Cingulate’s Phase 3 CTx‑1301 ADHD Results Published in Leading Child & Adolescent Psychiatry Journal

Key Points

• Phase 3 pediatric trial results for CTx‑1301 (dexmethylphenidate) in ADHD have been published in a respected child and adolescent psychopharmacology journal, adding peer‑reviewed support to earlier topline data.
• The once‑daily, trimodal formulation produced meaningful improvements in ADHD symptoms and global functioning in children and adolescents.
• CTx‑1301 showed a tolerability profile consistent with established stimulant medications, supporting its potential for everyday clinical use.

Cingulate Inc. (Nasdaq: CING) has announced the publication of its Phase 3 pediatric ADHD trial results for CTx‑1301 in a leading child and adolescent psychiatry journal. This marks an important milestone for the company, turning previously reported topline data into fully peer‑reviewed evidence accessible to clinicians, researchers, and regulators. The study evaluated CTx‑1301 in children and adolescents aged 6–17 and confirmed both the efficacy and safety of this once‑daily, dexmethylphenidate‑based treatment option.

What the Phase 3 trial found in pediatric ADHD

In the Phase 3 pediatric study, CTx‑1301 was tested across fixed doses in a randomized, double‑blind, placebo‑controlled design. Children and adolescents receiving CTx‑1301 showed clinically meaningful reductions in core ADHD symptoms, such as inattention and hyperactivity‑impulsivity, compared with placebo over the course of treatment. The results reinforce earlier data indicating that CTx‑1301 can deliver robust symptom control throughout the active day with a single morning dose.

Symptom improvement and everyday functioning

Beyond rating scale scores, the publication highlights improvements that matter to families and clinicians in daily life. Children treated with CTx‑1301 were more likely to be rated as “much improved” or “very much improved” on global clinical measures of change, reflecting better attention, impulse control, and overall functioning. These gains suggest that the benefits of CTx‑1301 translate into the classroom and home settings, not just into numbers on standardized scales.

Safety and tolerability consistent with stimulant standards

The Phase 3 data also underscore that CTx‑1301’s safety profile is in line with what clinicians expect from well‑established stimulant therapies. Reported side effects were generally mild to moderate and manageable, with no unexpected safety signals emerging during the trial. This consistency is important for parents and clinicians, who often weigh the need for effective symptom control against concerns about tolerability and long‑term use.

How CTx‑1301’s Precision Timed Release design fits into ADHD care

CTx‑1301 uses Cingulate’s Precision Timed Release technology to deliver a trimodal release of dexmethylphenidate, engineered to cover the full school and work day with a single dose. By reducing the need for multiple doses or midday boosters, the formulation is designed to simplify treatment routines, support adherence, and lessen the burden on caregivers and schools. With Phase 3 pediatric results now published and adult data also reported, CTx‑1301 is emerging as a next‑generation stimulant candidate that may broaden treatment choices for ADHD across age groups.