Cingulate Receives $4.3M Waiver from FDA Ahead of Imminent Filing for Marketing Approval of Lead ADHD Asset CTx-1301

Cingulate Inc. is a biopharmaceutical company. The Company is focused on the development, manufacturing, and commercialization of pharmaceutical products that utilize its precision timed release (PTR) drug delivery platform technology to create dosing schedules and drug release profiles. It focuses on the treatment of attention deficit/hyperactivity disorder (ADHD). The Company is in the development of two lead product candidates, such as CTx-1301 (dexmethylphenidate) and CTx-1302 (dextroamphetamine). The Company’s CTx-1301 and CTx-1302 are being developed for the treatment of ADHD in the three core patient segments: children (ages 6-12), adolescents (ages 13-17), and adults (ages18+). In addition, the Company has a third product to treat anxiety, CTx-2103, in a formulation stage. Its CTx-1301, CTx-1302 and CTx-2103 drug candidates contain three releases of active pharmaceutical ingredient combined into one small tablet dosage form.