The first phase 3 clinical trial of CTx-1301 for the treatment of ADHD has begun.
Researchers recently initiated the first phase 3 clinical trial of CTx-1301—a novel, investigational, trimodal, extended-release tablet formulation of dexmethylphenidate, a US Food and Drug Administration (FDA)-approved compound for the treatment of attention deficit/hyperactivity disorder (ADHD)—on January 4, 2023. The phase 3 clinical trial seeks to assess the onset, efficacy, and safety of CTx-1301 in adults with ADHD compared with placebo.1
“Cingulate’s approach to ADHD provides medication from proven molecules already available and well understood by providers, but for the first time ever, in a single tablet that is designed to provide entire active-day duration,” said Ann Childress, MD, President of the Center for Psychiatry and Behavior Medicine, and lead investigator in the CTx-1301 phase 3 trial. “Physicians have been wanting a treatment that provides entire active-day efficacy to treat ADHD. CTx-1301 is specifically designed to deliver 3 releases of medication, eliminating the need for a booster pill, with the goal of improving patient outcomes.”
No currently available ADHD medications offer a single oral dose that provides whole-day efficacy; CTx-1301 is the first medication aiming to achieve onset in 30 minutes or less, and up to 16 hours of efficacy.
“Stimulants have been the gold standard for ADHD treatment for over half of a century, and while these medications can be effective in addressing ADHD symptoms, no currently available formulation has been able to offer patients a single dose providing efficacy across the entire active day,” said Shane J Schaffer, Chairman and CEO of Cingulate. “Developing a true once-daily stimulant medication for ADHD means, along with addressing the crash-and-rebound effect, that we eliminate the problematic booster and recovery doses that 60% of patients have to take every single day.”
The trial is expected to take 3 months to complete and initial results are expected in the first half of 2023.
1. Cingulate initiates phase 3 study of lead asset CTx-1301, designed as a true entire active-day treatment for ADHD. News release. January 4, 2023. Accessed January 5, 2023. https://www.cingulate.com/news-releases/news-release-details/cingulate-initiates-phase-3-study-lead-asset-ctx-1301-designed