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프로그램 비교

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API CSV24행 · 3개 프로그램

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항목
AntibodyCurated CoreFDAstaleApproved
evolocumab (Repatha, AMG-145)
Amgen·PCSK9
143 trials
AntibodyCurated CoreFDAstaleApproved
inclisiran (Leqvio, KJX839, ALN-PCS)
Novartis·PCSK9 (siRNA)
72 trials
AntibodyCurated CoreFDAstaleApproved
alirocumab (Praluent, REGN727, SAR236553)
Sanofi / Regeneron·PCSK9
103 trials
Overview
Program
Repatha (evolocumab)Leqvio (inclisiran)Praluent (alirocumab)
Overview
Company
AmgenNovartisSanofi / Regeneron
Overview
Modality
ANTIBODYANTIBODYANTIBODY
Overview
Target
PCSK9PCSK9 (siRNA)PCSK9
Overview
Indication
Hyperlipidemia, ASCVD risk reduction, HeFH, HoFHHyperlipidemia, ASCVD, HeFH (LDL-C lowering)Hyperlipidemia, ASCVD, HeFH
Overview
Phase
APPROVEDAPPROVEDAPPROVED
Overview
Status
APPROVEDAPPROVEDAPPROVED
Overview
Content status
Curated CoreCurated CoreCurated Core
Overview
Data Confidence
Editorial scope · Curated CoreEditorial scope · Curated CoreEditorial scope · Curated Core
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · Established
Overview
Approval status
FDA approvedFDA approvedFDA approved
Positioning
Key differentiator
High LDL-C lowering without statin myalgia; autoinjector penInfrequent dosing (q6 months maintenance)Flexible q2w dosing; post-ACS outcomes label
Positioning
Known limitation
Statin non-adherence; rare anti-drug antibodiesInjection-site reactions; long-term siRNA durability generally maintained.resistance to immune checkpoint blockade
Positioning
Development positioning
Add-on to statin ± ezetimibe——
MoA
Mechanism
Evolocumab binds PCSK9, preventing PCSK9-mediated LDL receptor degradation on hepatocytes, increasing LDLR recycling and hepatic LDL-C clearance.Inclisiran is a GalNAc-conjugated siRNA that catalytically degrades PCSK9 mRNA in hepatocytes, reducing PCSK9 protein and increasing LDLR density.Alirocumab inhibits PCSK9, increasing available LDL receptors and lowering LDL-C similarly to evolocumab.
MoA
Biomarker
LDL-C, ApoB, non-HDL-C; Lp(a) modest reduction.LDL-C, PCSK9 protein levels.LDL-C, ApoB.
Toxicology
Species
Cynomolgus monkey, HamsterMouse, RatRat
Toxicology
Animal (cat.)
NHP——
Toxicology
Major finding
No major organ toxicity; injection-site reactionsInjection-site reactions, arthralgia, urinary tract infection.Injection-site reactions, flu-like symptoms.
Toxicology
CRS
N/AN/AN/A
Clinical
Safety signal
No major organ toxicity; injection-site reactionsInjection-site reactions, arthralgia, urinary tract infection.Injection-site reactions, flu-like symptoms.
Clinical
Program phase
APPROVEDAPPROVEDAPPROVED
Clinical
Trial activity
No active/completed countsNo active/completed countsNo active/completed counts
Preclinical
Animal (cat.)
Mouse, In vitro——