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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
inclisiran (Leqvio, KJX839, ALN-PCS)
Novartis·PCSK9 (siRNA)
72 trials·t½ 9 h
Overview
Program
Leqvio (inclisiran)
Overview
Company
Novartis
Overview
Modality
ANTIBODY
Overview
Target
PCSK9 (siRNA)
Overview
Indication
Hyperlipidemia, ASCVD, HeFH (LDL-C lowering)
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
Infrequent dosing (q6 months maintenance)
Positioning
Known limitation
Injection-site reactions; long-term siRNA durability generally maintained.
MoA
Mechanism
Inclisiran is a GalNAc-conjugated siRNA that catalytically degrades PCSK9 mRNA in hepatocytes, reducing PCSK9 protein and increasing LDLR density.
MoA
Biomarker
LDL-C, PCSK9 protein levels.
PK/PD
Half-life
9 h
PK/PD
Species
Mouse, Rat
PK/PD
Animal (cat.)
Mouse, Rat, Monkey
PK/PD
Experiment
pharmacokinetic
Toxicology
Species
Mouse, Rat
Toxicology
Major finding
Injection-site reactions, arthralgia, urinary tract infection.
Toxicology
CRS
N/A
Clinical
Safety signal
Injection-site reactions, arthralgia, urinary tract infection.
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts
Preclinical
Animal (cat.)
Mouse