Cingulate Kickstarts First Phase 3 Trial For ADHD Candidate, Data Expected In First Half 2023

Cingulate Inc CING has initiated the first Phase 3 clinical trial of its lead candidate CTx-1301, an extended-release tablet formulation of dexmethylphenidate, a compound approved by the FDA for attention-deficit/hyperactivity disorder (ADHD). 

What Happened: The Phase 3 trial is an adult dose-optimization study to assess the onset and duration of efficacy and the safety of CTx-1301 in adults with ADHD compared to a placebo.

The trial is expected to take three months to complete, and initial results are expected in the first half of 2023. 

The company says that CTx-1301 is the first medication aiming to achieve fast onset of action (in 30 minutes or less) and efficacy that lasts up to 16 hours. 

Related: Cingulate Shares Fall After Timeline Update For Its Lead Candidate In ADHD.

Why It Is Important: Cingulate’s proprietary PTR platform unlocks the opportunity to provide once-daily, multi-dose delivery tablets in large addressable markets, including the $18 billion U.S. ADHD market. 

The PTR platform can deliver medications in other large markets, including anxiety (CTx-2103 in development), insomnia, depression, bipolar disorder, Parkinson’s disease, xerostomia (dry mouth), migraine, and hypothyroidism. 

Price Action: CING shares closed at $1.07 on Tuesday.