Cingulate Awaits FDA Decision On ADHD Therapy CTx-1301

Cingulate Inc. (CING) is set to face a key FDA decision on May 31, 2026, for its once-daily ADHD candidate CTx-1301, currently under review via the 505(b)(2) regulatory pathway.

CTx-1301 is designed for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in both children and adults. The therapy uses Cingulate's Precision Timed Release (PTR) platform to deliver a multi-core formulation of dexmethylphenidate, an FDA-approved stimulant widely used in ADHD management. The PTR technology is engineered to provide consistent, all-day symptom control with a single morning dose—addressing limitations of existing extended-release stimulants, which often require multiple doses and may not maintain coverage throughout the active day.

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by TajSabreen Ahamed

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