Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as efgartigimod PH20 SC as a prefilled syringe presentation
efgartigimod PH20 as a prefilled syringe presentation · 1 trial · 1 indication
maximum observed plasma concentration
area under the concentration-time curve from 0 to infinity
| Arm | Type | Description |
|---|---|---|
| Efgartigimod PH20 SC - prefilled syringe | EXPERIMENTAL | efgartigimod PH20 SC administered by a prefilled syringe |
| Efgartigimod PH20 SC - vial + syringe | ACTIVE_COMPARATOR | efgartigimod PH20 SC administered by a vial + syringe |
| Name | Type | Description |
|---|---|---|
| efgartigimod PH20 SC as a prefilled syringe presentation | BIOLOGICAL | efgartigimod PH20 SC as a prefilled syringe presentation |
| efgartigimod PH20 SC as a vial + syringe presentation | BIOLOGICAL | efgartigimod PH20 SC as a vial + syringe presentation |
Inclusion Criteria: * Is at least the local legal age of consent for participation in a clinical study and ≤55 years when signing the ICF * Is capable of providing signed informed consent, and complying with protocol requirements * Agrees to use contraceptive measures consistent with local regulati...
Efgartigimod PH20 as a prefilled syringe presentation is an investigational formulation of efgartigimod, a monoclonal antibody, supplied as a prefilled syringe for subcutaneous administration. It is being developed by argenx SE (ticker ARGX). The presentation is designed to deliver efgartigimod PH20 SC without a separate vial and syringe preparation step.
Efgartigimod PH20 targets FCGRT, the neonatal Fc receptor, and acts as an antagonist. By binding FCGRT, the antibody blocks the receptor's recycling of immunoglobulin G, which reduces circulating IgG levels. This target class is the basis for the efgartigimod program developed by argenx SE.
Efgartigimod PH20 as a prefilled syringe presentation is developed by argenx SE, which trades under the ticker ARGX. Argenx is the sponsor of the clinical program evaluating this subcutaneous prefilled syringe presentation of efgartigimod PH20.
Efgartigimod PH20 as a prefilled syringe presentation is in Phase 1 development. It is investigational and has not been approved by the FDA. The Phase 1 program consists of one completed trial, a bioequivalence study conducted in healthy adult volunteers in the United States.
The presentation has been studied in NCT05817435, a Phase 1 bioequivalence study of efgartigimod PH20 SC administered via a prefilled syringe versus a vial plus syringe presentation in healthy adults. The trial enrolled 120 participants, was randomized and active controlled, and is now completed.
Yes. Efgartigimod PH20 SC as a prefilled syringe presentation is another name for efgartigimod PH20 as a prefilled syringe presentation. Both refer to the same subcutaneous prefilled syringe presentation of efgartigimod PH20 developed by argenx SE under ticker ARGX.