{"id":710151,"date":"2026-06-02T14:19:09","date_gmt":"2026-06-02T14:19:09","guid":{"rendered":"https:\/\/www.newsbeep.com\/ca\/710151\/"},"modified":"2026-06-02T14:19:09","modified_gmt":"2026-06-02T14:19:09","slug":"us-fda-declines-to-approve-cingulates-adhd-drug","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/ca\/710151\/","title":{"rendered":"US FDA declines to approve Cingulate&#8217;s ADHD drug"},"content":{"rendered":"\n<p class=\"yf-1fy9kyt\">June 2 (Reuters) &#8211; Cingulate said on Tuesday that the \u200cU.S. Food and Drug Administration \u200cdeclined to approve its drug to \u200btreat attention deficit hyperactivity disorder.<\/p>\n<p class=\"yf-1fy9kyt\">The FDA issued a complete response letter seeking additional information \u200crelated to \u2060manufacturing and controls, but did not flag any \u2060concerns about the drug&#8217;s safety or effectiveness, Cingulate said.<\/p>\n<p class=\"yf-1fy9kyt\">The drug, \u200bCTx-1301, is \u200bdesigned \u200bto target ADHD, \u200cwhich can cause persistent inattention, hyperactivity and impulsive behavior, often affecting children and continuing into adulthood.<\/p>\n<p class=\"yf-1fy9kyt\">The once-daily tablet form of \u200cdexmethylphenidate, an ingredient \u200bused in several \u200bapproved \u200bADHD drugs, aims to \u200cimprove attention and \u200breduce impulsive \u200band restless behavior in patients with ADHD.<\/p>\n<p class=\"yf-1fy9kyt\">(Reporting by Kunal \u200bDas \u200cand Siddhi Mahatole in Bengaluru; \u200bEditing by Vijay Kishore \u200band Diti Pujara)<\/p>\n","protected":false},"excerpt":{"rendered":"June 2 (Reuters) &#8211; Cingulate said on Tuesday that the \u200cU.S. Food and Drug Administration \u200cdeclined to approve&hellip;\n","protected":false},"author":2,"featured_media":710152,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[41666,49,48,257838,7453,84,257839,377],"class_list":["post-710151","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-attention-deficit-hyperactivity-disorder","tag-ca","tag-canada","tag-cingulate","tag-food-and-drug-administration","tag-health","tag-impulsive-behavior","tag-medication"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts\/710151","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/comments?post=710151"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts\/710151\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/media\/710152"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/media?parent=710151"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/categories?post=710151"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/tags?post=710151"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}