Lynavoy

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Primary Biliary CholangitisCholestasis

41 competitors in Primary Biliary Cholangitis

#DrugCompanyPhaseTrials

1

Cellcept

Roche

Approved

12

Ocaliva

IIntercept Pharmaceuticals

Approved

23

Cyclosporin a

Novartis

Approved

14

Iqirvo

Ipsen

Phase 3

35

Lipaglyn

ZZydus Therapeutics Inc.

Phase 3

46

Rayos

RRoxane Laboratories

Phase 3

17

Olumiant

Eli Lilly

Phase 2

18

Seladelpar

Gilead

Phase 3

69

Bezafibrate

IIntercept Pharmaceuticals

Phase 3

110

Selincro

IIndivior Inc.

Phase 2

1Show 22 more competitors

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

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Primary Biliary Cholangitis2 trials

Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)

Completed·GSK·Phase 3·NCT04950127·238 enrolled

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

Available·GSK··NCT05448170

Interaction1 trial

Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Adult Participants

Completed·GSK·Phase 1·NCT05133830·52 enrolled

Adult1 trial

Food Effect Study of Linerixibat Tablets in Healthy Adult Participants

Completed·GSK·Phase 1·NCT05435170·23 enrolled

Moderate Hepatic Impairment1 trial

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

Completed·GSK·Phase 1·NCT05393076·8 enrolled

Metabolism1 trial

Pharmacokinetics (PKs) and Metabolism of Radiolabelled Linerixibat

Completed·GSK·Phase 1·NCT03992014·6 enrolled

1 more indication

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·Phase 3·NCT04167358·242 enrolled

Regulatory

FDA Approval Timeline[4]

Details

Drug Info

Patent Landscape[5]

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