A Phase 3, Dose-Optimized, Double-Blind, Randomized, Placebo-Controlled, Parallel Efficacy and Safety Laboratory Classroom Study in Children (6-12) With Attention-Deficit/Hyperactivity Disorder (ADHD) Using CTx-1301 (Dexmethylphenidate)
Latest Information Update: 04 Sep 2025
At a glance
- Drugs Dexmethylphenidate (Primary)
- Indications Attention-deficit hyperactivity disorder
- Focus Registrational; Therapeutic Use
- Sponsors Cingulate Therapeutics
Most Recent Events
- 14 Aug 2025 Planned End Date changed from 1 Aug 2026 to 1 Mar 2026.
- 14 Aug 2025 Planned primary completion date changed from 1 Aug 2026 to 1 Mar 2026.
- 09 Jul 2025 According to a Cingulate Therapeutics media release, the company appoints Nilay Patel as chief legal officer to support growth ahead of New Drug Application planned to submit to the FDA in coming weeks.