Cingulate Inc. announced positive efficacy results from a Phase 3 clinical trial of CTx-1301, its dexmethylphenidate-based ADHD treatment, in children aged 6-17. The study showed statistically significant improvement in ADHD symptoms across all tested doses within five weeks, exceeding the predefined success parameters. This achievement triggered an early termination of the study, demonstrating the drug’s potential efficacy with a smaller-than-anticipated sample size.
This positive data strengthens Cingulate’s position in the growing ADHD market, particularly given the high prevalence of the condition in both children and adults, and the fact that a significant portion of patients remain untreated or experience symptoms that persist into adulthood. CTx-1301’s potential to address unmet needs, such as providing entire active-day efficacy, positions it as a potentially attractive option for both patients and healthcare providers seeking improved treatment outcomes. The strong effect sizes observed (0.737 to 1.185) further underscore the drug’s potential impact compared to existing long-acting stimulants, which have a mean effect size of 0.73.
The Phase 3 trial involved three fixed doses of CTx-1301 (18.75mg, 25mg, and 37.5mg) and included an evaluation using the ADHD-RS-5 rating scale as the primary efficacy endpoint. Positive top-line results from a previous food effect study indicated CTx-1301’s consistent performance regardless of food intake. Furthermore, safety data from eight clinical trials has consistently demonstrated a positive safety profile for CTx-1301. A comprehensive analysis incorporating both adult and pediatric safety and efficacy data will be submitted as part of the New Drug Application (NDA) planned for this summer.
The successful Phase 3 results pave the way for Cingulate to advance CTx-1301 towards regulatory approval and potential market launch. This anticipated approval could significantly impact the ADHD treatment landscape by offering a novel approach to medication delivery and addressing the need for more effective and convenient treatment options. With plans to launch CTx-1301 with eight dosage strengths, Cingulate is positioning itself to cater to a broad patient population, including a significant number of pediatric patients. These positive developments highlight the potential of Cingulate’s Precision Timed Release™ platform technology and suggest further opportunities for innovation within the pharmaceutical industry.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
