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A Phase 3, Dose-Optimized, Randomized, Double-Blind, Placebo-Controlled, Single-Center, Parallel Efficacy and Safety Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) Using CTx-1301 (Dexmethylphenidate)

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Trial Profile

A Phase 3, Dose-Optimized, Randomized, Double-Blind, Placebo-Controlled, Single-Center, Parallel Efficacy and Safety Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) Using CTx-1301 (Dexmethylphenidate)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 May 2025

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At a glance

  • Drugs Dexmethylphenidate (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Cingulate Therapeutics

Most Recent Events

  • 14 May 2025 According to a Cingulate Therapeutics Media Release, the company received feedback from the pre-NDA meeting with the FDA, which is aligned and plans to submit a new drug application for CTx-1301 this summer.
  • 03 Apr 2025 According to a Cingulate Therapeutics Media Release, the company has completed a Pre-NDA meeting with the USFDA to discuss the submission of a NDA for CTx-1301 for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). Company is on track for the NDA submission as planned for mid-2025.
  • 04 Mar 2025 According to a Cingulate Therapeutics Media Release, safety results of phase3 studies in adult and children have been analyzed and submitted to the FDA in preparation for an in-person Pre-NDA meeting which is scheduled for April 2, 2025. A final analysis that combines both adult and pediatric safety and efficacy data will be prepared and included in the NDA submission.

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