CTx-1302 utilizes Cingulate’s innovative Precision Timed Release™ (PTR™) drug delivery platform technology to create a breakthrough multi-core formulation of dextroamphetamine, a compound approved by the FDA for the treatment of ADHD. CTx-1302 combines layers of immediate release and sustained release active pharmaceutical ingredient in a single tablet intended to deliver the right amount of drug at the right time when patients need it; delivering a rapid onset and entire active day efficacy while providing a controlled descent of plasma drug levels to optimize treatment.
After submitting an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA), Cingulate plans to initiate clinical trials in the first half of 2024. The CTx-1302 Phase 3 clinical program will be designated Accomplish™ Trials.
If you represent an investigative site interested in participating in an upcoming clinical trial with Cingulate®, please send a copy of the Investigator’s CV to firstname.lastname@example.org.