Lynavoy

(Linerixibat)

Phase 3Small molecule

IIntercept Pharmaceuticals

Lynavoy is one of 5 small molecule programs targeting Cholestasis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

CholestasisActive, not recruiting

CholestasisPhase 3

Active, not recruiting

Competition

Competitive Landscape

4 competitors in Cholestasis

#DrugCompanyPhaseTrials

Lynavoy

IIntercept Pharmaceuticals

Phase 3

1 2

IC-Green

PProvepharm SAS

Phase 1

1 3

Tauroursodeoxycholic Acid

HHumanitas Mirasole SpA

Preclinical

1 4

Kinevac

UUniversity of Maia

Preclinical

1 5

Omegaven Emulsion

FFresenius

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 3Active, not recruiting

Cholestasis

NCT04167358

Clinical

Trials by Indication[1]

Interaction1 trial

Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Adult Participants

Completed· GSK logo

GSK·Phase 1·NCT05133830·52 enrolled

Metabolism1 trial

Pharmacokinetics (PKs) and Metabolism of Radiolabelled Linerixibat

Completed· GSK logo

GSK·Phase 1·NCT03992014·6 enrolled

Primary Biliary Cholangitis1 trial

Linerixibat Compassionate Use for Cholestatic Pruritus Adult Patients With Primary Biliary Cholangitis (PBC)

Available· GSK logo

GSK··NCT05448170

Moderate Hepatic Impairment1 trial

Phase I Study of Linerixibat in Adults With Moderate Hepatic Impairment and Healthy Controls

Completed· GSK logo

GSK·Phase 1·NCT05393076·8 enrolled

Adult1 trial

Food Effect Study of Linerixibat Tablets in Healthy Adult Participants

Completed· GSK logo

GSK·Phase 1·NCT05435170·23 enrolled

2 more indications

Pruritus1 trial

A Two-part, Randomized, Placebo Controlled, Double Blind, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis (PBC)

Completed· GSK logo

GSK·Phase 3·NCT04950127·238 enrolled

Cholestasis1 trial

Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis

Active, not recruiting· GSK logo

GSK·Phase 3·NCT04167358·242 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 17, 2026

LYNAVOY

NDA NDA220295

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for Linerixibat. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Linerixibat compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Linerixibat. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA220295). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Lynavoy. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Intercept Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: IIntercept Pharmaceuticals

Patent Landscape[5]

Patent Cliff

Sep 6, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9040518Sep 6, 2031

Lynavoy

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Trials by Indication[1]

Interaction1 trial

Metabolism1 trial

Primary Biliary Cholangitis1 trial

Moderate Hepatic Impairment1 trial

Adult1 trial

Pruritus1 trial

Cholestasis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Related News