Cingulate Initiates Phase 3 Study of Lead Asset CTx-1301, Designed as a True Entire Active-Day Treatment for ADHD
KANSAS CITY, Kan., Jan. 04, 2023 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced the initiation of the first Phase 3 clinical trial of its lead candidate CTx-1301, a novel, investigational, trimodal, extended release tablet formulation of dexmethylphenidate, a compound approved by the U.S. Food and Drug Administration (FDA) for the treatment of attention deficit/hyperactivity disorder (ADHD).
- The meetings will take place at the same time as the annual J.P. Morgan Healthcare Conference.
- The Phase 3 clinical trial is an adult dose-optimization study to assess the onset and duration of efficacy along with the safety of CTx-1301 in adults with ADHD compared to placebo.
- “Physicians have been wanting a treatment that provides entire active-day efficacy to treat ADHD.
- Cingulate is available to partner with existing therapeutic providers in these and other categories to improve delivery and provide ideal, once-daily dosing solutions for patients.