{"id":574421,"date":"2026-06-29T10:31:21","date_gmt":"2026-06-29T10:31:21","guid":{"rendered":"https:\/\/clarivate.com\/life-sciences-healthcare\/?p=574175"},"modified":"2026-06-30T08:25:07","modified_gmt":"2026-06-30T08:25:07","slug":"what-comes-after-fda-complete-response-letter","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/ja\/blog\/what-comes-after-fda-complete-response-letter\/","title":{"rendered":"CRL\u5f8c\u306e\u5c55\u671b\uff1a\u6b21\u306b\u53d6\u308b\u3079\u304d\u6226\u7565\u3068\u306f"},"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\u306b\u5bfe\u3057\u3066\u975e\u518d\u767a\u6027\u4e8c\u6b21\u6027\u9032\u884c\u578b\u591a\u767a\u6027\u786c\u5316\u75c7\uff08nrSP-MS\uff09\u6cbb\u7642\u85ac\u3068\u3057\u3066\u306e<a href=\"https:\/\/clarivate.com\/drugs-to-watch\/drugs-to-watch-listing\/tolebrutinib\/?utm_content=dtw-blog-series&amp;utm_term=blog-4&amp;campaignname=Drugs_to_Watch_Annual_Report_LeadGen_LS_Global_2026&amp;campaignid=701VO00000nqEKYYA2\">tolebrutinib<\/a>\u3001\u307e\u305f2025\u5e7412\u670830\u65e5\u306bCorcept Therapeutics\u306b\u5bfe\u3057\u3066\u30af\u30c3\u30b7\u30f3\u30b0\u75c7\u5019\u7fa4\u6cbb\u7642\u85ac\u3068\u3057\u3066\u306e<a href=\"https:\/\/clarivate.com\/drugs-to-watch\/drugs-to-watch-listing\/relacorilant\/?utm_content=dtw-blog-series&amp;utm_term=blog-4&amp;campaignname=Drugs_to_Watch_Annual_Report_LeadGen_LS_Global_2026&amp;campaignid=701VO00000nqEKYYA2\">relacorilant<\/a>\u306b\u767a\u884c\u3057\u305fComplete Response Letter\uff08CRL\uff09\u306b\u95a2\u3059\u308b<a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/ja\/blog\/navigating-fda-complete-response-letters-clarivate\">\u9023\u8f09<\/a>\u306e\u6700\u7d42\u56de\u3067\u3059\u3002\u4e21\u85ac\u5264\u306fClarivate<a href=\"https:\/\/clarivate.com\/ja\/drugs-to-watch\">\u300cDrugs to Watch 2026\u300d\u30ec\u30dd\u30fc\u30c8<\/a>\u306b\u63b2\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u304c\u3001\u3053\u308c\u3089\u306e\u5224\u65ad\u306f\u540c\u30ec\u30dd\u30fc\u30c8\u78ba\u5b9a\u5f8c\u306b\u4e0b\u3055\u308c\u307e\u3057\u305f\u3002<\/em><\/p>\n<p>FDA\u304b\u3089CRL\u3092\u53d7\u9818\u3057\u305f\u5f8c\u3001Sanofi\u3084Corcept Therapeutics\u306e\u3088\u3046\u306a\u4f01\u696d\u306f\u3001\u6b21\u306b\u4f55\u3092\u3059\u3079\u304d\u304b\u3068\u3044\u3046\u6975\u3081\u3066\u91cd\u8981\u306a\u5224\u65ad\u306b\u76f4\u9762\u3057\u307e\u3059\u3002CRL\u306b\u95a2\u3059\u308b\u904e\u53bb\u306e\u5148\u4f8b\u3092\u898b\u308b\u3068\u3001tolebrutinib\u3068relacorilant\u306f\u3044\u305a\u308c\u3082\u3001\u8ffd\u52a0\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u5275\u51fa\u3001\u30ea\u30b9\u30af\u7ba1\u7406\u8a08\u753b\u306e\u7cbe\u7dfb\u5316\u3001\u3042\u308b\u3044\u306f\u5bfe\u8c61\u60a3\u8005\u96c6\u56e3\u306e\u898b\u76f4\u3057\u3092\u901a\u3058\u3066\u3001\u6700\u7d42\u7684\u306a\u627f\u8a8d\u3078\u81f3\u308b\u9053\u7b4b\u3092\u6301\u3063\u3066\u3044\u308b\u3068\u8003\u3048\u3089\u308c\u307e\u3059\u3002CRL\u3092\u53d7\u3051\u305f\u85ac\u5264\u306e\u591a\u304f\u306f\u6700\u7