Posted by Michael Wonder on 16 Oct 2025
FDA accepts Cingulate’s new drug application for CTx-1301 in attention deficit hyperactivity disorder and sets a 31 May 2026 PDUFA date
14 October 2025 - Cingulate today announced that the US FDA has accepted for review the new drug application for CTx-1301 (dexmethylphenidate), the company’s lead candidate for the treatment of attention deficit hyperactivity disorder in children and adults.
The FDA has assigned a PDUFA target action date of 31 May 2026.
