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Cingulate Inc. (NASDAQ: CING) is a clinical-stage biopharmaceutical company dedicated to improving patient outcomes through its proprietary Precision Timed Release™ (PTR™) drug delivery platform. Headquartered in Kansas City, Kansas, the company is focused on developing next-generation pharmaceutical products that address conditions requiring burdensome daily dosing regimens and that often yield suboptimal treatment outcomes.
Cingulate’s lead candidates target Attention Deficit/Hyperactivity Disorder (ADHD) and anxiety disorders, with a particular emphasis on their flagship product, CTx-1301. CTx-1301 utilizes dexmethylphenidate, a compound approved by the FDA, to provide a rapid onset and entire active-day efficacy through three precisely timed medication releases. This approach aims to eliminate the need for booster doses and improve overall patient compliance and satisfaction. The product has already demonstrated significant promise in Phase 3 trials, with impressive clinical effect sizes that suggest broad potential impact.
Another key product in the pipeline is CTx-2103, a novel extended-release formulation of buspirone designed for the treatment of anxiety. CTx-2103 leverages the PTR platform to deliver three timed doses in one tablet, potentially offering substantial benefits over current multi-dose regimens. This product is currently progressing through clinical trials, with positive feedback from the FDA on its regulatory pathway.
In recent months, Cingulate has achieved several milestones: they announced successful Phase 3 trial data for CTx-1301, closed a $4 million public offering, and converted $5.8 million of debt into equity. These financial maneuvers have strengthened their balance sheet, enabling continued investment in their clinical programs. Additionally, Cingulate recently welcomed new executive leadership and independent directors, further fortifying their capabilities as they navigate the complexities of drug development and commercialization.
Cingulate is committed to ongoing research and development, leveraging its PTR platform not only for ADHD and anxiety but also exploring other therapeutic areas. This innovative platform integrates an Erosion Barrier Layer (EBL), which controls the drug release at precise times without premature release, enhancing the effectiveness and convenience of treatment.
For more information, visit their official website at Cingulate.com.
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