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Efgartigimod · Vyvgart, Vyvgart Hytrulo

Fusion protein · Antagonist of neonatal Fc receptor (FCGRT) · developed by Argenx Us

Approved FDA, Dec 2021
ARGX Developer
9 Registered trials

What is Efgartigimod?

Efgartigimod is a human IgG1-derived Fc fragment that binds the neonatal Fc receptor (FcRn) and blocks it, preventing IgG recycling and thereby reducing circulating IgG, including pathogenic autoantibodies. It is studied in myasthenia gravis, autoimmune encephalitis, immune thrombocytopenia and myositis. A subcutaneous coformulation with hyaluronidase is also described.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
Vyvgart, Vyvgart Hytrulo, ARGX-113, EFG PH20 SC
Drug type
Fusion protein
Targets
neonatal Fc receptor (FCGRT)
Mechanism
Antagonist of neonatal Fc receptor (FCGRT)
Pathways
IgG recycling and half-life extension, reduction of circulating IgG
Therapy area
Hematology, Immunology, Neurology
Developer
Argenx Us (ARGX)
Also in trials of
IQV
FDA status
Approved as Vyvgart, Vyvgart Hytrulo (December 17, 2021), BLA761304 · FDA label
UNII
961YV2O515

✅ FDA-approved uses

From the indications section of the FDA label (version of May 13, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT06637072 Phase 4 Chronic Inflammatory Demyelinating Polyneuropathy Completed ARGX
NCT06544499 Phase 3 Primary Immune Thrombocytopenia (ITP) Recruiting ARGX
NCT05523167 Phase 2/3 Active Idiopathic Inflammatory Myopathy Completed ARGX
NCT04225156 Phase 3 Primary Immune Thrombocytopenia Completed ARGX
NCT07583641 Phase 2 Autoimmune Encephalitis (AE) Not yet recruiting ARGX
NCT05701189 Phase 2 Guillain-Barre Syndrome Withdrawn ARGX
NCT06203457 Phase 2 Primary Sjögren's Syndrome Completed IQV
NCT07782775 Phase 1 Healthy Volunteer Recruiting ARGX
NCT07294170 N/A Myasthenia Gravis Recruiting ARGX

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

AChR-Ab Seropositive Generalized Myasthenia GravisAutoimmune Encephalitis (AE)Generalized Myasthenia GravisGeneralized Myasthenia Gravis (gMG)gMGHealthy Adult ParticipantsHealthy VolunteerMGMyasthenia GravisPrimary Immune Thrombocytopenia (ITP)Active Idiopathic Inflammatory MyopathyAntisynthetase SyndromeChronic Inflammatory Demyelinating PolyneuropathyDermatomyositis

More from Argenx Us

Sources

Updated Oct 11, 2026. Something wrong or missing? Report it on the ARGX page.

Follow ARGX, the company behind Efgartigimod

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

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