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

Core Insights - Cingulate Inc. has submitted a New Drug Application (NDA) to the FDA for CTx-1301, a medication aimed at providing once-daily symptom control for ADHD patients [1][2][3] - CTx-1301 is designed to address limitations of current ADHD therapies by offering fast onset and entire active-day efficacy with a single dose [2][3] - The ADHD market in the U.S. is valued at approximately $23 billion, and Cingulate aims to capture a significant share with CTx-1301 [3] Company Overview - Cingulate Inc. is a biopharmaceutical company focused on developing next-generation pharmaceutical products using its proprietary Precision Timed Release™ (PTR™) drug delivery platform [1][8] - The company is headquartered in Kansas City and is transitioning from a development-stage company to a commercial organization [3][8] Product Details - CTx-1301 is an extended-release tablet formulation of dexmethylphenidate, designed to provide a smooth pharmacokinetic profile and address the need for entire active-day efficacy [2][5] - The medication utilizes a multi-core formulation to deliver three releases of the active ingredient at predefined times, optimizing patient care [5][6] Market Context - ADHD affects over 20 million patients in the U.S., with a significant portion being adults; the prevalence of adult ADHD is growing faster than that of children and adolescents [4] - In 2022, only 53.6% of children and teens with ADHD were actively treating their symptoms with medication, indicating a substantial unmet need in the market [4] Technology Platform - The PTR™ platform technology includes an Erosion Barrier Layer (EBL) that controls drug release at precise times, allowing for true once-daily dosing [6][7] - Cingulate plans to leverage the PTR technology to develop additional product candidates in other therapeutic areas beyond ADHD [6][8]