Lynavoy (linerixibat)

New molecular entity

Region: 🇺🇸 US
Active substance: linerixibat
Company: Intercept
Status: Approved
FDA approval: Tue 17 Mar 2026
Designations: New molecular entity
Application: NDA220295
Official record: www.accessdata.fda.gov

Regulatory milestones

Thu 22 Oct 2026🇪🇺 EU approval (EC decision)

Lynavoy (Linerixibat) approved in the EU

Marketing authorisation to GlaxoSmithKline Trading Services Limited; Orphan, Additional monitoring · source

Thu 23 Jul 2026🇪🇺 CHMP positive opinion

Lynavoy (Linerixibat): CHMP positive opinion

GlaxoSmithKline Trading Services Limited; Orphan, Additional monitoring · source

Tue 17 Mar 2026🇺🇸 FDA approval

FDA approves Lynavoy (linerixibat), a new medicine

Intercept; NDA220295; New molecular entity; tablet · source

Same substance in other markets

🇪🇺 Lynavoy Authorised · GlaxoSmithKline Trading Services Limited

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.