Cingulate Releases Positive Top-Line Results from Phase 3 Clinical Trial for ADHD Treatment

Cingulate Inc., (NASDAQ: CING) has released positive topline results from its Phase 3 clinical trial evaluating the safety and efficacy of its lead candidate, CTx-1301 (dexmethylphenidate) in adults with attention deficit/hyperactivity disorder (ADHD).

CTx-1301 a novel, investigational treatment being developed as a true, once-daily stimulant medication for ADHD. Cingulate expects to submit a New Drug Application for CTx-1301 by mid-2024.

Highlights

The study assessed 21 adults (aged 18-55 years) with ADHD in an adult laboratory classroom setting and demonstrated a meaningful trend in improving ADHD symptoms with a rapid onset of action and entire active-day duration.

Cingulate plans to initiate its pivotal Phase 3 fixed-dose pediatric and adolescent study this month and a dose-optimization onset and duration trial in pediatric patients in August 2023.

While stimulants are the gold-standard of ADHD treatment, the challenge is providing patients with an entire day duration of action. CTx-1301 is designed to deliver three releases of medication in one tablet, with the third dose being released around the time when other extended-release stimulant products begin to wear off.

About Cingulate

Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its proprietary PTR drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders. Cingulate is headquartered in Kansas City. For more information visit Cingulate.com.