Cingulate Inc. (CING) announced the completion of its final Phase 3 safety trials for CTx-1301 or dexmethylphenidate, a once-daily stimulant medication designed to treat attention deficit hyperactivity disorder or ADHD.
The trials included pediatric and adolescent studies, as well as a food effect study with healthy adults, using a single 50mg dose of CTx-1301, the highest dosage tested.
The company has submitted the safety data from these studies to the FDA ahead of a Pre-NDA or New Drug Application meeting scheduled for April 2, 2025.
Cingulate is on track to file for FDA approval of CTx-1301 by mid-2025.
The trials evaluated the safety, pharmacokinetics, and efficacy of CTx-1301, and the results show no serious treatment-emergent adverse events or clinically relevant trends in side effects.
The primary goal was to assess the drug's ability to provide effective, consistent symptom control for ADHD throughout the entire active day, overcoming challenges faced by existing treatments.
CTx-1301, leveraging Cingulate' s proprietary Precision Timed Release or PTR platform, is expected to offer a breakthrough solution for ADHD patients by delivering multiple releases of medication throughout the day in one tablet.
Cingulate aims to address the longstanding unmet needs in ADHD treatment with this innovative once-daily medication.
Currently, CING is trading at $3.99 up by 1.15 percent on the Nasdaq.
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