d42\u7684\u306b\u627f\u8a8d\u3055\u308c\u3066\u3044\u307e\u3059\u304c\u3001\u305d\u306e\u6240\u8981\u671f\u9593\u306f\u6c42\u3081\u3089\u308c\u308b\u662f\u6b63\u5bfe\u5fdc\u306e\u5185\u5bb9\u306b\u3088\u3063\u3066\u5927\u304d\u304f\u7570\u306a\u308a\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>tolebrutinib\u306e\u4eca\u5f8c\u306e\u9053\u7b4b<\/strong><\/h3>\n<p>Sanofi\u306e\u4eca\u5f8c\u306e\u5bfe\u5fdc\u306f\u3001\u4e3b\u3068\u3057\u3066\u85ac\u5264\u6027\u809d\u969c\u5bb3\uff08DILI\uff09\u30ea\u30b9\u30af\u3078\u306e\u5bfe\u51e6\u306b\u304b\u304b\u3063\u3066\u304a\u308a\u3001\u305d\u306e\u969b\u306b\u306f\u4e3b\u8981\u8a55\u4fa1\u9805\u76ee\u3092\u9054\u6210\u3067\u304d\u306a\u304b\u3063\u305f\u4e00\u6b21\u9032\u884c\u578b\u591a\u767a\u6027\u786c\u5316\u75c7\uff08PP-MS\uff09\u8a66\u9a13\u306e\u30c7\u30fc\u30bf\u3092\u6d3b\u7528\u3067\u304d\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002FDA\u306f\u3001Sanofi\u304c\u809d\u6a5f\u80fd\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3092\u6bce\u9031\u5b9f\u65bd\u3059\u308b\u65b9\u5f0f\u306b\u5207\u308a\u66ff\u3048\u305f\u5f8c\u306f\u3001\u6b7b\u4ea1\u307e\u305f\u306f\u809d\u79fb\u690d\u306b\u81f3\u308bDILI\u75c7\u4f8b\u306f\u65b0\u305f\u306b\u767a\u751f\u3057\u306a\u304b\u3063\u305f\u3068\u6307\u6458\u3057\u3066\u304a\u308a\u3001\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306e\u5f37\u5ea6\u304c\u91cd\u8981\u3067\u3042\u308b\u3053\u3068\u3092\u793a\u5506\u3057\u3066\u3044\u307e\u3059\u3002Sanofi\u306f<a href=\"https:\/\/clarivate.com\/drugs-to-watch\/drugs-to-watch-listing\/tolebrutinib\/\">tolebrutinib<\/a>\u306e\u300c\u30ea\u30b9\u30af\u30fb\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u3092\u5f37\u304f\u4fe1\u3058\u3066\u3044\u308b\u300d\u3068\u8ff0\u3079\u3066\u304a\u308a\u3001\u518d\u7533\u8acb\u3092\u76ee\u6307\u3059\u610f\u5411\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002\u3055\u3089\u306b\u3001FDA\u304c\u62e1\u5927\u30a2\u30af\u30bb\u30b9\u30d7\u30ed\u30b0\u30e9\u30e0\u3092\u6c42\u3081\u305f\u3053\u3068\u306f\u3001\u7d99\u7d9a\u7684\u306a\u5bfe\u8a71\u304c\u9032\u3093\u3067\u3044\u308b\u3053\u3068\u3092\u793a\u3057\u3066\u304a\u308a\u3001\u3053\u308c\u306f\u3057\u3070\u3057\u3070\u518d\u7533\u8acb\u6210\u529f\u306e\u524d\u5146\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n<p>\u52a0\u3048\u3066\u3001\u3088\u308a\u9650\u5b9a\u7684\u306a\u9069\u5fdc\u30e9\u30d9\u30eb\u304c\u5fc5\u8981\u306b\u306a\u308b\u53ef\u80fd\u6027\u3082\u3042\u308a\u3001\u305d\u306e\u5834\u5408\u3001\u5bfe\u8c61\u60a3\u8005\u96c6\u56e3\u306f\u6d3b\u52d5\u6027MRI\u6240\u898b\u306e\u306a\u3044nrSP-MS\u306b\u307e\u3067\u7d5e\u3089\u308c\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002FDA\u306f\u3001MRI\u75c5\u5909\u6d3b\u52d5\u6027\u306e\u8a3c\u62e0\u304c\u3042\u308bnrSP-MS\u60a3\u8005\u306f\u300c\u6d3b\u52d5\u6027SP-MS\uff08\u518d\u767a\u578b\uff09\u300d\u3068\u307f\u306a\u3055\u308c\u308b\u3079\u304d\u3067\u3042\u308a\u3001\u3059\u3067\u306b\u518d\u767a\u578b\u60a3\u8005\u5411\u3051\u306b\u627f\u8a8