{"id":574416,"date":"2026-06-29T10:29:00","date_gmt":"2026-06-29T10:29:00","guid":{"rendered":"https:\/\/clarivate.com\/life-sciences-healthcare\/?p=574161"},"modified":"2026-06-30T08:24:39","modified_gmt":"2026-06-30T08:24:39","slug":"tolebrutinib-crl-safety-overrides-efficacy","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/ja\/blog\/tolebrutinib-crl-safety-overrides-efficacy\/","title":{"rendered":"Tolebrutinib\uff1a\u6709\u52b9\u6027\u30b7\u30b0\u30ca\u30eb\u3092\u4e0a\u56de\u308b\u5b89\u5168\u6027\u306e\u8ab2\u984c"},"content":{"rendered":"<p><em>\u672c\u30d6\u30ed\u30b0\u8a18\u4e8b\u306f\u3001\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u304c2025\u5e7412\u670823\u65e5\u306bSanofi\u306e\u975e\u518d\u767a\u6027\u4e8c\u6b21\u9032\u884c\u578b\u591a\u767a\u6027\u786c\u5316\u75c7\uff08nrSP-MS\uff09\u6cbb\u7642\u85ac tolebrutinib \u306b\u5bfe\u3057\u3066\u3001\u307e\u305f2025\u5e7412\u670830\u65e5\u306bCorcept Therapeutics\u306e\u30af\u30c3\u30b7\u30f3\u30b0\u75c7\u5019\u7fa4\u6cbb\u7642\u85ac relacorilant \u306b\u5bfe\u3057\u3066\u767a\u51fa\u3057\u305f Complete Response Letter\uff08CRL\uff09\u3092\u6271\u3046\u9023\u8f09\u30b7\u30ea\u30fc\u30ba\u306e\u7b2c2\u56de\u3067\u3059\u3002\u4e21\u85ac\u5264\u306f\u3044\u305a\u308c\u3082 Clarivate\u300cDrugs to Watch 2026\u300d\u30ec\u30dd\u30fc\u30c8\u306b\u63b2\u8f09\u3055\u308c\u3066\u3044\u307e\u3057\u305f\u304c\u3001\u3053\u308c\u3089\u306e\u5224\u65ad\u306f\u540c\u30ec\u30dd\u30fc\u30c8\u306e\u78ba\u5b9a\u5f8c\u306b\u4e0b\u3055\u308c\u307e\u3057\u305f\u3002<\/em><\/p>\n<p>BTK\uff08\u30d6\u30eb\u30c8\u30f3\u578b\u30c1\u30ed\u30b7\u30f3\u30ad\u30ca\u30fc\u30bc\uff09\u963b\u5bb3\u85ac\u3067\u3042\u308b tolebrutinib \u306b\u5bfe\u3059\u308b<a href=\"https:\/\/download.open.fda.gov\/crl\/CRL_NDA219624_20251223.pdf\" target=\"_blank\" rel=\"noopener\">CRL<\/a>\u3067\u306f\u3001\u4e3b\u306b4\u3064\u306e\u8ad6\u70b9\u304c\u793a\u3055\u308c\u307e\u3057\u305f\u3002(1) \u91cd\u7be4\u306a\u85ac\u7269\u6027\u809d\u969c\u5bb3\uff08DILI\u3001\u6b7b\u4ea1\u4f8b\u3092\u542b\u3080\uff09\u306e\u91cd\u5927\u306a\u30ea\u30b9\u30af\u3001(2) \u75be\u60a3\u30b5\u30d6\u30dd\u30d4\u30e5\u30ec\u30fc\u30b7\u30e7\u30f3\u306b\u304a\u3051\u308b\u6709\u76ca\u6027\u306b\u95a2\u3059\u308b\u4e0d\u78ba\u5b9f\u6027\u3001(3) \u518d\u767a\u6d3b\u52d5\u3068\u306f\u72ec\u7acb\u3057\u305f\u969c\u5bb3\u9032\u884c\u306e\u84c4\u7a4d\u6291\u5236\u52b9\u679c\u306b\u3064\u3044\u3066\u306e\u30a8\u30d3\u30c7\u30f3\u30b9\u4e0d\u8db3\u3001(4) \u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u30fb\u30ea\u30b9\u30af\u30fb\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u304c\u826f\u597d\u3068\u5224\u65ad\u3067\u304d\u308b\u8a66\u9a13\u5bfe\u8c61\u96c6\u56e3\u304c\u7279\u5b9a\u3055\u308c\u3066\u3044\u306a\u3044\u3053\u3068\u3001\u3067\u3059\u3002<\/p>\n<p>FDA\u306f\u809d\u6bd2\u6027\u30ea\u30b9\u30af\u306b\u3064\u3044\u3066\u3001\u300c\u4e00\u822c\u7684\u306a\u533b\u85ac\u54c1\u958b\u767a\u30d7\u30ed\u30b0\u30e9\u30e0\u5168\u4f53\u3068\u6bd4\u8f03\u3057\u3066\u3082\u3001\u307e\u305fMS\u6cbb\u7642\u85ac\u306b\u9650\u3063\u3066\u898b\u3066\u3082\u3001\u91cd\u5927\u304b\u3064\u7570\u4f8b\u306b\u9ad8\u3044\u300d\u3068\u4f4d\u7f6e\u3065\u3051\u307e\u3057\u305f\u3002\u7d042,700\u4eba\u306e\u53c2\u52a0\u8005\u306e\u3046\u30616\u75c7\u4f8b\u304cHy\u2019s