- Statistically significant improvements in ADHD symptoms achieved in pediatric Phase 3 trial.
- Effect sizes ranged from 0.737 to 1.185 across all dosages within 5 weeks.
- Plan to submit New Drug Application (NDA) this summer for CTx-1301.
Cingulate (CING), a pharmaceutical company innovating in ADHD treatment, announced promising results from its Phase 3 clinical trial of CTx-1301 (dexmethylphenidate HCl). Conducted on pediatric patients aged 6 to 17, the study showcased significant symptom improvement across all tested doses (18.75-mg, 25-mg, and 37.5-mg), with the effect sizes ranging from 0.737 to 1.185 over a 5-week period.
These findings are part of a randomized, double-blind, placebo-controlled trial that reinforced the efficacy of Cingulate's Precision Timed Releaseâ„¢ technology. This platform optimizes the delivery of dexmethylphenidate, setting a potential benchmark for ADHD treatments. Notably, CTx-1301 can be administered with or without food, further enhancing its flexibility in patient care.
With consistent safety profiles maintained across eight clinical trials, Cingulate plans to submit a New Drug Application (NDA) for CTx-1301 by summer 2025. Upon FDA approval, the product is anticipated to be available in eight dosage strengths, with six intended for patients under 18, aiming to meet various patient needs in the ADHD market.
