Cingulate® completed a proof-of-concept trial in human subjects to validate its Precision Timed Release™ (PTR™) drug delivery platform and in June 2019, announced positive results from a Phase 1/2 study of CTx-1301 (dexmethylphenidate) in ADHD patients establishing safety, tolerability, comparative bioavailability, and dose proportionality versus Focalin® XR.
Cingulate currently has three (3) product candidates, CTx-1301 (dexmethylphenidate), CTx-1302 (dextroamphetamine) and CTx-2103 (anxiety) in the pipeline. All three therapies utilize Cingulate’s innovative Precision Timed Release™ (PTR™) drug delivery platform technology. The two initial candidates are designed to fulfill long-standing unmet needs of patients with ADHD. No known competitive product currently in development is poised to overcome all unmet needs:
- works fast (less than 30 minutes)
- lasts the entire active day (up to 16 hours)
- provides a controlled descent of plasma drug levels to optimize treatment
Cingulate® plans to initiate Phase 3 trials for CTx-1301, in 2022 with the fixed-dose study slated to begin in the second quarter of 2022 and upon FDA guidance, plans to initiate the full clinical program for CTx-1302.
Cingulate® also intends to utilize its PTR™ technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas where two or more active pharmaceutical ingredients (API) need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies. Potential future candidates are being evaluated.
Cingulate® plans to initiate a formulation trial in human subjects for our third candidate, CTx-2103, to treat anxiety disorders in late 2022. CTx-2103 contains one of the most widely prescribed anxiolytic agents which must be taken several times a day. In 2020, United States sales for this API accounted for over $2 billion in the $5.2 billion anxiety market. CTx-2103 will be designed as a once-daily, multi-release tablet with clear differentiation and compelling advantages over standard treatment options.