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

The U.S. Food and Drug Administration has accepted Cingulate Inc.'s (NASDAQ: CING) New Drug Application for CTx-1301, a once-daily treatment for Attention-Deficit/Hyperactivity Disorder in children and adults. The FDA assigned a target action date of May 31, 2026, under the Prescription Drug User Fee Act.

CTx-1301 contains dexmethylphenidate and uses Cingulate's Precision Timed Release technology to deliver three timed releases of medication throughout the day. The application is being reviewed under the FDA's 505(b)(2) regulatory pathway, which allows companies to reference existing data on previously approved active ingredients.

The submission followed completion of adult and pediatric Phase 3 trials and a pre-NDA meeting in April 2025 that confirmed the adequacy of clinical and manufacturing data packages. In the Phase 3 trials, CTx-1301 demonstrated improvements in ADHD symptoms across multiple measurement scales in patients aged 6 years and older.

The adult dose-optimization study showed improvements on performance measures and symptom rating scales. The pediatric fixed-dose study demonstrated dose-dependent improvements on ADHD rating scales and clinical impression measures. No serious treatment-emergent adverse events were reported across studies, according to the company.

"FDA acceptance of our NDA marks a defining milestone for Cingulate," said Executive Chairman Jay Roberts. "CTx-1301 was engineered to address the practical shortcomings of today's stimulant therapies—multiple daily dosing, midday rebound, and adherence challenges—through a single, once-daily tablet."

Cingulate has established a manufacturing partnership with Bend Bio Sciences and completed process transfer and scale-up production. The company reports early payer research indicates formulary receptivity for the once-daily medication.

ADHD affects an estimated 20 million individuals in the U.S., including approximately 8 million children and 12 million adults, according to the press release.

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