Cingulate reports safety results from final Phase 3 trials for CTx-1301

Cingulate (CING) released Phase 3 safety data for its lead asset CTx-1301 for the treatment of Attention Deficit Hyperactivity Disorder, ADHD. The data readout includes safety data from two Phase 3 pediatric and adolescent studies – a fixed dose study and a dose optimization study – as well as a food effect study with healthy adults, using a single 50mg dose of CTx-1301, Cingulate’s highest dosage. “The safety data from these three studies has been reviewed thoroughly, and we are pleased that the safety profile of CTx-1301 has remained remarkably consistent and unprecedented over the course of nine clinical trials. As we look to bring to the market the first, true, once-daily stimulant medication that treats ADHD over the entire active day, we look forward to our in-person meeting with the FDA next month in preparation for the submission of our new drug application this summer,” said Cingulate Chairman and CEO Shane J. Schaffer.