Core Viewpoint - Cingulate Inc. is progressing towards submitting a New Drug Application (NDA) for its lead asset CTx-1301, a treatment for ADHD, following positive feedback from the FDA during a pre-NDA meeting [2][3]. Group 1: 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 [2][9]. - The company aims to improve treatment outcomes for patients with conditions requiring frequent dosing regimens, starting with ADHD and potentially expanding to anxiety disorders [9]. Group 2: Product Details - CTx-1301 is designed to provide a once-daily stimulant medication for ADHD, utilizing a multi-core formulation of dexmethylphenidate, which is known for its efficacy and safety [5]. - The drug delivery system aims to optimize patient care by delivering three doses of medication at specific times throughout the day, addressing the challenge of maintaining efficacy over an entire active day [5][6]. Group 3: Market Context - ADHD affects over 20 million patients in the U.S., with a significant portion being adults; however, only 53.6% of children and teens with ADHD were actively treating their symptoms with medication in 2022 [4]. - The prevalence of adult ADHD is increasing at a faster rate than that of children and adolescents, indicating a growing market opportunity for effective treatments [4]. Group 4: Regulatory Insights - The FDA's pre-NDA meeting minutes indicate that Cingulate has adequate nonclinical safety data to support its filing and that the proposed approach to integrated safety and efficacy summaries appears reasonable [7]. - The agency has agreed to a post-NDA approval commitment for additional stability data for various dosage strengths of CTx-1301, with an expected shelf-life of 24 months at launch [7].