{"id":579598,"date":"2026-02-24T08:55:13","date_gmt":"2026-02-24T08:55:13","guid":{"rendered":"https:\/\/clarivate.com\/life-sciences-healthcare\/?p=574168"},"modified":"2026-05-08T07:34:18","modified_gmt":"2026-05-08T07:34:18","slug":"relacorilant-crl-fda-evidence-bar","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/ko\/blog\/relacorilant-crl-fda-evidence-bar\/","title":{"rendered":"Relacorilant: \uaddc\uc81c \uae30\uc900\uc744 \ucda9\uc871\ud558\ub294 \uc21c\uac04"},"content":{"rendered":"<p><em>\uc774 \ube14\ub85c\uadf8\ub294 \ubbf8\uad6d \uc2dd\ud488\uc758\uc57d\uad6d(FDA)\uc774 2025\ub144 12\uc6d4 23\uc77c Sanofi\uc758 \ube44\uc7ac\ubc1c\uc131 \uc774\ucc28 \uc9c4\ud589\uc131 \ub2e4\ubc1c\uc131\uacbd\ud654\uc99d(nrSP-MS) \uce58\ub8cc\uc81c <a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/ko\/blog\/tolebrutinib-crl-safety-overrides-efficacy\/\">tolebrutinib<\/a>\uacfc, 2025\ub144 12\uc6d4 30\uc77c Corcept Therapeutics\uc758 \ucfe0\uc2f1 \uc99d\ud6c4\uad70 \uce58\ub8cc\uc81c relacorilant\uc5d0 \ub300\ud574 \ubc1c\ud589\ud55c Complete Response Letter(CRL)\ub97c \ub2e4\ub8e8\ub294 <a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/ko\/blog\/navigating-fda-complete-response-letters-clarivate\/\">\uc2dc\ub9ac\uc988<\/a>\uc758 \uc138 \ubc88\uc9f8 \uae00\uc785\ub2c8\ub2e4. \ub450 \uc57d\ubb3c \ubaa8\ub450 \ud074\ub798\ub9ac\ubca0\uc774\ud2b8\uc758 \u2018<a href=\"https:\/\/clarivate.com\/ko\/drugs-to-watch\/\">\ube14\ub85d\ubc84\uc2a4\ud130 \uc2e0\uc57d\ubcf4\uace0\uc11c(Drugs to Watch 2026)\u2019<\/a>\uc5d0 \ud3ec\ud568\ub418\uc5b4 \uc788\uc73c\uba70, \uc774\ubc88 \uacb0\uc815\uc740 \ubcf4\uace0\uc11c \ubc1c\uac04 \uc774\ud6c4\uc5d0 \uc774\ub8e8\uc5b4\uc84c\uc2b5\ub2c8\ub2e4.<\/em><\/p>\n<p><a href=\"https:\/\/corcept.gcs-web.com\/news-releases\/news-release-details\/corcept-receives-complete-response-letter-relacorilant-treatment\" target=\"_blank\" rel=\"noopener\">relacorilant<\/a>\uc5d0 \ub300\ud55c CRL\uc5d0\uc11c FDA\ub294 \u201cCorcept\uac00 \ucd94\uac00\uc801\uc778 \uc720\ud6a8\uc131 \uadfc\uac70\ub97c \uc81c\uc2dc\ud558\uc9c0 \uc54a\ub294 \ud55c \uae0d\uc815\uc801\uc778 benefit-risk \ud3c9\uac00\uc5d0 \ub3c4\ub2ec\ud560 \uc218 \uc5c6\ub2e4\u201d\uace0 \ubc1d\ud614\uc2b5\ub2c8\ub2e4. \uc774\ub294 \ud6a8\ub2a5\uc774\ub098 \uc548\uc804\uc131 \ub370\uc774\ud130 \uc790\uccb4\uc5d0 \ub300\ud55c \ubb38\uc81c \uc81c\uae30\ub77c\uae30\ubcf4\ub2e4\ub294, \uc774\uc775\uc774 \uc704\ud5d8\uc744 \uc0c1\ud68c\ud55c\ub2e4\ub294 \uc810\uc744 \uba85\ud655\ud788 \uc785\uc99d\ud558\uae30 \uc704\ud55c \ucd94\uac00\uc801\uc778 \uadfc\uac70\uac00 \ud544\uc694\ud558\ub2e4\ub294 \uc758\ubbf8\uc785\ub2c8\ub2e4.<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\uc784\uc0c1\uc801 \ub9e5\ub77d<\/strong><\/h3>\n<p><a href=\"https:\/\/clarivate.com\/drugs-to-watch\/drugs-to-watch-listing\/relacorilant\/?utm_content=dtw-blog-series&amp;utm_term=blog-3&amp;campaignname=Drugs_to_Watch_Annual_Report_LeadGen_LS_Global_2026&amp;campaignid=701VO00000nqEKYYA2\" target=\"_blank\" rel=\"noopener\">Relacorilant<\/a>\ub294 \uc120\ud0dd\uc801 \uae00\ub8e8\ucf54\ucf54\ub974\ud2f0\ucf54\uc774\ub4dc \uc218\uc6a9\uccb4 \uae38\ud56d\uc81c(SGRA)\ub85c, \ud504\ub85c\uac8c\uc2a4\ud14c\ub860 \uc218\uc6a9\uccb4\uc5d0 \uacb0\ud569\ud558\uc9c0 \uc54a\uc73c\uba74\uc11c \ucf54\ub974\ud2f0\uc194 \uc2e0\ud638\ub97c \ucc28\ub2e8\ud558\ub294 \uc810\uc5d0\uc11c \uae30\uc874 \uce58\ub8cc\uc81c\uc640 \ucc28\ubcc4\ud654\ub429\ub2c8\ub2e4. \uc774\uc9c8\uc801\uc778 \ucfe0\uc2f1 \uc99d\ud6c4\uad70 \ud658\uc790\uad70\uc744 \ub300\uc0c1\uc73c\ub85c \uc9c4\ud589\ub41c 3\uc0c1 GRACE \uc784\uc0c1\uc2dc\ud5d8\uc740 1\ucc28 \ud3c9\uac00\ubcc0\uc218\ub97c \ucda9\uc871\ud588\uc73c\uba70, \uace0\ud608\uc555 \ud658\uc790\uc5d0\uc11c 22\uc8fc \uc2dc\uc810 \uae30\uc900 \uc218\ucd95\uae30 \ubc0f \uc774\uc644\uae30 \ud608\uc555\uc774 \uac01\uac01 \ud3c9\uade0 -7.9 mmHg, -5.1 mmHg\ub85c \uc720\uc758\ubbf8\ud558\uac8c \uac1c\uc120\ub418\uc5c8\uc2b5\ub2c8\ub2e4(\ub450 \uc9c0\ud45c \ubaa8\ub450 P&lt;.0001).\ub610\ud55c \ubd80\uc2e0 \uc120\uc885 \ub610\ub294 \uacfc\ud615\uc131\uc73c\ub85c \uc778\ud55c \uacfc\ucf54\ub974\ud2f0\uc194\uc99d \ud658\uc790\ub97c \ub300\uc0c1\uc73c\ub85c \ud55c GRADIENT \uc2dc\ud5d8(\ubcf4\ub2e4 \uc81c\ud55c\ub41c \ud658\uc790 \ud558\uc704\uad70)\uc5d0\uc11c\ub3c4 \uc720\uc0ac\ud55c \ud608\uc555 \uc870\uc808 \ud6a8\uacfc\uac00 \ud655\uc778\ub418\uc5c8\uc2b5\ub2c8\ub2e4. 22\uc8fc \uc2dc\uc810\uc5d0\uc11c relacorilant\ub294 -6.6 mmHg, \uc704\uc57d\uc740 -2.1 mmHg\uc758 \ubcc0\ud654\ub97c \ubcf4\uc600\uc73c\uba70, relacorilant \uc790\uccb4\uc758 \uac10\uc18c\ub294 \ud1b5\uacc4\uc801\u00b7\uc784\uc0c1\uc801\uc73c\ub85c \uc720\uc758\ud588\uc9c0\ub9cc relacorilant\uc640 \uc704\uc57d \uac04 \ucc28\uc774\ub294 \uc720\uc758\ud558\uc9c0 \uc54a\uc558\uc2b5\ub2c8\ub2e4.<\/p>\n<h3><strong>\uc2dc\uc7a5 \uc601\ud5a5<\/strong><\/h3>\n<p>\ucfe0\uc2f1 \uc99d\ud6c4\uad70 \uce58\ub8cc\uc81c \uc2dc\uc7a5\uc740 \uaddc\ubaa8\ub294 \ud06c\uc9c0 \uc54a\uc9c0\ub9cc \uc0c1\ub2f9\ud55c \uae30\ud68c\ub97c \uc81c\uacf5\ud558\ub294 \uc2dc\uc7a5\uc785\ub2c8\ub2e4. 2025\ub144 \uae30\uc900 \uc57d 3\uc5b58,300\ub9cc~3\uc5b58,600\ub9cc \ub2ec\ub7ec \uaddc\ubaa8\ub85c \ud3c9\uac00\ub418\uba70, 2030\ub144\uae4c\uc9c0 \uc5f0\ud3c9\uade0 5.64%\uc758 \uc131\uc7a5\ub960\uc774 \uc608\uc0c1\ub429\ub2c8\ub2e4. Corcept\ub294 relacorilant\uac00 \uc2b9\uc778 \ud6c4 3~5\ub144 \ub0b4 \uc801\uc751\uc99d \uc804\ubc18\uc5d0\uc11c \uc5f0\uac04 30\uc5b5~50\uc5b5 \ub2ec\ub7ec \ub9e4\ucd9c\uc744 \ub2ec\uc131\ud560 \uc218 \uc788\uc744 \uac83\uc73c\ub85c \uc804\ub9dd\ud558\uace0 \uc788\uc73c\uba70, \uc774\ub294 \uacfc\ucf54\ub974\ud2f0\uc194\uc99d \uc2dc\uc7a5\uc5d0\uc11c \uc57d 50~85% \uc810\uc720\uc728\uc744 \uc758\ubbf8\ud569\ub2c8\ub2e4.<\/p>\n<p>Relacorilant\uc758 \uacbd\uc7c1\ub825\uc740 \ucc28\ubcc4\ud654\ub41c \uc548\uc804\uc131 \ud504\ub85c\ud30c\uc77c\uc5d0 \uc788\uc2b5\ub2c8\ub2e4. Corcept\uc758 \uae30\uc874 \uce58\ub8cc\uc81c\uc778 mifepristone(Korlym\u00ae)\uacfc \ub2ec\ub9ac, relacorilant\ub294 \ud504\ub85c\uac8c\uc2a4\ud14c\ub860 \uc218\uc6a9\uccb4\uc5d0 \uacb0\ud569\ud558\uc9c0 \uc54a\uc544 \ubd80\uc778\uacfc\uc801 \uc774\uc0c1\ubc18\uc751\uc744 \ucd5c\ub300 70%\uae4c\uc9c0 \uac10\uc18c\uc2dc\ud0ac \uac00\ub2a5\uc131\uc774 \uc788\uc2b5\ub2c8\ub2e4. \ub610\ud55c \ub2e4\ub978 \uce58\ub8cc\uc81c\uc5d0\uc11c \ub098\ud0c0\ub098\ub294 \ubd80\uc2e0 \uae30\ub2a5 \uc800\ud558\ub098 \uc800\uce7c\ub968\ud608\uc99d\uc744 \uc720\ubc1c\ud558\uc9c0 \uc54a\ub294\ub2e4\ub294 \uc810\uc5d0\uc11c\ub3c4 \ucc28\ubcc4\ud654\ub429\ub2c8\ub2e4.