d\u3055\u308c\u3066\u3044\u308b\u591a\u6570\u306e\u75be\u60a3\u4fee\u98fe\u7642\u6cd5\u306e\u5bfe\u8c61\u306b\u306a\u308b\u3068\u6307\u6458\u3057\u3066\u3044\u307e\u3059\u3002\u305f\u3060\u3057\u3001\u3053\u306e\u3088\u3046\u306b\u5bfe\u8c61\u96c6\u56e3\u304c\u72ed\u307e\u308b\u3068\u3001HERCULES\u8a66\u9a13\u30c7\u30fc\u30bf\u3060\u3051\u3067\u306f\u5341\u5206\u306a\u6709\u52b9\u6027\u3092\u793a\u305b\u306a\u3044\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>relacorilant\u306e\u4eca\u5f8c\u306e\u9053\u7b4b <\/strong><\/h3>\n<p>Corcept\u306e\u9053\u7b4b\u306f\u6bd4\u8f03\u7684\u660e\u78ba\u306b\u898b\u3048\u307e\u3059\u3002\u3068\u3044\u3046\u306e\u3082\u3001\u4eca\u56de\u306eCRL\u3067\u306f\u5b89\u5168\u6027\u3084\u6709\u52b9\u6027\u306b\u95a2\u3059\u308b\u6839\u672c\u7684\u306a\u61f8\u5ff5\u306f\u6307\u6458\u3055\u308c\u3066\u3044\u306a\u3044\u305f\u3081\u3067\u3059\u3002CEO\u306eJoseph Belanoff\u6c0f\u306f\u3001Corcept\u306f<a href=\"https:\/\/clarivate.com\/drugs-to-watch\/drugs-to-watch-listing\/relacorilant\/\">relacorilant<\/a>\u3092\u300c\u305d\u306e\u6069\u6075\u3092\u53d7\u3051\u5f97\u308b\u60a3\u8005\u306b\u5c4a\u3051\u308b\u65b9\u6cd5\u3092\u5fc5\u305a\u898b\u3064\u3051\u308b\u3068\u78ba\u4fe1\u3057\u3066\u3044\u308b\u300d\u3068\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002\u540c\u793e\u306fFDA\u3068\u9762\u8ac7\u3057\u3001\u5fc5\u8981\u306a\u6b21\u306e\u30b9\u30c6\u30c3\u30d7\u3092\u898b\u6975\u3081\u308b\u4e88\u5b9a\u3067\u3042\u308a\u3001\u305d\u3053\u306b\u306f\u65e2\u5b58\u306e\u7b2c3\u76f8\u8a66\u9a13\u30c7\u30fc\u30bf\u3092\u7279\u5b9a\u306e\u30b5\u30d6\u30b0\u30eb\u30fc\u30d7\u306b\u7126\u70b9\u3092\u5f53\u3066\u3066\u518d\u89e3\u6790\u3059\u308b\u3053\u3068\u3084\u3001\u65b0\u305f\u306a\u7b2c3\u76f8\u8a66\u9a13\u306e\u5b9f\u65bd\uff08\u5927\u5e45\u306a\u9045\u5ef6\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u3042\u308a\uff09\u304c\u542b\u307e\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>\u540c\u6642\u306b\u9032\u3081\u3066\u3044\u308b\u5375\u5de3\u304c\u3093\u9069\u5fdc\u3067\u306e\u627f\u8a8d\u8ffd\u6c42\u306f\u3001\u53ce\u76ca\u6a5f\u4f1a\u3068\u8ffd\u52a0\u30a8\u30d3\u30c7\u30f3\u30b9\u5275\u51fa\u306e\u4e21\u9762\u3067\u5229\u70b9\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u9069\u5fdc\u3067\u627f\u8a8d\u3055\u308c\u308c\u3070\u3001relacorilant\u306f\u305d\u306e\u4f5c\u7528\u6a5f\u5e8f\u3092\u6709\u3059\u308b\u521d\u306e\u4e0a\u5e02\u85ac\u3068\u306a\u308a\u3001\u3055\u3089\u306b\u5168\u751f\u5b58\u671f\u9593\u306e\u6539\u5584\u3092\u793a\u3057\u305f\u521d\u306e\u85ac\u5264\u306b\u3082\u306a\u308a\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u533b\u85ac\u54c1\u958b\u767a\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u306e\u4e00\u90e8\u3068\u3057\u3066\u306e\u627f\u8a8d\u4e0a\u306e\u5f8c\u9000<\/strong><\/h3>\n<p>tolebrutinib\u3068relacorilant\u306b\u5bfe\u3059\u308bCRL\u306f\u3001\u533b\u85ac\u54c1\u958b\u767a\u306b\u304a\u3051\u308b\u6839\u672c\u7684\u306a\u7dca\u5f35\u95a2\u4fc2\u3092\u6d6e\u304d\u5f6b\u