Cingulate Initiates Final Study for Lead ADHD Asset CTx-1301

Core Insights - Cingulate Inc. has initiated its final FDA-required food effect study for CTx-1301, a treatment for ADHD, with data expected by the end of 2024 [1][3] - The company has raised over $10 million in capital since mid-August 2024, with 58% from its at-the-market facility, and is now compliant with Nasdaq listing requirements [2] - Cingulate aims to submit a New Drug Application (NDA) for CTx-1301 by mid-2025 [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 [8] - The company is headquartered in Kansas City and is initially concentrating on ADHD treatment while exploring additional therapeutic areas such as anxiety disorders [8] Product Details - CTx-1301 is designed to provide a multi-core formulation of dexmethylphenidate, aiming for a rapid onset and full-day efficacy in ADHD treatment [6] - The drug delivery platform incorporates an Erosion Barrier Layer (EBL) to control drug release at precise times, enhancing patient care [7] ADHD Context - ADHD affects approximately 6.4 million children and adolescents in the U.S., with about 80% receiving treatment [5] - Adult ADHD prevalence is estimated at around 11 million patients, with only 20% receiving treatment [5]