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About Cingulate®

About Cingulate®

Cingulate® (CTx®) is a clinical stage biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to build and advance a pipeline of next-generation pharmaceutical products designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of Attention Deficit/Hyperactivity Disorder (ADHD), Cingulate is identifying and evaluating additional therapeutic areas where PTR™ technology may be employed to develop future product candidates.

CTx-1301 (dexmethylphenidate) and CTx-1302 (dextroamphetamine) are engineered using an innovative, versatile platform technology that will enable the formulation and manufacturing of multi-dose tablets designed to deliver a rapid onset and last the entire active-day while providing a controlled descent of drug to optimize treatment. The Company completed a proof of concept trial in human subjects to validate the novel Target Product Profiles for CTx-1301, submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA), and has now completed a Phase 1/2 comparative bioavailability study in ADHD patients. The Phase 3 program for CTx-1301 will be called Mastery™, whereas the Phase 3 program for CTx-1302 will be designated as Accomplish™.

Image that says Mastery
Image that says Accomplish

Cingulate plans to initiate a human trial for our third candidate, CTx-2103, to treat anxiety disorders in the fourth quarter of 2021. CTx-2103 contains one of the most widely prescribed anxiolytic agents which must be taken several times a day. CTx-2103 will be designed as a once-daily, multi-release tablet with clear differentiation and compelling advantages over standard treatment options.

The Cingulate® leadership team brings extensive expertise in ADHD, clinical trials, pharmaceutical development, manufacturing, commercialization, market access and patient care, and has partnerships with first-rate regulatory, legal, intellectual property, compliance, finance and investment organizations. In addition to establishing a world-class Scientific Advisory Board of key ADHD thought leaders, Cingulate leadership has also participated in:

  • 200+ clinical trials
  • 300+ publications
  • 30+ FDA drug approvals and the management of several billion-dollar brands

The company is headquartered in Kansas City.