{"id":736,"date":"2026-07-23T23:21:00","date_gmt":"2026-07-23T14:21:00","guid":{"rendered":"https:\/\/onepress.co.kr\/index.php\/briefing\/2026-07-23-lipfendra-oral-pcsk9-fda-2026-ja\/"},"modified":"2026-07-23T23:21:00","modified_gmt":"2026-07-23T14:21:00","slug":"2026-07-23-lipfendra-oral-pcsk9-fda-2026-ja","status":"publish","type":"briefing","link":"https:\/\/onepress.co.kr\/index.php\/briefing\/2026-07-23-lipfendra-oral-pcsk9-fda-2026-ja\/","title":{"rendered":"\u521d\u306e\u7d4c\u53e3PCSK9\u963b\u5bb3\u85ac\u627f\u8a8d\u3001LDL-C\u6cbb\u7642\u306e\u9078\u629e\u80a2\u304c\u5e83\u304c\u3063\u305f"},"content":{"rendered":"<p><strong>2026-07-23 23:18 KST<\/strong><\/p>\n<p>FDA\u306f2026\u5e747\u670817\u65e5\u3001Lipfendra(enlicitide)\u3092\u6210\u4eba\u9ad8\u30b3\u30ec\u30b9\u30c6\u30ed\u30fc\u30eb\u8840\u75c7\u306eLDL-C\u4f4e\u4e0b\u88dc\u52a9\u7642\u6cd5\u3068\u3057\u3066\u627f\u8a8d\u3057\u305f\u3068\u767a\u8868\u3057\u305f\u3002\u91cd\u8981\u306a\u306e\u306f\u3001\u6ce8\u5c04\u85ac\u4e2d\u5fc3\u3060\u3063\u305fPCSK9\u963b\u5bb3\u85ac\u306b\u521d\u306e\u7d4c\u53e3\u85ac\u304c\u52a0\u308f\u3063\u305f\u3053\u3068\u3067\u3042\u308a\u3001\u5fc3\u8840\u7ba1\u30a4\u30d9\u30f3\u30c8\u6e1b\u5c11\u304c\u78ba\u8a8d\u3055\u308c\u305f\u3068\u3044\u3046\u610f\u5473\u3067\u306f\u306a\u3044\u3002<\/p>\n<h2>\u8ab0\u306b\u95a2\u4fc2\u3059\u308b\u304b<\/h2>\n<p>\u5bfe\u8c61\u306f\u3001\u98df\u4e8b\u3068\u904b\u52d5\u306b\u52a0\u3048\u3066LDL-C\u3092\u4e0b\u3052\u308b\u5fc5\u8981\u304c\u3042\u308b\u6210\u4eba\u9ad8\u30b3\u30ec\u30b9\u30c6\u30ed\u30fc\u30eb\u8840\u75c7\u60a3\u8005\u3067\u3001heterozygous familial hypercholesterolemia\u3082\u542b\u3080\u3002FDA\u306f\u65e2\u5b58\u6cbb\u7642\u3067\u3082\u8ffd\u52a0\u306eLDL-C\u4f4e\u4e0b\u304c\u5fc5\u8981\u306a\u6210\u4eba\u3078\u306e\u9078\u629e\u80a2\u3068\u8aac\u660e\u3059\u308b\u3002\u81ea\u5df1\u5224\u65ad\u3067\u59cb\u3081\u308b\u85ac\u3067\u306f\u306a\u304f\u3001statin\u3001ezetimibe\u3001\u6ce8\u5c04\u578bPCSK9\u7642\u6cd5\u3001\u5168\u4f53\u30ea\u30b9\u30af\u3092\u533b\u7642\u8005\u304c\u6bd4\u8f03\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002<\/p>\n<h2>\u4f55\u304c\u5909\u308f\u308b\u304b<\/h2>\n<p>Lipfendra\u306f1\u65e51\u56de\u306e\u7d4c\u53e3\u9320\u5264PCSK9\u963b\u5bb3\u85ac\u3060\u3002FDA\u306fPCSK9\u963b\u5bb3\u85ac\u304c\u5f93\u6765\u306f\u6ce8\u5c04\u7642\u6cd5\u3060\u3051\u3060\u3063\u305f\u3068\u8aac\u660e\u3057\u3001Lipfendra\u3092PCSK9\u3092\u963b\u5bb3\u3059\u308b\u521d\u306e\u7d4c\u53e3\u85ac\u3068\u3059\u308b\u3002Merck\u306f20mg\u9320\u3068\u3057\u3066\u627f