Linerixibat

Treats cholestatic pruritus associated with primary biliary cholangitis (PBC). Sold as Lynavoy. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Linerixibat (sold as Lynavoy), first approved Mar 17, 2026, with 0 new uses approved and 0 published complete response letters.

First approved: Mar 17, 2026
Applications: 1
New uses approved: 0
Complete response letters: 0
Orphan exclusivity until: Mar 17, 2033
First approved in the EU: Oct 22, 2026

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

Treatment of Primary Biliary CholangitisIntercept Pharmaceuticals, Inc. (A wholly owned subsidiary of Alfasigma S.p.A.) · designated Sep 18, 2019 · approved Mar 17, 2026 · exclusive to Mar 17, 2033

Approvals in the EU (EMA)

First approved in the EU 7 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Lynavoy, new substanceGlaxoSmithKline Trading Services Limited · Oct 22, 2026

Clinical Trials

2 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


J-LINX: Japan LINerixibat eXtension StudyPruritus · GlaxoSmithKline	Phase 3	Not yet recruiting	Oct 6, 2026
Linerixibat Long-term Safety, and Tolerability StudyCholestasis · GlaxoSmithKline	Phase 3	Active, not recruiting	Nov 18, 2019

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Mar 17, 2026	LynavoyNDA 220295 · New molecular entity	Intercept	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA