Clinical TrialJul 30, 2026, 08:32 AM
Cingulate Phase 3 CTx-1301 ADHD Trial Results Published
AI Summary
Cingulate Inc. announced the publication of positive Phase 3 clinical trial results for its lead asset, CTx-1301 (dexmethylphenidate HCl), for ADHD treatment in the Journal of Child and Adolescent Psychopharmacology. The peer-reviewed publication reinforces the efficacy and safety profile of CTx-1301 and the potential of Cingulate’s Precision Timed Release™ (PTR™) platform technology. The study demonstrated clinically meaningful improvements in ADHD symptoms across all three dose groups compared to placebo, with significant p-values and strong effect sizes, moving the company closer to potential regulatory approval and commercialization.
Key Highlights
- CTx-1301 Phase 3 results published in Journal of Child and Adolescent Psychopharmacology.
- 18.75 mg dose group showed p-value of 0.018 for ADHD-RS-5 score improvement.
- 25 mg dose group showed p-value of 0.011 for ADHD-RS-5 score improvement.
- 37.5 mg dose group showed p-value of 0.001 for ADHD-RS-5 score improvement.
- Placebo-adjusted effect sizes were 0.737, 0.782, and 1.185 for the dose groups.
- Overall mean effect size of 0.901 observed across the study population.
- Study involved pediatric population (6-17) with ADHD.
- US ADHD market estimated at 100 million annual prescriptions.
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