Empasiprubart

Phase 3Biologic

Empasiprubart is one of 57 biologic programs targeting Chronic Inflammatory Demyelinating Polyneuropathy. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Chronic Inflammatory Demyelinating PolyneuropathyRecruiting

Multifocal Motor Neuropathy (MMN)Recruiting

Generalized Myasthenia GravisRecruiting

NeuropathyRecruiting

DermatomyositisActive, not recruiting

Chronic Inflammatory Demyelinating PolyneuropathyPhase 3

Recruiting

Multifocal Motor Neuropathy (MMN)Phase 1

Recruiting

Generalized Myasthenia GravisPhase 2

Recruiting

NeuropathyPhase 3

Recruiting

DermatomyositisPhase 2

Active, not recruiting

Competition

Competitive Landscape

24 competitors in Neuropathy

#DrugCompanyPhaseTrials

Elavil

AstraZeneca

Approved

—2

Lyrica

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

3 3

Accupril

Pfizer

Approved

1 4

Mexitil

Boehringer Ingelheim

Approved

1 5

Pamelor

SSpecgx

Approved

1 6

Epsom Salt

FFresenius Kabi USA, LLC

Immunoglobulin

4 8

Rituxan

Roche

Phase 2

2 9

Calciferol

Jazz Pharmaceuticals

Phase 2

1 10

Calquence

AstraZeneca

Phase 2

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

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Dermatomyositis

NCT06284954

Q1 2028

Phase 2Recruiting

Generalized Myasthenia Gravis

NCT07284420

Recruiting

Myasthenia Gravis

NCT07294170

Q2 2028

Phase 2Recruiting

Generalized Myasthenia Gravis

NCT07673627

Q1 2029

Phase 2Not yet recruiting

Guillain-Barré Syndrome

NCT07821762

Clinical

Trials by Indication[1]

Generalized Myasthenia Gravis2 trials

ISA2 to Master Protocol ARGX-999-2-MG-2000 - an Exploratory, Phase 2a, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis

Recruiting· Argenx logo

Argenx·Phase 2·NCT07673627·40 enrolled

An ISA to Master Protocol ARGX-999-2-MG-2000 for an Exploratory, Phase 2a, Proof-of-Concept Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV as Add-On Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod

Recruiting· Argenx logo

Argenx·Phase 2·NCT07284420·70 enrolled

Chronic Inflammatory Demyelinating Polyneuropathy2 trials

A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Intravenous Empasiprubart Versus Intravenous Immunoglobulin in Adults With Chronic Inflammatory Demyelinating Polyneuropathy

Recruiting· Argenx logo

Argenx·Phase 3·NCT06920004·218 enrolled

A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy

Recruiting· Argenx logo

Argenx·Phase 3·NCT07091630·160 enrolled

Dermatomyositis1 trial

A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis

Active, not recruiting· Argenx logo

Argenx·Phase 2·NCT06284954·3 enrolled

Neuropathy1 trial

A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults With Multifocal Motor Neuropathy

Recruiting· Argenx logo

Argenx·Phase 3·NCT06742190·115 enrolled

Myasthenia Gravis1 trial

A Master Protocol for an Exploratory, Phase 2a, Proof-of-Concept Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis

Recruiting· Argenx logo

Argenx··NCT07294170·70 enrolled

2 more indications

Guillain-Barré Syndrome1 trial

A Phase 2, Randomized, Double-Blinded, Placebo-Controlled Study to Assess the Efficacy and Safety of Empasiprubart as Add-On Therapy to IVIg in Adult Participants With Guillain-Barré Syndrome

Not yet recruiting· Argenx logo

Argenx·Phase 2·NCT07821762·63 enrolled

Multifocal Motor Neuropathy (MMN)1 trial

An Open-Label, Single-Arm, Phase 1b Study to Evaluate the Effect of Empasiprubart on Nerve Morphology by Ultrasound in Adults With Multifocal Motor Neuropathy

Recruiting· Argenx logo

Argenx·Phase 1·NCT07610564·60 enrolled

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for Empasiprubart. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Empasiprubart compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Empasiprubart. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Argenx company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Biologic[2]
Highest Phase: Phase 3[1]
Company: Argenx

Empasiprubart

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2028

Q2 2028

Q1 2029

Trials by Indication[1]

Generalized Myasthenia Gravis2 trials

Chronic Inflammatory Demyelinating Polyneuropathy2 trials

Dermatomyositis1 trial

Neuropathy1 trial

Myasthenia Gravis1 trial

Guillain-Barré Syndrome1 trial

Multifocal Motor Neuropathy (MMN)1 trial

References

Drug Info

Quick Facts

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