Drugs / Efgartigimod Alfa
Efgartigimod Alfa
also known as
efgartigimod · ARGX-113 · EFG · Efgartigimod alfa component of vyvgart hytrulo · Efgartigimod Alfa-Fcab · Efgartigimod alfa-qvfc · efgartigimod alpha · Vyvgart
Protein / enzyme biologic targets FCGRT via inhibition
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | VYVGART | — | 2024-08-08 – 2026-05-08 | fda.gov ↗ |
| Approved | EU (EMA) | Vyvgart | — | 2022-08-10 | europa.eu ↗ |
| Approved | US (FDA) | VYVGART | — | 2021-12-17 | fda.gov ↗ |
Trials 63 · started per year
today
US approved 2021
EU approved 2022
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20172018201920202021202220232024202520262027
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT05927415 | Jul 2023 → Jun 2024 | impaired renal function disease | argenx | Completed | No outcome recorded |
| Phase 1 | NCT05163834 | Nov 2021 → Mar 2022 | — | argenx | Completed | No outcome recorded |
| Phase 1 | NCT04564066 | Aug → Dec 2020 | — | argenx | Completed | No outcome recorded |
| Phase 1 | NCT04073589 | Jul → Sep 2019 | — | argenx | Completed | No outcome recorded |
| Phase 1 | NCT03334084 | Oct 2017 → Sep 2018 | — | argenx | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07011589 | Jul 2026 → Jan 2028 expected | acquired epidermolysis bullosa, recessive dystrophic epidermolysis bullosa | M. Peter Marinkovich | Not yet recruiting | No outcome recorded |
| Phase 219 trials | ||||||
| Phase 2 | NCT07583641 | Jul 2026 → Jan 2029 expected | autoimmune encephalitis | argenx | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07025330 | Nov 2025 → Mar 2028 expected | immunoglobulin G4-related sclerosing disease | Stanford University | Recruiting | No outcome recorded |
| Phase 2 | NCT06831058 | May 2025 → May 2028 expected | acquired thrombotic thrombocytopenic purpura | University of Minnesota | Recruiting | No outcome recorded |
| Phase 2 | NCT06528392 | Apr 2025 → Dec 2026 expected | stiff-person syndrome | University of South Florida | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06655155 | Nov 2024 → Feb 2027 expected | systemic sclerosis | argenx | Recruiting | No outcome recorded |
| Phase 2 | NCT05701189 | Sep 2024 → Jan 2026 | Guillain-Barre syndrome | Chafic Karam | Withdrawn | No outcome recorded |
| Phase 2 | NCT06503731 | Aug 2024 → Nov 2027 expected | transplant rejection | argenx | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06497374 | Jul 2024 → Dec 2025 overdue | neuromyelitis optica spectrum disorder with anti-AQP4 antibodies | Tianjin Medical University General Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06221501 | Feb 2024 → Dec 2026 expected | myasthenia gravis | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06203457 | Nov 2023 → Feb 2025 | Sjogren syndrome | argenx | Completed | No outcome recorded |
| Phase 2 | NCT05918978 | Jun 2023 → Aug 2024 | postural orthostatic tachycardia syndrome | argenx | Terminated | No outcome recorded |
| Phase 2 | NCT05817669 | Apr 2023 → Jan 2024 | Sjogren syndrome | argenx | Completed | No outcome recorded |
| Phase 2 | NCT05810948 | Feb 2023 → Jul 2025 | lupus nephritis | argenx | Completed | No outcome recorded |
| Phase 2 | NCT05810961 | Feb 2023 → Aug 2024 | membranous glomerulonephritis | argenx | Terminated | No outcome recorded |
| Phase 2 | NCT05633407 | Sep 2022 → Apr 2024 | postural orthostatic tachycardia syndrome | argenx | Completed | No outcome recorded |
| Phase 2 | NCT04280718 | Sep 2020 → Apr 2027 expected | polyneuropathy, inflammatory demyelinating, chronic | argenx | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04281472 | Apr 2020 → May 2023 | polyneuropathy, inflammatory demyelinating, chronic | argenx | Completed | No outcome recorded |
| Phase 2 | NCT03334058 | Oct 2017 → Oct 2020 | pemphigus foliaceus, pemphigus vulgaris | argenx | Completed | No outcome recorded |
| Phase 2 | NCT03102593 | Mar 2017 → Apr 2019 | autoimmune thrombocytopenia | argenx | Completed | No outcome recorded |
| Phase 2/37 trials | ||||||
| Phase 2/3 | NCT07194850 | Oct 2025 → Oct 2028 expected | autoimmune thrombocytopenic purpura | argenx | Recruiting | No outcome recorded |
