About Cingulate Therapeutics

About Cingulate Therapeutics

Cingulate Therapeutics, LLC (CTx) is a privately held, clinical stage biopharmaceutical company focused on the development of innovative new products for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). Cingulate is developing two (2) proprietary, first-line medications, CTX-1301 (Dexmethylphenidate) and CTX-1302 (Dextroamphetamine), via the accelerated 505 (b)(2) regulatory pathway for the treatment of ADHD seeking indications for all patient segments: children, adolescents and adults.

 

CTX-1301 and CTX-1302 utilize an innovative, flexible core tableting technology that enables the formulation and manufacturing of multi-cored tablets designed to deliver a rapid onset and last the entire active day while minimizing the afternoon crash and impact on sleep and appetite.  The Company has completed its proof of concept trial in human subjects to validate the novel Target Product Profiles for both CTX-1301 and CTX-1302. After a planned submission of an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) in the first quarter of 2018, Cingulate intends to implement the full clinical plan for both CTX-1301 and CTX-1302 in 2018.

 

CTX-1301 and CTX-1302 have the potential  to capture $1.5 – 2 billion annually in the $12 billion US market alone, which is projected to increase to $20B by 2025 Outside of the United States, Cingulate intends to seek additional regulatory approvals where the ADHD market is also substantial, growing and facing the same unmet needs seen in the U.S. The multi-billion dollar global ADHD therapeutics market has also been projected to grow at a CAGR of 6.2% through the end of 2024, demonstrating the global need for a true once-daily therapy. Cingulate is protecting its unique assets by investing in and building a strong patent estate with US and international patent applications filed, licensed and in development.

 

Cingulate’s leadership team brings extensive expertise in ADHD, clinical trials, pharmaceutical development, manufacturing, commercialization, market access and patient care. The Cingulate team has participated in 200+ clinical trials, 300+ publications, 30+ FDA drug approvals and the management of billion dollar brands. Adding to this pool of knowledge are world-class partnerships with expert regulatory, legal, intellectual property, compliance, finance and investment organizations.

 

The company has offices in Kansas City, KS and Morristown, NJ.