Cingulate submits FDA application for ADHD drug CTx-1301

Go back to Cingulate submits FDA application for ADHD drug CTx-1301

Cingulate Submits New Drug Application to FDA for Lead ADHD Asset CTx-1301

August 6, 2025 8:45 AM EDT

KANSAS 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