CTX-1301 utilizes a breakthrough multi-core formulation of dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD. CTX-1301 combines layers of immediate release and sustained release active pharmaceutical ingredient in a single pill intended to deliver pulses of active ingredient when patients need it, delivering a rapid onset and lasting the entire active day while minimizing the afternoon crash and impact on sleep and appetite.
Cingulate has completed a randomized, three arm, open-label crossover study in healthy volunteers to establish the in vivo behavior of CTX-1301 using an gammascintigraphy and pharmacokinetic analysis to evaluate the body’s absorption, distribution, metabolism, and excretion of CTX-1301. The Company anticipates reporting data from this trial, which will demonstrate the functionality of its triphasic multi-core tablet technology in humans, in the second quarter of 2017.
After a submitting an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) planned in the first quarter of 2018, Cingulate intends to implement the full clinical plan for CTX-1301 in 2018.