308a\u306b\u3057\u3066\u3044\u307e\u3059\u3002\u3059\u306a\u308f\u3061\u3001\u5fc5\u8981\u306a\u6cbb\u7642\u3092\u60a3\u8005\u306b\u8fc5\u901f\u306b\u5c4a\u3051\u308b\u5fc5\u8981\u6027\u3068\u3001\u305d\u308c\u3089\u306e\u6cbb\u7642\u304c\u5b89\u5168\u304b\u3064\u6709\u52b9\u3067\u3042\u308b\u3053\u3068\u3092\u78ba\u5b9f\u306b\u3059\u308b\u5fc5\u8981\u6027\u3068\u306e\u30d0\u30e9\u30f3\u30b9\u3067\u3059\u3002\u3053\u3046\u3057\u305f\u51fa\u6765\u4e8b\u306f\u4f01\u696d\u3001\u6295\u8cc7\u5bb6\u3001\u305d\u3057\u3066\u65b0\u305f\u306a\u6cbb\u7642\u9078\u629e\u80a2\u3092\u5f85\u3064\u60a3\u8005\u306b\u5f71\u97ff\u3092\u53ca\u307c\u3057\u307e\u3059\u304c\u3001\u540c\u6642\u306b\u305d\u308c\u306f\u898f\u5236\u30b7\u30b9\u30c6\u30e0\u304c\u672c\u6765\u306e\u8a2d\u8a08\u3069\u304a\u308a\u6a5f\u80fd\u3057\u3066\u3044\u308b\u3053\u3068\u306e\u8868\u308c\u3067\u3082\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>\u3088\u308a\u5e83\u3044\u88fd\u85ac\u696d\u754c\u306b\u3068\u3063\u3066\u3001\u3053\u308c\u3089\u306e\u4e8b\u4f8b\u306f\u3001\u300c\u6ce8\u76ee\u3059\u3079\u304d\u85ac\u5264\u300d\u3067\u3042\u308b\u3053\u3068\u304c\u3001\u771f\u306e\u5546\u696d\u7684\u30fb\u6cbb\u7642\u7684\u53ef\u80fd\u6027\u3092\u53cd\u6620\u3057\u3066\u3044\u305f\u3068\u3057\u3066\u3082\u3001\u898f\u5236\u5bfe\u5fdc\u304c\u9806\u8abf\u306b\u9032\u3080\u4fdd\u8a3c\u306b\u306f\u306a\u3089\u306a\u3044\u3053\u3068\u3092\u6539\u3081\u3066\u793a\u3057\u3066\u3044\u307e\u3059\u3002\u79d1\u5b66\u7684\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u3092\u627f\u8a8d\u6e08\u307f\u533b\u85ac\u54c1\u3078\u3068\u8ee2\u63db\u3059\u308b\u306b\u306f\u3001\u81e8\u5e8a\u30a8\u30d3\u30c7\u30f3\u30b9\u3060\u3051\u3067\u306a\u304f\u3001\u6226\u7565\u7684\u306a\u898f\u5236\u5bfe\u5fdc\u3001\u5305\u62ec\u7684\u306a\u5b89\u5168\u6027\u8a55\u4fa1\u3001\u305d\u3057\u3066\u3057\u3070\u3057\u3070\u5f8c\u9000\u5c40\u9762\u306b\u8010\u3048\u308b\u30ec\u30b8\u30ea\u30a8\u30f3\u30b9\u304c\u5fc5\u8981\u3067\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u8fc5\u901f\u306a\u610f\u601d\u6c7a\u5b9a\u3092\u652f\u3048\u308bAI\u6d3b\u7528\u306e\u512a\u4f4d\u6027<\/strong><\/h3>\n<p>\u4f01\u696d\u306f\u3001Clarivate\u306e\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u306e\u3088\u3046\u306a\u3001AI\u3092\u6d3b\u7528\u3057\u305f\u4fe1\u983c\u6027\u306e\u9ad8\u3044\u7d71\u5408\u578b\u696d\u754c\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30b9\u3092\u7528\u3044\u308b\u3053\u3068\u3067\u3001\u4e88\u6e2c\u304c\u96e3\u3057\u3044\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u696d\u754c\u306b\u304a\u3044\u3066\u3001\u3088\u308a\u6a5f\u52d5\u7684\u306b\u5bfe\u5fdc\u3057\u7d9a\u3051\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li><strong>\u6a5f\u80fd\u6a2a\u65ad\u30c1\u30fc\u30e0\u5168\u4f53\u3067\u30a2\u30af\u30bb\u30b9\u3092\u6c11\u4e3b\u5316\uff1a<\/strong>\u81ea\u7136\u8a00\u8a9e\u3067\u8abf\u67fb\u53ef\u80fd\u306a\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u306b\u3088\u308a\u3001\u898f\u5236\u3001\u81e8\u5