Cingulate Completes Final FDA Study for CTx-1301 ADHD Treatment

On January 7, 2025, Cingulate Inc. (NASDAQ:CING) announced the successful completion of its final FDA-required study for CTx-1301 (dexmethylphenidate) aimed at treating Attention Deficit Hyperactivity Disorder (ADHD). This study, specifically a food effect study, represents a significant milestone in the development of the drug.

The study involved the administration of a single 50mg dose of CTx-1301 to subjects to evaluate its efficacy in both fed and fasted states. Notably, there were no serious adverse events reported during this phase. Further analysis on bioavailability with or without food is anticipated to be available in the second quarter of 2025. The company’s timeline includes a New Drug Application submission to the FDA targeted for mid-2025.

CTx-1301, Cingulate’s lead asset, leverages the company’s proprietary Precision Timed Release™ (PTR™) drug delivery platform technology. This platform aims to tailor the pharmacokinetic profile of stimulant medications such as dexmethylphenidate to meet the specific needs of ADHD patients, irrespective of food intake and dosage size.

Chairman and CEO of Cingulate, Shane J. Schaffer, expressed that the completion of this study is crucial for customizing the pharmacokinetic profile of CTx-1301, emphasizing its once-daily dosing ability throughout an active day. The company’s innovative platform has enabled the creation of a multi-core formulation for the drug, ensuring a sustained release mechanism to provide long-lasting efficacy.

Cingulate’s Precision Timed Release™ (PTR™) technology allows for precise dosage delivery at predetermined times, enhancing patient care through optimized drug efficacy. This breakthrough technology is pivotal in ensuring a consistent therapeutic effect throughout the medication’s duration.

ADHD affects a significant portion of the population, spanning from childhood into adulthood. The development of CTx-1301 as a potential once-daily stimulant represents a significant advancement in addressing the challenges associated with managing ADHD symptoms effectively over the course of a day.

Investors and stakeholders await further developments from Cingulate as they move forward with their NDA submission to the FDA and advance the potential treatment landscape for individuals suffering from ADHD.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Cingulate’s 8K filing here.

Cingulate Company Profile

Cingulate Inc, a biopharmaceutical company, focuses on the development of pharmaceutical products for the treatment of attention deficit/hyperactivity disorder and anxiety in the United States. The company’s stimulant medications are CTx-1301 (dexmethylphenidate), which is in phase 3 clinical trial, as well as CTx-1302 (dextroamphetamine), which is in investigational new drug application development for the treatment of attention deficit/hyperactivity disorder intended for children, adolescents, and adults.