FDA accepts Cingulate's drug application for ADHD treatment CTx-1301

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Go back to FDA accepts Cingulate's drug application for ADHD treatment CTx-1301

FDA Accepts Cingulate’s New Drug Application for CTx-1301 in Attention-Deficit/Hyperactivity Disorder (ADHD) and sets a May 31, 2026 PDUFA Date

October 14, 2025 8:00 AM EDT

Once-daily Precision Timed Release (PTR) stimulant designed to deliver rapid onset of effect and entire active-day duration NDA accepted under the FDAs 505(b)(2) regulatory pathway

KANSAS CITY, Kan., Oct. 14, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING) a biopharmaceutical company developing and advancing a pipeline of next-generation pharmaceutical products utilizing its proprietary Precision Timed Release (PTR) drug-delivery platform, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA)... More