e8a\u3001\u5546\u696d\u90e8\u9580\u306e\u5404\u30c1\u30fc\u30e0\u306f\u6280\u8853\u7684\u306a\u969c\u58c1\u306a\u3057\u306b\u8907\u96d1\u306a\u554f\u3044\u3092\u63a2\u7d22\u3067\u304d\u3001\u3042\u3089\u3086\u308b\u6a5f\u80fd\u306b\u3068\u3063\u3066\u91cd\u8981\u306a\u9ad8\u5ea6\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30b9\u3092\u6d3b\u7528\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>\u610f\u601d\u6c7a\u5b9a\u307e\u3067\u306e\u6642\u9593\u3092\u77ed\u7e2e\uff1aCRL\u3078\u306e\u5bfe\u5fdc\u3067\u306f\u3001\u6642\u9593\u305d\u306e\u3082\u306e\u304c\u7af6\u4e89\u512a\u4f4d\u306b\u306a\u308a\u307e\u3059\u3002\u9045\u308c\u304c1\u304b\u6708\u751f\u3058\u308b\u3054\u3068\u306b\u7af6\u5408\u306f\u524d\u9032\u3057\u307e\u3059\u3002Clarivate\u306eAI\u6d3b\u7528\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u306f\u3001\u898f\u5236\u5bfe\u5fdc\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u304b\u3089\u7af6\u5408\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30b9\u5206\u6790\u307e\u3067\u3001\u6642\u9593\u306e\u304b\u304b\u308b\u624b\u4f5c\u696d\u306e\u5206\u6790\u3092\u3001\u6839\u62e0\u30bd\u30fc\u30b9\u306b\u88cf\u4ed8\u3051\u3089\u308c\u305f\u8fc5\u901f\u306a\u6d1e\u5bdf\u3078\u3068\u5909\u3048\u3001\u81ea\u4fe1\u3042\u308b\u610f\u601d\u6c7a\u5b9a\u3092\u53ef\u80fd\u306b\u3057\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>\u6226\u7565\u7684\u4e00\u8cab\u6027\u3092\u78ba\u4fdd\uff1a\u4e00\u8cab\u6027\u3042\u308b\u518d\u7533\u8acb\u6226\u7565\u306b\u306f\u3001\u898f\u5236\u4e0a\u306e\u5148\u4f8b\uff08<a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/ja\/research-development\/regulatory-compliance-intelligence\/regulatory-intelligence-solutions\/\">Cortellis Regulatory Intelligence<\/a>\uff09\u3001\u81e8\u5e8a\u8a66\u9a13\u8a2d\u8a08\u306e\u6700\u9069\u5316\uff08<a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/ja\/research-development\/discovery-development\/cortellis-clinical-trials-intelligence\/\">Cortellis Clinical Trials Intelligence<\/a>\uff09\u3001\u5dee\u5225\u5316\u30dd\u30b8\u30b7\u30e7\u30cb\u30f3\u30b0\u306e\u305f\u3081\u306e\u30ea\u30a2\u30eb\u30ef\u30fc\u30eb\u30c9\u30a8\u30d3\u30c7\u30f3\u30b9\uff08<a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/ja\/drg-fusion\/\">DRG Fusion<\/a>\uff09\u3001\u7af6\u4e89\u74b0\u5883\uff08<a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/ja\/portfolio-strategy\/competitive-intelligence\/cortellis-competitive-intelligence-analytics\/\">Cortellis Competitive Intelligence<\/a>\uff09\u3001\u5e02\u5834\u4e88\u6e2c\uff08<a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/ja\/disease-intelligence-analytics\/\">Disease Landscape and