Law\u306e\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3001\u305d\u306e\u4e2d\u306b\u306f\u809d\u79fb\u690d\u5f8c\u306b\u6b7b\u4ea1\u3057\u305f1\u4f8b\u3082\u542b\u307e\u308c\u307e\u3059\u3002\u5f53\u5c40\u306f\u3001Sanofi\u304c\u63d0\u6848\u3057\u305fREMS\u306b\u304a\u3051\u308b\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u4f53\u5236\u306e\u5341\u5206\u6027\u306b\u61f8\u5ff5\u3092\u793a\u3057\u3001\u300ctolebrutinib \u306b\u95a2\u9023\u3059\u308b\u81f4\u6b7b\u7684DILI\u30ea\u30b9\u30af\u306f\u3001BTK\u963b\u5bb3\u85ac\u30af\u30e9\u30b9\u306e\u4e2d\u3067\u3082\u6700\u3082\u9ad8\u3044\u90e8\u985e\u306b\u898b\u3048\u308b\u300d\u3068\u6307\u6458\u3057\u307e\u3057\u305f\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u81e8\u5e8a\u7684\u80cc\u666f<\/strong><\/h3>\n<p>CRL\u306e\u5f71\u97ff\u306f\u3001tolebrutinib \u306e\u81e8\u5e8a\u6210\u7e3e\u3092\u8e0f\u307e\u3048\u308b\u3068\u6975\u3081\u3066\u5927\u304d\u3044\u3068\u8a00\u3048\u307e\u3059\u3002\u7b2c3\u76f8 HERCULES \u8a66\u9a13\u3067\u306f\u3001tolebrutinib \u306f\u4e3b\u8981\u8a55\u4fa1\u9805\u76ee\u3092\u9054\u6210\u3057\u3001\u30d7\u30e9\u30bb\u30dc\u3068\u6bd4\u3079\u30666\u304b\u6708\u9593\u6301\u7d9a\u78ba\u8a8d\u3055\u308c\u305f\u969c\u5bb3\u9032\u884c\u306e\u767a\u73fe\u307e\u3067\u306e\u6642\u9593\u309231\uff05\u9045\u5ef6\u3055\u305b\u307e\u3057\u305f\u3002\u3053\u308c\u306f nrSP-MS \u306b\u304a\u3044\u3066\u969c\u5bb3\u9032\u884c\u306e\u6709\u610f\u306a\u6291\u5236\u3092\u521d\u3081\u3066\u793a\u3057\u305f\u85ac\u5264\u3067\u3042\u308a\u3001\u81e8\u5e8a\u7684\u306b\u91cd\u8981\u306a\u6210\u679c\u3067\u3057\u305f\u3002<\/p>\n<p>\u3057\u304b\u3057\u3001\u3053\u306e\u85ac\u5264\u306e\u3088\u308a\u5e83\u7bc4\u306a\u958b\u767a\u30d7\u30ed\u30b0\u30e9\u30e0\u3067\u306f\u8907\u96d1\u3055\u3082\u660e\u3089\u304b\u306b\u306a\u308a\u307e\u3057\u305f\u30022024\u5e749\u6708\u3001\u518d\u767a\u578bMS\u3092\u5bfe\u8c61\u3068\u3057\u305f3\u672c\u306e\u7b2c3\u76f8\u8a66\u9a13\u306e\u3046\u30612\u672c\u3067\u3001tolebrutinib \u306f\u4e3b\u8981\u8a55\u4fa1\u9805\u76ee\u3092\u9054\u6210\u3067\u304d\u307e\u305b\u3093\u3067\u3057\u305f\u3002\u3055\u3089\u306b\u6700\u8fd1\u3067\u306f\u3001\u4e00\u6b21\u9032\u884c\u578bMS\u3092\u5bfe\u8c61\u3068\u3057\u305f PERSEUS \u8a66\u9a13\u3067\u3082\u4e3b\u8981\u8a55\u4fa1\u9805\u76ee\u304c\u672a\u9054\u3068\u306a\u308a\u3001Sanofi\u306f\u5f53\u8a72\u9069\u5fdc\u3067\u306e\u958b\u767a\u4e2d\u6b62\u3092\u6c7a\u5b9a\u3057\u307e\u3057\u305f\u30022022\u5e74\u306b\u306f\u809d\u5b89\u5168\u6027\u3078\u306e\u61f8\u5ff5\u304b\u3089\u90e8\u5206\u7684\u306a\u81e8\u5e8a\u30db\u30fc\u30eb\u30c9\u3082\u767a\u52d5\u3055\u308c\u3066\u304a\u308a\u3001\u3053\u3046\u3057\u305f\u7d4c\u7def\u304c\u91cd\u306a\u3063\u3066\u898f\u5236\u4e0a\u304d\u308f\u3081\u3066\u53b3\u3057\u3044\u72b6\u6cc1\u304c\u751f\u307e\u308c\u307e\u3057\u305f\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u5e02\u5834