efgartigimod
Trade name: Vyvgart
Recombinant proteinapprovedOrphan Drug FDAFast Track FDA
Approved
Dec 17, 2021
Clinical trial activity
65 trials · 26 clinical orgs · 1 marketing orgs
Phase 1
8
Phase 2
44
Phase 3
31
Phase 4
5
Earliest trial started Sep 9, 2015 (NCT03457649)
Timeline
2010s
Indications
Approved for
Studied for
- Autoimmune Diseases · Phase 3
- Cardiomyopathies · Phase 3
- COVID-19 · Phase 2
- Dermatomyositis · Phase 3
- Drug Therapy · Phase 3
- Epidermolysis Bullosa · Phase 1/Phase 2
- Epidermolysis Bullosa Acquisita · Phase 1/Phase 2
- Epidermolysis Bullosa Dystrophica · Phase 1/Phase 2
- Glomerulonephritis, Membranous · Phase 2
- Graft Rejection · Phase 2
- Graves Ophthalmopathy · Phase 3
- Guillain-Barre Syndrome · Phase 2
- Healthy Volunteers · Phase 1
- Immune System Diseases · Phase 3
- Immunoglobulin G4-Related Disease · Phase 2
- Immunoglobulins, Intravenous · Phase 3
- Inosine Triphosphate · Phase 2/Phase 3
- Kidney Failure, Chronic · Phase 1
- Lupus Nephritis · Phase 2
- Myasthenia Gravis · Phase 3
- Myositis · Phase 3
- Neuromyelitis Optica · Phase 2
- Pemphigoid, Bullous · Phase 3
- Pemphigus · Phase 3
- Pharmacology · Phase 1
- Polymyositis · Phase 3
- Polyradiculoneuropathy · Phase 2
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating · Phase 4
- Postural Orthostatic Tachycardia Syndrome · Phase 2
- Purpura · Phase 2/Phase 3
- Purpura, Thrombocytopenic, Idiopathic · Phase 2/Phase 3
- Purpura, Thrombotic Thrombocytopenic · Phase 2
- Sclerosis · Phase 2
- Sjogren's Syndrome · Phase 3
- Stiff-Person Syndrome · Phase 2
- Therapeutic Equivalency · Phase 1
- Thrombocytopenia · Phase 3
Mechanism of action
- IgG receptor FcRn large subunit p51ANTAGONIST
FCGRT antagonist
Combination products
vyvgart hytrulo
with hyaluronidase (human recombinant)
Also known as efgartigimod alfa and hyaluronidase-qvfc
Approval history
- approvedFast trackDec 17, 2021
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
First in class
Sources
- ChEMBLCHEMBL4297551 ↗
Also known as
- argx-113
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07284420 | Phase 2 | Dec 31, 2025 | argenx |
| NCT07231523 | Phase 3 | Dec 1, 2025 | Fudan University, Guangzhou University, Huazhong University of Science and Technology, Nanjing Medical University, People's Liberation Army of China, Sichuan University, Soochow University, Wenzhou Medical University, Xuzhou Medical University |
| NCT07217587 | Phase 3 | Nov 28, 2025 | — |
| NCT07025330 | Phase 2 | Nov 12, 2025 | Stanford University |
| NCT07194850 | Phase 2/Phase 3 (Phase 3) | Oct 20, 2025 | argenx |
| NCT07072988 | Phase 4 | Sep 19, 2025 | University of Nice Sophia Antipolis |
| NCT07011589 | Phase 1/Phase 2 (Phase 2) | Jul 31, 2025 | argenx, Stanford University |
| NCT06831058 | Phase 2 | May 1, 2025 | University of Minnesota |
| NCT06909214 | Phase 4 | Apr 17, 2025 | argenx |
| NCT06885762 | Phase 2/Phase 3 (Phase 3) | Apr 13, 2025 | People's Liberation Army of China |
| NCT06860633 | Phase 4 | Mar 15, 2025 | argenx, University of Colorado, Denver |
| NCT06827587 | N/A | Feb 28, 2025 | Ningbo Medical Center Lihuili Eastern Hospital, Wenzhou Medical University, Zhejiang University |
| NCT06765161 | Phase 3 | Feb 6, 2025 | argenx, Clinique Neuro-Outaouais |
| NCT06684847 | Phase 3 | Dec 31, 2024 | argenx |
| NCT06637072 | Phase 4 | Nov 30, 2024 | argenx |
| NCT06655155 | Phase 2 | Nov 18, 2024 | argenx |
| NCT06688253 | Phase 4 | Nov 15, 2024 | argenx, Technion University |
| NCT06544499 | Phase 3 | Oct 31, 2024 | argenx |
| NCT06558279 | Phase 3 | Sep 18, 2024 | argenx |
| NCT06503731 | Phase 2 | Aug 30, 2024 | argenx |
Showing 20 of 65 trials
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Organizations
Research & Development (26)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| argenx | For profit | 55 | 50 | 5 | 2015 |
| IQVIA | For profit | 6 | 0 | 1 | 2016 |
| People's Liberation Army of China | Government | 2 | 1 | 1 | 2025 |
| Stanford University | Academic/Hospital | 2 | 2 | 1 | 2025 |
| Wenzhou Medical University | Academic/Hospital | 2 | 1 | 2 | 2025 |
| Zai Lab Pty. Ltd. | For profit | 2 | 0 | 1 | 2023 |
| Capital Medical University | Academic/Hospital | 1 | 0 | 1 | 2024 |
| Clinique Neuro-Outaouais | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Fudan University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Guangzhou University | Academic/Hospital | 1 | 0 | 1 | 2025 |
| Huazhong University of Science and Technology | Academic/Hospital | 1 | 0 | 1 | 2025 |
| Nanjing Medical University | Academic/Hospital | 1 | 0 | 1 | 2025 |
| Ningbo Medical Center Lihuili Eastern Hospital | Academic/Hospital | 1 | 0 | 1 | 2025 |
| Sichuan University | Academic/Hospital | 1 | 0 | 1 | 2025 |
| Soochow University | Academic/Hospital | 1 | 0 | 1 | 2025 |
| Technion University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Tianjin Medical University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| University of Colorado, Denver | Academic/Hospital | 1 | 1 | 1 | 2025 |
| University of London | Academic/Hospital | 1 | 0 | 1 | 2017 |
| University of Minnesota | Academic/Hospital | 1 | 1 | 1 | 2025 |
26 organizations
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