Cingulate unveils new peer-reviewed pharmacokinetic data supporting its multi-release ADHD medication CTx-1301, strengthening its clinical evidence amid ongoing FDA review delays.
Cingulate says new peer-reviewed data strengthen the scientific case for its once-daily ADHD medicine CTx-1301, after a study in CNS Drugs found the formulation delivered three distinct releases of dexmethylphenidate over the course of the day. The company’s latest results come after a separate phase 3 trial reported positive efficacy and safety findings, giving the drug a growing evidence base even as it awaits a clearer regulatory path.
The pharmacokinetic study compared CTx-1301 with a bimodal modified-release dexmethylphenidate product in adults with attention-deficit hyperactivity disorder. In the randomised crossover trial, 45 participants received single doses of the two formulations and researchers measured blood levels over time, including peak concentration and overall exposure. According to the paper, the key exposure measures were bioequivalent, while the CTx-1301 profile showed faster early absorption and higher concentrations later in the dosing window, a pattern intended to reduce the late-day loss of effect seen with some stimulants.
Ann Childress, who led Cingulate’s phase 3 efficacy and safety study, said the findings support the idea that CTx-1301 is designed as a true once-daily medicine. In a statement accompanying the publication, Shane Schaffer, the company’s chairman and chief executive, said the new analysis, alongside the phase 3 data, provides a peer-reviewed foundation for the product and helps explain its delivery technology.
CTx-1301 uses Cingulate’s Precision Timed Release platform, which is designed to release medication in three separate stages through the day. The company says the formulation includes an erosion barrier layer that helps control when each release occurs. Cingulate has also reported that food does not delay absorption, a finding it says could make dosing more flexible.
The new publication arrives after a difficult stretch on the regulatory front. In June 2026, the Food and Drug Administration issued a complete response letter for CTx-1301, but Cingulate said the agency’s concerns were limited to chemistry, manufacturing and controls issues rather than safety or efficacy. The drug is being reviewed under the FDA’s 505(b)(2) pathway, which allows developers to rely in part on existing data for an approved ingredient while showing a new clinical or delivery benefit.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