\u3078\u306e\u5f71\u97ff<\/strong><\/h3>\n<p>Clarivate\u306e\u30a2\u30ca\u30ea\u30b9\u30c8\u306f\u3001\u627f\u8a8d\u3055\u308c\u305f\u5834\u5408\u30012031\u5e74\u307e\u3067\u306bG7\u5e02\u5834\u306714\u5104\u30c9\u30eb\u306e\u30d4\u30fc\u30af\u58f2\u4e0a\u3092\u898b\u8fbc\u3093\u3067\u3044\u307e\u3057\u305f\u3002\u4e00\u90e8\u306e\u63a8\u8a08\u3067\u306f\u3001\u7c73\u56fd\u3060\u3051\u3067\u308230\u5104\u301c35\u5104\u30c9\u30eb\u306e\u5e02\u5834\u6a5f\u4f1a\u304c\u3042\u308b\u3068\u3055\u308c\u3066\u3044\u307e\u3057\u305f\u3002\u3053\u306e\u85ac\u5264\u306f\u3001\u627f\u8a8d\u6cbb\u7642\u304c\u307b\u3068\u3093\u3069\u5b58\u5728\u3057\u306a\u3044 nrSP-MS \u306b\u304a\u3044\u3066\u3001\u300c\u53c2\u7167\u85ac\u300d\u3042\u308b\u3044\u306f\u300c\u6a19\u6e96\u6cbb\u7642\u300d\u306b\u306a\u308a\u5f97\u308b\u5b58\u5728\u3068\u3057\u3066\u4f4d\u7f6e\u3065\u3051\u3089\u308c\u3066\u3044\u307e\u3057\u305f\u3002<\/p>\n<p>FDA\u306b\u3088\u308b\u5be9\u67fb\u9045\u5ef6\u3068 PERSEUS \u8a66\u9a13\u4e0d\u6210\u529f\u306e\u540c\u6642\u767a\u8868\u3092\u53d7\u3051\u3066\u3001Sanofi\u306e\u682a\u4fa1\u306f6\uff05\u4e0b\u843d\u3057\u307e\u3057\u305f\u3002\u540c\u793e\u306f\u73fe\u5728\u30012021\u5e74\u306b tolebrutinib \u3092\u7372\u5f97\u3057\u305f37\u5104\u30c9\u30eb\u898f\u6a21\u306e Principia Biopharma \u8cb7\u53ce\u306b\u95a2\u9023\u3057\u3066\u3001\u6e1b\u640d\u8a08\u4e0a\u306e\u53ef\u80fd\u6027\u3092\u691c\u8a0e\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u60a3\u8005\u304a\u3088\u3073\u81e8\u5e8a\u9762\u3067\u306e\u793a\u5506<\/strong><\/h3>\n<p>\u6709\u52b9\u306a\u6cbb\u7642\u9078\u629e\u80a2\u304c\u591a\u6570\u5b58\u5728\u3059\u308b\u518d\u767a\u578bMS\u3068\u306f\u7570\u306a\u308a\u3001nrSP-MS \u3067\u306f\u5229\u7528\u53ef\u80fd\u306a\u6cbb\u7642\u9078\u629e\u80a2\u304c\u9650\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u75be\u60a3\u306f\u3001\u4ed6\u306eMS\u75c5\u578b\u3092\u7279\u5fb4\u3065\u3051\u308b\u767a\u4f5c\u7684\u518d\u767a\u3092\u4f34\u308f\u305a\u3001\u969c\u5bb3\u304c\u9032\u884c\u6027\u306b\u84c4\u7a4d\u3059\u308b\u70b9\u306b\u7279\u5fb4\u304c\u3042\u308a\u3001\u6cbb\u7642\u304c\u6975\u3081\u3066\u96e3\u3057\u3044\u3053\u3068\u3067\u77e5\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>FDA\u304c\u62e1\u5927\u30a2\u30af\u30bb\u30b9\u30fb\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u63d0\u51fa\u3092\u6c42\u3081\u305f\u3053\u3068\u306f\u3001\u5f53\u5c40\u304c\u3053\u306e\u30a2\u30f3\u30e1\u30c3\u30c8\u30cb\u30fc\u30ba\u3092\u8a8d\u8b58\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u5506\u3057\u3066\u3044\u307e\u3059\u3002Jefferies\u306e\u30a2\u30ca\u30ea\u30b9\u30c8\u304c\u8ff0\u3079\u305f\u3088\u3046\u306b\u3001\u300cFDA\u304c\u62e1\u5927\u30a2\u30af\u30bb\u30b9\u30fb\u30d7\u30ed\u30b0\u30e9\u30e0\u3092\u8981\u8acb\u3057\u305f\u3068\u3044\u3046\u4e8b\u5b9f\u306f\u3001\u73fe\u6642\u70b9\u3067\u306f\u5f53\u5c40\u304c\u30ea\u30b9\u30af\uff0f\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u3092\u53d7\u3051\u5165\u308c\u53ef\u80fd\u3068\u898b\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3057\u3066\u3044\u308b\u300d\u3068\u3082\u89e3\u91c8\u3067\u304d\u3001\u4eca\u5f8c\u306e\u524d\u9032\u4f59\u5730\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002\u3082\u3057\u627f\u8a8d\u3055\u308c\u308c\u3070\u3001nrSP-MS \u3092\u7279\u7570\u7684\u306b\u9069\u5fdc\u75c7\u30e9\u30d9\u30eb\u306b\u6301\u3064\u521d\u306e\u85ac\u5264\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>Clarivate\u304c\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3051\u308b\u5f8c\u9000\u3078\u306e\u5bfe\u5fdc\u3092\u3069\u306e\u3088\u3046\u306b\u652f\u63f4\u3067\u304d\u308b\u304b<\/strong><\/h3>\n<p>Clarivate\u306e\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u306b\u7d44\u307f\u8fbc\u307e\u308c\u305fAI\u6d3b\u7528\u578b\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30b9\u3092\u6d3b\u7528\u3059\u308b\u3053\u3068\u3067\u3001\u88fd\u85ac\u4f01\u696d\u306fCRL\u3092\u542b\u3080\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u4e0a\u306e\u5f8c\u9000\u306b\u5bfe\u3057\u3001\u3088\u308a\u8fc5\u901f\u304b\u3064\u7cbe\u7dfb\u306b\u3001\u898f\u5236\u8981\u4ef6\u3068\u306e\u6574\u5408\u6027\u3092\u4fdd\u3061\u306a\u304c\u3089\u5bfe\u5fdc\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n<h4>Cortellis Regulatory Intelligence + AI-powered Regulatory Assistant<\/h4>\n<p>Cortellis Regulatory Intelligence \u306f\u3001\u5e45\u5e83\u304f\u6df1\u3044\u30a4\u30f3\u30b5\u30a4\u30c8\u3068\u4e3b\u984c\u5c02\u9580\u77e5\u8b58\u3092\u7d44\u307f\u5408\u308f\u305b\u305f\u91cd\u8981\u306a\u898f\u5236\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30b9\u3092\u63d0\u4f9b\u3057\u3001AI\u642d\u8f09\u6a5f\u80fd \u306b\u3088\u3063\u3066 Regulatory Assistant \u3092\u901a\u3058\u3055\u3089\u306b\u5f37\u5316\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li><strong>\u5148\u4f8b\u5206\u6790\uff1a<\/strong><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\u672c\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u306b\u306f\u30012000\u5e74\u4ee5\u964d\u306eFDA AdComm\u30c8\u30e9\u30f3\u30b9\u30af\u30ea\u30d7\u30c8\u3068\u300128.5\u4e07\u4ef6\u8d85\u306e\u6587\u66f8\u304a\u3088\u30737,000\u4ef6\u306e\u30ec\u30dd\u30fc\u30c8\u306b\u57fa\u3065\u304f\u5c02\u9580\u5bb6\u5206\u6790\u304c\u53ce\u8f09\u3055\u308c\u3066\u304a\u308a\u3001\u4ed6\u793e\u304c\u985e\u4f3c\u306e\u5b89\u5168\u6027\u61f8\u5ff5\u306b\u3069\u306e\u3088\u3046\u306b\u5bfe\u5fdc\u3057\u3066\u304d\u305f\u304b\u3092\u6b63\u78ba\u306b\u628a\u63e1\u3067\u304d\u307e\u3059\u3002AI Assistant \u3078\u306e\u554f\u3044\u5408\u308f\u305b\u4f8b\u3068\u3057\u3066\u306f\u3001\u300c\u809d\u5b89\u5168\u6027\u4e0a\u306e\u61f8\u5ff5\u306b\u3088\u308bCRL\u5f8c\u306b\u627f\u8a8d\u3055\u308c\u305f\u809d\u6bd2\u6027\u85ac\u3092\u8868\u793a\u3057\u3066\u300d\u3084\u300c\u91cd\u7be4\u306aDILI\u30ea\u30b9\u30af\u7ba1\u7406\u306b\u6210\u529f\u3057\u305fREMS\u6226\u7565\u3092\u6bd4\u8f03\u3057\u3066\u300d\u306a\u3069\u304c\u8003\u3048\u3089\u308c\u307e\u3059\u3002<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>\u898f\u5236\u6226\u7565\u306e\u7d71\u5408\uff1aAI Assistant \u306f\u95a2\u9023\u6587\u66f8\u3092\u53d6\u5f97\u3057\u3001\u5404\u56fd\u30fb\u5730\u57df\u306b\u307e\u305f\u304c\u308b\u898f\u5236\u8981\u4ef6\u3092\u7d71\u5408\u3057\u3066\u3001\u5b9f\u884c\u53ef\u80fd\u306a\u793a\u5506\u3092\u751f\u6210\u3067\u304d\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001FDA\u3001EMA\u3001PMDA \u306a\u3069\u306b\u304a\u3051\u308b\u809d\u6bd2\u6027\u30ea\u30b9\u30af\u7ba1\u7406\u306e\u898f\u5236\u5f53\u5c40\u306e\u671f\u5f85\u3092\u8fc5\u901f\u306b\u6574\u7406\u3067\u304d\u307e\u3059\u3002<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>\u900f\u660e\u6027\u3068\u76e3\u67fb\u53ef\u80fd\u6027\uff1aClarivate \u306eAI\u30a2\u30d7\u30ed\u30fc\u30c1\u306f\u3001\u5e38\u306b\u30bd\u30fc\u30b9\u6587\u66f8\u3078\u306e\u30ea\u30f3\u30af\u3092\u63d0\u793a\u3059\u308b\u3053\u3068\u3067\u900f\u660e\u6027\u3092\u78ba\u4fdd\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306fAI\u306e\u4fe1\u983c\u6027\u306b\u95a2\u3059\u308b\u61f8\u5ff5\u306b\u5bfe\u5fdc\u3057\u3001\u5b8c\u5168\u306a\u76e3\u67fb\u53ef\u80fd\u6027\u3092\u7dad\u6301\u3057\u307e\u3059\u3002<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li>\u6cd5\u57df\u6a2a\u65ad\u306e\u6bd4\u8f03\u5206\u6790\uff1atolebrutinib \u306e\u958b\u767a\u306f\u4ed6\u5e02\u5834\u3067\u3082\u7d99\u7d9a\u3057\u3066\u3044\u307e\u3059\u3002\u898f\u5236\u52d5\u5411\u306e\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u76e3\u8996\u3001\u627f\u8a8d\u7d4c\u8def\u306b\u95a2\u3059\u308b\u5148\u4f8b\u5206\u6790\u3001\u5404\u6cd5\u57df\u306b\u304a\u3051\u308b\u898f\u5236\u6226\u7565\u306e\u6bd4\u8f03\u8a55\u4fa1\u306b\u3088\u308a\u3001\u898f\u5236\u30a2\u30d7\u30ed\u30fc\u30c1\u306e\u76f8\u9055\uff08\u305f\u3068\u3048\u3070 EMA \u3084 PMDA \u304c\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u30fb\u30ea\u30b9\u30af\u3092\u7570\u306a\u308b\u898b\u65b9\u3067\u8a55\u4fa1\u3059\u308b\u53ef\u80fd\u6027\uff09\u3092\u628a\u63e1\u3057\u3001FDA\u3078\u306e\u518d\u7533\u8acb\u6226\u7565\u306b\u6d3b\u304b\u3059\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h4>DRG Fusion<\/h4>\n<p><a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/ja\/real-world-data\/drg-fusion\/?utm_content=dtw-blog-series\">DRG Fusion<\/a>\u306f\u3001\u72ec\u81ea\u306b\u63a5\u7d9a\u3055\u308c\u305f\u30ea\u30a2\u30eb\u30ef\u30fc\u30eb\u30c9\u30c7\u30fc\u30bf\u306b\u3088\u308a\u3001\u3042\u3089\u3086\u308b\u89d2\u5ea6\u304b\u3089\u306e\u75be\u60a3\u5206\u6790\u3092\u53ef\u80fd\u306b\u3057\u307e\u3059\u3002<\/p>\n<p><strong>\u8ffd\u52a0\u306e\u30ea\u30a2\u30eb\u30ef\u30fc\u30eb\u30c9\u5b89\u5168\u6027\u30a8\u30d3\u30c7\u30f3\u30b9\u3092\u5275\u51fa\u3057\u3001\u3088\u308a\u4f4e\u30ea\u30b9\u30af\u306a\u30b5\u30d6\u30dd\u30d4\u30e5\u30ec\u30fc\u30b7\u30e7\u30f3\u3092\u7279\u5b9a\u3059\u308b <\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li><strong>\u30af\u30e9\u30b9\u5168\u4f53\u306e\u5b89\u5168\u6027\u5206\u6790\uff1a<\/strong><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\u533b\u7642\u30fb\u85ac\u5c40\u8acb\u6c42\u30c7\u30fc\u30bf\u304a\u3088\u3073\u305d\u306e\u4ed6\u306e\u30ea\u30a2\u30eb\u30ef\u30fc\u30eb\u30c9\u30c7\u30fc\u30bf\u30bd\u30fc\u30b9\u306b\u57fa\u3065\u304d\u3001BTK\u963b\u5bb3\u85ac\u30af\u30e9\u30b9\uff08ibrutinib\u3001acalabrutinib\u3001zanubrutinib\uff09\u5168\u4f53\u306e\u809d\u6bd2\u6027\u30d1\u30bf\u30fc\u30f3\u3092\u5206\u6790\u3059\u308b\u3053\u3068\u3067\u3001tolebrutinib \u306e\u5b89\u5168\u6027\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u3092\u76f8\u5bfe\u7684\u306b\u4f4d\u7f6e\u3065\u3051\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>\u60a3\u8005\u30b5\u30d6\u30dd\u30d4\u30e5\u30ec\u30fc\u30b7\u30e7\u30f3\u306e\u7279\u5b9a\uff1a\u60a3\u8005\u30bb\u30b0\u30e1\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3\u6a5f\u80fd\u306b\u3088\u308a\u3001\u30d9\u30fc\u30b9\u30e9\u30a4\u30f3\u3067\u306e\u809d\u30ea\u30b9\u30af\u304c\u4f4e\u3044 nrSP-MS \u60a3\u8005\u30b5\u30d6\u30b0\u30eb\u30fc\u30d7\u3001\u305f\u3068\u3048\u3070\u4ee3\u8b1d\u6027\u4f75\u5b58\u75be\u60a3\u304c\u306a\u3044\u60a3\u8005\u3001\u98f2\u9152\u6b74\u306e\u306a\u3044\u60a3\u8005\u3001\u809d\u6bd2\u6027\u306e\u3042\u308b\u4f75\u7528\u85ac\u3092\u4f7f\u7528\u3057\u3066\u3044\u306a\u3044\u60a3\u8005\u306a\u3069\u3092\u7279\u5b9a\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>\u6587\u8108\u3092\u8e0f\u307e\u3048\u305f\u6bd4\u8f03\u6709\u52b9\u6027\u8a55\u4fa1\uff1aMS\u96c6\u56e3\u306b\u304a\u3051\u308b\u30ea\u30a2\u30eb\u30ef\u30fc\u30eb\u30c9\u3067\u306e\u6709\u52b9\u6027\u30a2\u30a6\u30c8\u30ab\u30e0\u3092\u5206\u6790\u3059\u308b\u3053\u3068\u3067\u3001\u9069\u5207\u306b\u9078\u629e\u3055\u308c\u305f\u60a3\u8005\u306b\u304a\u3044\u3066\u306f\u3001tolebrutinib \u306e\u6709\u52b9\u6027\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u304c\u614e\u91cd\u306a\u30ea\u30b9\u30af\u7ba1\u7406\u3092\u6b63\u5f53\u5316\u3057\u5f97\u308b\u3068\u3044\u3046\u8ad6\u62e0\u3092\u88dc\u5f37\u3067\u304d\u307e\u3059\u3002<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li>\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u6226\u7565\u306e\u691c\u8a3c\uff1a\u672c\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u306f\u3001\u5f37\u5316\u3055\u308c\u305fREMS\u6226\u7565\u306e\u958b\u767a\u3092\u652f\u63f4\u3059\u308b\u305f\u3081\u3001\u5b9f\u81e8\u5e8a\u306b\u304a\u3051\u308b\u809d\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u5b9f\u8df5\u3092\u8a55\u4fa1\u3067\u304d\u307e\u3059\u3002\u30ea\u30a2\u30eb\u30ef\u30fc\u30eb\u30c9\u30c7\u30fc\u30bf\u306f\u3001Sanofi \u304c\u63a1\u7528\u3057\u305f\u96c6\u4e2d\u7684\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u6709\u52b9\u6027\u691c\u8a3c\u306b\u3082\u5f79\u7acb\u3061\u307e\u3059\u3002<\/li>\n<\/ul>\n<h4>Cortellis\u81e8\u5e8a\u958b\u767a\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30b9\u30fb\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\uff1a\u30d7\u30ed\u30c8\u30b3\u30eb\u6700\u9069\u5316<\/h4>\n<p><a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/ja\/research-development\/discovery-development\/cortellis-clinical-trials-intelligence\/\">Cortellis Clinical Trials