Cingulate Inc (NASDAQ:CING) plans to initiate Phase 3 studies for CTx-1301 for Attention Deficit/Hyperactivity Disorder (ADHD) in 2022.
- ADHD is a chronic neurobiological and developmental disorder.
- The planned studies include a fixed-dose pediatric & adolescent safety and efficacy study, a dose-optimization study extension, and a pediatric safety & efficacy study to assess the onset and duration of efficacy.
- Specifically, the pivotal, fixed-dose study will begin in Q2 of 2022.
- These studies are instrumental for the filing of the New Drug Application to the FDA, expected in 2H of 2023.
- Based on feedback from the FDA regarding the CTx-1301 initial Pediatric Study Plan and longstanding guidance on the 505(b)(2) pathway, Cingulate has accelerated its study timeline, with a strong likelihood of reducing capital requirements by condensing the number and design of studies, therefore potentially reducing its time to approval.
- Price Action: CING shares are down 5.46% at $1.73 during the market session on the last check Tuesday.
