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Efgartigimod PH20 SC
Efgartigimod PH20 SC is a FcRn antagonist Biologic drug developed by argenx. It is currently FDA-approved for Generalized myasthenia gravis (gMG), Chronic inflammatory demyelinating polyneuropathy (CIDP). Also known as: ARGX-113 PH20 SC, ARGX-113.
Efgartigimod is an IgG Fc fragment that binds to the neonatal Fc receptor (FcRn) to reduce circulating immunoglobulin levels, particularly IgG antibodies.
Efgartigimod PH20 SC is a protein-based antagonist that targets the IgG receptor FcRn large subunit p51. It is being studied in clinical trials for various conditions, including Thyroid Eye Disease, Chronic Inflammatory Demyelinating Polyneuropathy, and Generalized Myasthenia Gravis.
At a glance
| Generic name | Efgartigimod PH20 SC |
|---|---|
| Also known as | ARGX-113 PH20 SC, ARGX-113 |
| Sponsor | argenx |
| Drug class | FcRn antagonist |
| Target | Neonatal Fc receptor (FcRn) |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
Efgartigimod competitively binds to FcRn, a receptor responsible for recycling and maintaining IgG levels in circulation. By blocking this interaction, the drug accelerates IgG catabolism and reduces pathogenic autoantibody levels. The PH20 subcutaneous formulation uses hyaluronidase to enable subcutaneous administration with improved bioavailability.
Approved indications
- Generalized myasthenia gravis (gMG)
- Chronic inflammatory demyelinating polyneuropathy (CIDP)
Common side effects
- Infection
- Infusion-related reactions
- Headache
- Fatigue
Key clinical trials
- Pre-Approval Access for Efgartigimod PH20 SC in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- A Study to Evaluate the Safety and Tolerability of Efgartigimod PH20 SC Given by Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection (AMR) (PHASE2)
- A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome (PHASE3)
- A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease (PHASE3)
- A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease. (PHASE3)
- Real-World Efgartigimod Effectiveness in CIDP: A Prospective Study
- A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis (PHASE2)
- A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Efgartigimod PH20 SC CI brief — competitive landscape report
- Efgartigimod PH20 SC updates RSS · CI watch RSS
- argenx portfolio CI
Frequently asked questions about Efgartigimod PH20 SC
What is Efgartigimod PH20 SC?
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What is Efgartigimod PH20 SC used for?
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Is Efgartigimod PH20 SC also known as anything else?
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What does Efgartigimod PH20 SC target?
Related
- Drug class: All FcRn antagonist drugs
- Target: All drugs targeting Neonatal Fc receptor (FcRn)
- Manufacturer: argenx — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Generalized myasthenia gravis (gMG)
- Indication: Drugs for Chronic inflammatory demyelinating polyneuropathy (CIDP)
- Also known as: ARGX-113 PH20 SC, ARGX-113
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing