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Cingulate Reports Safety Results from Final Phase 3 Trials for Lead ADHD Asset CTx-1301: On Track to File for FDA Approval Mid-2025 [Yahoo! Finance]

Cingulate Inc. (CING) 
Company Research Source: Yahoo! Finance
CTx-1301 is the First, True, Once-Daily Stimulant Medication to Treat ADHD Over the Entire Active Day KANSAS CITY, Kan., March 04, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING) , a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today released Phase 3 safety data for its lead asset CTx-1301 (dexmethylphenidate) 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 results of these studies have been analyzed and submitted to the FDA in preparation for an in-person Pre-NDA meeting which is scheduled for April 2, 2025. A final analysis that combine Show less Read more
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