Intelligence<\/a> \u3068<a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/ja\/research-development\/pharmacovigilance-drug-safety\/off-x\/\">OFF-X<\/a>\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u9032\u6357\u3001\u7af6\u5408\u6226\u7565\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u8a2d\u8a08\u6700\u9069\u5316\u306b\u95a2\u3059\u308b\u30a4\u30f3\u30b5\u30a4\u30c8\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002<\/p>\n<p><strong>\u5f37\u5316\u3055\u308c\u305f\u5b89\u5168\u6027\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u30fb\u30d7\u30ed\u30c8\u30b3\u30eb\u3068\u3001\u30b5\u30d6\u30dd\u30d4\u30e5\u30ec\u30fc\u30b7\u30e7\u30f3\u8a66\u9a13\u306e\u53ef\u80fd\u6027\u3092\u8a2d\u8a08\u3059\u308b<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li><strong>\u5b89\u5168\u6027\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306e\u30d9\u30f3\u30c1\u30de\u30fc\u30ad\u30f3\u30b0\uff1a<\/strong><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>60\u4e07\u4ef6\u8d85\u306e\u81e8\u5e8a\u8a66\u9a13\u3092\u6a2a\u65ad\u3057\u3066\u6210\u529f\u4f8b\u3068\u306a\u3063\u305f\u809d\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u30fb\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u5206\u6790\u3059\u308b\u3053\u3068\u3067\u3001\u8a66\u9a13\u306e\u5b9f\u884c\u53ef\u80fd\u6027\u3092\u640d\u306a\u3046\u3053\u3068\u306a\u304f\u5b89\u5168\u6027\u3092\u6700\u5927\u5316\u3059\u308b\u6700\u9069\u306a\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u3001\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u983b\u5ea6\u3001\u65e9\u671f\u4e2d\u6b62\u30eb\u30fc\u30eb\u3092\u7279\u5b9a\u3067\u304d\u307e\u3059\u3002<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li>\u30b5\u30d6\u30dd\u30d4\u30e5\u30ec\u30fc\u30b7\u30e7\u30f3\u5411\u3051\u30d7\u30ed\u30c8\u30b3\u30eb\u8a2d\u8a08\uff1aSanofi \u304c\u3088\u308a\u4f4e\u30ea\u30b9\u30af\u306a\u30b5\u30d6\u30dd\u30d4\u30e5\u30ec\u30fc\u30b7\u30e7\u30f3\u306b\u5bfe\u8c61\u3092\u7d5e\u3063\u305f\u627f\u8a8d\u6226\u7565\u3092\u8ffd\u6c42\u3059\u308b\u5834\u5408\u3001MS\u60a3\u8005\u30b5\u30d6\u30b0\u30eb\u30fc\u30d7\u306b\u7279\u5316\u3057\u305f\u81e8\u5e8a\u8a66\u9a13\u9032\u6357\u3001\u7af6\u5408\u6226\u7565\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u8a2d\u8a08\u6700\u9069\u5316\u306b\u95a2\u3059\u308b\u30a4\u30f3\u30b5\u30a4\u30c8\u3092\u5f97\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/li>\n<\/ul>\n<p>\u3053\u306e\u30b7\u30ea\u30fc\u30ba\u306e\u6b21\u56de\u8a18\u4e8b\u3067\u306f\u3001Relacorilant\uff1a\u30a8\u30d3\u30c7\u30f3\u30b9\u304c\u65e2\u5b58\u306e\u627f\u8a8d\u57fa\u6e96\u306b\u7167\u3089\u3055\u308c\u305f\u3068\u304d \u3068\u984c\u3057\u3066\u30012026\u5e74\u306e Drugs to Watch \u306e\u4e00\u3064\u3067\u3042\u308b Corcept Therapeutics \u306e relacorilant \u306b\u5bfe\u3059\u308b\u5e74\u672b\u306eCRL\u304c\u3082\u305f\u3089\u3057\u305f\u5f71\u97ff\u3068\u3001Clarivate\u306e\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30b9\u3092\u3069\u306e\u3088\u3046\u306b\u6d3b\u7528\u3057\u3066\u524d\u9032\u3067\u304d\u308b\u304b\u3092\u53d6\u308a\u4e0a\u3052\u307e\u3059\u3002<\/p>\n<p><em><a href=\"https:\/\/clarivate.com\/ja\/drugs-to-watch\/\">Drugs to Watch 2026<\/a>\u306e\u8a73\u7d30\u3084\u3001<a