Fully human anti-PCSK9 mAb; lowers LDL-C ~60% on top of statins. SC q2w or q4w; established LDL-lowering class leader with outcomes data (FOURIER). 대표 임상 효능: ORR 59% (FOURIER).
PCSK9
Hyperlipidemia, ASCVD risk reduction, HeFH, HoFH
Global
Approved
Monoclonal antibody
Human IgG2 anti-PCSK9
High LDL-C lowering without statin myalgia; autoinjector pen
ASCVD, HeFH, statin-intolerant or LDL above goal on max statin
Add-on to statin ± ezetimibe
SC autoinjector
q2w or q4w (140 mg monthly option)
LDL-C reduction ≥50% vs placebo
Injection-site reactions, nasopharyngitis; low neutralizing Ab rate
PCSK9 mAb vs inclisiran siRNA (Leqvio) dosing convenience trade-off
Binds PCSK9 → prevents LDLR degradation → increased hepatic LDL clearance
cytokine release, vascular smooth muscle cell proliferation, and impaired endothelial repair-mechanisms implicated i
apoptosis-related proteins, and signaling pathway-related proteins were determined via Western blotting
LDL-C, ApoB, non-HDL-C, Lp(a) modest reduction
Statin non-adherence; rare anti-drug antibodies
차트 로드 중…
임상시험이 많습니다. 임상시험 탭에서 Phase/Status 필터·검색을 사용하세요.
수집된 임상 필드(phase, status, endpoint 등) 기반 자동 요약입니다.
FDA approval (hyperlipidemia)
APPROVAL · 2015년 8월
Fully human anti-PCSK9 mAb; lowers LDL-C ~60% on top of statins. SC q2w or q4w; established LDL-lowering class leader with outcomes data (FOURIER). 대표 임상 효능: ORR 59% (FOURIER).
PCSK9
Hyperlipidemia, ASCVD risk reduction, HeFH, HoFH
Global
Approved
Monoclonal antibody
Human IgG2 anti-PCSK9
High LDL-C lowering without statin myalgia; autoinjector pen
ASCVD, HeFH, statin-intolerant or LDL above goal on max statin
Add-on to statin ± ezetimibe
SC autoinjector
q2w or q4w (140 mg monthly option)
LDL-C reduction ≥50% vs placebo
Injection-site reactions, nasopharyngitis; low neutralizing Ab rate
PCSK9 mAb vs inclisiran siRNA (Leqvio) dosing convenience trade-off
Binds PCSK9 → prevents LDLR degradation → increased hepatic LDL clearance
cytokine release, vascular smooth muscle cell proliferation, and impaired endothelial repair-mechanisms implicated i
apoptosis-related proteins, and signaling pathway-related proteins were determined via Western blotting
LDL-C, ApoB, non-HDL-C, Lp(a) modest reduction
Statin non-adherence; rare anti-drug antibodies
차트 로드 중…
임상시험이 많습니다. 임상시험 탭에서 Phase/Status 필터·검색을 사용하세요.
수집된 임상 필드(phase, status, endpoint 등) 기반 자동 요약입니다.
FDA approval (hyperlipidemia)
APPROVAL · 2015년 8월