Business

FDA and Cingulate Aligned with Filing Requirements for New Drug Application for Lead ADHD Asset CTx-1301

Pre-NDA Minutes from April 2, 2025, Meeting Received NDA Submission Planned this Summer KANSAS CITY, Kan., May 14, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, announced that it has received formal pre-New Drug Application (NDA) meeting minutes from the U.S. Food and Drug Administration (FDA)

articleCingulate Inc.May 14, 20256/company/cingulate-inc/news/fda-cingulate-aligned-filing-requirements-120000722
FDA and Cingulate Aligned with Filing Requirements for New Drug Application for Lead ADHD Asset CTx-1301

About this update from Cingulate Inc.

[{"type":"image","alt":"Cingulate Inc.","displaySize":"","headline":null,"caption":"Cingulate Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":300,"url":"https://media.zenfs.com/en/globenewswire.com/e62a6f953f929d09857897121e95d193"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/lmh6sY4ewRXV2DZQkTXk7Q--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTQyMDtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/e62a6f953f929d09857897121e95d193","width":300,"height":300}},"lazy":false},{"type":"text","content":"Pre-NDA Minutes from April 2, 2025, Meeting Received","length":52,"tagName":"p"},{"type":"text","content":"NDA Submission Planned this Summer ","length":34,"tagName":"p"},{"type":"text","content":"KANSAS CITY, Kan., May 14, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, announced that it has received formal pre-New Drug Application (NDA) meeting minutes from the U.S. Food and Drug Administration (FDA) for it’s lead asset CTx-1301 (dexmethylphenidate) for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD).","length":537,"tagName":"p"},{"type":"text","content":"“We are pleased that the feedback we received from our pre-NDA meeting with the FDA is aligned with our plans to submit a new drug application for CTx-1301 this summer. We thank the agency for its guidance and a constructive dialogue over the past seven years, which has been crucial in helping us generate data to demonstrate the safety, consistency and therapeutic benefit of CTx-1301. Today we are one step closer to bringing to market the first, true, once-daily stimulant medication to treat ADHD over the entire active day,” said Cingulate Chairman and CEO Shane J. Schaffer.","length":581,"tagName":"p"},{"type":"text","content":"Details of the FDA’s minutes include the following, all of which will be a matter of review during the approval process:","length":120,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"The agency agreed to a post-NDA approval commitment of additional stability date for the 6 intermediate dose strengths of 12.5-mg, 18.75-mg, 25-mg, 31.25-mg, 37.5-mg, and 43.75-mg.","length":180,"tagName":"p"}]},{"v...

More updates from Cingulate Inc.

ADHDCingulateCingulate IncFood and Drug Administrationpharmaceutical productsdrug deliverystimulant medicationadult ADHD