href=\"https:\/\/clarivate.com\/ai\/\">Clarivate\u304cAI\u30c4\u30fc\u30eb\u3092\u3069\u306e\u3088\u3046\u306b\u6d3b\u7528\u3057\u3066\u3001<\/a> \u9867\u5ba2\u306e\u3088\u308a\u8fc5\u901f\u3067\u7684\u78ba\u306a\u610f\u601d\u6c7a\u5b9a\u3092\u652f\u63f4\u3057\u3066\u3044\u308b\u304b\u306b\u3064\u3044\u3066\u3001\u305c\u3072\u3054\u89a7\u304f\u3060\u3055\u3044\u3002<\/em><br \/>\n\u203b\u672c\u8a18\u4e8b\u306fClarivate.com\u306e\u82f1\u8a9e\u539f\u6587\u3092AI\u7ffb\u8a33\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u672c\u30d6\u30ed\u30b0\u8a18\u4e8b\u306f\u3001\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u304c2025\u5e7412\u670823\u65e5\u306bSanofi\u306e\u975e\u518d\u767a\u6027\u4e8c\u6b21\u9032\u884c\u578b\u591a\u767a\u6027\u786c\u5316\u75c7\uff08nrSP-MS\uff09\u6cbb\u7642\u85ac tolebrutinib \u306b\u5bfe\u3057\u3066\u3001\u307e\u305f2025\u5e7412\u670830\u65e5\u306bCorcept Therapeutics\u306e\u30af\u30c3\u30b7\u30f3\u30b0\u75c7\u5019\u7fa4\u6cbb\u7642\u85ac relacorilant \u306b\u5bfe\u3057\u3066\u767a\u51fa\u3057\u305f Complete Response Letter\uff08CRL\uff09\u3092\u6271\u3046\u9023\u8f09\u30b7\u30ea\u30fc\u30ba\u306e\u7b2c2\u56de\u3067\u3059\u3002\u4e21\u85ac\u5264\u306f\u3044\u305a\u308c\u3082 Clarivate\u300cDrugs to Watch 2026\u300d\u30ec\u30dd\u30fc\u30c8\u306b\u63b2\u8f09\u3055\u308c\u3066\u3044\u307e\u3057\u305f\u304c\u3001\u3053\u308c\u3089\u306e\u5224\u65ad\u306f\u540c\u30ec\u30dd\u30fc\u30c8\u306e\u78ba\u5b9a\u5f8c\u306b\u4e0b\u3055\u308c\u307e\u3057\u305f\u3002 BTK\uff08\u30d6\u30eb\u30c8\u30f3\u578b\u30c1\u30ed\u30b7\u30f3\u30ad\u30ca\u30fc\u30bc\uff09\u963b\u5bb3\u85ac\u3067\u3042\u308b tolebrutinib \u306b\u5bfe\u3059\u308bCRL\u3067\u306f\u3001\u4e3b\u306b4\u3064\u306e\u8ad6\u70b9\u304c\u793a\u3055\u308c\u307e\u3057\u305f\u3002(1) \u91cd\u7be4\u306a\u85ac\u7269\u6027\u809d\u969c\u5bb3\uff08DILI\u3001\u6b7b\u4ea1\u4f8b\u3092\u542b\u3080\uff09\u306e\u91cd\u5927\u306a\u30ea\u30b9\u30af\u3001(2) \u75be\u60a3\u30b5\u30d6\u30dd\u30d4\u30e5\u30ec\u30fc\u30b7\u30e7\u30f3\u306b\u304a\u3051\u308b\u6709\u76ca\u6027\u306b\u95a2\u3059\u308b\u4e0d\u78ba\u5b9f\u6027\u3001(3) \u518d\u767a\u6d3b\u52d5\u3068\u306f\u72ec\u7acb\u3057\u305f\u969c\u5bb3\u9032\u884c\u306e\u84c4\u7a4d\u6291\u5236\u52b9\u679c\u306b\u3064\u3044\u3066\u306e\u30a8\u30d3\u30c7\u30f3\u30b9\u4e0d\u8db3\u3001(4) \u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u30fb\u30ea\u30b9\u30af\u30fb\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u304c\u826f\u597d\u3068\u5224\u65ad\u3067\u304d\u308b\u8a66\u9a13\u5bfe\u8c61\u96c6\u56e3\u304c\u7279\u5b9a\u3055\u308c\u3066\u3044\u306a\u3044\u3053\u3068\u3001\u3067\u3059\u3002 FDA\u306f\u809d\u6bd2\u6027\u30ea\u30b9\u30af\u306b\u3064\u3044\u3066\u3001\u300c\u4e00\u822c\u7684\u306a\u533b\u85ac\u54c1\u958b\u767a\u30d7\u30ed\u30b0\u30e9\u30e0\u5168\u4f53\u3068\u6bd4\u8f03\u3057\u3066\u3082\u3001\u307e\u305fMS\u6cbb\u7642\u85ac\u306b\u9650\u3063\u3066\u898b\u3066\u3082\u3001\u91cd\u5927\u304b\u3064\u7570\u4f8b\u306b\u9ad8\u3044\u300d\u3068\u4f4d\u7f6e\u3065\u3051\u307e\u3057\u305f\u3002\u7d042,700\u4eba\u306e\u53c2\u52a0\u8005\u306e\u3046\u30616\u75c7\u4f8b\u304cHy\u2019s 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