\u8a8d\u3055\u308c\u305f\u3068\u767a\u8868\u3057\u305f\u3002\u7bc4\u56f2\u306f\u7c73\u56fdFDA\u627f\u8a8d\u3067\u3042\u308a\u3001\u4ed6\u56fd\u306e\u627f\u8a8d\u3084\u4fdd\u967a\u9069\u7528\u306f\u5225\u306b\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002<\/p>\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" src=\"https:\/\/onepress.co.kr\/wp-content\/uploads\/2026\/07\/lipfendra-oral-pcsk9-fda-2026-ja.png\" alt=\"\u5faa\u74b0\u5668\u76f8\u8ac7\u5ba4\u3067LDL\u691c\u67fb\u3068\u7d4c\u53e3\u6cbb\u7642\u9078\u629e\u80a2\u3092\u8aac\u660e\u3059\u308b\u753b\u50cf\" loading=\"eager\" \/><figcaption class=\"op-briefing-image-caption\">\u5236\u4f5c\u753b\u50cf\uff1aONEPRESS\u304cLDL\u691c\u67fb\u3001\u5fc3\u8840\u7ba1\u30ea\u30b9\u30af\u76f8\u8ac7\u3001\u7d4c\u53e3PCSK9\u6cbb\u7642\u9078\u629e\u80a2\u306e\u6982\u5ff5\u3092\u8aac\u660e\u7528\u306b\u69cb\u6210\u3057\u305f\u3002\u7279\u5b9a\u88fd\u54c1\u306e\u5ba3\u4f1d\u753b\u50cf\u3067\u306f\u306a\u3044\u3002<\/figcaption><\/figure>\n<h2>\u6839\u62e0<\/h2>\n<p>FDA\u306ehuman-drug\u30da\u30fc\u30b8\u306f\u3001NCT05952856\u3068NCT05952869\u3068\u3044\u3046\u4e8c\u3064\u306erandomized, double-blind, placebo-controlled trial\u3067\u8a083,207\u4eba\u306e\u6210\u4eba\u3092\u8a55\u4fa1\u3057\u305f\u3068\u8aac\u660e\u3059\u308b\u300224\u9031\u6642\u70b9\u306eLDL-C\u5909\u5316\u306f\u3001\u7b2c\u4e00\u8a66\u9a13\u3067placebo\u6bd4-56%\u3001HeFH\u8a66\u9a13\u3067-59%\u3060\u3063\u305f\u3002Merck\u306fCORALreef Lipids\u3068CORALreef HeFH\u3092\u627f\u8a8d\u6839\u62e0\u3068\u3057\u3066\u3044\u308b\u3002<\/p>\n<h2>\u9650\u754c\u3068\u6ce8\u610f<\/h2>\n<p>\u91cd\u8981\u306a\u9650\u754c\u306f\u3001\u3053\u308c\u306fLDL-C\u4f4e\u4e0b\u306e\u627f\u8a8d\u3060\u3068\u3044\u3046\u70b9\u3060\u3002\u78ba\u8a8d\u3057\u305f\u627f\u8a8d\u8cc7\u6599\u306f\u3001\u5fc3\u7b4b\u6897\u585e\u3001\u8133\u5352\u4e2d\u3001\u6b7b\u4ea1\u3092\u6e1b\u3089\u3059\u3053\u3068\u3092\u793a\u3059\u3082\u306e\u3067\u306f\u306a\u3044\u3002FDA\u306fHeFH\u6210\u4eba\u3067diarrhea\u3068dizziness\u304cplacebo\u3088\u308a\u591a\u304b\u3063\u305f\u3068\u8aac\u660e\u3059\u308b\u3002\u9ad8\u30b3\u30ec\u30b9\u30c6\u30ed\u30fc\u30eb\u8840\u75c7\u306f\u75c7\u72b6\u304c\u306a\u3044\u3053\u3068\u3082\u591a\u304f\u3001\u8840\u6db2\u691c\u67fb\u3068\u7dcf\u5408\u30ea\u30b9\u30af\u8a55\u4fa1\u304c\u5148\u306b\u306a\u308b\u3002<\/p>\n<h2>\u516c\u5f0f\u78ba\u8a8d\u5148<\/h2>\n<p>FDA\u767a\u8868\u3067\u627f\u8a8d\u65e5\u3001\u9069\u5fdc\u3001\u521d\u306e\u7d4c\u53e3PCSK9\u306e\u7bc4\u56f2\u3092\u78ba\u8a8d\u3059\u308b\u3002FDA