Cingulate Files FDA New Drug Application for Lead ADHD Drug CTx-1301

Cingulate Inc., a biopharmaceutical company specializing in next-generation pharmaceutical products through its proprietary Precision Timed Release (PTR) technology, announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead ADHD treatment candidate, CTx-1301 (dexmethylphenidate HCl).

CTx-1301 is an extended-release tablet designed to provide a fast onset of action, all-day efficacy, and a smooth pharmacokinetic profile with just one daily dose. This novel formulation aims to overcome key limitations of current ADHD therapies by delivering consistent symptom control throughout the day.

The FDA is expected to determine whether it will accept the NDA for review within 60 days of the July 31 submission date.

Dr. Matthew Brams, Chief Medical Officer at Cingulate, highlighted the significance of the submission, stating, “The submission of the NDA for CTx-1301 is the culmination of years of clinical and manufacturing development focused on delivering a true, once-daily ADHD treatment that offers fast onset, entire active-day efficacy, and a consistent therapeutic experience. We believe CTx-1301 addresses key limitations of existing therapies and has the potential to improve outcomes for patients across age groups.”

Cingulate’s Chairman and CEO, Shane J. Schaffer, emphasized the commercial potential of the drug, noting, “With a differentiated profile supported by robust clinical data, we believe CTx-1301 has the potential to capture meaningful share in the $23 billion U.S. ADHD market, bringing us closer to delivering long-term value for our shareholders as we transition from a development-stage company to a commercial organization.”

Schaffer also underscored the broader implications of this NDA submission, marking it as the first regulatory application for Cingulate’s proprietary PTR platform. He described the platform as “an innovative and scalable technology” poised to add significant value across multiple therapeutic areas with unmet medical needs.

The company’s progress with CTx-1301 positions it as a promising player in the ADHD treatment landscape, with hopes of offering patients a more effective and convenient therapeutic option.