Trial Profile

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)

Status: Suspended

Phase of Trial: Phase III

Latest Information Update: 19 May 2025

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At a glance

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 Results published in the Media Release

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