Core Insights - Cingulate Inc. announced positive top-line results from the CTx-1301-013 study, confirming that its lead candidate CTx-1301 can be taken with or without food, demonstrating a favorable tolerability profile [1][2][6] - CTx-1301 is designed to be a once-daily stimulant medication for ADHD, providing an entire active day of treatment with eight dose strengths for optimal patient care [3][9] - The study involved 27 healthy adult subjects and assessed the pharmacokinetics of a 50 mg dose of CTx-1301 in both fed and fasted states [4][5] 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][11] - The company aims to improve treatment outcomes for patients with conditions requiring frequent dosing regimens, starting with ADHD and potentially expanding to anxiety disorders [11] Product Details - CTx-1301 is a novel, investigational, trimodal, extended-release tablet formulation of dexmethylphenidate, which is FDA-approved for ADHD treatment [1][8] - The unique formulation of CTx-1301 allows for a rapid onset and sustained efficacy throughout the day, addressing the challenge of providing an entire active-day duration of action [9][10] Market Context - ADHD affects over 20 million patients in the U.S., with a significant portion of adults experiencing symptoms that persist from childhood [7] - Current trends indicate that the prevalence of adult ADHD is growing faster than that of children and adolescents combined [7]