ARGX-119

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Congenital Myasthenic SyndromeSpinal Muscular Atrophy (SMA)

4 competitors in Congenital Myasthenic Syndrome

#DrugCompanyPhaseTrials

1

Ephedrine Sulfate

DDr. Reddys Laboratories, SA

Approved

—2

Adimanebart IV

Argenx

Phase 3

13

ARGX-119

Argenx

Phase 2

14

Alloex

TThe Foundation for Orthopaedics and Regenerative Medicine

Phase 1

15

Firdapse

CCatalyst Pharmaceuticals, Inc.

Preclinical

1

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

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Immunogenicity1 trial

A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Ascending Doses of ARGX-119 in Healthy Participants

Completed·Argenx·Phase 1·NCT05670704·112 enrolled

Amyotrophic Lateral Sclerosis1 trial

A Phase 2a, Double-Blinded, Randomized, Placebo-Controlled, and Active-Treatment Extension Study to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of ARGX-119 in Participants With Amyotrophic Lateral Sclerosis

Terminated·Argenx·Phase 2·NCT06441682·60 enrolled

Spinal Muscular Atrophy (SMA)1 trial

A Phase 2 Double-Blinded, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Intravenous Administration of ARGX-119 in Pediatric Participants Aged 5 to Less Than 18 Years With Spinal Muscular Atrophy

Recruiting·Argenx·Phase 2·NCT07287982·60 enrolled

Congenital Myasthenic Syndrome1 trial

A Phase 1b, Double-Blinded, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Efficacy of ARGX-119 in Adult Participants With DOK7-Congenital Myasthenic Syndromes

Active, not recruiting·Argenx·Phase 1·NCT06436742·15 enrolled

Details

Drug Info

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