<\/p>\n<p>CRL \ubc1c\ud45c \uc774\ud6c4 Corcept\uc758 \uc8fc\uac00\ub294 50.4% \ud558\ub77d\ud588\uc73c\uba70, \uc774\ub294 \ud22c\uc790\uc790\uc758 \ubc18\uc751\uacfc \uac1c\ubc1c \ub9ac\uc2a4\ud06c\uc5d0 \ub300\ud55c \uc7ac\ud3c9\uac00\ub97c \ubc18\uc601\ud569\ub2c8\ub2e4.<\/p>\n<h3>\uae0d\uc815\uc801\uc778 \uce21\uba74: \ub09c\uc18c\uc554 \uacbd\ub85c<\/h3>\n<p>Relacorilant\uc758 \uaddc\uc81c \uc5ec\uc815\uc740 \ucfe0\uc2f1 \uc99d\ud6c4\uad70\uc744 \ub118\uc5b4 \ud655\uc7a5\ub418\uace0 \uc788\uc2b5\ub2c8\ub2e4. \ubc31\uae08 \uc800\ud56d\uc131 \ub09c\uc18c\uc554 \uc801\uc751\uc99d\uc5d0 \ub300\ud55c NDA\ub294 2026\ub144 7\uc6d4 11\uc77c PDUFA \uacb0\uc815\uc77c\uc774 \uc608\uc815\ub418\uc5b4 \uc788\uc2b5\ub2c8\ub2e4. 3\uc0c1 ROSELLA \uc784\uc0c1\uc2dc\ud5d8\uc758 \uae0d\uc815\uc801\uc778 \uacb0\uacfc\uac00 \uc774\ub97c \ub4b7\ubc1b\uce68\ud558\uba70, relacorilant\uc640 nab-paclitaxel \ubcd1\uc6a9\uc694\ubc95\uc740 \ub2e8\ub3c5 \uc694\ubc95 \ub300\ube44 \ubb34\uc9c4\ud589 \uc0dd\uc874\uae30\uac04(6.5\uac1c\uc6d4 vs 5.5\uac1c\uc6d4)\uacfc \uc804\uccb4 \uc0dd\uc874\uae30\uac04(16.0\uac1c\uc6d4 vs 11.5\uac1c\uc6d4)\uc744 \uac1c\uc120\ud558\uba74\uc11c\ub3c4 \ucd94\uac00\uc801\uc778 \ub3c5\uc131 \uc99d\uac00 \uc5c6\uc774 \uc6b0\uc218\ud55c \uacb0\uacfc\ub97c \ubcf4\uc600\uc2b5\ub2c8\ub2e4.\ub610\ud55c \uc774\ubc88 CRL\uc740 \ucfe0\uc2f1 \uc99d\ud6c4\uad70 \uc801\uc751\uc99d\uc5d0 \ud55c\uc815\ub41c \uac83\uc73c\ub85c, \uc57d\ubb3c\uc758 \uc804\ubc18\uc801\uc778 \ud6a8\ub2a5\uc774\ub098 \uc548\uc804\uc131\uc5d0 \ub300\ud55c \ud3ec\uad04\uc801\uc778 \uc6b0\ub824\ub97c \uc758\ubbf8\ud558\uc9c0 \uc54a\uc73c\uba70, \ub09c\uc18c\uc554 \uc801\uc751\uc99d \uc81c\ucd9c\uacfc\ub3c4 \ubcc4\uac1c\uc758 \uc0ac\uc548\uc785\ub2c8\ub2e4.<\/p>\n<p>\ud604\uc7ac \ubc31\uae08 \uc800\ud56d\uc131 \ub09c\uc18c\uc554 \uce58\ub8cc \uc601\uc5ed\uc5d0\uc11c\ub294 \ubbf8\ucda9\uc871 \uc218\uc694\uac00 \ub9e4\uc6b0 \ud06c\uba70, 2\ucc28 \ubc0f 3\ucc28 \uce58\ub8cc \uc2dc\uc7a5\uc740 2034\ub144\uae4c\uc9c0 23\uc5b5 \ub2ec\ub7ec \uaddc\ubaa8\ub85c \uc131\uc7a5\ud574 \uc8fc\uc694 \uc2dc\uc7a5 \ub9e4\ucd9c\uc758 \uc57d 39%\ub97c \ucc28\uc9c0\ud560 \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4.<\/p>\n<h3>\uaddc\uc81c \uacfc\uc81c\ub97c \ud574\uacb0\ud558\uae30 \uc704\ud55c \ud074\ub798\ub9ac\ubca0\uc774\ud2b8\uc758 \uc9c0\uc6d0<\/h3>\n<h4>Cortellis Regulatory Intelligence + AI \uae30\ubc18\u00a0 Regulatory Assistant<\/h4>\n<p><a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/ko\/research-development\/regulatory-compliance-intelligence\/regulatory-intelligence-solutions\/\">Cortellis Regulatory Intelligence<\/a>\ub294 \ud3ed\ub113\uace0 \uae4a\uc774 \uc788\ub294 \uc778\uc0ac\uc774\ud2b8\uc640 \uc804\ubb38\uc131\uc744 \uacb0\ud569\ud55c \ud575\uc2ec \uaddc\uc81c \uc778\ud154\ub9ac\uc804\uc2a4\ub97c \uc81c\uacf5\ud558\uba70, <a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/ko\/lp\/decades-of-trusted-regulatory-guidance-meet-ai-powered-insights-ko\/\">AI \uae30\ubc18 Regulatory Assistant<\/a>\ub97c \ud1b5\ud574 \ud55c\uce35 \uac15\ud654\ub418\uc5c8\uc2b5\ub2c8\ub2e4. Corcept\uac00 \uc9c1\uba74\ud55c \uacfc\uc81c\ub294 \ub2e8\uc21c\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. FDA\ub294 \ub370\uc774\ud130\ub97c \uc778\uc815\ud588\uc9c0\ub9cc \ucd94\uac00\uc801\uc778 \uadfc\uac70\ub97c \uc694\uad6c\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. Regulatory Assistant\ub294 \uc774\ub7ec\ud55c \uc0c1\ud669\uc5d0\uc11c \u201c\ucd94\uac00\uc801\uc778 \uadfc\uac70\u201d\uac00 \uc2e4\uc81c\ub85c \ubb34\uc5c7\uc744 \uc758\ubbf8\ud558\ub294\uc9c0 \uad6c\uccb4\uc801\uc73c\ub85c \uc774\ud574\ud558\ub294 \ub370 \ub3c4\uc6c0\uc744 \uc904 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p><strong>FDA\uc758 \uaddc\uc81c\uae30\uc900(evidence bar) \ubc0f \uc131\uacf5\uc801\uc778 \uc120\ub840 \uc774\ud574<\/strong><\/p>\n<ul>\n<li><strong>\uc2b9\uc778 \uacbd\ub85c \uad00\ub828 \uc120\ub840 \ubd84\uc11d (Querying precedents for approval pathways): <\/strong>\uc720\uc0ac\ud55c \uc0c1\ud669\uacfc \uc131\uacf5\uc801\uc778 \ud574\uacb0 \uc804\ub7b5\uc744 \ubcf4\ub2e4 \ud6a8\uacfc\uc801\uc73c\ub85c \ud30c\uc545\ud558\uae30 \uc704\ud574, Regulatory Assistant\ub97c \ud65c\uc6a9\ud558\uba74 \u201c\ud76c\uadc0 \ub0b4\ubd84\ube44 \uc9c8\ud658\uc5d0\uc11c \u2018\uadfc\uac70 \ubd80\uc871(insufficient evidence)\u2019 CRL \uc774\ud6c4 \uc131\uacf5\uc801\uc73c\ub85c \uc7ac\uc81c\ucd9c\ub41c \uc0ac\ub840\u201d \ubc0f \u201c\uc18c\uaddc\ubaa8 \ud658\uc790\uad70\uc5d0\uc11c benefit-risk \ud3c9\uac00\ub97c \uc704\ud55c FDA\uc758 \uc99d\uac70 \uae30\uc900\u201d\uacfc \uac19\uc740 \ucffc\ub9ac\ub97c \uae30\ubc18\uc73c\ub85c \uad00\ub828 \uc120\ub840\ub97c \uc2e0\uc18d\ud558\uac8c \ubd84\uc11d\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n<li><strong>\uc99d\uac70 \uae30\uc900 \ube44\uad50 \ubd84\uc11d (Evidence standards comparison): <\/strong>Corcept\ub294 \uaddc\uc81c \uc804\ub7b5\uc5d0 \ub300\ud55c \uc9c0\uc5ed \uac04 \ube44\uad50 \ubd84\uc11d\uc744 \ud1b5\ud574, \uacfc\ucf54\ub974\ud2f0\uc194\uc99d\uc5d0 \ub300\ud55c EMA\uc640 FDA\uc758 \uc99d\uac70 \uae30\uc900 \ucc28\uc774\ub97c \ud30c\uc545\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub97c \ud1b5\ud574 \uc720\ub7fd \uc81c\ucd9c \uc804\ub7b5\ubfd0\ub9cc \uc544\ub2c8\ub77c FDA \uc7ac\uc81c\ucd9c \uc2dc \ud65c\uc6a9 \uac00\ub2a5\ud55c \ub17c\ub9ac\uae4c\uc9c0 \ud568\uaed8 \ub3c4\ucd9c\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n<li><strong>\uac00\uc18d \uc2b9\uc778 \uacbd\ub85c \ubd84\uc11d (Accelerated pathway analysis):<\/strong>\ubcf8 \ud50c\ub7ab\ud3fc\uc740 \ud604\uc7ac \uc9c4\ud589 \uc911\uc778 \ub09c\uc18c\uc554 \uc801\uc751\uc99d \uc2b9\uc778(PDUFA: 2026\ub144 7\uc6d4 11\uc77c)\uc5d0\uc11c \ud655\ubcf4\ub420 \ucd94\uac00 \ub370\uc774\ud130\uac00 \ucfe0\uc2f1 \uc99d\ud6c4\uad70 \uc7ac\uc81c\ucd9c\uc744 \uc5b4\ub5bb\uac8c \uc9c0\uc6d0\ud560 \uc218 \uc788\ub294\uc9c0 \ud0d0\uc0c9\ud560 \uc218 \uc788\ub3c4\ub85d \ud569\ub2c8\ub2e4. \ub610\ud55c \ub2e4\uc911 \uc801\uc751\uc99d \ub370\uc774\ud130\uac00 benefit-risk \ud3c9\uac00\ub97c \uac15\ud654\ud55c \uc120\ub840\ub97c \ubd84\uc11d\ud558\ub294 \ub370\uc5d0\ub3c4 \ud65c\uc6a9\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n<\/ul>\n<h4>DRG Fusion<\/h4>\n<p><a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/ko\/drg-fusion\/\">DRG Fusion<\/a>\uc740 \uace0\uc720\ud558\uac8c \uc5f0\uacb0\ub41c \ub9ac\uc5bc\uc6d4\ub4dc \ub370\uc774\ud130\uc640 AI \uae30\ubc18 \uacbd\ud5d8\uc744 \ubc14\ud0d5\uc73c\ub85c, \uc9c8\ud658\uc744 \ub2e4\uc591\ud55c \uac01\ub3c4\uc5d0\uc11c \ubd84\uc11d\ud560 \uc218 \uc788\ub3c4\ub85d \uc9c0\uc6d0\ud569\ub2c8\ub2e4.<\/p>\n<p><strong>\ub9ac\uc5bc\uc6d4\ub4dc \ub370\uc774\ud130 \uae30\ubc18\uc758 \uc720\ud6a8\uc131 \ubc0f \uc548\uc804\uc131 \uadfc\uac70 \ud655\ubcf4<\/strong><\/p>\n<ul>\n<li><strong>\uc790\uc5f0\uc0ac \ube44\uad50 \ubd84\uc11d:<\/strong> DRG Fusion\uc758 \ud1b5\ud569 \uccad\uad6c \ub370\uc774\ud130\ub294 \uce58\ub8cc\ub97c \ubc1b\uc9c0 \uc54a\uc558\uac70\ub098 \ucda9\ubd84\ud788 \uce58\ub8cc\ub418\uc9c0 \uc54a\uc740 \ucfe0\uc2f1 \uc99d\ud6c4\uad70 \ud658\uc790\uc758 \uc2e4\uc81c \uc9c8\ubcd1 \uc9c4\ud589 \uacbd\uacfc\ub97c \ubd84\uc11d\ud560 \uc218 \uc788\ub3c4\ub85d \uc9c0\uc6d0\ud569\ub2c8\ub2e4. \uc774\ub97c \ud1b5\ud574 \uc784\uc0c1\uc2dc\ud5d8 \uacb0\uacfc\ub97c \uc2e4\uc81c \uc784\uc0c1 \ud658\uacbd\uc5d0\uc11c \ud574\uc11d\ud558\uace0, \uc784\uc0c1\uc801 \uc720\uc758\uc131\uc744 \ubcf4\ub2e4 \uba85\ud655\ud558\uac8c \uc785\uc99d\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n<li><strong>Mifepristone\uc758 \ub9ac\uc5bc\uc6d4\ub4dc \uc720\ud6a8\uc131:<\/strong>Corcept\uc758 \uccab \ubc88\uc9f8 \uce58\ub8cc\uc81c\uc778 mifepristone(Korlym)\uc740 \uc2e4\uc81c \ud658\uc790 \ub370\uc774\ud130\ub97c \uae30\ubc18\uc73c\ub85c \uc720\ud6a8\uc131 \ud328\ud134, \uce58\ub8cc \ubc18\uc751\uc758 \uc9c0\uc18d\uc131, \uc7a5\uae30 \uc548\uc804\uc131\uc5d0 \ub300\ud55c \uadfc\uac70\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4. \uc774\ub294 SGRA \uacc4\uc5f4 \uc57d\ubb3c\uc5d0 \ub300\ud55c \ud074\ub798\uc2a4 \ud6a8\uacfc\ub97c \ub4b7\ubc1b\uce68\ud558\uac70\ub098, relacorilant\uc758 \ucc28\ubcc4\ud654\ub41c \ud2b9\uc131\uc744 \uc785\uc99d\ud558\ub294 \ub370 \ud65c\uc6a9\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n<li><strong>\ud658\uc790 \uc5ec\uc815 \ubd84\uc11d:<\/strong> \ud50c\ub7ab\ud3fc\uc758 \ud658\uc790 \uc5ec\uc815 \ubd84\uc11d \ubaa8\ub4c8\uc740 \ucfe0\uc2f1 \uc99d\ud6c4\uad70 \ud658\uc790\uc758 \uc2e4\uc81c \uce58\ub8cc \uacbd\ud5d8\uc744 \uc2dc\uac01\ud654\ud558\uc5ec, \uce58\ub8cc \uacf5\ubc31\uacfc \ubbf8\ucda9\uc871 \uc218\uc694, \uadf8\ub9ac\uace0 relacorilant\uac00 \uc784\uc0c1\uc801\uc73c\ub85c \uc758\ubbf8 \uc788\ub294 \ud61c\ud0dd\uc744 \uc81c\uacf5\ud560 \uc218 \uc788\ub294 \uce58\ub8cc \ub9e5\ub77d\uc744 \uba85\ud655\ud788 \ubcf4\uc5ec\uc90d\ub2c8\ub2e4. \uc774\ub97c \ud1b5\ud574 \uc784\uc0c1\uc801 \uc720\uc758\uc131\uc744 \uac15\ud654\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n<li><strong>\uc7a5\uae30 \uc548\uc804\uc131 \uac80\uc99d:<\/strong>\ub9ac\uc5bc\uc6d4\ub4dc \uc548\uc804\uc131 \ub370\uc774\ud130\ub294 \uc784\uc0c1\uc2dc\ud5d8 \uacb0\uacfc\ub97c \ubcf4\uc644\ud558\uc5ec, \uc7a5\uae30\uc801\uc778 \ub0b4\uc57d\uc131 \ud504\ub85c\ud30c\uc77c\uc774 \uc218\uc6a9 \uac00\ub2a5\ud55c \uc218\uc900\uc784\uc744 \uc785\uc99d\ud558\uace0 \uc720\uc775\uc131-\uc704\ud574\uc131 \ud3c9\uac00\ub97c \uac15\ud654\ud558\ub294 \ub370 \uae30\uc5ec\ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n<h4>Cortellis Clinical Trials Intelligence<\/h4>\n<p><a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/ko\/research-development\/discovery-development\/cortellis-clinical-trials-intelligence\/\">Cortellis Clinical Trials Intelligence<\/a>\ub294 \uc784\uc0c1\uc2dc\ud5d8 \uc9c4\ud589 \ud604\ud669, \uacbd\uc7c1 \uc804\ub7b5, \uadf8\ub9ac\uace0 \ud504\ub85c\ud1a0\ucf5c \uc124\uacc4 \ucd5c\uc801\ud654\uc5d0 \ub300\ud55c \uc778\uc0ac\uc774\ud2b8\ub97c \uc81c\uacf5\ud558\uc5ec, \ucd94\uac00\uc801\uc778 \uc804\ud5a5\uc801 \uc5f0\uad6c\uac00 \ud544\uc694\ud55c \uacbd\uc6b0 \uc774\ub97c \ud6a8\uacfc\uc801\uc73c\ub85c \ucd5c\uc801\ud654\ud560 \uc218 \uc788\ub3c4\ub85d \uc9c0\uc6d0\ud569\ub2c8\ub2e4.<\/p>\n<p><strong>\uc131\uacf5 \uac00\ub2a5\uc131\uc744 \uadf9\ub300\ud654\ud558\ub294 \ub9de\ucda4\ud615 \ucd94\uac00 \uc5f0\uad6c \uc124\uacc4<\/strong><\/p>\n<ul>\n<li><strong>\uc5d4\ub4dc\ud3ec\uc778\ud2b8 \uc120\uc815: <\/strong>\uacfc\ucf54\ub974\ud2f0\uc194\uc99d \ubd84\uc57c\uc5d0\uc11c Corcept\ub294 \ud608\uc555 \uc870\uc808, \ud3ec\ub3c4\ub2f9 \ub300\uc0ac, \uc0b6\uc758 \uc9c8, \uccb4\uc911 \uac10\uc18c \ub4f1 \ub2e4\uc591\ud55c \uc5d4\ub4dc\ud3ec\uc778\ud2b8 \uc911, \ud76c\uadc0 \ub0b4\ubd84\ube44 \uc9c8\ud658\uc5d0\uc11c \uaddc\uc81c\uae30\uad00\uc744 \uc124\ub4dd\ud558\ub294 \ub370 \uac00\uc7a5 \ud6a8\uacfc\uc801\uc778 \uc9c0\ud45c\ub97c \ubca4\uce58\ub9c8\ud0b9\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n<li><strong>\uc784\uc0c1\uc2dc\ud5d8 \uc0ac\uc774\ud2b8 \ucd5c\uc801\ud654: <\/strong>\uc804 \uc138\uacc4 200\uac1c\uad6d, 27\ub9cc 7\ucc9c \uac1c \uc774\uc0c1\uc758 \uc784\uc0c1\uc2dc\ud5d8 \uc0ac\uc774\ud2b8 \ub370\uc774\ud130\ub97c \uae30\ubc18\uc73c\ub85c, Corcept\ub294 \ucfe0\uc2f1 \uc99d\ud6c4\uad70\uc5d0 \ub300\ud55c \uc804\ubb38\uc131\uacfc \ud658\uc790 \uc811\uadfc\uc131\uc744 \uac16\ucd98 \ub0b4\ubd84\ube44 \uc804\ubb38 \uc13c\ud130\ub97c \uc2dd\ubcc4\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub294 \ud76c\uadc0\uc9c8\ud658 \uc5f0\uad6c\uc5d0\uc11c \ub9e4\uc6b0 \uc911\uc694\ud55c \uc694\uc18c\uc785\ub2c8\ub2e4.<\/li>\n<li><strong>\ud504\ub85c\ud1a0\ucf5c \uc2e4\ud589 \uac00\ub2a5\uc131 \ubd84\uc11d:<\/strong>\ubcf8 \ud50c\ub7ab\ud3fc\uc740 \uc131\uacf5\uc801\uc778 \ud504\ub85c\ud1a0\ucf5c, \uc784\uc0c1\uc2dc\ud5d8 \uc0ac\uc774\ud2b8, \ud658\uc790 \uc138\uadf8\uba3c\ud2b8\uc5d0 \ub300\ud55c \uc774\ud574\ub97c \ubc14\ud0d5\uc73c\ub85c, \uc5ed\ud559 \ub370\uc774\ud130, \uc0ac\uc774\ud2b8 \uac00\uc6a9\uc131, \ud658\uc790 \ubaa8\uc9d1 \uac00\ub2a5\uc131 \ub4f1\uc744 \ud1b5\ud569\uc801\uc73c\ub85c \ubc18\uc601\ud55c \uc815\uad50\ud55c \uc784\uc0c1\uc2dc\ud5d8 \uc2e4\ud589 \uac00\ub2a5\uc131 \ubd84\uc11d\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/li>\n<li><strong>\ud658\uc790\uad70 \uc138\ubd84\ud654 \uc804\ub7b5:<\/strong>\ud76c\uadc0 \ub0b4\ubd84\ube44 \uc9c8\ud658 \uc784\uc0c1\uc5d0\uc11c \uc131\uacf5\uc801\uc73c\ub85c \ud65c\uc6a9\ub41c \ud658\uc790\uad70 \uc138\ubd84\ud654 \uc811\uadfc\ubc95\uc744 \ubd84\uc11d\ud568\uc73c\ub85c\uc368, \uc774\uc9c8\uc801\uc778 \ud658\uc790 \uc9d1\ub2e8 \uc804\ubc18\uc5d0\uc11c \uce58\ub8cc \ud6a8\uacfc\ub97c \uc785\uc99d\ud560 \uc218 \uc788\ub3c4\ub85d \ud504\ub85c\ud1a0\ucf5c \uc124\uacc4\ub97c \ucd5c\uc801\ud654\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n<\/ul>\n<h4>Epidemiology Intelligence<\/h4>\n<p><a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/ko\/commercialization\/market-access\/\">Epidemiology Intelligence<\/a>\ub294 1,000\uac1c \uc774\uc0c1\uc758 \uc9c8\ud658 \ubc0f \uc2dc\uc220\uc5d0 \ub300\ud55c \ubc1c\uc0dd\ub960\uacfc \uc720\ubcd1\ub960 \ubb38\ud5cc \ubd84\uc11d\uc744 \uae30\ubc18\uc73c\ub85c, \uc2dc\uc7a5 \uaddc\ubaa8\ub97c \uc0b0\uc815\ud558\uace0 \ud658\uc790\uad70\uc744 \ubcf4\ub2e4 \uc815\ubc00\ud558\uac8c \uc774\ud574\ud560 \uc218 \uc788\ub3c4\ub85d \uc9c0\uc6d0\ud569\ub2c8\ub2e4.<\/p>\n<p><strong>\uac00\uc7a5 \uba85\ud655\ud55c \uce58\ub8cc \ud6a8\uacfc\uac00 \uc785\uc99d\ub41c \ucfe0\uc2f1 \uc99d\ud6c4\uad70 \ud558\uc704 \ud658\uc790\uad70 \uc815\uc758<\/strong><\/p>\n<ul>\n<li><strong>\ucfe0\uc2f1 \uc99d\ud6c4\uad70 \ud558\uc704 \ud658\uc790\uad70 \ud2b9\uc131\ud654 :<\/strong>\ubcf8 \ud50c\ub7ab\ud3fc\uc740 \ubcd1\uc778(\ub1cc\ud558\uc218\uccb4, \ubd80\uc2e0, \uc774\uc18c\uc131), \uc9c8\ud658 \uc911\uc99d\ub3c4, \ub3d9\ubc18 \uc9c8\ud658 \ud504\ub85c\ud30c\uc77c\uc744 \uae30\uc900\uc73c\ub85c \ud658\uc790\uad70\uc744 \uc138\ubd84\ud654\ud558\uace0 \uc815\uc758\ud560 \uc218 \uc788\ub3c4\ub85d \uc9c0\uc6d0\ud569\ub2c8\ub2e4.<\/li>\n<li><strong>\ud0c0\uac9f \ud658\uc790\uad70 \uaddc\ubaa8 \uc815\ub7c9\ud654:<\/strong>\uaddc\uc81c \ubc0f \uc0c1\uc5c5\ud654 \uc804\ub7b5\uc758 \ud0c0\ub2f9\uc131\uc744 \uac80\uc99d\ud560 \uc218 \uc788\ub3c4\ub85d, \uc2e4\uc81c \uc811\uadfc \uac00\ub2a5\ud55c \ud658\uc790\uad70 \uaddc\ubaa8\ub97c \uc815\ub7c9\uc801\uc73c\ub85c \ud3c9\uac00\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n<li><strong>\uc815\ubc00 \ud0c0\uac9f\ud305 \uc804\ub7b5 \uc9c0\uc6d0:<\/strong>\uc798 \uc815\uc758\ub41c \ud658\uc790 \uc138\uadf8\uba3c\ud2b8 \ub0b4\uc5d0\uc11c \uc784\uc0c1\uc801\uc73c\ub85c \uc758\ubbf8 \uc788\ub294 \uce58\ub8cc \ud6a8\uacfc\ub97c \uc785\uc99d\ud560 \uc218 \uc788\ub294 \uc804\ub7b5\uc744 \ub3c4\ucd9c\ud558\uace0, \uc774\ub97c \ud1b5\ud574 \ubcf4\ub2e4 \uc124\ub4dd\ub825 \uc788\ub294 \uadfc\uac70\ub97c \ub9c8\ub828\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n<\/ul>\n<p>\uc774\uc804 \ube14\ub85c\uadf8 <a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/ko\/blog\/tolebrutinib-crl-safety-overrides-efficacy\/\">Tolebrutinib: \uc720\ud6a8\uc131\ubcf4\ub2e4 \uc548\uc815\uc131 \uc6b0\ub824\uac00 \uc6b0\uc120\ub41c \uacbd<\/a>\uc6b0\uc5d0\uc11c\ub294 tolebrutinib\uc5d0 \ub300\ud55c CRL\uc758 \uc601\ud5a5\uacfc, \uc2e0\ub8b0\ud560 \uc218 \uc788\ub294 \uc778\ud154\ub9ac\uc804\uc2a4\uac00 FDA\uc758 \uc6b0\ub824\ub97c \uc5b4\ub5bb\uac8c \ud574\uacb0\ud558\ub294 \ub370 \uae30\uc5ec\ud560 \uc218 \uc788\ub294\uc9c0\ub97c \uc0b4\ud3b4\ubcf4\uc558\uc2b5\ub2c8\ub2e4. \uc774\ubc88 \uc2dc\ub9ac\uc988\uc758 \ub9c8\uc9c0\ub9c9 \uae00\uc5d0\uc11c\ub294 Sanofi\uc640 Corcept \uc0ac\ub840\ub97c \ud1b5\ud574 \ub3c4\ucd9c\ud560 \uc218 \uc788\ub294 \uc8fc\uc694 \uc778\uc0ac\uc774\ud2b8\uc640 \ud568\uaed8, \uae30<a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/ko\/blog\/navigating-fda-complete-response-letters-clarivate\/\">\uc5c5\ub4e4\uc774 CRL \uc774\ud6c4 \uc5b4\ub5a4 \uc804\ub7b5\uc801 \ubc29\ud5a5\uc744 \uc124\uc815<\/a>\ud560 \uc218 \uc788\ub294\uc9c0\uc5d0 \ub300\ud574 \ub2e4\ub8f9\ub2c8\ub2e4.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\uc774 \ube14\ub85c\uadf8\ub294 \ubbf8\uad6d \uc2dd\ud488\uc758\uc57d\uad6d(FDA)\uc774 2025\ub144 12\uc6d4 23\uc77c Sanofi\uc758 \ube44\uc7ac\ubc1c\uc131 \uc774\ucc28 \uc9c4\ud589\uc131 \ub2e4\ubc1c\uc131\uacbd\ud654\uc99d(nrSP-MS) \uce58\ub8cc\uc81c tolebrutinib\uacfc, 2025\ub144 12\uc6d4 30\uc77c Corcept Therapeutics\uc758 \ucfe0\uc2f1 \uc99d\ud6c4\uad70 \uce58\ub8cc\uc81c relacorilant\uc5d0 \ub300\ud574 \ubc1c\ud589\ud55c Complete Response Letter(CRL)\ub97c \ub2e4\ub8e8\ub294 \uc2dc\ub9ac\uc988\uc758 \uc138 \ubc88\uc9f8 \uae00\uc785\ub2c8\ub2e4. \ub450 \uc57d\ubb3c \ubaa8\ub450 \ud074\ub798\ub9ac\ubca0\uc774\ud2b8\uc758 \u2018\ube14\ub85d\ubc84\uc2a4\ud130 \uc2e0\uc57d\ubcf4\uace0\uc11c(Drugs to Watch 2026)\u2019\uc5d0 \ud3ec\ud568\ub418\uc5b4 \uc788\uc73c\uba70, \uc774\ubc88 \uacb0\uc815\uc740 \ubcf4\uace0\uc11c \ubc1c\uac04 \uc774\ud6c4\uc5d0 \uc774\ub8e8\uc5b4\uc84c\uc2b5\ub2c8\ub2e4.<\/p>\n","protected":false},"author":141,"featured_media":574164,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_links_to":"","_links_to_type":0,"footnotes":""},"categories":[2452],"tags":[2776,2867,2870,2686,2941,1836,2939,2840,1398,1401,2838],"class_list":["post-579598","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-biopharma","tag-fda","tag-regulatory","tag-safety","tag-u-s","tag-2941","tag-market-access","tag-2939","tag-2840","tag-clinical-trial","tag-pharmaceutical","tag-2838","clarivate-industry-life-sciences-and-healthcare"],"acf":[],"lang":"ko","translations":{"ko":579598,"en":574168,"ja":574418},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"pll_sync_post":[],"_links":{"self":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/579598","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/users\/141"}],"replies":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/comments?post=579598"}],"version-history":[{"count":8,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/579598\/revisions"}],"predecessor-version":[{"id":581312,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/579598\/revisions\/581312"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/media\/574164"}],"wp:attachment":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/media?parent=579598"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/categories?post=579598"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/tags?post=579598"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}