Cingulate(US:CING) Globenewswire·2025-10-14 12:00Core Insights - Cingulate Inc. announced that the FDA has accepted the New Drug Application (NDA) for CTx-1301, a treatment for ADHD, with a target action date of May 31, 2026 [1][3] - The NDA is being reviewed under the FDA's 505(b)(2) pathway, allowing Cingulate to leverage existing data on dexmethylphenidate while demonstrating novel clinical benefits [2][10] - CTx-1301 has shown significant improvements in ADHD symptoms during Phase 3 trials, indicating its potential to address gaps in current ADHD management [4][6] Regulatory Milestone - The acceptance of the NDA marks a significant regulatory milestone for Cingulate and the CTx-1301 program, validating the completeness of their submission [3][5] - The FDA's review will assess the efficacy, safety, and overall risk-benefit profile of CTx-1301 [7] Clinical Results - Phase 3 trials demonstrated that CTx-1301 provides rapid onset of effect and sustained efficacy throughout the day, addressing issues with current stimulant therapies [4][6] - No serious treatment-emergent adverse events were reported, indicating a favorable safety profile [6] Commercial Strategy - Cingulate is preparing for a timely launch of CTx-1301, having completed process transfer and scale-up production with its manufacturing partner [7] - The company is leveraging an AI-driven omnichannel platform to optimize prescriber reach and patient support, with early research indicating strong formulary receptivity for CTx-1301 [8] Market Context - ADHD affects approximately 20 million individuals in the U.S., with stimulant medications being the gold standard for treatment [9] - Current extended-release formulations often require multiple doses, highlighting the need for a once-daily solution like CTx-1301 [9][10]