Cingulate submits FDA application for ADHD drug CTx-1301
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Cingulate Submits New Drug Application to FDA for Lead ADHD Asset CTx-1301
August 6, 2025 8:45 AM EDTKANSAS CITY, Kan., Aug. 06, 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, today announced that it has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for CTx-1301(dexmethylphenidate HCl), the companys lead asset for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD).
CTx-1301 is a novel, extended-release tablet formulation of dexmethylphenidate designed to deliver fast onset, entire active-day efficacy, and a smooth... More
