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항목
AntibodyCurated CoreFDAApproved
lecanemab (Leqembi, BAN2401, lecanemab-irmb)
Eisai / Biogen·Amyloid-beta protofibrils
37 trials·t½ ~5–7 days
Overview
Program
Leqembi (lecanemab)
Overview
Company
Eisai / Biogen
Overview
Modality
ANTIBODY
Overview
Target
Amyloid-beta protofibrils
Overview
Indication
Early symptomatic Alzheimer's disease (MCI or mild dementia) with confirmed amyloid pathology
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
Protofibril selectivity targets the species most closely tied to synaptic toxicity, with lower ARIA-E rates than plaque-directed antibodies at comparable clearance.
Positioning
Known limitation
Amyloid clearance does not fully arrest tau pathology, so clinical benefit is partial rather than disease-arresting.
Positioning
Development positioning
Head-to-head with Kisunla; differs on titration, dosing interval, and stopping rules.
MoA
Mechanism
Binds soluble amyloid-beta protofibrils and promotes microglial clearance of aggregated amyloid, reducing plaque burden and downstream tau and neurodegeneration markers.
MoA
Biomarker
Amyloid PET centiloid reduction, plasma p-tau181/217, CSF Aβ42/40 ratio.
PK/PD
Half-life
~5–7 days
PK/PD
Species
Amyloid PET SUVR, plasma p-tau217, CDR-SB and ADAS-Cog trajectory
PK/PD
Animal (cat.)
Human, In vitro
PK/PD
Experiment
pharmacodynamic
Toxicology
Species
Mouse
Toxicology
Major finding
Boxed warning for ARIA — amyloid-related imaging abnormalities with edema (ARIA-E) and microhemorrhage (ARIA-H). ApoE ε4 homozygotes carry the highest risk; concomitant anticoagulation raises hemorrhage concern.
Toxicology
CRS
N/A
Clinical
Safety signal
Boxed warning for ARIA — amyloid-related imaging abnormalities with edema (ARIA-E) and microhemorrhage (ARIA-H). ApoE ε4 homozygotes carry the highest risk; concomitant anticoagulation raises hemorrhage concern.
Clinical
Selected reported efficacy
27%
Clinical
Result source
CLARITY AD (NCT03887455)
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT03887455
Preclinical
Animal (cat.)
Mouse