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Linerixibat

Not yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetListed from FDA or ClinicalTrials.gov records; an editor has not checked it yet.

Also known as Lynavoy

INTERCEPT PHARMACEUTICALS, INC.

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Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Approved

    Not recorded

  • Linked trials

    0

    From ClinicalTrials.gov

  • Latest FDA action

    Approved

    NDA220295,

Recalls, shortages, patents and EU status at a glance

Key information

Sponsor
INTERCEPT PHARMACEUTICALS, INC. Source: Company record for INTERCEPT PHARMACEUTICALS, INC. (opens in a new tab)
Indications
Not recorded
Application
NDA 220295 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 220295 (opens in a new tab)
Designations
None recorded
Next catalyst
None scheduled

Development timeline

  1. Preclinical Completed
  2. Phase 1 Completed
  3. Phase 2 Completed
  4. Phase 3 Completed
  5. Filed Completed
  6. Approved Current stageFirst approval 17 Mar 2026

Overview

Mechanism
Not recorded
Route
Not recorded
Modality
Not recorded
Specialties
Not recorded

Overview text is written by HealthTrade editors.

Key dates

No catalysts yet. Editors add each date together with its source.

FDA designations

No FDA designations are on record for Linerixibat. Editors add each one with its source.

Filed application

No filed application is on record for Linerixibat. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for Linerixibat.

Clinical trials

No trials are linked to this drug yet.

Trial quality

About CT-VCA

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FDA actions

Original approvals and new-indication supplements for Linerixibat, newest first
ApplicationActionDateOutcomeReviewSource
NDA220295Action letter for NDA220295 (opens in a new tab) Original 1 Type 1 - New Molecular EntityApprovedstandardDrugs@FDA via openFDA (opens in a new tab)

Data provided by the U.S. Food and Drug Administration.

FDA recalls load here.

FDA drug shortages load here.

Orange Book patents load here.

FAERS adverse event counts load here.

Papers and preprints load here.

Community discussion loads here.

EU status (EMA)

OpinionOrphan medicine

Lynavoy (EMEA/H/C/006241)

Authorised
Not given
Therapeutic area
Liver Cirrhosis, Biliary;Pruritus
Marketing authorisation holder
GlaxoSmithKline Trading Services Limited
Active substance (INN)
Linerixibat
ATC code
A05AX

Matched by active substance: EMA's INN or active substance equals this drug's name.

EMA page for Lynavoy (opens in a new tab)EMA medicine data (opens in a new tab)

Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.

Related news

No recent headlines mention this drug.

Sources

Record updated .

Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.