Trial Profile

A phase 3 pediatric/adolescent safety and efficacy study to assess the onset and duration of efficacy of CTx-1301

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 16 Jul 2025

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At a glance

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.
12 Sep 2024 According to a Cingulate Therapeutics media release, NDA submission for CTx-1301, is targeted for mid 2025.
11 Sep 2023 According to a Cingulate Therapeutics media release, company initiated its pivotal Phase 3 fixed-dose pediatric and adolescent study in July 2023.

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