- Cingulate Inc. (CING, Financial) targets the $22 billion U.S. ADHD market with its lead product, CTx-1301.
- The company plans to submit a New Drug Application (NDA) for CTx-1301 in mid-2025.
- Supported by nine clinical trials, CTx-1301 demonstrates strong efficacy, safety, and offers flexible dosing.
Stonegate Capital Partners has initiated coverage on Cingulate Inc. (CING), as the company progresses toward the commercialization of its flagship ADHD treatment, CTx-1301. Utilizing its proprietary Precision Timed Release (PTR) platform, Cingulate aims to address existing therapy limitations by providing a once-daily stimulant therapy with rapid onset and sustained efficacy, thus eliminating the need for additional booster doses.
CTx-1301 targets the significant U.S. ADHD market, valued at approximately $22 billion. The company is on track to submit a New Drug Application (NDA) by mid-2025. This submission will be underpinned by data from nine extensive clinical trials, which include successful pediatric and high-dose studies. These trials have confirmed CTx-1301's effectiveness, safety profile, and flexible dosing capabilities.
As Cingulate prepares for the U.S. market launch, it is also exploring international out-licensing opportunities to expand its market reach. The strategic plan includes scaling up for a targeted product launch following anticipated FDA approval. This expansion could potentially generate additional revenue streams from international markets.
