CTx-1301 utilizes Cingulate’s innovative Precision Timed Release™ (PTR™) drug delivery platform technology to create a breakthrough multi-core formulation of dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD. CTx-1301 combines layers of immediate release and sustained release active pharmaceutical ingredient (API) 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.
Cingulate® has completed a randomized, three arm, open-label crossover study in healthy volunteers to establish the in vivo behavior of CTx-1301 using gammascintigraphy and pharmacokinetic analysis to evaluate the body’s absorption, distribution, metabolism, and excretion of CTx-1301. The Company reported data from this trial demonstrating the functionality of its triphasic multi-core tablet technology in humans at the 2017 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and the 2018 American Professional Society of ADHD and Related Disorders (APSARD) Annual Meeting.
Cingulate’s CTx-1301 now has an active Investigational New Drug Application (IND) and the company has conducted a bioavailability trial. Results were obtained in 2020. The Company will embark on its Mastery™ Phase 3 clinical program expected to start December 2023.
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