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타깃 · 모달리티 · 임상 근거 · 비임상 맥락으로 최대 5개 프로그램을 나란히 비교합니다. · 다음 갱신 D-6 · 마지막 9월 2일

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항목
AntibodyCurated CoreFDAApproved
efgartigimod (Vyvgart, ARGX-113, Vyvgart Hytrulo, efgartigimod alfa-fcab)
argenx·FcRn (neonatal Fc receptor)
48 trials·t½ ~3–4 days, but the IgG-lowering effect outlasts plasma exposure
Overview
Program
Vyvgart (efgartigimod)
Overview
Company
argenx
Overview
Modality
ANTIBODY
Overview
Target
FcRn (neonatal Fc receptor)
Overview
Indication
Generalized myasthenia gravis (AChR antibody positive), chronic inflammatory demyelinating polyneuropathy
Overview
Phase
APPROVED
Overview
Status
APPROVED
Overview
Content status
Curated Core
Overview
Data Confidence
Data Confidence · High
Overview
Development Signal
Development Signal · Established
Overview
Approval status
FDA approved
Positioning
Key differentiator
Selective IgG reduction without touching albumin, other immunoglobulin classes, or complement — so infection risk stays much lower than with broad immunosuppression.
Positioning
Known limitation
Seronegative or non-IgG-mediated disease does not respond; effect reverses on withdrawal.
Positioning
Development positioning
First-in-class FcRn blocker, now competing with rozanolixizumab and nipocalimab.
MoA
Mechanism
Binds FcRn and blocks IgG recycling, so pathogenic IgG autoantibodies are routed to lysosomal degradation; total IgG falls roughly 60–70% within a treatment cycle.
MoA
Biomarker
Total IgG and anti-AChR antibody titer; MG-ADL and QMG scores.
PK/PD
Half-life
~3–4 days, but the IgG-lowering effect outlasts plasma exposure
PK/PD
Species
Cynomolgus monkey, Total IgG reduction, anti-AChR titer, MG-ADL change
PK/PD
Animal (cat.)
Human, NHP
PK/PD
Experiment
Pharmacokinetic
Toxicology
Species
Mouse, Rat
Toxicology
Major finding
Headache, respiratory and urinary tract infection, and injection-site reactions. IgG reduction is selective and reversible, so cumulative immunosuppression is limited compared with conventional agents.
Toxicology
CRS
N/A
Clinical
Safety signal
Headache, respiratory and urinary tract infection, and injection-site reactions. IgG reduction is selective and reversible, so cumulative immunosuppression is limited compared with conventional agents.
Clinical
Selected reported efficacy
68%
Clinical
Result source
ADAPT (NCT03669588)
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT03669588
Preclinical
Animal (cat.)
NHP