CTx-1301 improves pediatric ADHD symptoms in phase 3 trial

Cingulate reported peer-reviewed publication of phase 3 findings for CTx-1301, an investigational once-daily, trimodal formulation of dexmethylphenidate hydrochloride, in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). The fixed-dose trial found statistically significant improvements in clinician-rated ADHD symptoms with each evaluated dose compared with placebo.¹

“The study demonstrated clinically meaningful improvements in ADHD symptoms while maintaining a favorable safety profile,” said lead investigator Ann Childress, MD, in the company announcement.¹

The multicenter CTx-1301-005 trial was a phase 3, randomized, double-blind, placebo-controlled, parallel-group study enrolling patients aged 6 to 17 years with ADHD. Participants received fixed daily doses of 18.75 mg, 25 mg, or 37.5 mg of CTx-1301 or placebo. The study included screening, a double-blind randomized phase, and a safety follow-up visit.¹

The primary end point was change from baseline in ADHD Rating Scale-5 (ADHD-RS-5) score at week 5. Compared with placebo, all 3 dose groups demonstrated statistically significant improvement: P = .018 for 18.75 mg, P = .011 for 25 mg, and P = .001 for 37.5 mg. Reported placebo-adjusted effect sizes were 0.737, 0.782, and 1.185, respectively, with a mean effect size of 0.901 across the study population.¹,²

ADHD is a chronic neurodevelopmental disorder characterized by impairing inattention and/or hyperactivity and impulsivity. The company cited US estimates exceeding 8 million diagnosed individuals younger than 17 years and reported that 53.6% of children and adolescents with ADHD were receiving medication in 2022.¹

CTx-1301 contains dexmethylphenidate hydrochloride and uses a multicore tablet designed to release medication at 3 predefined times after a single daily dose. The formulation incorporates an erosion-barrier layer around drug-containing cores. According to Cingulate, the intended profile is rapid onset followed by symptom coverage across the active day; the present fixed-dose trial evaluated symptom change over 5 weeks rather than directly establishing full-day duration in routine clinical practice.¹

The candidate is being developed through the US Food and Drug Administration’s 505(b)(2) pathway, which can permit reliance in part on existing findings for a previously studied active ingredient while requiring evidence specific to the proposed product.

References

1. Cingulate Inc. Cingulate announces publication of phase 3 ADHD trial results in Journal of Child and Adolescent Psychopharmacology. GlobeNewswire. Published July 30, 2026. https://www.globenewswire.com/news-release/2026/07/30/3336045/0/en/cingulate-announces-publication-of-phase-3-adhd-trial-results-in-journal-of-child-and-adolescent-psychopharmacology.html

2. Efficacy and safety of trimodal dexmethylphenidate (CTx-1301) in children and adolescents with attention-deficit/hyperactivity disorder: results from a phase 3, randomized, double-blind, fixed-dose, placebo-controlled trial. J Child Adolesc Psychopharmacol. Published 2026.