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Argenx Se (ARGX)
NASDAQ:ARGX
Empasiprubart Iv
Chronic Inflammatory Demyelinating Polyneuropathy, Cidp, Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Phase III
Not Yet 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 - Chronic Inflammatory Demyelinating Polyneuropathy, Cidp
Phase III
Not Yet Recruiting
A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
Mar 26, 2025
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Argx-109
Healthy Volunteer
Phase I
Recruiting
A Study to Assess the Safety of ARGX-109 in Healthy Volunteers
Jan 23, 2025
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Efgartigimod Ph20 Sc
Primary Sjogrens Disease
Phase III
Recruiting
A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome
Nov 10, 2024
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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: Empasiprubart Iv, Argx-213, Efgartigimod Ph20 Sc. These drug candidates are in various stages of clinical development as the company works toward FDA approval.