety Concerns?
Important warnings include:
- Liver test elevations
- Diarrhea
- Fat-soluble vitamin deficiency
Patients may need laboratory monitoring during treatment, especially if symptoms or risk factors are present.
Are Drug Interactions Important?
Yes.
Bile acid-binding resins can interfere with Lynavoy.
The FDA label includes specific timing instructions when these medicines are used together, so patients should review all current medications with a pharmacist or prescriber.
Bottom Line
Lynavoy (linerixibat) is a newly FDA-approved oral treatment for cholestatic itching associated with primary biliary cholangitis in adults.
It is taken twice daily and works by reducing intestinal reabsorption of bile acids. Because diarrhea, liver test abnormalities, and fat-soluble vitamin deficiency can occur, treatment should be monitored appropriately.
Sources
- U.S. Food and Drug Administration (FDA) — Novel Drug Approvals for 2026.
- U.S. Food and Drug Administration (FDA) — Lynavoy (linerixibat) Prescribing Information, March 2026.
- U.S. Food and Drug Administration (FDA) — Integrated Review for Lynavoy.