Efficacy Results Announced from Cingulate’s Phase 3 Pediatric Study of CTx-1301 (dexmethylphenidate) for ADHD

Core Insights - Cingulate Inc. announced positive efficacy results for its lead asset CTx-1301 in a Phase 3 clinical study for ADHD treatment, demonstrating significant improvements in symptoms within 5 weeks [1][3][5] - The company plans to submit a New Drug Application (NDA) to the FDA this summer, with expectations to launch CTx-1301 in multiple dosage strengths [1][2][4] Efficacy Results - The primary efficacy endpoint was measured using the ADHD-RS-5 rating scale, with statistically significant p-values of 0.018, 0.011, and 0.001 for the 18.75-mg, 25-mg, and 37.5-mg doses respectively [5][10] - Effect sizes ranged from 0.737 to 1.185 across all doses, indicating robust therapeutic benefits [3][10] Safety Profile - CTx-1301's safety profile has remained consistent across eight clinical trials, with a final analysis combining adult and pediatric data planned for the NDA submission [4][6] Market Context - ADHD affects over 20 million individuals in the U.S., with a significant portion of patients remaining untreated [6] - The adult ADHD prevalence is growing faster than that of children and adolescents, highlighting a substantial market opportunity for effective treatments [6] Product Overview - CTx-1301 utilizes Cingulate's proprietary Precision Timed Release™ (PTR™) platform, designed to provide a multi-core formulation for optimized medication delivery [7][8] - The product aims to offer a full-day efficacy with a unique release mechanism that addresses the limitations of existing stimulant medications [7][8] Company Background - Cingulate Inc. focuses on developing next-generation pharmaceutical products to improve treatment outcomes for conditions like ADHD, with plans to expand into other therapeutic areas [9]