FDA · United States
efgartigimod alfa — FDA regulatory status
efgartigimod alfa (VYVGART) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- VYVGART
- Mechanism
- IgG receptor FcRn large subunit p51 antagonist
- Target
- IgG receptor FcRn large subunit p51
- Structured fields
- 6
Pharmacology context used for competitive intelligence: IgG receptor FcRn large subunit p51 antagonist. Target: IgG receptor FcRn large subunit p51. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 24 published clinical programs and 0 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| ARGX-113 | Phase 3 | Argenx | 2024-513147-90-00 |
| ARGX-113 | Phase 3 | Argenx | 2024-511504-17-00 |
| ARGX-113-2007 | Phase 3 | Argenx | 2024-512785-33-00 |
| ARGX-113-2008 | Phase 3 | Argenx | 2023-507379-23-00 |
| ARGX-113-2306 | Phase 3 | Argenx | 2024-516609-22-00 |
| ARGX-113-2308 | Phase 3 | Argenx | 2024-511796-15-00 |
| ARGX-113-2309 | Phase 3 | Argenx | 2023-509198-22-00 |
| ARGX-113-2315 | Phase 3 | Argenx | 2024-514133-38-00 |
| ARGX-113-2402 | Phase 3 | Argenx | 2024-515451-38-00 |
| EFGARTIGIMOD ALFA, JNJ-80202135 | Phase 3 | Janssen-Cilag International N.V | 2025-521130-28-00 |
| Efgartigimod PH20 SC | Phase 3 | Argenx | NCT06684847 |
| Efgartigimod, Placebo for efgartigimod | Phase 3 | Argenx | 2023-509197-35-00 |
Related hubs
FAQ
What is the FDA approval status of efgartigimod alfa?
efgartigimod alfa currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get efgartigimod alfa regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to efgartigimod alfa?
This spoke lists 24 published programs associated with efgartigimod alfa in our pipeline index.