Forecast<\/a>\uff09\u3092\u7d71\u5408\u7684\u306b\u5206\u6790\u3059\u308b\u3053\u3068\u304c\u6b20\u304b\u305b\u307e\u305b\u3093\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>\u898f\u5236\u306e\u8907\u96d1\u6027\u3092\u4e57\u308a\u8d8a\u3048\u308b\uff1a\u30b0\u30ed\u30fc\u30d0\u30eb\u88fd\u85ac\u696d\u754c\u3067\u306f\u3001\u4f01\u696d\u306fFDA\u8981\u4ef6\u3060\u3051\u3067\u306a\u304f\u3001\u4ed6\u5730\u57df\u3067\u306e\u4e26\u884c\u7533\u8acb\u306b\u3082\u5bfe\u5fdc\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002Clarivate\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u306e\u6bd4\u8f03\u6cd5\u57df\u5206\u6790\u306f\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3068\u76e3\u67fb\u53ef\u80fd\u6027\u3092\u78ba\u4fdd\u3057\u306a\u304c\u3089\u3001\u30b0\u30ed\u30fc\u30d0\u30eb\u5e02\u5834\u3054\u3068\u306b\u7570\u306a\u308b\u898f\u5236\u7d4c\u8def\u3001\u30a8\u30d3\u30c7\u30f3\u30b9\u8981\u4ef6\u3001\u653f\u6cbb\u7684\u529b\u5b66\u306e\u7ba1\u7406\u3092\u652f\u63f4\u3057\u307e\u3059\u3002<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li>\u76e3\u67fb\u53ef\u80fd\u6027\u3092\u7dad\u6301\uff1a\u900f\u660e\u6027\u306e\u9ad8\u3044AI\u306b\u5bfe\u3059\u308bClarivate\u306e\u30a2\u30d7\u30ed\u30fc\u30c1\u3067\u306f\u3001\u51fa\u529b\u7d50\u679c\u304c\u5143\u306e\u30bd\u30fc\u30b9\u6587\u66f8\u306b\u76f4\u63a5\u3072\u3082\u3065\u3051\u3089\u308c\u308b\u305f\u3081\u3001\u3042\u3089\u3086\u308b\u6d1e\u5bdf\u3001\u63d0\u8a00\u3001\u6226\u7565\u7684\u610f\u601d\u6c7a\u5b9a\u3092\u6a29\u5a01\u3042\u308b\u30bd\u30fc\u30b9\u307e\u3067\u8ffd\u8de1\u3067\u304d\u307e\u3059\u3002\u3053\u306e\u53ef\u8996\u6027\u306f\u3001\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u7531\u6765\u304c\u91cd\u8981\u3068\u306a\u308b\u898f\u5236\u7533\u8acb\u306b\u304a\u3044\u3066\u4e0d\u53ef\u6b20\u3067\u3059\u3002<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3><strong>\u5f8c\u9000\u3092\u6226\u7565\u7684\u512a\u4f4d\u3078\u3068\u8ee2\u63db\u3059\u308b<\/strong><\/h3>\n<p>CRL\u306f\u91cd\u5927\u306a\u5f8c\u9000\u3092\u610f\u5473\u3057\u307e\u3059\u304c\u3001\u6700\u7d42\u7684\u306a\u6210\u529f\u3092\u6c7a\u5b9a\u3065\u3051\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u9069\u5207\u306a\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30b9\u3001\u6226\u7565\u7684\u6d1e\u5bdf\u3001\u30a8\u30d3\u30c7\u30f3\u30b9\u5275\u51fa\u80fd\u529b\u304c\u3042\u308c\u3070\u3001Sanofi\u3068Corcept Therapeutics\u306f\u3044\u305a\u308c\u3082FDA\u306e\u5177\u4f53\u7684\u306a\u61f8\u5ff5\u4e8b\u9805\u306b\u5bfe\u5fdc\u3057\u3001\u305d\u306e\u898f\u5236\u4e0a\u306e\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3092\u3001\u3088\u308a\u7126\u70b9\u3092\u7d5e\u3063\u305f\u958b\u767a\u6226\u7565\u3078\u3068\u8ee2\u63db\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002Clarivate\u306e\u7d71\u5408\u578bAI\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u7fa4\u306f\u3001\u898f\u5236\u4e0a\u306e\u8ab2\u984c\u3092\u3001\u3088\u308a\u5f37\u56fa\u306a\u627f\u8a8d\u7533\u8acb\u30b1\u30fc\u30b9\u3092\u69cb\u7bc9\u3059\u308b\u6a5f\u4f1a\u3078\u3068\u5909\u3048\u308b\u305f\u3081\u306e\u5148\u4f8b\u5206\u6790\u3092\u63d0\u4f9b\u3057\u3001\u6700\u7d42\u7684\u306b\u306f\u3001\u3053\u308c\u3089\u306e\u5909\u9769\u7684\u306a\u6cbb\u7642\u3092\u5f85\u3064nrSP-MS\u304a\u3088\u3073\u30af\u30c3\u30b7\u30f3\u30b0\u75c7\u5019\u7fa4\u306e\u60a3\u8005\u306b\u8ca2\u732e\u3057\u307e\u3059\u3002<\/p>\n<p><em>\u8a73\u3057\u304f\u306f\u30012026 