Cingulate Advances CTx-1301 for ADHD Treatment with Positive Phase III Safety Data and Upcoming FDA Pre-NDA Meeting
• Cingulate Inc. has completed its fast-fed study and submitted safety data from Phase III trials for CTx-1301, its ADHD treatment candidate, with no serious adverse events reported in pediatric and adolescent studies.
• The company has scheduled a pre-NDA meeting with the FDA for April 2nd, 2025, and plans to file its New Drug Application by mid-2025, potentially leading to commercialization in 2026.
• Cingulate secured $5 million in financing to support clinical, manufacturing, and regulatory activities, while pursuing potential international partnerships to fund the U.S. launch of CTx-1301.
Cingulate's Once-Daily ADHD Drug CTx-1301 Shows Promising Safety Profile in Phase 3 Trials
• Cingulate's CTx-1301, a novel once-daily dexmethylphenidate formulation for ADHD, demonstrated consistent safety results across three Phase 3 trials with no serious adverse events reported.
• The drug utilizes Precision Timed Release technology to deliver three precisely timed doses throughout the day, potentially eliminating the need for multiple daily medications.
• With FDA meeting scheduled for April 2025 and NDA submission planned for mid-2025, CTx-1301 could address a significant unmet need in ADHD treatment affecting over 17 million Americans.
Cingulate Stock Rated Buy by Roth/MKM, Anticipates $1.6B Sales Potential
Roth/MKM has initiated coverage on Cingulate with a Buy rating, setting a price target of $12.00, significantly above its current trading price. The firm's optimism is based on the promising Phase 3 data of Cingulate's CTx-1301 for ADHD treatment, projecting sales of $1.6 billion by 2035.
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