Drug intelligence / Profile preview

CTx-1301

Development stage
Phase 3
Lead developer
Cingulate
Modality
Small Molecules
Administration
Oral
01

Overview

CTx-1301 is a novel, investigational once-daily oral stimulant medication for the treatment of attention-deficit/hyperactivity disorder (ADHD). It is a proprietary multi-core (tri-modal) formulation of dexmethylphenidate hydrochloride designed to provide rapid onset and sustained therapeutic levels throughout the entire active day—up to 14–16 hours. The tablet contains an immediate-release layer, a delayed extended-release layer, and a final immediate-release core. This design aims to minimize rebound effects and improve tolerability by controlling the descent of drug levels. Developed using Precision Timed Release™ technology in collaboration with BDD Pharma, CTx-1301 has demonstrated statistically significant improvements in ADHD symptoms in both pediatric and adult phase 3 clinical trials. The drug is being developed by Cingulate as a potential first-line therapy for ADHD patients aged 6 years and older[1][3][5][6][7].

Brand names
CTx-1301CTx1301CTx 1301
Other names
dexmethylphenidate multi-core formulationtri-modal d-MPH tabletdexmethylphenidate HCl (CTx-1301)
02

Targets

NET (Norepinephrine Transporter)DAT (Dopamine plasma membrane transport protein)

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