human-drug\u30da\u30fc\u30b8\u3067\u8a66\u9a13\u898f\u6a21\u3001\u8a66\u9a13\u756a\u53f7\u300124\u9031LDL-C\u4f4e\u4e0b\u7387\u3001\u5b89\u5168\u6027\u3092\u78ba\u8a8d\u3059\u308b\u3002Merck\u767a\u8868\u3067\u9320\u5264\u7528\u91cf\u3068CORALreef\u8a66\u9a13\u540d\u3092\u7167\u5408\u3059\u308b\u3002<\/p>\n<h2>\u516c\u5f0f\u51fa\u5178<\/h2>\n<p><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-first-oral-pcsk9-inhibitor-lower-ldl-cholesterol-adults-high-cholesterol\" target=\"_blank\" rel=\"noopener noreferrer\">FDA\u767a\u8868\uff1a\u627f\u8a8d\u65e5\u3001\u9069\u5fdc\u3001\u521d\u306e\u7d4c\u53e3PCSK9\u7bc4\u56f2<\/a><\/p>\n<p><a href=\"https:\/\/www.fda.gov\/drugs\/news-events-human-drugs\/fda-approves-first-oral-therapy-inhibits-proprotein-convertase-subtilisinkexin-type-9-pcsk9-lower\" target=\"_blank\" rel=\"noopener noreferrer\">FDA human-drug\u30da\u30fc\u30b8\uff1a\u8a66\u9a13\u898f\u6a21\u300124\u9031LDL-C\u4f4e\u4e0b\u3001\u5b89\u5168\u6027<\/a><\/p>\n<p><a href=\"https:\/\/www.merck.com\/news\/mercks-lipfendra-enlicitide-is-the-first-and-only-once-daily-oral-pcsk9-inhibitor-approved-by-the-u-s-fda-to-reduce-ldl-c-in-adults-with-hypercholesterolemia\/\" target=\"_blank\" rel=\"noopener noreferrer\">Merck\u767a\u8868\uff1a\u9320\u5264\u7528\u91cf\u3068CORALreef\u8a66\u9a13\u540d<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA\u306f2026\u5e747\u670817\u65e5\u3001Lipfendra(enlicitide)\u3092\u6210\u4eba\u9ad8\u30b3\u30ec\u30b9\u30c6\u30ed\u30fc\u30eb\u8840\u75c7\u306eLDL-C\u4f4e\u4e0b\u88dc\u52a9\u7642\u6cd5\u3068\u3057\u3066\u627f\u8a8d\u3057\u305f\u3068\u767a\u8868\u3057\u305f\u3002\u91cd\u8981\u306a\u306e\u306f\u3001\u6ce8\u5c04\u85ac\u4e2d\u5fc3\u3060\u3063\u305fPCSK9\u963b\u5bb3\u85ac\u306b\u521d\u306e\u7d4c\u53e3\u85ac\u304c\u52a0\u308f\u3063\u305f\u3053\u3068\u3067\u3042\u308a\u3001\u5fc3\u8840\u7ba1\u30a4\u30d9\u30f3\u30c8\u6e1b\u5c11\u304c\u78ba\u8a8d\u3055\u308c\u305f\u3068\u3044\u3046\u610f\u5473\u3067\u306f\u306a\u3044\u3002<\/p>\n","protected":false},"featured_media":0,"template":"","meta":[],"class_list":["post-736","briefing","type-briefing","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/onepress.co.kr\/index.php\/wp-json\/wp\/v2\/briefing\/736","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/onepress.co.kr\/index.php\/wp-json\/wp\/v2\/briefing"}],"about":[{"href":"https:\/\/onepress.co.kr\/index.php\/wp-json\/wp\/v2\/types\/briefing"}],"wp:attachment":[{"href":"https:\/\/onepress.co.kr\/index.php\/wp-json\/wp\/v2\/media?parent=736"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}