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항목
AntibodyCurated CoreFDAApproved
donanemab (Kisunla, LY3002813, donanemab-azbt)
Eli Lilly·N3pG amyloid-beta plaque
21 trials·t½ ~12 days
Overview
Program
Kisunla (donanemab)
Overview
Company
Eli Lilly
Overview
Modality
ANTIBODY
Overview
Target
N3pG amyloid-beta plaque
Overview
Indication
Early symptomatic Alzheimer's disease 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
Plaque-only specificity permits aggressive clearance and pre-specified treatment discontinuation once amyloid PET turns negative.
Positioning
Known limitation
High baseline tau burden limits clinical benefit despite full plaque clearance.
Positioning
Development positioning
Monthly dosing and a finite course versus Leqembi's biweekly, open-ended schedule.
MoA
Mechanism
Binds the N3pG epitope present in deposited plaque and drives microglial phagocytic clearance, converting amyloid-PET-positive patients to negative within months.
MoA
Biomarker
Amyloid PET centiloid, plasma p-tau217; baseline tau PET stratifies benefit.
PK/PD
Half-life
~12 days
PK/PD
Species
Amyloid PET clearance rate, plasma p-tau217, iADRS/CDR-SB slope
PK/PD
Animal (cat.)
Human, In vitro
PK/PD
Experiment
pharmacodynamic
Toxicology
Species
Mouse
Toxicology
Major finding
Boxed warning for ARIA. Infusion-related reactions are common; the modified titration schedule was added to lower ARIA-E incidence.
Toxicology
CRS
N/A
Clinical
Safety signal
Boxed warning for ARIA. Infusion-related reactions are common; the modified titration schedule was added to lower ARIA-E incidence.
Clinical
Selected reported efficacy
25.12%
Clinical
Result source
ClinicalTrials.gov NCT05738486
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT05738486
Preclinical
Animal (cat.)
Mouse