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CTx-1301

CTx-1301 utilizes a breakthrough multi-core formulation of dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD.

Product Description

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.

Clinical Trials

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 has been granted an active Investigational New Drug Application (IND) and the company has conducted a bioavailability trial, a fed/fast trial, and an adult laboratory classroom study. A pediatric classroom and the pivotal Phase 3 fixed dose pediatric and adolescent studies are now ongoing (Mastery® clinical program).

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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 clinicaltrials@cingulate.com.