Cingulate submits FDA application for ADHD drug CTx-1301

Cingulate Inc. (NASDAQ: CING) submitted a New Drug Application to the U.S. Food and Drug Administration for CTx-1301, its lead treatment for Attention Deficit/Hyperactivity Disorder, the company announced.

CTx-1301 is an extended-release tablet formulation of dexmethylphenidate designed to provide fast onset and all-day efficacy with a single dose. The FDA has 60 days from the July 31 submission date to determine whether the application will be accepted for review.

"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," said Chief Medical Officer Matthew Brams.

The drug utilizes Cingulate's proprietary Precision Timed Release platform technology, which delivers three releases of medication at predetermined times to optimize patient care. According to the company, the third dose releases around the time when other extended-release stimulant products begin to wear off.

CEO Shane Schaffer noted that this represents the first regulatory application using the company's PTR platform technology. The U.S. ADHD market is valued at $23 billion, with over 20 million diagnosed patients, including 12 million adults and 8 million children under 17.

Dexmethylphenidate is part of the stimulant class of medicines that increases norepinephrine and dopamine activity in the brain. The active ingredient is already FDA-approved for ADHD treatment in other formulations.

According to CDC data cited by the company, only 53.6 percent of children and teens with ADHD were actively treating symptoms with medication in 2022, with 65-90 percent demonstrating symptoms that persist into adulthood.

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