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API CSV24행 · 5개 프로그램

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항목
AntibodyCurated CoreFDAstaleApproved
evolocumab (Repatha, AMG-145)
Amgen·PCSK9
143 trials
AntibodyCurated CoreFDAstaleApproved
alirocumab (Praluent, REGN727, SAR236553)
Sanofi / Regeneron·PCSK9
103 trials
AntibodyCurated CoreFDAstaleApproved
inclisiran (Leqvio, KJX839, ALN-PCS)
Novartis·PCSK9 (siRNA)
72 trials
AntibodyLimited DatastalePhase 2
PCSK9 Inhibitor (Tolecizumab, Tolecizumab (PCSK9 Inhibitor))
Daping Hospital and the Research I…·Colon Adenocarcinoma
1 trials
AntibodyLimited DatastalePreclinical
PCSK9 inhibitor (PCSK9 inhibitor)
Yun Dai Chen·Acute Myocardial Infarction
1 trials
Overview
Program
Repatha (evolocumab)Praluent (alirocumab)Leqvio (inclisiran)Tolecizumab (PCSK9 Inhibitor)PCSK9 inhibitor
Overview
Company
AmgenSanofi / RegeneronNovartisDaping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityYun Dai Chen
Overview
Modality
ANTIBODYANTIBODYANTIBODYANTIBODYANTIBODY
Overview
Target
PCSK9PCSK9PCSK9 (siRNA)Colon AdenocarcinomaAcute Myocardial Infarction
Overview
Indication
Hyperlipidemia, ASCVD risk reduction, HeFH, HoFHHyperlipidemia, ASCVD, HeFHHyperlipidemia, ASCVD, HeFH (LDL-C lowering)Colon AdenocarcinomaAcute Myocardial Infarction
Overview
Phase
APPROVEDAPPROVEDAPPROVEDPHASE_2PRECLINICAL
Overview
Status
APPROVEDAPPROVEDAPPROVEDRECRUITINGRECRUITING
Overview
Content status
Curated CoreCurated CoreCurated CoreLimited DataLimited Data
Overview
Data Confidence
Editorial scope · Curated CoreEditorial scope · Curated CoreEditorial scope · Curated CoreEditorial scope · limited dataEditorial scope · limited data
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · EmergingDevelopment Signal · Watch
Overview
Approval status
FDA approvedFDA approvedFDA approvedInvestigationalInvestigational
Positioning
Key differentiator
High LDL-C lowering without statin myalgia; autoinjector penFlexible q2w dosing; post-ACS outcomes labelInfrequent dosing (q6 months maintenance)——
Positioning
Known limitation
Statin non-adherence; rare anti-drug antibodiesresistance to immune checkpoint blockadeInjection-site reactions; long-term siRNA durability generally maintained.——
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.Alirocumab inhibits PCSK9, increasing available LDL receptors and lowering LDL-C similarly to evolocumab.Inclisiran is a GalNAc-conjugated siRNA that catalytically degrades PCSK9 mRNA in hepatocytes, reducing PCSK9 protein and increasing LDLR density.——
MoA
Biomarker
LDL-C, ApoB, non-HDL-C; Lp(a) modest reduction.LDL-C, ApoB.LDL-C, PCSK9 protein levels.——
Toxicology
Species
Cynomolgus monkey, HamsterRatMouse, Rat——
Toxicology
Animal (cat.)
NHP————
Toxicology
Major finding
No major organ toxicity; injection-site reactionsInjection-site reactions, flu-like symptoms.Injection-site reactions, arthralgia, urinary tract infection.——
Toxicology
CRS
N/AN/AN/A——
Clinical
Safety signal
No major organ toxicity; injection-site reactionsInjection-site reactions, flu-like symptoms.Injection-site reactions, arthralgia, urinary tract infection.——
Clinical
Program phase
APPROVEDAPPROVEDAPPROVEDPHASE_2PRECLINICAL
Clinical
Trial activity
No active/completed countsNo active/completed countsNo active/completed counts——
Preclinical
Animal (cat.)
Mouse, In vitro————