Independent reference. Not affiliated with, endorsed by, or speaking for the U.S. Food and Drug Administration.
FDA Medication Tracker

← All approvals · Kidney, liver & lung · 2026

Lynavoy (linerixibat)

The FDA approved Lynavoy (linerixibat) on March 17, 2026 to treat cholestatic pruritus associated with primary biliary cholangitis.
Brand name
Lynavoy
Generic name
linerixibat
FDA approval date
March 17, 2026
Approved use (FDA wording)
To treat cholestatic pruritus associated with primary biliary cholangitis
Company
Intercept
Application
NDA220295
Dosage form / route
TABLET · ORAL
Drug class (EPC)
Ileal Bile Acid Transporter Inhibitor [EPC]
Boxed warning on label
Not listed
Category on this site
Kidney, liver & lung

Indications and usage, from the FDA label

LYNAVOY is indicated for the treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adult patients. Limitations of Use Avoid use of LYNAVOY in patients with decompensated cirrhosis or those with prior or active hepatic decompensation events (e.g. variceal hemorrhage, ascites, hepatic encephalopathy) [see Use in Specific Populations (8.7) , Clinical Pharmacology (12.3) ] . LYNAVOY is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adult patients. ( 1 ) Limitations of Use Avoid use of LYNAVOY in patients with decompensated cirrhosis or those with prior or act…

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.