
Core Insights - Cingulate Inc. has completed the manufacturing of twelve registration batches for its lead asset CTx-1301, which is intended for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [9][10] - The company is preparing to submit a New Drug Application (NDA) for CTx-1301, with expectations to file in the first half of 2025 [2] - CTx-1301 utilizes Cingulate's proprietary Precision Timed Release (PTR) drug delivery platform, designed to optimize medication release for ADHD treatment [4][5] Company Overview - Cingulate Inc. is a biopharmaceutical company focused on developing next-generation pharmaceutical products using its PTR drug delivery technology [9][14] - The company is headquartered in Kansas City and is publicly traded on NASDAQ under the ticker symbol CING [15] Product Details - CTx-1301 is a multi-core formulation of dexmethylphenidate, a compound approved for ADHD treatment, designed to provide a full-day efficacy with precise medication release [4][5] - The PTR platform incorporates an Erosion Barrier Layer (EBL) that controls drug release at specific times, enhancing patient care by minimizing the need for multiple daily doses [5][6] Market Context - ADHD affects approximately 6.4 million children and adolescents in the U.S., with a significant portion continuing to experience symptoms into adulthood [3] - The adult ADHD population is estimated at around 11 million, indicating a substantial market opportunity for effective treatment options [3]