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항목
AntibodyCurated CoreFDAApproved
alirocumab (Praluent, REGN727, SAR236553)
Sanofi / Regeneron·PCSK9
103 trials·t½ 12 h
Overview
Program
Praluent (alirocumab)
Overview
Company
Sanofi / Regeneron
Overview
Modality
ANTIBODY
Overview
Target
PCSK9
Overview
Indication
Hyperlipidemia, ASCVD, HeFH
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
Flexible q2w dosing; post-ACS outcomes label
Positioning
Known limitation
resistance to immune checkpoint blockade
MoA
Mechanism
Alirocumab inhibits PCSK9, increasing available LDL receptors and lowering LDL-C similarly to evolocumab.
MoA
Biomarker
LDL-C, ApoB.
PK/PD
Half-life
12 h
PK/PD
Species
Mouse, LDL-C ↓~58%
PK/PD
Animal (cat.)
Mouse
PK/PD
Experiment
pharmacokinetic
Toxicology
Species
Mouse, Rat
Toxicology
Major finding
Injection-site reactions, flu-like symptoms.
Toxicology
CRS
N/A
Clinical
Safety signal
Injection-site reactions, flu-like symptoms.
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts
Preclinical
Animal (cat.)
Mouse