Final Study Completed for Cingulate's Lead Asset CTx-1301

Core Insights - Cingulate Inc. has completed its final FDA-required food effect study for CTx-1301, a medication aimed at treating ADHD, with no serious adverse events reported [2][3][4] - The company plans to submit a New Drug Application (NDA) to the FDA by mid-2025, marking a significant milestone in the development of CTx-1301 [4] 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][12] - The company is headquartered in Kansas City and aims to improve treatment outcomes for patients with conditions requiring complex dosing regimens, starting with ADHD [12] Product Development - CTx-1301 is designed to be a once-daily stimulant medication that provides effective treatment for ADHD throughout the day, regardless of food intake [4][10] - The drug utilizes a multi-core formulation of dexmethylphenidate, which is part of the stimulant class of medications known for their efficacy in treating ADHD [9][10] Study Details - The food effect study involved administering a single 50mg dose of CTx-1301 to subjects in both fed and fasted states, with results expected in Q2 2025 [3][9] - Previous studies indicated that CTx-1301 could be taken with or without food, demonstrating its versatility [3] ADHD Context - ADHD affects approximately 6.4 million children and adolescents in the U.S., with a significant portion continuing to experience symptoms into adulthood [8] - The adult ADHD population is estimated at around 11 million, with only about 20% receiving treatment [8] Technology Platform - Cingulate's PTR technology allows for precise control of drug release, aiming to enhance patient care by providing a tailored dosing experience [11] - The platform is designed to deliver medication at specific intervals, improving upon existing therapies for ADHD and potentially other conditions [11]