| Phase 2/3 | NCT06885762 | Apr 2025 → Jun 2026 overdue | Guillain-Barre syndrome | Zhongming Qiu | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT06392386 | Jun 2024 → Sep 2026 expected | generalized myasthenia gravis | argenx | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05523167 | Oct 2022 → Dec 2026 expected | antisynthetase syndrome, dermatomyositis, immune-mediated necrotizing myopathy | argenx | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT05374590 | Aug 2022 → Sep 2029 expected | generalized myasthenia gravis | argenx | Enrolling by invitation | No outcome recorded |
| Phase 2/3 | NCT05267600 | Jun 2022 → Sep 2024 | bullous pemphigoid | argenx | Completed | No outcome recorded |
| Phase 2/3 | NCT04833894 | Oct 2021 → Mar 2027 expected | generalized myasthenia gravis | argenx | Recruiting | No outcome recorded |
| Phase 325 trials | ||||||
| Phase 3 | NCT07596849 | Jun 2026 → Jun 2028 expected | Graves disease | argenx | Recruiting | No outcome recorded |
| Phase 3 | NCT07570316 | Jun 2026 → Jun 2028 expected | Graves disease | argenx | Recruiting | No outcome recorded |
| Phase 3 | NCT07231523 | Dec 2025 → Jun 2027 expected | AChR+ myasthenia gravis | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06765161 | Feb 2025 → Jan 2027 expected | myasthenia gravis | Clinique Neuro-Outaouais | Recruiting | No outcome recorded |
| Phase 3 | NCT06684847 | Jan 2025 → Jul 2027 expected | Sjogren syndrome | argenx | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06544499 | Oct 2024 → Jun 2028 expected | primary thrombocytopenia | argenx | Recruiting | No outcome recorded |
| Phase 3 | NCT06558279 | Sep 2024 → Jan 2026 overdue | ocular myasthenia gravis | argenx | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06298552 | Apr 2024 → Jun 2025 overdue | generalized myasthenia gravis | argenx | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06307626 | Mar 2024 → Dec 2025 | disease of orbital part of eye adnexa | argenx | Terminated | No outcome recorded |
| Phase 3 | NCT06307613 | Mar 2024 → Dec 2025 | endocrine exophthalmos | argenx | Terminated | No outcome recorded |
| Phase 3 | NCT05979441 | Sep 2023 → Sep 2028 expected | antisynthetase syndrome, dermatomyositis, immune-mediated necrotizing myopathy | argenx | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT06587867 | Jun 2023 → May 2025 overdue | generalized myasthenia gravis | University Health Network, Toronto | Recruiting | No outcome recorded |
| Phase 3 | NCT05681481 | Mar 2023 → Mar 2025 | bullous pemphigoid | argenx | Terminated | No outcome recorded |
| Phase 3 | NCT04980495 | Dec 2021 → Aug 2023 | generalized myasthenia gravis | argenx | Completed | No outcome recorded |
| Phase 3 | NCT04812925 | Nov 2021 → Oct 2026 expected | autoimmune thrombocytopenia | argenx | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04598477 | Jul 2021 → Mar 2024 | pemphigus foliaceus, pemphigus vulgaris | argenx | Terminated | No outcome recorded |
| Phase 3 | NCT04818671 | Apr 2021 → Dec 2024 | generalized myasthenia gravis | argenx | Completed | No outcome recorded |
| Phase 3 | NCT04735432 | Feb → Nov 2021 | generalized myasthenia gravis | argenx | Completed | No outcome recorded |
| Phase 3 | NCT04687072 | Dec 2020 → Oct 2023 | autoimmune thrombocytopenia | argenx | Completed | No outcome recorded |
| Phase 3 | NCT04598451 | Dec 2020 → Aug 2023 | pemphigus foliaceus, pemphigus vulgaris | argenx | Completed | No outcome recorded |
| Phase 3 | NCT04274452 | Jun 2020 → Sep 2021 | autoimmune thrombocytopenia | argenx | Withdrawn | No outcome recorded |
| Phase 3 | NCT04225156 | Jun 2020 → Mar 2026 | autoimmune thrombocytopenia | argenx | Completed | No outcome recorded |
| Phase 3 | NCT04188379 | Dec 2019 → Feb 2022 | primary thrombocytopenia | argenx | Completed | No outcome recorded |
| Phase 3 | NCT03770403 | Mar 2019 → Jun 2022 | generalized myasthenia gravis | argenx | Completed | No outcome recorded |