Drugs to Watch\u3092\u3054\u89a7\u304f\u3060\u3055\u3044\u3002\u307e\u305f\u3001Clarivate\u304c\u3069\u306e\u3088\u3046\u306bAI\u30c4\u30fc\u30eb\u3092\u6d3b\u7528\u3057\u3066\u3001\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\u306f\u3001\u3053\u3061\u3089\u3067\u3054\u89a7\u3044\u305f\u3060\u3051\u307e\u3059\u3002 <\/em><\/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\u306b\u5bfe\u3057\u3066\u975e\u518d\u767a\u6027\u4e8c\u6b21\u6027\u9032\u884c\u578b\u591a\u767a\u6027\u786c\u5316\u75c7\uff08nrSP-MS\uff09\u6cbb\u7642\u85ac\u3068\u3057\u3066\u306etolebrutinib\u3001\u307e\u305f2025\u5e7412\u670830\u65e5\u306bCorcept Therapeutics\u306b\u5bfe\u3057\u3066\u30af\u30c3\u30b7\u30f3\u30b0\u75c7\u5019\u7fa4\u6cbb\u7642\u85ac\u3068\u3057\u3066\u306erelacorilant\u306b\u767a\u884c\u3057\u305fComplete Response Letter\uff08CRL\uff09\u306b\u95a2\u3059\u308b\u9023\u8f09\u306e\u6700\u7d42\u56de\u3067\u3059\u3002\u4e21\u85ac\u5264\u306fClarivate\u300cDrugs to Watch 2026\u300d\u30ec\u30dd\u30fc\u30c8\u306b\u63b2\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u304c\u3001\u3053\u308c\u3089\u306e\u5224\u65ad\u306f\u540c\u30ec\u30dd\u30fc\u30c8\u78ba\u5b9a\u5f8c\u306b\u4e0b\u3055\u308c\u307e\u3057\u305f\u3002 FDA\u304b\u3089CRL\u3092\u53d7\u9818\u3057\u305f\u5f8c\u3001Sanofi\u3084Corcept Therapeutics\u306e\u3088\u3046\u306a\u4f01\u696d\u306f\u3001\u6b21\u306b\u4f55\u3092\u3059\u3079\u304d\u304b\u3068\u3044\u3046\u6975\u3081\u3066\u91cd\u8981\u306a\u5224\u65ad\u306b\u76f4\u9762\u3057\u307e\u3059\u3002CRL\u306b\u95a2\u3059\u308b\u904e\u53bb\u306e\u5148\u4f8b\u3092\u898b\u308b\u3068\u3001tolebrutinib\u3068relacorilant\u306f\u3044\u305a\u308c\u3082\u3001\u8ffd\u52a0\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u5275\u51fa\u3001\u30ea\u30b9\u30af\u7ba1\u7406\u8a08\u753b\u306e\u7cbe\u7dfb\u5316\u3001\u3042\u308b\u3044\u306f\u5bfe\u8c61\u60a3\u8005\u96c6\u56e3\u306e\u898b\u76f4\u3057\u3092\u901a\u3058\u3066\u3001\u6700\u7d42\u7684\u306a\u627f\u8a8d\u3078\u81f3\u308b\u9053\u7b4b\u3092\u6301\u3063\u3066\u3044\u308b\u3068\u8003\u3048\u3089\u308c\u307e\u3059\u3002CRL\u3092\u53d7\u3051\u305f\u85ac\u5264\u306e\u591a\u304f\u306f\u6700\u7d42\u7684\u306b\u627f\u8a8d\u3055\u308c\u3066\u3044\u307e\u3059\u304c\u3001\u305d\u306e\u6240\u8981\u671f\u9593\u306f\u6c42\u3081\u3089\u308c\u308b\u662f\u6b63\u5bfe\u5fdc\u306e\u5185\u5bb9\u306b\u3088\u3063\u3066\u5927\u304d\u304f\u7570\u306a\u308a\u307e\u3059\u3002 &nbsp; tolebrutinib\u306e\u4eca\u5f8c\u306e\u9053\u7b4b Sanofi\u306e\u4eca\u5f8c\u306e\u5bfe\u5fdc\u306f\u3001\u4e3b\u3068\u3057\u3066\u85ac\u5264\u6027\u809d\u969c\u5bb3\uff08DILI\uff09\u30ea\u30b9\u30af\u3078\u306e\u5bfe\u51e6\u306b\u304b\u304b\u3063\u3066\u304a\u308a\u3001\u305d\u306e\u969b\u306b\u306f\u4e3b\u8981\u8a55\u4fa1\u9805\u76ee\u3092\u9054\u6210\u3067\u304d\u306a\u304b\u3063\u305f\u4e00\u6b21\u9032\u884c\u578b\u591a\u767a\u6027\u786c\u5316\u75c7\uff08PP-MS\uff09\u8a66\u9a13\u306e\u30c7\u30fc\u30bf\u