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CTx-1302

CTx-1302 utilizes a breakthrough multi-core formulation of dextroamphetamine, a compound approved by the FDA for the treatment of ADHD.

Product Description

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.

Clinical Trials

Cingulate plans to conduct an initial formulation study evaluating pharmacokinetics, followed by all necessary studies to support an NDA submission under the 505(b)(2) regulatory pathway.