| Phase 3 | NCT03669588 | Aug 2018 → Apr 2020 | generalized myasthenia gravis | argenx | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT07072988 | Sep 2025 → Oct 2027 expected | generalized myasthenia gravis | Centre Hospitalier Universitaire de Nice | Recruiting | No outcome recorded |
| Phase 4 | NCT06909214 | Apr 2025 → Aug 2026 overdue | generalized myasthenia gravis | argenx | Recruiting | No outcome recorded |
| Phase 4 | NCT06860633 | Mar 2025 → Dec 2026 expected | AChR+ myasthenia gravis | University of Colorado, Denver | Recruiting | No outcome recorded |
| Phase 4 | NCT06637072 | Dec 2024 → Feb 2026 | polyneuropathy, inflammatory demyelinating, chronic | argenx | Completed | No outcome recorded |
| Phase 4 | NCT06688253 | Nov 2024 → Jan 2025 overdue | generalized myasthenia gravis | Rambam Health Care Campus | Not yet recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT06827587 | Feb 2025 → Feb 2026 overdue | generalized myasthenia gravis, neuromuscular disease | First Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | No outcome recorded |
Also used as a comparator or background therapy in 5 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03457649 Comparator | Sep 2015 → Nov 2016 | — | argenx | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07284420 Background | Dec 2025 → Mar 2028 expected | AChR+ myasthenia gravis, generalized myasthenia gravis | argenx | Recruiting | No outcome recorded |
| Phase 2 | NCT06453694 Comparator | Aug 2025 → Dec 2026 expected | optic neuritis | Anastasia Vishnevetsky, MD, MPH | Recruiting | No outcome recorded |
| Phase 2 | NCT02965573 Comparator | Dec 2016 → Oct 2017 | generalized myasthenia gravis | argenx | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07217587 Comparator | Jan 2026 → Sep 2027 expected | generalized myasthenia gravis | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 70 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | efgartigimod alfa | “Efgartigimod alfa, a human IgG1 antibody Fc fragment, has demonstrated efficacy and safety in patients with generalised myasthenia gravis.” PMID 39304241 ↗ Oct 2024 |
| Known as | ARGX-113 | “Efgartigimod PH20 (ARGX-113) SC” NCT07583641 ↗ |
| Known as | EFG | “This study is a prospective, multi-center, randomized controlled study to evaluate the efficacy and safety of efgartigimod (EFG) and intravenous immunoglobulin (IVIG) in the...” NCT07231523 ↗ |
| Known as | efgartigimod | “METHODS: A randomized, double-blind, placebo-controlled first-in-human study was conducted in 62 healthy volunteers to explore single and multiple ascending intravenous doses...” PMID 30040076 ↗ Jul 201861“Efgartigimod is a human IgG1 antibody Fc-fragment, a natural ligand of the neonatal Fc receptor (FcRn), engineered for increased affinity to FcRn, while preserving its...” PMID 31821591 ↗ Dec 2019 “subcutaneous administration of efgartigimod with recombinant human hyaluronidase PH20 (rHuPH20)” NCT04073589 ↗ “Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer” NCT05523167 ↗ |
| Known as | Efgartigimod alfa component of vyvgart hytrulo | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297551 ↗ |
| Known as | Efgartigimod Alfa-Fcab | “Drug: Efgartigimod Alfa-Fcab” NCT05701189 ↗ |
| Known as | Efgartigimod alfa-qvfc | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297551 ↗ |
| Known as | efgartigimod alpha | “Patients will receive efgartigimod alpha via intravenous infusion at a dose of 10 mg/kg, each infusion lasting approximately 2 hours, on Week 0, 1, 2 and 3.” NCT06497374 ↗ |
| Known as | Vyvgart | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297551 ↗ |
| Action | Inhibit | “Efgartigimod blocks FcRn, preventing IgG recycling, and causing targeted IgG degradation.” PMID 31821591 ↗ Dec 20191“IgG receptor FcRn large subunit p51 antagonist” CHEMBL4297551 ↗ |
| Modality | Protein / enzyme biologic | “Efgartigimod is a human IgG1 antibody Fc-fragment” PMID 31821591 ↗ Dec 2019 |
| Route | Intravenous | “four weekly intravenous infusions of either placebo (N = 12) or efgartigimod” PMID 31821591 ↗ Dec 2019 |
| Target | FCGRT | “IgG receptor FcRn large subunit p51 antagonist” CHEMBL4297551 ↗ |