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Argenx Se (ARGX)
NASDAQ:ARGX
Argx-124
Healthy Volunteers
Phase I
Recruiting
A Study to Assess the Safety of ARGX-124 in Healthy Volunteers
Jan 22, 2026
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Efgartigimod Iv, Empasiprubart Iv
Generalized Myasthenia Gravis (Gmg), Gmg, Mg, Achr-Ab Seropositive Generalized Myasthenia Gravis, Generalized Myasthenia Gravis, Myasthenia Gravis
Phase II
Recruiting
ADAPT Forward 1 - ISA1 - a Study to Evaluate 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
Dec 08, 2025
Efgartigimod Iv
Itp, Idiopathic Thrombocytopenic Purpura (Itp), Immune Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura, Itp - Immune Thrombocytopenia, Immune Thrombocytopenic Purpura ( Itp ), Immune Thrombocytopenia (Itp)
Phase II/III
Recruiting
A Study of Efgartigimod IV in Participants From 12 Years to Less Than 18 Years of Age With Chronic Immune Thrombocytopenia (ITP)
Sep 19, 2025
Empasiprubart Iv
Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Polyneuropathy, Cidp
Phase III
Recruiting
A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP
Jul 22, 2025
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Argx-213
Healthy Volunteers
Phase I
Recruiting
A Study to Assess the Safety of ARGX-213 in Healthy Volunteers
May 05, 2025
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Efgartigimod Ph20 Sc
New Onset Generalized Myasthenia Gravis (Gmg)
Phase IV
Recruiting
A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)
Mar 27, 2025
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Ivig, Empasiprubart
Chronic Inflammatory Demyelinating Polyneuropathy, Cidp, Cidp - Chronic Inflammatory Demyelinating Polyneuropathy
Phase III
Recruiting
A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
Mar 26, 2025
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Argenx Se (ARGX) have in its pipeline
ARGX is currently developing the following drugs: Argx-124, Argx-119 Iv, Efgartigimod Iv, Empasiprubart Iv. These drug candidates are in various stages of clinical development as the company works toward FDA approval.