FDA Accepts Cingulate's NDA For ADHD Candidate CTx-1301

(RTTNews) - Cingulate Inc. (CING), a biopharmaceutical company, on Tuesday said the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for CTx-1301, the company's lead candidate for treating Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adults. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026 for the application.

The NDA submission follows the completion of adult and pediatric Phase 3 trials, all FDA-requested studies, and a positive pre-NDA meeting in April 2025, which confirmed that the clinical and Chemistry, Manufacturing, and Controls (CMC) data packages are adequate for review.