Cingulate submits NDA to FDA for lead ADHD drug CTx-1301

Cingulate Inc.

Submitted NDA on July 31, 2025 for CTx-1301 (dexmethylphenidate) for ADHD.
FDA will decide on acceptance within 60 days of July 31 submission.
Drug designed as novel extended-release tablet for once-daily, entire active-day symptom control.
Cingulate targets $23B U.S. ADHD market; over 20M patients diagnosed in US.
NDA is first regulatory application of company's proprietary Precision Timed Release platform.

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