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CTx-1301

CTx-1301 utilizes a breakthrough multi-core formulation of dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD.

Product Description

CTx-1301 utilizes Cingulate’s innovative Precision Timed Release™ (PTR™) drug delivery platform technology to create 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 (API) in a single tablet intended to deliver the right amount of drug at the right time when patients need it; delivering a rapid onset and entire active day efficacy while providing a controlled descent of plasma drug levels to optimize treatment.

Clinical Trials

Cingulate completed a proof-of-concept study in 2017 evaluating pharmacokinetics for a trimodal tablet delivering three precisely timed doses of dexmethylphenidate. Scintigraphic imaging visualized tablet transit through the gastrointestinal tract to confirm release site and onset, which was correlated with pharmacokinetic data to establish the full release profile.

In October 2020, the Company announced positive results from a Phase I/2 study in ADHD patients, establishing tolerability, comparative bioavailability, and dose proportionality versus Focalin XR®.

To meet NDA pharmacology requirements under the 505(b)(2) pathway, Cingulate completed food effect studies in October 2022 (25 mg dose) and December 2024 (50 mg dose), both demonstrating that CTx-1301 can be taken with or without food.

A Phase 3 dose-optimization study in adults (NCT05631626) was conducted from December 2022 to June 2023. Results were presented at the 2023 Psych Congress and APSARD 2024.

Additionally, two Phase 3 studies were conducted in pediatric and adolescent patients:

  • Fixed-dose study (NCT05286762)
  • Dose-optimized onset and duration study in a laboratory classroom setting (NCT05924594)

Cingulate submitted an NDA to the FDA for CTx-1301 on July 31, 2025.