Cingulate Inc. (NASDAQ: CING) took a critical step toward commercializing its lead ADHD treatment candidate, CTx-1301, announcing the successful completion of a Pre-New Drug Application (Pre-NDA) meeting with the U.S. Food and Drug Administration. The company remains on track to submit its NDA in mid-2025, a milestone that sent Cingulate shares sharply higher, gaining approximately 44% on the day.
- Cingulate held its Pre-NDA meeting with the FDA on April 2 and confirmed its NDA filing timeline for mid-2025 remains intact
- The NDA will include comprehensive safety and efficacy data from both adult and pediatric populations
CTx-1301 is a novel, once-daily, extended-release formulation of dexmethylphenidate for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). Utilizing Cingulate’s proprietary Precision Timed Release™ (PTR™) technology, the therapy delivers three distinct, controlled drug releases throughout the day—addressing one of the most persistent challenges in ADHD care: maintaining efficacy across the full active day without the need for multiple doses.
CTx-1301 is designed to deliver three precisely timed releases of medication in a single tablet, optimizing onset and duration of symptom control
The formulation builds on nine clinical trials, including recent Phase 3 safety data and a food effect study. A 50mg dose—the highest tested—demonstrated a consistent safety profile and reliable performance, even under varying dietary conditions. Cingulate will consolidate this data for its NDA submission.
CTx-1301’s safety profile has remained consistent across nine clinical studies to date
With over 20 million ADHD diagnoses in the U.S.—including more than 12 million adults—Cingulate is aiming to bring the first true once-daily stimulant to a rapidly growing and underserved segment. Adult ADHD diagnoses now outpace pediatric cases, yet treatment adherence and satisfaction remain low, largely due to the limitations of existing therapies that often wear off mid-day.
“Our meeting with the FDA yesterday was very productive, and we remain on track for an NDA filing of CTx-1301 in mid-2025,” said Shane J. Schaffer, Chairman and CEO of Cingulate. “This important milestone is validation of our mission to bring to market the first, true, once-daily stimulant medication to treat ADHD over the entire active day.”
Cingulate’s PTR technology, developed in collaboration with BDD Pharma, uses an Erosion Barrier Layer to release active drug at precisely pre-set intervals. The platform has broad potential, and Cingulate is already applying it to additional candidates for anxiety and other high-frequency dosing conditions.
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