3092\u6d3b\u7528\u3067\u304d\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002FDA\u306f\u3001Sanofi\u304c\u809d\u6a5f\u80fd\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3092\u6bce\u9031\u5b9f\u65bd\u3059\u308b\u65b9\u5f0f\u306b\u5207\u308a\u66ff\u3048\u305f\u5f8c\u306f\u3001\u6b7b\u4ea1\u307e\u305f\u306f\u809d\u79fb\u690d\u306b\u81f3\u308bDILI\u75c7\u4f8b\u306f\u65b0\u305f\u306b\u767a\u751f\u3057\u306a\u304b\u3063\u305f\u3068\u6307\u6458\u3057\u3066\u304a\u308a\u3001\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306e\u5f37\u5ea6\u304c\u91cd\u8981\u3067\u3042\u308b\u3053\u3068\u3092\u793a\u5506\u3057\u3066\u3044\u307e\u3059\u3002Sanofi\u306ftolebrutinib\u306e\u300c\u30ea\u30b9\u30af\u30fb\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u3092\u5f37\u304f\u4fe1\u3058\u3066\u3044\u308b\u300d\u3068\u8ff0\u3079\u3066\u304a\u308a\u3001\u518d\u7533\u8acb\u3092\u76ee\u6307\u3059\u610f\u5411\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002\u3055\u3089\u306b\u3001FDA\u304c\u62e1\u5927\u30a2\u30af\u30bb\u30b9\u30d7\u30ed\u30b0\u30e9\u30e0\u3092\u6c42\u3081\u305f\u3053\u3068\u306f\u3001\u7d99\u7d9a\u7684\u306a\u5bfe\u8a71\u304c\u9032\u3093\u3067\u3044\u308b\u3053\u3068\u3092\u793a\u3057\u3066\u304a\u308a\u3001\u3053\u308c\u306f\u3057\u3070\u3057\u3070\u518d\u7533\u8acb\u6210\u529f\u306e\u524d\u5146\u3068\u306a\u308a\u307e\u3059\u3002 \u52a0\u3048\u3066\u3001\u3088\u308a\u9650\u5b9a\u7684\u306a\u9069\u5fdc\u30e9\u30d9\u30eb\u304c\u5fc5\u8981\u306b\u306a\u308b\u53ef\u80fd\u6027\u3082\u3042\u308a\u3001\u305d\u306e\u5834\u5408\u3001\u5bfe\u8c61\u60a3\u8005\u96c6\u56e3\u306f\u6d3b\u52d5\u6027MRI\u6240\u898b\u306e\u306a\u3044nrSP-MS\u306b\u307e\u3067\u7d5e\u3089\u308c\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002FDA\u306f\u3001MRI\u75c5\u5909\u6d3b\u52d5\u6027\u306e\u8a3c\u62e0\u304c\u3042\u308bnrSP-MS\u60a3\u8005\u306f\u300c\u6d3b\u52d5\u6027SP-MS\uff08\u518d\u767a\u578b\uff09\u300d\u3068\u307f\u306a\u3055\u308c\u308b\u3079\u304d\u3067\u3042\u308a\u3001\u3059\u3067\u306b\u518d\u767a\u578b\u60a3\u8005\u5411\u3051\u306b\u627f\u8a8d\u3055\u308c\u3066\u3044\u308b\u591a\u6570\u306e\u75be\u60a3\u4fee\u98fe\u7642\u6cd5\u306e\u5bfe\u8c61\u306b\u306a\u308b\u3068\u6307\u6458\u3057\u3066\u3044\u307e\u3059\u3002\u305f\u3060\u3057\u3001\u3053\u306e\u3088\u3046\u306b\u5bfe\u8c61\u96c6\u56e3\u304c\u72ed\u307e\u308b\u3068\u3001HERCULES\u8a66\u9a13\u30c7\u30fc\u30bf\u3060\u3051\u3067\u306f\u5341\u5206\u306a\u6709\u52b9\u6027\u3092\u793a\u305b\u306a\u3044\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002 &nbsp; relacorilant\u306e\u4eca\u5f8c\u306e\u9053\u7b4b Corcept\u306e\u9053\u7b4b\u306f\u6bd4\u8f03\u7684\u660e\u78ba\u306b\u898b\u3048\u307e\u3059\u3002\u3068\u3044\u3046\u306e\u3082\u3001\u4eca\u56de\u306eCRL\u3067\u306f\u5b89\u5168\u6027\u3084\u6709\u52b9\u6027\u306b\u95a2\u3059\u308b\u6839\u672c\u7684\u306a\u61f8\u5ff5\u306f\u6307\u6458\u3055\u308c\u3066\u3044\u306a\u3044\u305f\u3081\u3067\u3059\u3002CEO\u306eJoseph 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