{"id":30781,"date":"2022-06-13T18:06:00","date_gmt":"2022-06-13T10:06:00","guid":{"rendered":"https:\/\/flcube.com\/?p=30781"},"modified":"2025-03-27T18:09:05","modified_gmt":"2025-03-27T10:09:05","slug":"pfizers-ritlecitinib-earns-cde-breakthrough-designation-for-ulcerative-colitis","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=30781","title":{"rendered":"Pfizer&#8217;s Ritlecitinib Earns CDE Breakthrough Designation for Ulcerative Colitis"},"content":{"rendered":"\n<p>The Center for Drug Evaluation (CDE) website indicates that Pfizer&#8217;s (<a href=\"https:\/\/www.google.com\/finance\/quote\/PFE:NYSE\">NYSE: PFE<\/a>) category 1 drug ritlecitinib (PF-06651600) has obtained breakthrough therapy designation (BTD) status for use in moderate to severe active ulcerative colitis (UC) in adults.<\/p>\n\n\n\n<p><strong>Mechanism of Action<\/strong><br>Ritlecitinib, a Janus kinase 3 (JAK3) inhibitor, selectively inhibits JAK isoenzymes through covalent interaction with the specific residue cys-909 of JAK3.<\/p>\n\n\n\n<p><strong>Clinical Progress<\/strong><br>The drug has entered Phase III clinical trials for alopecia areata. It received BTD status in the US in September 2018 and was granted BTD by China\u2019s CDE in December 2020.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Center for Drug Evaluation (CDE) website indicates that Pfizer&#8217;s (NYSE: PFE) category 1 drug&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[863,309],"class_list":["post-30781","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-nyse-pfe","tag-pfizer"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Pfizer&#039;s Ritlecitinib Earns CDE Breakthrough Designation for Ulcerative Colitis - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The Center for Drug Evaluation (CDE) website indicates that Pfizer&#039;s (NYSE: PFE) category 1 drug ritlecitinib (PF-06651600) has obtained breakthrough therapy designation (BTD) status for use in moderate to severe active ulcerative colitis (UC) in adults.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=30781\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pfizer&#039;s Ritlecitinib Earns CDE Breakthrough Designation for Ulcerative Colitis\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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