CINGULATE,INC

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.